Clinical Research Associate (Remote) Job

MEDICAL RESEARCH ASSOCIATE is needed for a CONTRACT opportunity for our client located in REMOTE.

WHAT YOU'LL BE DOING:

- Act as First line of contact to address non-medical site questions as outlined in the local Trial Operations Plan created by the CML.
- Track protocol violations by creating and maintaining a PV log from site visit reports.
- Provide protocol amendments to site as needed and track receipt/signature pages.
- Integrate QC findings into protocol.
- Track submission to and approval from IRB, 1572 changes correspondence, site changes.
- If site makes changes to informed consent, submit revised document to IRB and follow to approval.
- Review and approve advertising with CML.
- Track RDR releases and verify when sites are ready for drug shipments.
- Initiate the IVRS/IWRS system after regulatory approval has been obtained and the site budget/contract has been executed.
- Ensure ample drug supply is available to meet projected enrollment at each site including IVRS.
- Notifies the CML when drug issues arise, such as drug expiration.
- Complete drug shipment orders for non-IVRS trials.
- Complete vendor address spreadsheets or trackers.
- Identify issues in the site visit and create and manage a list of outstanding issues.
- Provide access to training modules to site personnel.
- Develop or contribute to newsletters for assigned studies based on information provided by CML and/or CRA Manager.
- Maintain FAQ list for assigned trial(s).
- Follow-up on site patient recruitment with site coordinators and CRAs.
- Submit regulatory documentation and correspondence to the personnel for filing in the Clinical Trial Master File (CTMF).
- Perform CTMF reconciliation for assigned studies on a quarterly basis or as directed by the CML.

WHAT YOU NEED TO BRING TO THE TABLE:

- Bachelors or RN degree must.
- Monitoring experience required.
- Remote monitor is helpful and plus.

OPPORTUNITY IS CALLING, APPLY NOW!

RECRUITER: Krista Leach

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V.

J2W: CLINICAL

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SFSF: LS