Loren Data's SAM Daily™

SAMDAILY.US - ISSUE OF FEBRUARY 06, 2021 SAM #7009
SOLICITATION NOTICE

A -- Monitoring IDIQ Extended Added SOW information. Added Appendix C, Line item structure and questions as attachments.

Notice Date

2/4/2021 12:34:18 PM
 

Notice Type

Combined Synopsis/Solicitation
 

NAICS

541611 — Administrative Management and General Management Consulting Services
 

Contracting Office

RPO EAST (36C24E) PITTSBURGH PA 15212 USA
 

ZIP Code

15212
 

Solicitation Number

36C24E21Q0042
 

Response Due

2/15/2021 7:00:00 AM
 

Archive Date

05/16/2021
 

Point of Contact

Michael Haydo, Contracting Officer, Phone: (412) 822-3158
 

E-Mail Address

michael.haydo@va.gov
(michael.haydo@va.gov)
 

Small Business Set-Aside

SDVOSBC Service-Disabled Veteran-Owned Small Business (SDVOSB) Set-Aside (FAR 19.14)
 

Awardee

null
 

Description

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. The solicitation number 36C24E21Q0042 is issued as a request for quotation (RFQ). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2005-92. This requirement will be made using a cascading set-aside under the associated NAICS code 541611 Administrative Management and General Management Consulting Services with a small business size standard of $16.5M. The full solicitation document is included as an attachment to this notice; to include: a list of contract line items, a Description of requirements for the items to be acquired, SOW, Date(s) and place(s) of delivery, and applicable clauses and provisions. Evaluation procedures: Evaluation of offers will be made in accordance with FAR 13.106-2, and award made on the basis of best value to the government. Statement of Work Good Clinical Practice (GCP) Clinical Research Quality Associate (CRQA) Monitoring Services Introduction: This requirement is for a Multiple Award Indefinite Delivery/Indefinite Quantity (IDIQ) contract to provide Good Clinical Practice (GCP) Clinical Research Quality Associate (CRQA) Monitoring Services. Background: The Department of Veterans Affairs, Cooperative Studies Program (CSP), Site Monitoring, Auditing and Resource Team (SMART) requires an Indefinite Delivery/Indefinite Quantity (IDIQ) contract for Good Clinical Practice (GCP) Clinical Research Quality Associate (CRQA) monitoring services for clinical trials conducted by or requested by CSP. These trials are conducted at VA facilities and associated non-VA facilities throughout the United States and vary over time in number, size, and design. At any given time, CSP will have approximately 25 trials conducted at 300 to 400 investigative sites in various stages of activities (planning, on-going, closeout) but typically only 5 to 10 trials are actively monitor each fiscal year. SMART, co-located with the CSP Clinical Research Pharmacy Coordinating Center (CSPCRPCC) in Albuquerque, New Mexico and tenant to the New Mexico Veterans Affairs Health Care System (NMVAHCS) is responsible for ensuring VA CSP clinical trials are conducted in compliance with the scientific and ethical principles embodied in the GCP regulations and guidelines. SMART accomplishes this task by training VA personnel conducting/supporting clinical trials are trained in GCP and identifying any compliance problems at participating research sites and resolved through a program of CRQA site visits (both on-site and virtual/remote off-site monitoring techniques are utilized). The VA SMART program does not have the required manpower authorized or assigned to support the full workload and relies on experienced contractors to provide support. This requirement is a follow-on to a current contract for like services. Scope: The Contractor shall provide services under an IDIQ contract for Clinical Research Quality Associate (CRQA) services to the Site Monitoring, Auditing and Resource Team (SMART). The tasks include performing on- and off-site visits, providing post-visit reports, and providing GCP Program Quality Support (PQS) following SMART guidelines. Additionally, if requested, the contractor will identify to SMART, a monitor to fulfill the role of a Lead CRQA for a specific study. This Lead will coordinate the overall study monitoring plan and associated activities under the direction and supervision of the VA Employed Chief of SMART Monitoring. Specific Tasks: The contractor shall provide Clinical Research Quality Associate (CRAQ) visits and associated services as requested by the VA SMART Program. The contractor shall inspect a clinical trial site using a clinical trial specific monitoring plan developed and provided to the contract monitor by the Chief of SMART Monitoring or