Clinical Research Nurse Coordinator

Pharmaron • Baltimore, MD

265d • $100,000 - $115,000

About The Position

The Clinical Research Nurse Coordinator is responsible for the coordination and execution of clinical trials in accordance with Good Clinical Practices (GCP), institutional policies, and all applicable regulatory guidelines. This role requires a licensed Registered Nurse with proven clinical experience, preferably in a research setting, who is capable of working independently and collaboratively to ensure the safety, well-being, and informed consent of all research participants.

Requirements

• Bachelor of Science in Nursing (BSN).
• Active and unrestricted Registered Nurse (RN) license in the State of Maryland (required).
• Minimum of three (3) years of experience in clinical research or a similar clinical coordination role, preferably within a Phase I or early-phase research setting.
• ACLS certification (or ability to obtain within 3 months of hire).
• Strong knowledge of GCP, ICH guidelines, and FDA regulatory requirements.
• Exceptional organizational and communication skills, with the ability to manage multiple projects and priorities concurrently.
• Proficiency in electronic data capture systems and Microsoft Office Suite.
• Ability to work in a physically demanding environment, including lifting up to 50 lbs., and standing for extended periods as needed.

Responsibilities

• Implement clinical research protocols as approved by the Institutional Review Board (IRB), ensuring compliance with GCP, FDA regulations, and internal Standard Operating Procedures (SOPs).
• Oversee all aspects of participant care during study visits, including medical assessments, study procedure scheduling, and safety monitoring.
• Perform and/or supervise clinical procedures as required by study protocols, including but not limited to phlebotomy, ECGs, vital signs, BMI calculations, specimen collection, and investigational product administration.
• Provide clear, detailed explanations to study participants regarding study objectives, procedures, risks, and benefits, and obtain and document informed consent in accordance with regulatory standards.
• Maintain comprehensive and accurate documentation in source documents and case report forms (CRFs), whether paper or electronic (eCRFs).
• Identify and report adverse events and protocol deviations in a timely manner; assist in developing corrective and preventive action plans as necessary.
• Collaborate with clinical and regulatory teams to ensure that study start-up and close-out procedures are completed effectively, including inventory management, document archiving, and audit readiness.
• Serve as a clinical resource and mentor for junior staff, including Clinical Research Coordinators and Research Assistants.
• Maintain up-to-date certifications and participate in continuing education and training related to clinical research, safety protocols, and nursing practice.
• Other duties may be assigned as needed.

Benefits

• Insurance including Medical, Dental & Vision with significant employer contributions
• Employer-funded Health Reimbursement Account
• Healthcare & Dependent Care Flexible Spending Accounts
• 100% Employer-paid Employee Life and AD&D Insurance, Short- and Long-Term Disability Insurance
• 401k plan with generous employer match
• Access to an Employee Assistance Program

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Professional, Scientific, and Technical Services
• Education Level: Bachelor's degree