Clinical Trial Associate
Proclinical is currently recruiting for a Clinical Trial Associate with a pharmaceutical company located in Collegeville, PA. Provides clinical trial coordination support including clinical status tracking, in-house study management, document management and data review activities in accordance with standard operating procedures, clinical operational plans, regulatory requirements and Good Clinical Practice.
- Support the Clinical Trial Manager in management of clinical trials, including site start-up activities
- Complete study tracking and report on study status
- Perform data entry into the Clinical Trial Management System (CTMS)
- Participate in vendor and study team meetings, including drafting of agendas, minutes and other meeting materials as needed
- Manage trial-related documents in the Trial Master File (TMF); review documents for completeness, accuracy and compliance with protocol and applicable regulations and standard operating procedures
- Perform quality checks and follow-up on resolution of open issues to ensure cross functional study team members are compliant with use of required systems and documentation e.g. eTMF, CTMS, study team share points and others as required
- Assist with review and preparation of external and internal documentation for assigned trials
- Track delivery and receipt of required supplies and materials to study sites
- Support investigator meeting preparation and collection/distribution of materials
- May participate in the training of CRO teams, investigators and study team members
- May serve as the point of contact for vendors and oversee selected vendor activities
- May assist CTM in coordination and review of study related payments (investigator and/or vendor)
- Other duties, as assigned, supporting clinical trial activities
Skills and Requirements:
- Bachelor's degree in life sciences or equivalent training required
- 2 years of relevant work experience in clinical trial support, data coordination or a pharmaceutical or CRO environment
- Excellent verbal and written communication
- Working knowledge of ICH/GCP regulations and clinical protocols
- Demonstrated computer aptitude in MS Office Suite and other systems
- Accommodates a flexible work schedule according to clinical trial(s) priorities
If you are having difficulty in applying or if you have any questions, please contact Nikki Ranieri at 215-531-5288.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.