Clinical Operations Manager

Job Description

Job Description

Summary: The Clinical Operations Manager is responsible for operational implementation of assigned studies at their research site. The incumbent supervises clinical trial staff and works closely with the Principal Investigator, Site Director and Regional Director, and cross-functional teams to ensure successful completion of research activities. This role serves as the primary liaison between the research site, sponsors, CROs, and other stakeholders while maintaining compliance with regulations.

Duties and Responsibilities:

Clinical Trial Management

• Oversee daily operations of clinical research staff and studies
• Coordinate multiple projects with competing priorities and deadlines
• Monitor adherence to protocols and study timelines
• Act as primary liaison with sponsors, CROs, and vendors
• Prepare for and facilitate study monitor visits

Regulatory Compliance

• Ensure adherence to Standard Operating Procedures (SOPs), FDA regulations, and other regulatory references
• Maintain subject and document confidentiality and privacy
• Assist with regulatory submissions and file maintenance
• Create and implement corrective and preventive action plans when appropriate

Study Documentation

• Supervise creation and completion of study-related documents
• Supervise completion of case report forms
• Supervise documentation of adverse events and subject history
• Prepare reports as requested

Study Participant Coordination

• Supervise study assessments with study participants including informed consent
• Supervise subject screening and recruitment
• Supervise appointment scheduling and visit implementation
• Supervise collection of vital signs and study participant assessments
• Supervise phlebotomy, specimen processing, and biological sample shipping

Resource Management

• Identify departmental needs for supplies, staffing, and equipment
• Improve research processes within established guidelines

Supervisory Responsibilities:  Directly supervises Clinical Research Coordinators and Research Assistants, ensuring compliance with SOPs and regulations. Carries out supervisory responsibilities according to organizational policies and applicable laws, including:

• Training employees
• Planning, assigning, and directing work (with management guidance)
• Appraising performance
• Addressing complaints and resolving problems

Education/Experience:

• High school diploma or GED required; Bachelor's degree preferred
• Three to five years of experience in a Clinical Research Coordinator role
• Previous experience managing clinical research coordinators preferred
• For CNS sites, experience conducting rating scales such as MMSE

Certificates and Licenses:

• Good Clinical Practice training certification
• IATA training certification
• Valid driver's license and insurance

Knowledge, Skills, and Other Abilities:

• Strong oral and written communication abilities
• Excellent organizational skills and attention to detail
• Professional interpersonal skills with a positive demeanor
• Adaptability to changing priorities
• Medical knowledge including terminology
• Thorough understanding of regulations, regulatory guidance, and SOPs
• Proficiency with Microsoft Office, web browsers, and electronic case report form systems

Work Environment and Physical demands:

The work environment and physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Office/laboratory and clinical environment.
• Exposure to biological fluids and/or bloodborne pathogens. 
• Personal protective equipment required
• Occasional domestic and international travel
• Ability to maintain upright/stationary position for 6-10 hours daily
• Frequent mobility required.
• Occasional squatting, kneeling, or bending.
• Light to moderate lifting (20-50 lbs)

Perks of working at Summit Clinical Research Solutions:

• 401k
• Medical, dental, vision, long term disability, short term disability, FSA, and life insurance
• 3 weeks of paid time off
• 14 paid company holidays
• Scrub voucher (for eligible positions)
• And more!