designee. These inspections can be off-site (remote review of key critical data) or on-site (in-person or virtual equivalent). The monitoring plan will be compliant with the following standards (or as amended / deleted by the government) which the contract monitor is expected to have familiarity: VHA Directive 1200.1 Research and Development Committee VHA Directive 1200.5(1) Requirements for the Protection of Human Subjects in Research VHA Handbook 1108.04 Investigational Drugs and Supplies VHA Handbook 1058.01 Research Compliance Reporting Requirements VHA Handbook 1907.01 Health Information Management and Health Records 45 CFR 46 Protection of Human Subjects 38 CFR 16 Protection of Human Subjects - (VA Common Rule) ICH E6 (R2) International Conference on Harmonization (ICH) Guidelines Good Clinical Practice FDA Regulations (e.g. 21 CRF 312 Investigational New Drug Application; 21 CFR 812 FDA Form 1572 requirements and guidance CSP Investigator Guidelines CSP Program level Global Standard Operating Procedures (SOPs) CSP Study Protocol and Operations Manuals SMART SOPs and Approved Methods and Procedures (AMPs) Service requirements consist of the following which are explained in further detail in the requirements TASK 1 In-Person (or Virtual Equivalent) Site Visit TASK 2 Travel associated with performing an In-Person Site Visit TASK 3 GCP Program Quality Support (PQS) including Off-Site Visits The contractor shall be required to conduct off-site remote / virtual visits and to travel to conduct on-site visits. Travel arrangements shall be the responsibility of the contractor for on-site visits. Travel expenses will be reimbursed in accordance with Federal Travel Regulations (Chapter 300 through 304) utilizing Government rates. Contractors will be reimbursed for actual travel expenses, but the contractor will use the most economical method of travel available, including non-refundable airfares and mid-range hotels matching government per diem rates whenever possible. Reimbursable costs include airfare, car rental, hotel, taxis, and meals and incidentals (M&IE). M&IE expenses are included only at the Federal Per Diem Rate. To receive reimbursement, the Contractor shall submit his/her invoices along with travel expense worksheet (which is supplied at the time of award), receipts and all other supporting documents to SMART focal point. Documentation to support lowest cost available is required for reimbursement. Travel time is not reimbursable. For on-site visits requiring travel, portal-to-portal travel time should be considered as part of the overall cost of the visit. Contractor (PRIME if there are Subcontractors) will submit all required documents noted above. If travel dates or location are changed at the request of the program, the change fee for new date and/or location will be reimbursed however no expenses will be reimbursed for changes made for the convenience of the CRQA. Changes for convenience are the responsibility of the contractor. Documentation supporting change in location or dates must come from CSP program officials and /or site staff and must be submitted when invoicing. 3.1 Task 1 CRQA visits with pre and post work, (INCLUDES PORTAL-TO-PORTAL TRAVEL TIME) The contractor shall conduct site initiation visits as defined by the CRQA Monitoring Plan and SMART Standard Operating Procedures (SOPs) with the support of the Lead CRQA. The visits shall be scheduled after the Investigator s Meeting. When conducting a site initiation visit, the CRQA shall perform an evaluation as specified in the CRQA Monitoring Plan that will include at least the following, and additional items as relevant to the design of the trial: Protocol procedures including inclusion/exclusion criteria Subject informed consent process Screening procedure Randomization procedure Investigational Product Accountability Unanticipated Adverse Event reporting and Serious Adverse Event Reports Source document review and verification Current requirements and availability Case Report Form (CRF) completion, correction, QA procedures Institutional Review Board (IRB) policies and procedures (i.e., adverse events and protocol deviations) Regulatory and other study document completion and maintenance Site correspondence with sponsor, CRQA and maintenance Un-blinding procedures of a blinded study Other related protocol procedures The contractor shall assure the following regulatory information is present in the site files: Current IRB approval protocol/amendments Current IRB approval consents(s) Current IRB membership list or documentation of IRB compliance Investigator agreements Financial disclosures