Medical Research Associate MRA

MEDICAL RESEARCH ASSOCIATE

Support for Trial/Study Sites

Working remotely as a member of the Clinical Trial Services Group (CTSG), the Medical Research Associate (MRA) will provide in-house study site manager trial support during normal business hours for approximately 40-50 sites per person within a suite of trials (including rollover trials). The number of trials assigned will depend on the complexity and needs of the trial(s).

Below is a sampling of tasks/activities that the MRA may be asked to perform. Other tasks may be assigned as needed.

Task List:

• Site Contact

1. a.First line of contact to address non-medical site questions as outlined in the local Trial Operations Plan created by the CML.
   1. a.Track protocol violations by creating and maintaining a PV log from site visit reports.
   2. b.Provide protocol amendments to sites as needed
   3. c.Assist in the review of Informed Consent Forms (ICFs).
   4. a.Track submission to and approval from IRB, 1572 changes (including obtaining medical licenses and CVs related to these changes), correspondence, and site changes.
   5. b.If site makes changes to informed consent, track and follow to approval.
   6. c.Work with Regulatory Document Review (RDR) group to facilitate translation for site study documents as needed.
      1. d.Assist CML with review of advertising.
      2. e.Track RDR releases and verify when sites are ready for drug shipments.
      3. a.Initiate the IVRS/ IWRS system after regulatory approval has been obtained and the site budget/contract has been executed.
      4. b.Track and ensure ample drug supply is available to meet projected enrollment at each site.
      5. c.Notifies the CML when drug issues arise, such as drug expiration.
      6. d.Request access for additional site users for the IVRS/IWRS system.
      7. e.Activate, deactivate sites on an as needed basis in IVRS.
      8. f.Make sure IVRS system is up to date with current investigator addresses.
      9. g.Order and track rescue medication and other ancillary supplies as needed.
      10. h.Complete drug shipment orders for non-IVRS trials.
      11. a.Follow up with assigned sites to confirm that they have adequate supplies and equipment as required by protocol. This may include HBGM equipment and supplies, weight scales, blood pressure equipment, ECG supplies, etc.
      12. b.Assist sites with re-supply
      13. c.Create and maintain tracker for any supplies.
      14. d.Complete vendor address spreadsheets or trackers.
      15. a.Perform monitoring trip report review as required.
          1. b.Identify significant issues from the site visit and escalate to CML as appropriate. Track relevant issues to resolution.
          2. c.Provide trip report revision feedback to CML and/or CRA Manager for discussion.
             1. d.Based on CML and/or CRA Manager direction, follow-up on revision requests with CRA to resolution.
             2. e.When significant non-compliances are identified, escalate them to appropriate team members and assist in the implementation of a corrective action plan as needed. Follow issues to resolution.
             3. a.Confirm and track that all key site personnel have completed Investigator meeting training and any study specific training modules as identified in the training plan.
             4. b.Provide access to training modules for site personnel.
             5. c.Provide and track training documentation such as attendance certificates if applicable.
             6. a.Contribute to newsletters for assigned studies based on information provided by CML and/or CRA Manager.
             7. b.Maintain FAQ list for assigned trial(s).
             8. a.Follow-up on site patient recruitment with site coordinators and CRAs. Provide feedback to CML and/or CRA manager if recruitment trends towards falling below expectations.
             9. b.Get detailed feedback from sites as to causes for recruitment challenges and best practices from high performing sites.
             10. c.Assist with development patient recruitment materials as needed.
             11. d.Create and file site contact reports.
             12. e.Create, send, and track site selection and termination letters.
             13. a.Follow-up with sites on data entry and cleaning to ensure that trial is being performed according to protocol and agreed upon timelines.
             14. b.If no IVRS system, track patient screen failures/discontinuations and reasons.
             15. c.Follow SAE queries until resolution.

·       Protocol

·       IRB

·       Drug Supply

·       Equipment and trial supplies

·       Site visit reports

·       Training

·       Newsletters

·       Site Patient Recruitment, Retention and Communications

·       Data Follow-up

1. d.Assist with expedited queries during database lock.
2. e.Review various trial data listings and follow-up with sites as required.
3. f.Follow-up with lab queries and/or alerts.
4. a.Submit regulatory documentation and correspondence to the designated company personnel for filing in the Trial Master File (TMF). Submissions are paper based or electronic.
5. b.Assist with performance of TMF reconciliation for assigned studies.
   1. a.Facilitate updates to CTMS for assigned trial(s).
   2. b.QC CTMS information and provide findings to CML.

·       TMF

·       CTMS

·       Financial Disclosure

a.   Collect and track financial disclosures during designated study time point.

·       Budget

a.   Review and reconcile site invoices with CML as required.

·       Site Selection

1. a.Identify additional study sites with CML as needed.
2. b.Maintain site selection tracker spreadsheets.
3. a.Participate in regularly scheduled trial team meetings.
4. b.Assist with writing meeting minutes and distributing as requested.

·       Team Meetings

·       Spreadsheets/Trackers

a.    Be proficient in creating and managing Excel trial spreadsheets/trackers.

·       General Communication

1. a.Escalate identified threats to patient safety, data integrity, timelines, & cost to CML as appropriate.
2. b.Assist with risk identification, mitigation and contingency planning.
3. a.Answer and manage calls routed to the MRA Group.
4. b.Document calls appropriately and follow-up until closure.

·       Call Management