Clinical Research Coordinator

JOB TYPE

Classification:Exempt

Supervises Positions:No

JOB SUMMARY

Clinical Research Coordinator- 4, Non-Licensed (CRC-4, NL), plan, organize, lead, and perform comprehensive and advanced level clinical research duties for multiple and/or complex clinical trials. A CRC 4 has the ability to directly impact the overall efficiency, productivity and success of each clinical trial they coordinate. The CRC in this role is able to work independently and has the authority to interact with internal or external stakeholders involved in a clinical trial or modify clinical trial workflow or processes within their respective Department or Division to meet the needs of a given study. A CRC in this role may manage or support a research team of CRCs.

• Manage multiple Principal Investigator relationships with internal and external research stakeholders.

• Provide guidance and assistance to Principle Investigators for grant submissions, budget management and research compliance oversight to ensure full compliance with local, state and federal policies and procedures.

• Serve as the primary liaison with the Sponsor for assigned studies.

• Assist Principal Investigator in developing clinical trial protocols and submit the required documentation to the Institutional

• Review Board, the University, federal regulators n industry or government sponsor.

• Coordinate and manage all aspects of clinical trial conduct for multiple ongoing clinical trials of any level of complexity.

• Prepare and submit all types of clinical research documentation to the IRB of record (central or local) for review and approval.

• Participate in planning and analysis of research portfolios, in conjunction with department management and Principal Investigators.

• Oversee the financial management of multiple clinical research projects, including budget development, billing reconciliation, and quarterly review of all Principal Investigator accounts.

• Manage a team of Clinical Research Coordinators and/or laboratory or research support staff, with responsibilities that include hiring, scheduling, workload management, compensation, rewards, professional development, and performance management.

• Coordinate clinical research education, training and/or orientation for new Faculty, Fellows, Residents or medical students.

• Develop administrative and financial recommendations for department management and Principal Investigators for research portfolio review.

• Compile data and documents during internal and external audits and is ultimately responsible for quality of submissions.

• Participate in at least 1 research-related working group at the institutional level, or lead a process improvement initiative at a department or division level.

• Conduct research data analysis and literature searches. Co-author scientific papers, publications or presentations

Analysis:Analyzes processes and creates deliverables to provide information and recommendations for improvements.

• Breaks down problems and issues into sub-components and assesses the costs, benefits, and risks of various options.

• Is able to select and recommend the best solution based on a thorough examination of all considerations.

• Is able to explain and justify actions in a systematic and logical fashion.

Communication:Shares and receives information using clear oral, written, and interpersonal communication skills.

• Demonstrates effective written and oral communication skills.

• Actively listens, provides constructive feedback, and demonstrates respect for differing views.

• Tailors communications to diverse audiences.

Quality Improvement:Demonstrates involvement in the unit's annual and/or periodic assessment efforts, including efforts to improve the quality services.

• Understands the value of innovation and quality improvement.

• Improves processes and practices by identifying inefficiencies and redundancies.

• Demonstrates efficiency and quality in one's own work.

Customer Service:Builds relationships and maintains strategic partnerships with key internal and external stakeholders.

• Understands the importance of quality service.

• Is able to adjust and adapt service delivery to diverse customer needs and sensitivities.

• Frequently suggests and implements changes to improve the quality of service.

Financial Management:Manages tasks and resources within the department to achieve quality and meet budget requirements.

• Ensures that financial and material resources are used effectively and efficiently.

• Leverages resources to maximize utility and return on investment (ROI).

• Implements measures to minimize theft, damage, or equipment breakdown.

The incumbent may be asked to perform additional duties as assigned.

QUALIFICATIONS

Education:Bachelor's Degree Required or equivalent combination of experience, education and or certifications.

Experience: At least seven years of clinical research experience demonstrating progressive levels of responsibility and complexity of work.

Master's or other advanced degree may substitute for one year of clinical research experience.

Licensure: Clinical Research Coordinator (CCRC) and/or Certified Clinical Research Professional (CCRP) is required within one year of hire.

Additional Skills/Requirements Preferred:

PHYSICAL DEMANDS

Physical Demand Code:

Work Function/Activity:

OTHER

• May require the use of safety equipment, such as HEPA mask, for infection prevention: Yes

• On call responsibilities as directed: Yes

• Ability to travel between campus buildings, remote facilities, and out of town as needed: Yes