Clinical Trials Navigator: Study Operations & Compliance

Prolerity Clinical Research, Inc.; Somers Point (NJ); On-site; USD 48,000 - 72,000; Full time

Job summary

Prolerity Clinical Research, Inc. is seeking a Clinical Research Coordinator to oversee daily operational activities of assigned studies. You will work with investigators, clinical staff, sponsors, and CROs to ensure adherence to protocols, regulatory requirements, and ethical standards.

You will own study coordination, documentation, data management, and sponsor communications from start-up through close-out, maintaining quality and compliance across all trial phases.

Qualifications

• Bachelor’s degree in a related field.
• Minimum of two (2) years of clinical research or clinical trial management experience.
• Preferred credentials: medical certification or licensure (e.g., MS, LPN, RN).
• Phlebotomy experience with blood draws and handling specimens.

Responsibilities

• Study Management & Coordination: Organize, plan, and coordinate all aspects of assigned clinical trials from initiation through close-out.
• Recruitment, Enrollment & Consent: Collaborate with recruitment teams to support participant screening and enrollment; conduct informed consent discussions.
• Clinical Oversight & Subject Monitoring: Monitor and assess study subjects; document adverse events; escalate safety concerns as required.
• Documentation, Data & Systems: Maintain source documentation, enter data into EDC, resolve sponsor or monitor queries; report protocol deviations.
• Investigational Product & Specimen Management: Manage investigational product records; collect, process, package, and ship specimens; perform phlebotomy when trained.
• Quality, Compliance & Team Support: Ensure compliance with SOPs/GCP, assist audits, mentor coordinators, maintain confidentiality.
• Communication & Outreach: Serve as primary sponsor/CRO contact; participate in outreach events; communicate study updates and issues.
• Additional Responsibilities: Duties may evolve with protocol complexity and business needs.

Skills

Leadership

Communication

Organization

Attention to detail

Independent work

Time management

Office software

Confidentiality

Education

Bachelor’s degree in a related field

Tools

EDC systems

Job description

Prolerity Clinical Research, Inc. is seeking a Clinical Research Coordinator to oversee daily operational activities of assigned studies. You will work with investigators, clinical staff, sponsors, and CROs to ensure adherence to protocols, regulatory requirements, and ethical standards.

You will own study coordination, documentation, data management, and sponsor communications from start-up through close-out, maintaining quality and compliance across all trial phases.