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About the Role

The Clinical Operations Manager oversees the operational implementation of assigned studies at their research site, supervising clinical trial staff and collaborating with cross-functional teams to ensure successful research activities. This role acts as the primary liaison between the research site, sponsors, CROs, and other stakeholders, ensuring regulatory compliance.

Responsibilities

• 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
• 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
• 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
• 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
• Identify departmental needs for supplies, staffing, and equipment
• Improve research processes within established guidelines
• Directly supervises Clinical Research Coordinators and Research Assistants, ensuring compliance with SOPs and regulations
• Training employees
• Planning, assigning, and directing work (with management guidance)
• Appraising performance
• Addressing complaints and resolving problems

Requirements

• High school diploma or GED required
• 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
• Good Clinical Practice training certification
• IATA training certification
• Valid driver's license and insurance
• 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)

Skills

• 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

Location

• Office/laboratory and clinical environment

Work Type

• Full-time

Experience Level

• 3-5 years experience
• Management experience preferred

Education Level

• High school diploma or GED required
• Bachelor's degree preferred

Benefits

• 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)

About the Company

• Summit Clinical Research Solutions is an equal opportunity employer.

Equal Opportunity

• All applicants will be considered for employment without regard to race, color, religion, disability, gender, national origin, age, genetic information, military or veteran status, sexual orientation, gender identity, marital status or any other protected Federal, State/Province or Local status unrelated to the performance of the work involved.