Senior Clinical Trial Associate EnVivo Pharmaceuticals
THIS JOB HAS EXPIRED Position Summary:
The Clinical Trials Associate (CTA) will work within the Clinical Operations Department and reports to the Director. The CTA assists in performing and coordinating all aspects of clinical trials in accordance with GCP, ICH, U.S. IND Regulations, EnVivo SOP?s.
A qualified CTA is responsible for coordination of all aspects of an assigned clinical trial including recruiting and enrolling subjects, performing necessary clinical study procedures, compiling data, and communicating well with subjects, institutional review boards, and regulatory agencies
Position Responsibilities and Tasks:
Principal duties and responsibilities include the following:
? Participate in the direction, planning, execution and interpretation of the clinical research project through site management and communications both in-house and in the field.
? Administer, maintain and coordinate the logistical aspects of the clinical trials according to GCP and SOPs.
? Work side-by-side with CRA/PM and assisting in some of their tasks
? Study various documents and CRFs
? Perform liaison activities with the Independent Ethics Committees
? Establish and be the central contact between the contract laboratory, study team and study site
? Provide logistical support for the clinical trial
? Provide agenda, minutes and action points for meetings
? Create and maintain tools to report and measure study progress.
? Assist with contract management, invoicing
? The CTA must have the ability to function in an atmosphere of changing priorities and tight deadlines.
? Self-motivated and independent and should thrive in a team-oriented environment.
? Must have good oral and written communication skills and demonstrate attention to detail.
? Requires a strong knowledge of clinical research study design, GCP and regulatory compliance guidelines for clinical trials combined with strong prioritization, organizational and problem solving skills.
? Extremely accurate and have strong interpersonal communication skills.
? Excellent computer skills including Word, Excel and Power Point.
? Since site visits will be required, the CTA must be willing to travel (30% of the time).
? 2-5 years experience in clinical research with work history as a CTA.
? Bachelor of Science degree not required, but ideal.
||Watertown, MA |
THIS JOB HAS EXPIRED