Senior Clinical Trial Associate - Cambridge, MA
Senior Clinical Trial Associate (CTA) assists the Clinical Project Managers and other Project Team Members in the conduct of clinical trials. He/She performs work within established protocols according to the pharmaceutical company's Standard Operations Procedures and relevant Federal and State regulations. CTA performs the duty under general supervision.
- Clinical Trial Associate assists the Clinical Project Managers and other in the conduct of trials and may be responsible for managing startup activities, vendor communication or other project activities as assigned.
- He/She performs work within established protocols under general supervision.
- Assists with preparation of all external and internal documentation, for assigned trials, to ensure such documentation is completed in accordance with GCP regulatory requirements and is consistent with the study protocol, under close supervision
- Assists Clinical Project Manager in site management activities which could include review of monitoring report, tracking of site visits, communication with monitors and sites, and other activities as assigned
- Maintains and tracks revisions to all documentation for accuracy, including patient Informed Consent Forms and Case Report Forms
- Assists the Clinical Project Manager in ensuring compliance with Clinical Study Protocol and provides timely updates to assigned Clinical Project Manager to confirm compliance
- Organizes and prepares study files related to study tracking and reporting and submits them to the Trial Master File within established guidelines
- May participate in the training of external vendors teams, investigators and staff as needed regarding assigned logistics of the clinical trial conducted by the pharmaceutical company and company's Partners and Vendors
- Tracks delivery and receipt of required supplies and materials to study sites and provides regular status updates
- May mentor more junior Clinical Operations & DM Staff or participate in the on boarding of new personnel
- Performs other duties as assigned
- Education: B.S. (or equivalent experience)
- Ability to work efficiently and effectively in a matrix environment
- Some past experience in clinical trials support or pharmaceutical industry experience required.
- Substantial experience using computerized information systems, electronic mail, word processing and electronic spreadsheets required. Through knowledge of ICH and US regulatory authority drug research and development regulations required.
- Experience with PC-Windows, word processing, and electronic spreadsheets required Ability to operate standard office equipment
If you or a Senior Clinical Trial Associate you know feel this could be an opportunity you would like to explore please send your most up to date resume to myself at Sara.Shields (at sign) Realstaffing.com to discuss this role.
Sthree US is acting as an Employment Agency in relation to this vacancy.