Clinical Research Supervisor I
About The Position
The Clinical Research Supervisor I supervises staff involved in routine research study coordination and oversees operational aspects of clinical studies in accordance with study protocols, standard operating procedures, good clinical practice, and applicable regulations. The role provides immediate supervision to an operational or technical employee group, ensures compliance with organizational policies and internal controls, and supports responsible stewardship of operational, financial, and human resources. The supervisor oversees assigned work, trains and mentors staff, and helps improve the quality and quantity of their work. The position coordinates clinical trials and studies, including study initiation, recruitment materials and processes, patient accrual and eligibility review, data collection and submission, regulatory documentation, audit preparation, research billing, and sample management. It also contributes to staff development and personnel processes, serving as a liaison between staff and program leaders and promoting communication across research teams.
Requirements
- Working knowledge of clinical or laboratory research, clinical trial recruitment and eligibility, protocol adherence, quality data submission, and adverse-event reporting.
- Ability to manage multiple priorities, prioritize projects, and meet demands in a fast-paced, dynamic work environment.
- Adaptability to quickly changing priorities.
- Demonstrated employee supervision and human-resources administration skills.
- Demonstrated experience training others, particularly in research.
- Critical-thinking skills to evaluate issues and identify potential solutions.
- Clear, concise verbal and written communication skills.
- Strong interpersonal skills, including problem-solving, teamwork development, leadership, and mentorship.
- Ability to motivate others and work collaboratively toward common goals.
- Ability to build relationships with stakeholders at multiple administrative levels.
- Ability to perform commonly applicable functions in word-processing and spreadsheet software.
- Effective use of campus clinical information and documentation applications.
- Proven ability to use clinical trial management systems.
Responsibilities
- Distribute work and monitor the progress, quality, and quantity of assigned staff work.
- Research and resolve issues and discrepancies, and report staff performance and work effort to management.
- Ensure assigned staff follow internal policies, processes, and research requirements.
- Train employees on research regulatory processes, database entry, and working with participant families.
- Implement and maintain defined research study processes, and serve as a liaison between staff and program leaders.
- Promote communication and teamwork among cross-functional research teams.
- Initiate clinical trial studies and oversee study coordination.
- Review studies and help develop systems and forms for research billing, recruitment packets, and calendars.
- Review patient accrual and clinical trial eligibility to support human-subject protection compliance and quality recruitment.
- Prioritize multiple tasks to coordinate studies smoothly and ensure patient safety.
- Supervise the timeliness and quality of data collection, submission, and completion.
- Train study coordinators in source documentation, adverse-event reporting forms, and protocol adherence to federal regulations.
- Monitor and audit visits, oversee audit preparation, and attend auditor meetings.
- Ensure data and regulatory documentation are sufficient and up to date; use computer applications to generate reports and perform data-entry quality assurance.
- Assist assigned staff with monitoring site compliance.
- Track patient charges, identify billable triggers, and coordinate with billing to resolve disputed charges.
- Understand clinical trial budget preparation and train study coordinators in proper research billing procedures.
- Oversee data received from samples, ensure it is entered and reviewed in the appropriate databases, and protect sample integrity and security.
- Recommend salary actions, promotions, terminations, and other personnel-related actions.
- Participate in recruiting and orienting new employees, evaluate assigned staff performance, and provide guidance and sound judgment.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
Education Level
No Education Listed