Investigator curriculum vitae (CV) Research and indemnity (if applicable) agreement All training requirements GCP, Health Insurance Portability and Accountability Act (HIPAA) and Human Subjects Protections (HSP) Additionally, the contractor shall ensure the following Study Management Documents are completed (if applicable) and appropriately filed in the Essential Document Binder (Regulatory Binder): Delegation of Authority Form or CRF Authorization Log IRB policy and procedures (i.e., adverse event and protocol deviation reporting) IRB correspondence Sponsor correspondence Study contact list Subject list Site Visit Log CRFs (all versions) CVs 3.1.1 Subtask 1a Conduct Routine Monitoring Visits - one to four days (with pre and post work, (INCLUDES PORTAL-TO-PORTAL TRAVEL TIME) The contractor shall conduct periodic routine visits per the CRQA Plan and SMART Standard Operating Procedures (SOPs) to inspect VA investigators for compliance with GCP and with VA and CSP Research policies. Frequency of Visits The frequency and timing of contractor visits will be determined by SMART Leadership for each site based on the following: Lead CRQA and Study Team recommendations Subject accrual rate at the site Total number of subjects to be enrolled at the site Complexity and risk level of the study protocol Data collection and record keeping proficiency at the site Observations and corrective actions from previous monitoring visits 3.1.2 Subtask 1b Preparing for site visits Scheduling After approval of planned visit by monitoring study Lead, the contractor shall coordinate visit dates with site Study Coordinator and Site Investigator. The contractor will request current contact information and mailing address. The contractor shall contact the site coordinator to set up a date/time for the visit and to discuss: Tentative Agenda Estimated time needed on site with the Site Investigator/Coordinator Specific documents needed for review After the contractor has set up a date/time for the visit, the contractor shall submit a request to the SMART Program Manager (PM) email group for a site announcement letter using the provided email template. Documents and resources Prior to the contractor visits, the contractor shall assemble all documents and resource materials needed to conduct the visit (i.e., correspondence, previously completed monitoring documents, etc.). Visit will be conducted following the studies Integrated Monitoring Plan. 3.1.3 Subtask 1c Conducting site visits In conducting these sites visits, the contractor shall: Review subject and investigator study records for compliance with GCP, VA and CSP research policy Check for study protocol compliance Review Essential Documents Binder (EDB) Conduct Informed Consent and HIPPA review Conduct participant data review Verify Case Report From (CRF) data against Source documents Review source documents for Adverse Events (AE)/Serious Adverse Events (SAE) Review electronic medical record for unidentified SAEs Review CRFs for accuracy and legibility Check for CRF submission to Data Coordinating Center Know and comply with VA Privacy and Data Security Policy during site visits Provide CSP Director and SMART Staff Leadership immediate feedback of significant discoveries made during site visits Provide guidance during site visits on study conduct and use of GCP tools to improve study site practices Assess effectiveness of interactions between the investigator site study team and the contractor and other representatives of CSP Determine follow-up actions to be taken Provide relevant GCP training and re-education as needed Conduct exit interview with study team to discuss site status Notify the Lead CRQA and SMART of recurrent and/or serious compliance deficiencies immediately of becoming aware of such deficiencies Assist during and after the visit as necessary with development and implementation of Corrective Actions and/or Preventive Actions (CAPAs) to mitigate recurrence of compliance deficiency 3.1.4 Subtask 1d Prepare site visit reports and summary letters Study specific templates are provided to the monitor upon assignment of study training and visit. Within ten calendar days (or current SOP requirement) of last day on site of site visit, the contractor shall complete a site visit report, Summary for Investigator and applicable attachments (using provided templates), and provide these documents to the SMART PM group by posting to SMART SharePoint site or other location as directed by SMART leadership. See Section 4. Deliverable Schedule. Provide all QA visit logs and scanned documents related to site visit to SMART and Monitor contractor