West Conshohocken, PA
Our client is currently seeking a Clinical Research Associate/ Associate Manager This job will have the following responsibilities:
•Provide direction and leadership to clinical operations study team.
•Provide day to day operational management of internal and/or contract CRAs.
•Coordinate & manage clinical monitoring activities from site start up to site closeout including:
oProvides overall tactical support for the study.
oGuides investigative site activities at multiple clinical trial sites, including SAE reporting, identification of protocol deviations, essential document status, eCRF completion, and investigational product accountability. oProactively identifies and resolves study-related issues.
oOversee the assignment of appropriate project specific training for CRAs.
oDevelop and/or provide input in the development of clinical trial related documents including but not limited to: protocols, study tools, monitoring tools, presentations, meeting materials, case report forms, informed consents, timelines, monitoring plans, site reference manuals, pharmacy manuals, laboratory manuals, and training materials.
oReview of clinical monitoring reports to ensure timely completion and identification of issues.
•Perform qualification, initiation, interim and close out visits and provide visit reports as per monitoring guidelines, as needed.
•Co-monitor study sites with assigned CRAs as required.
Qualifications & Requirements:
•BA/BS Degree required; degrees in health sciences strongly preferred.
•A minimum of five (5) years of monitoring/site management experience is required, or equivalent combination of education, training, and experience.
oExperience must include early phase clinical studies/Phase I-III studies.
oExperience with global/international studies is highly desired. oExperience in oncology and/or infectious disease is highly desired.
•Prior project team leadership experience preferred.
[ Link removed ] - Click here to apply to Clinical Research Associate/ Associate Manager
- Case Report Forms
- Clinical Monitoring
- Clinical Research
- Clinical Trials
- Clinical Works
- Infectious Diseases