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Reference Number:
BA_CRAMA
Job Description:
A leading Fortune 100 Pharmaceutical client of ours is looking for a Clinical Research Associate CRA based in Boston, MA.
Delivery of high quality data according to agreed time lines and budget, ensuring
adherence to international and local regulations and client's SOP standards.
Demonstrate exceptional customer focus as evidenced by positive feedback from client's colleagues and external customers (Investigators).
Participate in the site nomination process; perform evaluation of site capability to deliver the contractually agreed to number of patients and high quality data then make recommendation for inclusion in the clinical trial.
Assume ambassadorial role to facilitate communication between sites and client's line functions to increase value proposition to investigators.
Facilitate preparation and collection of site level documents.
Execute site initiation and training activities.
Perform monitoring visits according to monitoring plan and author study monitoring reports.
Manage site drug supply management.
Resolve site level update of technical systems (ClinAdmin, EDC).
Ensure site activities in line with milestones (i.e. startup, recruitment, closeout, etc).
Manage recruitment implementing appropriate contingency plans as needed.
Assure continual GCP, ICH and client's SOP compliance (Informed consent process, source data verification, AE and SAE reporting, IN, protocol, drug accountability etc.).
Resolve deviations to standard by remedial action and training.
Perform data query resolution process (both at Site and with Data Management).
Execute site closeout activities.
May act as local (or global) CRA Lead, as assigned.
May act as a mentor to new associates for purposes of field training, as assigned.
Coordinators with Oncology experience will also be considered for this position
Experience Level:
2 Years
Requirements:
Basic medical and business knowledge.
Desired competency in clinical research or having demonstrated adequate level of proficiency within the CRA II competency profile.
Understands and can apply knowledge of clinical trial designs to trial execution.
Knowledge and experience in international standards (GCP/ICH), international (FDA, EMEA) and local regulations.
Expertise in communication, managing multiple priorities and computer literacy.
Oncology experience strongly preferred
Travel requirements will vary depending on where candidate lives and will be able to maintain within the 8 hour per diem agreement
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