study lead for review, follow-up and finalization. QA activities performed include: Summary of findings, conclusions, and any actions taken or planned to correct any deficiencies noted during the visit. All documents must be submitted in the specified electronic format using the required templates. Content must be understandable by SMART staff, site staff and CSP study personnel. Content shall be grammatically correct, and content verified for accuracy. Inform the SMART study lead monitor of recurrent and/or serious compliance deficiencies Assist with development and implementation of Corrective Actions and/or Preventive Actions (CAPAs) in order to mitigate recurrence of compliance deficiency The contractor shall communicate with and provide follow up with the study lead monitor to answer all questions and issues prior to visit report approval and Summary for Investigator distribution to the intended recipients within current SOP/AMP requirement. The contractor shall upload QA documents to the SMART portal which includes reports and follow-up summary letter. All reports and letters will be grammatically correct and sent to the SMART in the specified electronic format. 3.2 Task 2 CRQA Visits without pre and post work (INCLUDES PORTAL-TO-PORTAL TRAVEL TIME) 3.2.1 Subtask 2a Support of another CRQA conducting CRQA visits - one to four days on site (or Virtual Equivalent) The CRQA may support another CRQA in conducting site Monitoring visits at the request of the Lead CRQA or SMART Leadership. For example, this may include providing support to the lead monitor during a site visit, most often during a monitoring visit, or training as a new monitor on conducting site visits.  The supporting monitor is not responsible for the pre work such as scheduling visits, pre visit log reviews, developing special tools for the visit, or any of the post work such as visit summary, visit report, summary attachments or post monitoring communication between site and lead. In summary support of another monitor - requires no pre or post work but does include travel and actions conducted at the site. Subtask 2b Support of study kickoff, annual, program meetings or training - one to four days on site (or Virtual Equivalent) The contractor may be required to attend or present at study kickoff meetings, annual meetings or other meetings at the direction of the Lead study monitor or SMART Leadership The contractor may be required to attend in-house (or Virtual Equivalent) training or perform PQS tasks at the direction of the SMART Leadership. 3.3 Task 3 GCP Program Quality Support (PQS) to the VA Cooperative Studies Program Hourly; no travel required 3.3.1 Subtask 3a Create site visit tools 3.3.2 Subtask 3b Develop GCP tools for use by participating sites 3.3.3 Subtask 3c Design data from casebooks for organizing patient files at investigative sites 3.3.4 Subtask 3d Develop requirements, procedures and guidance for source documentation of key study data within each trial 3.3.5 Subtask 3e Off-Site records review of key critical data in support of risk-based integrated monitoring. Does not include off-site record review related to the preparation for CLIN 1 & 2 On-site (or virtual equivalent) Visits with Pre and Post Activities . This subtask includes but is not limited to: Conduct Informed Consent and HIPPA review Review of the Electronic Health Record (HER) for eligibility and protocol/regulatory compliance Review of the electronic date capture system (EDC), CRF completion, correction, QA procedures Review for study endpoints or primary outcomes data Review for safety (unanticipated adverse event reporting and serious adverse event reporting) Determine follow-up actions to be taken. 3.3.6 Subtask 3f Study Orientation 3.3.7 Subtask 3g Completion of training required by the Department of Veterans Affairs, VA CSP and SMART 3.3.8 Subtask 3h Serves as the Sponsor s Designated Representative (SDR) The SDR shall finalize and approve reports prior to distribution. The SDR shall complete the site visit portion of the SDR form. The SDR shall submit a request to the SMART Program Manager (PM) email group for a site visit follow up letter using the provided email template. The SDR shall review site visit response, verify actions, communicate with site staff and site monitor prior to approving response and submitting response and SDR form to close out study visit. Lead contractor will submit a request to the SMART Program Manager (PM) email group and provide documentation of completion using current business process and forms. Once the investigator correction action response has been received from the site the