US
0 suggestions are available, use up and down arrow to navigate them
PROCESSING APPLICATION
Hold tight! We’re comparing your resume to the job requirements…
ARE YOU SURE YOU WANT TO APPLY TO THIS JOB?
Based on your Resume, it doesn't look like you meet the requirements from the employer. You can still apply if you think you’re a fit.
Job Requirements of Senior Clinical Study Associate III:
-
Employment Type:
Contractor
-
Location:
Cambridge, MA (Onsite)
Do you meet the requirements for this job?
Senior Clinical Study Associate III
Careers Integrated Resources Inc
Cambridge, MA (Onsite)
Contractor
Duties:
Schedule Notes: Hybrid, 3 days per week onsite.
Hours Per Week: 40.00
- Participates in the day-to-day supervision of clinical trial execution, with a focus on site start up, patient enrollment, monitoring, and data flow metrics from the clinical sites, CROs and central labs
- Supports complex clinical trial activities in support of the Clinical Study Manager and other team members
- Prepare study documents (i.e. consent forms, site instructions, study specific materials such as the Manual of Operations, Pharmacy binder, etc.)
- Ensures tracking of essential documents are received and filed in the TMF, reviews site documents for accuracy; provides clinical team support with TMF filing and management
- Ensures tracking of patient status throughout the study at investigative sites
- Tracks and monitors sample collection, central laboratory reporting, and manages laboratory testing schedule
- Assists with laboratory vendor management and liaises with the CRO and clinical trial sites to ensure appropriate sample handling, shipment and result reporting
- Review monitoring trip reports, track data query reports, site visit metrics, and overall site performance
- Attends site initiation, routine monitoring and close-out visits at a limited # of clinical sites, as well as co-monitoring with CRO
- Ensures quality of the data generated from clinical sites and assists in resolving subject eligibility and protocol deviation issues
- Assists in the preparation of, and may present at investigator vendor meetings and workshops
- Actively involved in the performance of study feasibility assessments
- Review of site contracts and budgets for study start-up
- Coordinate the activities from third party vendors including metrics, accruals, process planning, and implementation
- 3 or more years of industry experience, working in Clinical Operations preferred
- Experience working in a global clinical trial
- Working knowledge in Good Clinical Practices (GCP) regulations and Standard Operating Procedures
- Understanding of study phases and general knowledge of how they apply to clinical development
- Advanced knowledge of Word, Excel, and PowerPoint.
- Knowledge of the principles and practices of computer applications in database management
- Strong verbal and written communication skills.
- Bachelors degree or higher
Schedule Notes: Hybrid, 3 days per week onsite.
Hours Per Week: 40.00
Get job alerts by email.
Sign up now!
Join Our Talent Network!