Nurse Research Coordinator

🎯 Role Definition

As a Nurse Research Coordinator, you are the cornerstone of successful clinical trials. You will serve as a vital link between the Principal Investigator, study sponsors, the Institutional Review Board (IRB), and most importantly, the study participants. This multifaceted role requires a unique combination of clinical nursing skills, meticulous data management, and exceptional interpersonal abilities. You will be responsible for the day-to-day execution of research protocols, from patient recruitment and informed consent to data collection and regulatory oversight. Your work directly contributes to the development of new therapies and the advancement of patient care, making this a highly rewarding career for a detail-oriented and compassionate nursing professional.

📈 Career Progression

Typical Career Path

Entry Point From:

Registered Nurse (RN) with clinical experience
Clinical Research Assistant
Data Coordinator

Advancement To:

Senior Research Nurse Coordinator
Clinical Research Manager
Clinical Trial Manager
Lead Clinical Research Associate (CRA)

Lateral Moves:

Clinical Research Associate (CRA)
Regulatory Affairs Specialist
Medical Science Liaison

Core Responsibilities

Primary Functions

Coordinate and implement all aspects of assigned clinical research protocols from initiation through to close-out, ensuring adherence to the study timeline and objectives.
Screen potential participants for protocol eligibility, perform comprehensive recruitment activities, and ensure the informed consent process is conducted ethically and correctly.
Manage the complete lifecycle of study participants, including scheduling all necessary visits, administering study medications or interventions, and performing detailed clinical assessments.
Perform a variety of protocol-specific clinical procedures such as phlebotomy, IV infusions, EKG administration, and the precise collection of vital signs and other biological specimens.
Ensure the accurate, complete, and timely collection and documentation of study data onto Case Report Forms (CRFs) and into Electronic Data Capture (EDC) systems.
Maintain meticulous and audit-ready regulatory binders, source documents, and other essential study files in strict accordance with GCP, FDA, and IRB regulations.
Serve as the primary liaison and communication point between study subjects, the Principal Investigator, study sponsors, Contract Research Organizations (CROs), and the Institutional Review Board (IRB).
Prepare for, participate in, and respond to findings from site initiation visits, routine monitoring visits, internal/external audits, and study close-out visits conducted by sponsors or regulatory agencies.
Educate patients, their families, and other healthcare professionals on the intricate details of the study protocol, including procedures, visit schedules, and potential risks and benefits.
Schedule and coordinate all subject study visits, including complex appointments with ancillary departments like radiology, pharmacy, and specialized laboratories, ensuring seamless patient flow.
Promptly identify, document, and report all adverse events (AEs), serious adverse events (SAEs), and protocol deviations to the Principal Investigator, sponsor, and IRB per established guidelines.
Manage the full accountability of the investigational product (IP), including receipt, secure temperature-monitored storage, accurate dispensing, patient compliance tracking, and final reconciliation or return.
Assist the Principal Investigator with the preparation, submission, and maintenance of all IRB-related documents, including initial applications, amendments, continuing reviews, and final reports.
Conduct ongoing quality control and quality assurance activities, such as source data verification, to ensure the integrity of clinical data and unwavering adherence to the study protocol.
Collaborate effectively with a multidisciplinary team, including physicians, data managers, pharmacists, and administrative staff, to ensure seamless and efficient study execution.
Proactively identify and resolve logistical challenges, patient care issues, and procedural roadblocks that arise during the dynamic course of a clinical trial.
Develop and implement innovative and effective patient recruitment strategies in order to meet or exceed enrollment goals and contractual timelines.
Perform comprehensive clinical assessments of study participants and meticulously evaluate their response to treatment, communicating all critical findings to the investigator team.
Champion the protection of human research subjects by ensuring all study activities uphold the highest ethical standards and safeguard participant rights, safety, confidentiality, and well-being.
Abstract and transcribe complex medical information from electronic health records (EHR) and other source documents into study-specific databases and case report forms.
Assist in managing the study budget by tracking subject visits, procedures, and associated costs to ensure financial compliance and facilitate timely sponsor invoicing.
Participate in investigator meetings, site trainings, and continuing education activities to remain current on therapeutic areas and evolving research best practices.

Secondary Functions

Support the development of new research protocols, including feasibility assessment and budget creation.
Contribute to the creation of study-specific source document templates and patient-facing educational materials.
Mentor and provide guidance to junior research staff, such as Clinical Research Assistants or Data Coordinators.
Participate in process improvement initiatives aimed at enhancing the efficiency and quality of clinical research operations.

Required Skills & Competencies

Hard Skills (Technical)

In-depth knowledge of Good Clinical Practice (GCP), FDA regulations, and Institutional Review Board (IRB) requirements.
Proficiency with Electronic Data Capture (EDC) systems (e.g., Medidata Rave, InForm, Oracle Clinical) and Clinical Trial Management Systems (CTMS).
Competent clinical nursing skills including phlebotomy, IV management, medication administration, EKG, and comprehensive patient assessment.
Expertise in navigating Electronic Medical/Health Record (EMR/EHR) systems such as Epic, Cerner, or Allscripts for data abstraction.
Experience with investigational product (IP) management, including storage, dispensing, and accountability logs.
High proficiency in the Microsoft Office Suite (Word, Excel, PowerPoint, Outlook) for documentation, tracking, and communication.

Soft Skills

Meticulous attention to detail and superior organizational skills to manage complex, multi-faceted projects.
Exceptional interpersonal and communication skills (written and verbal) for interacting effectively with patients, sponsors, and diverse clinical teams.
Strong critical thinking, problem-solving, and proactive decision-making abilities in a fast-paced environment.
Proven ability to work autonomously with minimal supervision while also functioning as a highly collaborative team member.
Excellent time management and prioritization skills to handle multiple complex protocols and competing deadlines simultaneously.
Unwavering patient advocacy and a deep sense of empathy and compassion for research participants.

Education & Experience

Educational Background

Minimum Education:

Associate's Degree in Nursing (ADN) or Bachelor of Science in Nursing (BSN).
Active, unencumbered Registered Nurse (RN) license in the state of practice.
Basic Life Support (BLS) certification.

Preferred Education:

Bachelor of Science in Nursing (BSN) or Master of Science in Nursing (MSN).
Clinical Research Certification (e.g., CCRC from ACRP or CCRP from SoCRA).

Relevant Fields of Study:

Nursing
Health Sciences
Biological Sciences

Experience Requirements

Typical Experience Range: 2-5 years of professional experience.

Preferred:

At least 2 years of clinical nursing experience in a hospital or clinic setting.
1-2 years of direct experience as a Clinical Research Coordinator or Nurse Research Coordinator.