Clinical Research Nurse Coordinator

Pharmaron • Baltimore, MD

1d • $100,000 - $113,000 • Onsite

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).
• 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.
• Active and unrestricted Registered Nurse (RN) license in the State of Maryland (required).
• ACLS certification (or ability to obtain within 3 months of hire).
• Strong knowledge of GCP, ICH guidelines, and FDA regulatory requirements.

Responsibilities

• Demonstrates knowledge and application of all privacy and safety standards as they relate to job responsibilities, human research subjects, staff, and the general operation of the unit.
• Interacts and communicates with, as well as delegates to (as necessary) all internal departments to achieve successful coordination and participant care during the entire duration of study.
• Maintains detailed knowledge and understanding of assigned protocols, including all protocol requirements for patient/subject visits, obtaining informed consent, visit schedules, tests, procedures, laboratory information, and drug accountability requirements.
• Assists or creates, and assesses the completion of enrollment log, deviation log, and all study documentation forms, including source documents consistent with the IRB approved protocol and other study specific documents.
• Completes electronic data capture training for each study and reviews case report forms, when available, for each study against the IRB approved protocol and provide recommendations, as deemed necessary.
• Communicate to research participants, both orally and written, concerning research activities, and risks and benefits of study participation, in all study documents and research participant communications.
• Maintain subject level Prepare documents, equipment, or supplies for research visits. Conduct and document visits and protocol- specific testing/interviews according to study protocol.
• Performs nursing and study-related tasks and procedures, such as obtaining and preparing medication orders, investigational product administration, phlebotomy, urine collections, placement, and maintenance of IV catheters, vital signs and ECGs as required by both inpatient and outpatient protocols.
• Collect, prepare, or process adverse event information per protocol, and provide input for adverse event May complete and submit Adverse Events Reports, according to institution and sponsor-specific prompt reporting requirements (timelines and forms).

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