1+ months

Senior Clinical Reseach Associate

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Conducts monitoring (pre study, initiation, routine monitoring and closeout visit), if require

Conducts co monitoring visits, if required

Ensures that study milestones for sites responsible are met as planned (i.e., study startup, recruitment, database analyses, closeout, etc.)

Attends onboarding--, disease indication and project specific training and general CRA training as required

Documents monitoring activities appropriately following ICH GCP and standards

Conducts Quality Oversight Visits, as requested

Completes monitoring visit reports timely

Assists with investigator/site identification

Assists site to prepare Ethics Committee submissions

Facilitates clinical trial site contract and budget negotiation

Manages site queries and communications

Assists in managing clinical trials, if required

Establishes regular lines of communication with sites

Provides protocol and related study training to assigned sites

Evaluates the quality and integrity of site practices escalating quality issues as appropriate

Manages site performance by tracking regulatory submissions, recruitment, case report form (CRF) completion, and data query resolution

Collaborates with study team to ensure recruitment plans and execute contingency plans, as needed

Performs additional task as assigned

Qualification Required:

Bachelor's level degree or above in life sciences, pharmacy, nursing or medical Understands clinical trial processes with a thorough knowledge of ICH and associated regulatory guidelines

3 years or more (SCRA) monitoring experience in the pharmaceutical or CRO industry

Excellent communication and interpersonal skills

Excellent organizational skills and ability to prioritize and multi-task

Fluent in English (writing and speaking)

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

Posted: 2020-03-05 Expires: 2020-05-28
Sponsored by:
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Senior Clinical Reseach Associate


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