Sponsor s Designated Representative (SDR) evaluates the corrective action response for acceptability and completeness. The SDR ensure the Site Investigator response is acceptable and complete by: Reviewing and evaluating the Site Investigator s written response Discussing the findings and specified actions with site personnel and Study Leadership as needed Maintaining the secure CSP Monitor file of documents and correspondence. Consulting, as needed, with the appropriate CSP Coordinating Center Project Manager, QA Nurse Specialist or designee to assist site personnel in resolving issues raised in the SMART Monitoring report. Documents resolution and closeout of site visit Deliverable Schedule The contractor shall deliver the following as stated in the table below: SOW Task Deliverable Description Due Date Electronic submission to: Task 1 See subtasks See subtasks See subtasks Subtask 1a Site Initiation Visits Site Initiation final report, investigator summary and supporting documents Site Initiation 10 calendar days from last day of visit unless otherwise required by CSP Director SMART Leadership, SMART PM Subtask 1b Routine Monitoring Visit final report, investigator summary and supporting documents Routine Monitoring 10 calendar days from last day of visit unless otherwise required by CSP Director SMART Monitoring Lead SMART PM email group ABQCSPSMART-PM@va.gov Subtask 1c Schedule as directed by SMART Leadership and submit a request to the SMART Program Manager (PM) email group for a site announcement letter (See Attachment D-Announcement Letter) 30 days prior to visit but no later than 14 days. SMART Monitoring Lead SMART PM email group ABQCSPSMART-PM@va.gov Subtask 1c Contractor shall assemble all documents and resource materials needed to conduct the visit according to monitoring plan and save documents received from site coordinator Prior to first day of visit SMART SharePoint site, URL https://www.csp.va.gov/smart/SitePages/Home.aspx Subtask 1d Perform monitoring visit During visit dates SMART SharePoint site, URL https://www.csp.va.gov/smart/SitePages/Home.aspx Subtask 1e The contractor shall finalize and provide logs, site visit report, Summary for Investigator and applicable attachments Within ten calendar days (or current SOP requirement) of last day on site of site visit SMART Monitoring Lead SMART PM SMART SharePoint site, URL https://www.csp.va.gov/smart/SitePages/Home.aspx Subtask 1f Monitoring Report Follow-up and Resolution By requested date SMART Monitoring Lead SMART PM Task 2 See subtasks See subtasks See subtasks Subtask 2a Services provided to support another contractor visit completion By requested date SMART Monitoring Lead SMART PM - Subtask 2b Support services provided By requested date SMART Monitoring Lead SMART PM Task 3 See subtasks See subtasks See subtasks Subtask 3a Site tools submitted By requested date SMART Monitoring Lead SMART PM Subtask 3b GCP tool/s submitted By requested date SMART Monitoring Lead SMART PM Subtask 3c Design data submitted By requested date SMART Monitoring Lead SMART PM Subtask 3d Documents submitted By requested date SMART Monitoring Lead SMART PM Subtask 3e Off-Site Records By requested date SMART Monitoring Lead SMART PM Subtask 3f Documentation of completed study orientation Upon completion of training, no later than due date of training requirement. SMART PM email group ABQCSPSMART-PM@va.gov Subtask 3g Documentation of completed training Upon completion of training, no later than due date of training requirement. SMART PM email group ABQCSPSMART-PM@va.gov Subtask 3h Properly completed and submitted SDR review activities of visit reports and documents Post Visit Properly completed and submitted SDR review activities of visit reports and documents Post Site Response Due 30 days from last date of visit or current SOP requirement. Due as determined by Director of SMART SMART Monitoring Lead SMART PM ABQCSPSMART-PM@va.gov Task 4 Successfully complete the appropriate training courses in TMS Before being granted access to VA info and systems and annually thereafter ABQCSPSMART-PM@va.gov COR Task 5 Submit expenses incurred utilizing the invoice template, travel expense and professional service worksheets and training supplied at the time of award. Invoices should be submitted in VIS Within 30 days of visit. And after all QA services are complete and all associated QA documents are submitted. Within 30 days of visit and after SMART PM approves the invoice, the contractor will submit the final invoice as directed in the contract ABQCSPSMART-PM@va.gov Note -All communications regarding invoicing from a subcontractor