Clinical Operations Manager

Pinnacle Clinical Research; Corpus Christi (TX); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

401k

Full benefits (Medical, dental, vision

Long-term disability

Short-term disability

FSA

Life insurance

3 weeks PTO

14 company holidays

Scrub voucher

Job summary

Pinnacle Clinical Research in Corpus Christi, TX seeks a Clinical Operations Manager to oversee daily clinical research activities, supervise coordinators, and ensure compliant execution of trials. You will coordinate multiple projects, liaise with sponsors and CROs, and prepare regulatory submissions as needed.

The role emphasizes leadership, adherence to SOPs and FDA regulations, and effective communication across cross-functional teams in a fast-paced research environment.

Qualifications

• High school diploma or GED required; Bachelor's degree preferred.
• Three to five years of experience as a Clinical Research Coordinator.
• Experience supervising clinical research staff or coordinators preferred.
• GCP and IATA training certifications required.
• Valid driver's license and insurance.

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 liaison with sponsors, CROs, and vendors.
• Prepare for and facilitate study monitor visits.

Skills

Communication skills

Organization

Interpersonal skills

Adaptability

Medical terminology

Regulatory knowledge

Education

High school diploma or GED

Bachelor's degree preferred

Job description

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

Clinical Operations Manager

Full Time Corpus Christi, TX, US

2 days ago Requisition ID: 1111

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)
• 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

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 Pinnacle Clinical Research:

• 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!

Pinnacle Clinical Research is an equal opportunity employer. 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.