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Job Requirements of Clinical Trial Associate (CTA):
-
Employment Type:
Contractor
-
Location:
Cambridge, MA (Onsite)
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Clinical Trial Associate (CTA)
Careers Integrated Resources Inc
Cambridge, MA (Onsite)
Contractor
Job Title: Clinical Trial Associate (CTA)
Location: Cambridge, MA (Hybrid)
Duration: 7 Months+ (Possible Extension)
Pay Range : $45.00 - $55.00/Hour. on W2
Job Description:
Purpose of the position:
Main responsibilities and tasks
Experience / Qualifications Experience:
Location: Cambridge, MA (Hybrid)
Duration: 7 Months+ (Possible Extension)
Pay Range : $45.00 - $55.00/Hour. on W2
Job Description:
Purpose of the position:
- Assists and provides support to the members of the clinical operations study team in administrative activities to facilitate the overall management of Company sponsored studies
- Execute tasks assigned by the CPM related to the conduct of clinical studies, study budget forecasting and tracking
- Responsible for collecting, tracking and supports reporting of research related Transfer of Value (TOV) to enable compliance with Transparency reporting requirements (US and EU) Responsible for ensuring study documentation (including trial master files, study related contracts and financial level documentation) and study documentation is processed, maintained/archived in compliance with ICH-GCP, Company policy and procedures. Includes liaison with service providers in regards.
- e-TMF process and resolving issues related to missing documentation
- Performing QC checks on TMFs to ensure completeness and readiness for audit/inspection
- Contributes to clinical trial excellence initiatives
Main responsibilities and tasks
- Be responsible for setting up, monitoring, verifying and archiving the clinical Trial Master File (TMF)
- In charge of the Client electronic TMF (and/or paper TMF, if applicable) set-up and administration.
- Manage the clinical study creation and set-up for the country and site binders and the trial milestones.
- Prepare and customize the TMF Oversight plan, TMF Management plan, TMF master index & business rules, according to the clinical study specificities with the CRM/CPM and the Document Owners.
- Inform the appropriate role of all study team members (CRO/***) newcomers or departure.
- Ensure the TMF is being maintained up-to-date, and all essential documents are appropriately filed in the TMF.
- Perform continuous oversight of the CRO/*** TMF activities, in checking the documents consistency and the respect of the SOP timelines to maintain the TMF data integrity and by communicating this oversight status to all relevant Client study team members.
- Coordinate the TMF Quality Check (per SOP) with the CRO/ Client to ensure eTMF inspection readiness.
- Coordinate the final TMF reconciliation with the CRM/CPM.
Experience / Qualifications Experience:
- Ideal: experience in clinical study environment within CRO or Pharmaceutical company.
- Minimum: Knowledge of the clinical study environment with a strong theorical or practical administrative organization.
- Scientific background is an asset.
- Ideal: 3-year degree in a scientific, or clinical or research field and a 1 minimum of 1year relevant work experience in a clinical research/study management environment (academia or pharma or CRO).
- Minimum : 2-year relevant scientific focused degree and a minimum of 2 years relevant work experience within clinical research /study management environment
- Language:
- English: Strong intermediate level Key Required
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