shall be directed through the primary contract holder. If for any reason a deliverable cannot be delivered as scheduled, the contractor shall notify the COR three business days prior to the due date. This notice must include the reason(s) for the delay, and the impact on the overall project. Identification, Parking, Smoking, and VA Regulations: Contract monitors shall be issued VA identification and shall wear it in accordance with VA provided guidance while on the premises of any VA facility. It is the responsibility of the Contractor to park in the appropriate designated parking areas. Information on parking is available from the VA Police Section at the specific VA facility. VAHCS will not invalidate or make reimbursement for parking violations of the Contractor under any conditions. Smoking is prohibited inside any buildings at VA facility and prohibited area may extend as far the facility perimeter. Possession of weapons is prohibited. Enclosed containers, including tool kits, shall be subject to search. Violations of VA regulations may result in citation answerable in the United States (Federal) District Court, not a local district, state, or municipal court. Information Security: In accordance with Appendix A, Handbook 6500.6 Checklist blocks 7, the C&A requirements do not apply to this requirement, and Security Accreditation Package is not required. PHI/PII Protected Health Information/Personally Identifiable Information: PHI/PII is any information about an individual maintained by an agency, including (1) any information that can be used to distinguish or trace an individual s identity, such as name, social security number that is linked or linkable to an individual, such as medical, educational, financial, and employment information. The CRQA will have access to PHI/PII data during performance of the tasks stated in the Statement of Work. CRQA must know and comply with VA Privacy and Date Security Policy during site visits and properly protect this information. Other Pertinent Information or Special Considerations: In accordance with VHA Directive 1192.01, SEASONAL INFLUENZA VACCINATION PROGRAM FOR VHA HEALTH CARE PERSONNEL, contractor personnel performing direct services requiring physically visiting medical facilities must meet annual flu shot requirements.  Contractors are expected to follow the stated guidance and provide the SMART Program Manager and COR the required documentation. Failure to comply could result in the individual not allowed to perform work on VA facilities. Contracting Officer s Representative Name: Dave Older Section: Division of Administrative Operations (DAO) Address: VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center 2401 Centre Avenue, SE Albuquerque, NM 87106-4180 Phone Number: (505) 248-3203 Fax Number: (505) 248-3205 Email: david.older@va.gov Period of Performance: Ordering Period 1 April 17, 2021 April 16, 2022 Ordering Period 2 April 17, 2022 April 16, 2023 Ordering Period 3 April 17, 2023 April 16, 2024 Contractor Qualifications: The contractor, contractor s employees, sub-contractor and individuals who will perform work under this contract must meet all the qualifications listed below and submit copies of documents requested below to meet contractor qualifications. Statements such as certificates available up request is cause for rejection of the proposal if the requested documents for all individuals named in the proposal are not provided with the submission. When it is the intent of the contractor to add additional staff after contract award, SMART reserves the right to review the qualifications of and reject proposed additional staff who do not meet the qualifications. Current Curriculum Vitae (CV) or detailed resume. Documentation of a Bachelor s degree (BA/BS) in a scientific or health-related field or licensure as health care provider, (e.g., RPh, RN, MD, DO, PA CNP, etc.), or advanced degree in health-related or clinical research-related field (e.g. Pharm.D., Masters, Ph.D.) OR Certified as a Clinical Research Associate (CCRA) by the Association of Clinical Research Professionals (ACRP) or by an equivalent certifying body. Acceptable documentation: copies of degree certificate, transcripts showing awarding of degree, copy of licenses, certification certificate. Documentation of completed Good Clinical Practice training provided by nationally recognized training providers (e.g., Barnett International, ACRP, CITI, CFPA). Acceptable documentation: training certification certificate. Documentation of Specific training or certification in monitoring of clinical research trials and documentation in human subjects