What are the responsibilities and job description for the Senior Clinical Research Associate position at Integrated Resources, Inc ( IRI )?
Title: Senior Clinical Study Associate III
Location: Cambridge, MA (Hybrid- 3 days per week onsite)
Duration: 6 months
Job Description:
- 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
Skills:
- 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.
Education:
- Bachelors’ degree or higher
Salary : $84 - $86