What are the responsibilities and job description for the Clinical Research Regional Manager (Contract) position at ARIZONA ARTHRITIS & RHEUMATOLOGY ASSOCIATES?
Job Description
Job Description
Description :
POSITION DESCRIPTION : The Research Manager reports to the Director and is responsible for the clinical research staff & daily operations at each office.
RESPONSIBILITIES :
- Travels daily to AARA Clinical Research Sites
- Manage and supervise all study coordinators and research assistants
- Ensure workloads are balanced among coordinators and assistants in each office
- Assign studies and tasks to coordinators and assistants
- Ensure all site responsibilities and goals are met, including monthly productivity goals for staff
- Monitor recruitment efforts and ensure enrollment goals are met in each office.
- Meet with each staff member monthly for a one-on-one meeting
- Perform HR responsibilities including interviews, 90 day and annual reviews, reprimands, and terminations for clinical staff
- Ensure the research clinical staff have the skills and resources necessary for success
- Perform quality assurance and complete corrective action and prevention assessment plans.
- Monitor compliance with protocols, policies, standard operating procedures, ICH-GCP Standards, local and FDA regulations and implement solutions to increase compliance as needed
- Ensure company SOPs and Handbook are followed by research staff and affiliates at all times, including all training and regulatory obligations
- Maintain professional and positive work environment for all offices
- Available as an expert resource on all clinical trials and related questions to all staff members
- Provide ongoing support, needs assessment, and issue resolution to sites and staff on an ongoing basis, and will escalate to Director if needed
- Performs coordinating functions when there is any lapse in coverage at the offices
- May coordinate a limited number of clinical trials
- Participates in the training and mentorship of new staff
- Participate in Pre-Study Visits and Site Initiation Visits as needed
- Meet with administrative staff and department managers regularly to ensure all research operations are running smoothly
- Communicates with clinic staff, vendors, sponsors and CROs as needed to address and resolve outstanding issues
- Participate in ongoing education to remain knowledgeable on all protocols at the institution, staff handbook, standard operating procedures, ICH-GCP regulations, FDA 21 CFR, IRB Guidelines, and all applicable local and federal Laws
Requirements : Qualifications :
