Job Description

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JOB OVERVIEW

The Clinical Research Site Manager oversees all daily study-coordination activities—from protocol design and study start-up through close-out. In this leadership role, you will mentor and train staff while guiding the planning, execution, monitoring, and evaluation of clinical trials. Responsibilities include:

• Directing study operations, ensuring protocols are implemented accurately and on schedule.
• Providing hands-on leadership and mentorship to research investigators, nurses, and coordinators.
• Developing, refining, and enforcing research policies and procedures that safeguard participants and uphold regulatory compliance.

This position blends strategic oversight with clinical expertise to ensure each study meets its scientific goals while protecting the well-being of every participant.

CORE JOB FUNCTIONS

• ·Works with investigators and study teams to help meet targets and milestones, ensures timely and accurate submission to IRBs, sponsors and master agreements, and coordinates with the Site Director on remediation.
• Coordinates the efforts of relevant team members to manage, retain and control all applicable Regulatory Affairs.
• Plans, implements, and evaluates strategies to effectively monitor, document, report, and follow-up on protocol deviations, unanticipated occurrences, adverse effects and evaluates and manages preventive/corrective actions.
• Oversees administrative duties related to study personnel including orientation, assuring core competencies, certification mandates, safety/responsible conduct of research education; conducts performance reviews.
• Assesses, documents, promotes, and problem solves study participants’, research team members’, and clinical personnel’s adherence to clinical research procedures, protocol, and timeline.
• Manages investigator relationships. Supervises clinicians’ administration of study drugs/device/materials according to practice standards and clinical credentials. Ensures licensed and trained personnel administer study products according to protocol, safety standards, and credentialing mandates.
• Assumes leadership in clinical meetings, conferences, and seminars as clinical research study liaison.
• Tracks proposals and other study-relevant documentation through signature/approval processes, then through collaboration with Contracts and budgets.
• Serves as liaison and facilitates meetings between project stakeholders and leadership and completes and maintains professional documentation for projects and deliverables, develops SOPs as needed, and assists in the auditing and monitoring of studies.
• Identifies areas for improvement within daily functions, internal procedures, and regulatory agency interactions.
• Interacts with project team members to define submission logistics and workflow scheduling.
• Develops, implements, maintains, and oversees internal policies and SOPs to maintain compliance with FDA regulations and other Clinical Research Best Practices.

SKILLS

• Exceptional leadership and communication skills with experience in clinical research development.
• Knowledge of business and management principles.
• Ability to direct, manage, implement, and evaluate department operations.
• Ability to establish department goals, and objectives that support the strategic plan.
• Ability to effectively plan, delegate and/or supervise the work of others.
• Ability to lead, motivate, develop, and train others.

This list of duties and responsibilities is not intended to be all-inclusive and may be expanded to include other duties or responsibilities as necessary.

MINIMUM QUALIFICATION

Education:

Master’s degree in relevant field preferred.

Certification and Licensing:

SOCRA or ACRP certification is required.

Experience:

Five (5) years of experience managing an extensive clinical research program or project is required.

This position is onsite.

Join our team as a Site Manager where you can contribute to advancing medical research while leading a dedicated team in a dynamic environment.

Job Type: Full-time

Pay: $83,200.00 - $104,000.00 per year

Benefits:

• Dental insurance
• Health insurance
• Paid time off
• Parental leave
• Vision insurance

Schedule:

• 8 hour shift
• Monday to Friday
• Weekends as needed

Education:

• Bachelor's (Required)

Experience:

• clinical (NOT IN A LABORATORY) research site management: 5 years (Required)
• clinical (NOT IN A LABORATORY) research: 7 years (Required)

Language:

• Spanish (Preferred)

License/Certification:

• CCRC/CCRP certification from SOCRA or ACRP? (Required)

Ability to Commute:

• Miami, FL 33142 (Required)

Work Location: In person

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