protection (HSP), provided by a nationally recognized training providers, e.g., Barnett International, ACRP, CITI, CFPA, University of North Carolina, etc., OR certification as a Clinical Research Associate, (CCRA) by the Association of Clinical Research Professionals (ACRP) or by an equivalent certifying body. Clinical trial auditing training or experience is given added consideration. Acceptable documentation: training certification or certification documents OR if clinical trial monitoring training is all on-the-job (OJT) the contractor shall provide a listing of the specifics for each individual clinical trial, duration of the work on the clinical trial and frequency of monitoring visits, disease state monitored. Documentation of a minimum of ten (10) years providing Good Clinical Practice (GCP) clinical trial monitoring specifically of clinical research sites. Additional consideration given to monitoring of multi-site clinical trials as well as auditing of clinical trials. Acceptable documentation: Experience should be documented in the current Curriculum Vitae or detailed resume of each names monitor in the submission. Documentation of a minimum of five (5) years experience providing GCP monitoring (or auditing) services for federally funded research with additional consideration to delivery of these servicers to VA funded/sponsored clinical research trials. Monitoring at a VA clinical trial site for a commercial study-sponsor does not qualify as monitoring or auditing of federally funded research. Acceptable documentation: Provide, for each of the proposed monitors, a listing of the trial sponsors (e.g. a university trial sponsor with funding by NIA, a NIH trial, a VA funded trial, etc.), number of clinical sites monitored for the trial and frequency of monitoring visits, duration of monitoring work for each clinical trial. If the monitoring experience was through a CRO (contract research organization) contracted by a university or NIH to manage the trial, please so indicate. Provide at least three (3) references for listed experience of delivering GCP monitoring or auditing services for federally funded research. Experience in medical record and clinical chart review. Resume or CV must demonstrate experience, specifying the type of medical record systems (paper, electronic). For electronic health records specify commercial system experienced with and the tools used to access the electronic health record. Indicate experience with VA electron health record and tools used to access it. h) Computer knowledge Skilled in MicrosoftOffice Programs (e.g., Outlook Email, Word, PowerPoint, Excel and SharePoint), and Adobe Acrobat. Resume or CV must demonstrate experience by describing examples such as giving presentations with PowerPoint slides, documents written with Word, schedule planning with Excel, or combine files in Adobe Acrobat. Quality Assurance: The contractor shall detail their internal processes for working with a customer with regards to: Selection, assignment and evaluation of qualified personnel. Communication with a customer regarding scheduling, report transmittals, general interface with the customer, etc. Security Requirements: All Contractor employees who require access to the Department of Veterans Affairs' computer systems shall be the subject of a background investigation and must receive a favorable adjudication from the VA Law Enforcement Training Center/SIC. The level of background security investigation will be in accordance with VA Directive 0710 dated June 4, 2010 and is available at: http://vaww.va.gov/vapubs (VA Handbook 0710, Appendix A, Tables 1 and 2). Appropriate Background Investigation (BI) forms will be provided upon contract (or task order) award and are to be completed and returned to the VA Law Enforcement Training Center/SIC within 30 days for processing. Contractors will be notified by VA Law Enforcement Training Center/SIC when the BI has been completed and adjudicated. These requirements are applicable to all Contractor personnel requiring the VA computer access. If the security clearance investigation is not completed prior to the start date of the contract, the employee may work on the contract while the security clearance is being processed. However, the investigation must be completed / approved before any site visits are conducted. The Contractor shall be responsible for the actions of those individuals they provide to perform work for the VA. If damage arises from work performed by Contractor personnel, under the auspices of the contract, the Contractor sha...
 

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