Clinical Research Manager (Site Manager)
- Under the direction of the Principal Investigator or Sub-Investigator, manage the conduct of clinical research activities.
- Responsible for coordinating and implementing assigned protocols in compliance with FDA CFR, GCP and company SOPs.
- Collects and records clinical research data, assists in patient assessments, scheduling, maintaining study files, study supplies and study medication accountability.
- CRC responsibilities as listed in the Job Description along with the following:
- The day-to-day operations of the research program
- Approve flexing of time worked
- Manager of designated research staff
- Train/Retrain new research staff with annual retraining and, as needed
- Review weekly screening and clinic volume to meet and/or exceed goals
- Regulatory and /or Quality Assurance/Quality Compliance duties at site as needed
- Daily Research Operations
- Manager of CRC 1,2,3, Research Phlebotomist
- Daily issues/concerns, work quality
- If needed, triage issues for escalation to Director of Clinical Research. Serious issues to be referred to Director of Human Resources and Chief Medical Director of Research immediately as well.
- Provides leadership and support to the clinical staff to ensure high quality, high volume and efficient productivity.
- Site specific team building activities
- Proactive team building
- Incentive/Rewards
- Report to PI and Director of Clinical Research on status of research operations
- Maintain effective, and positive, working relationships with patients, sponsors, providers and employees.
- Troubleshoot and resolve clinic, protocol, and SOP issues and advise CRCs
- Changes to SOPs and clinic process to be discussed with PI and Director of Clinical Research
- Assist ad fill in for CRCs (level 1-3) with assigned tasks as necessary
- Allocate work in cooperation with Director of Clinical Research
- 30/60/90- day and annual review for Clinical research staff: CRC, Phlebotomists
- Assist in establishing and enforcing departmental standards
- Conduct weekly meetings with the research personnel at the site
- Attend and present at scheduled meetings with research staff, Director of Clinical Research and Chief Medical Director of Research
- Direct/Assist with projects and tasks as assigned
- Provide assistance with study protocol adherence as necessary
- Ensure site staff completes assigned tasks
- A thorough understanding of regulatory requirements, principles of GCP and biomedical research ethics.
- Strong Interpersonal and communication and customer service skills, both verbal and written.
- Able to interact effectively with professional, administrative staff, sponsor and regulatory representatives, patients, potential subjects and referral sources. Can communicate clearly and effectively.
- Strong organization, time-management, and leadership/teaching skills required
- Ability and commitment to training, coaching, and mentoring a team is required
- Ability to maintain professional and positive attitude
- Ability to provide all employees and research subjects with an excellent service experience by consistently demonstrating professional decorum.
- Knowledge of FDA regulatory requirements is required. Has knowledge of commonly used concepts, practices and procedures within particular field. Rely on instructions and pre-established guidelines to perform the functions of the job. Work under immediate supervision of Director of Clinical Research.
- Bachelors Degree or Graduate degree preferred
- Minimum Ten (10) years of Research experience leading a team in high-growth clinical research setting
- Study-specific training
- Experience and training in the conduct of clinical research (specific experience and/or training in clinical research, including IRB submissions, reporting and source documentation and trial management)
- Managerial and Leadership experience and/or related training and certifications is required
- Able to lift at least 25 lbs.
- Able to walk and stand for at least 50% of the day
- Able to sit for at least 50% of the day
- Communicate: hearing, talking, vision
- Able to type and do computer work for long periods
- Some interoffice travel may be required with use of company vehicle or mileage reimbursement
- Must have valid documentation and authorization to work in the U.S. for any employer. Sponsorship, work visa, and/or visa transfer is not provided
- Health, Dental, Vision (with HSA plans and employer contribution)
- 3 weeks PTO
- 5 days Sick Time
- 7 Company Paid holidays + 2 Paid Half-days
- 401K with 6% company match
- Short & Long Term Disability
- Educational Assistance
- Shared company vehicles for required travel
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