CLINICAL RESEARCH NURSE JOB DESCRIPTION

A Clinical Research Nurse is the person a study protocol cannot function without on the floor. Coordinating ICH/GCP-compliant trial activities, managing informed consent, and maintaining IRB-required documentation are the steady work of each week. The role sits within hospital-based or sponsor-supported research units, answering to a Principal Investigator while serving study subjects, clinical teams, and regulatory agencies simultaneously. Adverse event reporting and enrollment retention are the two measures that most visibly reflect how well this seat is held.

As the Clinical Research Nurse, you own the direct clinical and regulatory execution of assigned trials, from subject screening and consent through adverse event documentation and protocol closeout. The position operates within a multidisciplinary research team, coordinating across investigators, IRB representatives, sponsors, and bedside nursing staff to keep study timelines and compliance standards intact.

Career Impact: Hands-on management of FDA-regulated investigational product studies and GCP-governed protocols builds a documented compliance record that distinguishes candidates at senior research and lead coordinator levels.

Business Impact: Enrollment rates, adverse event turnaround, and source documentation accuracy in this role directly determine whether a sponsor continues site funding and whether subject safety is maintained across trial phases.

Growth Opportunity: Experience across Phase 1 through Phase 4 trials, combined with eligibility for ACRP or SOCRA certification, expands scope toward Clinical Trials Manager and Principal Investigator-adjacent functions.

• Coordinate daily clinical trial activities across assigned protocols, ensuring staffing levels and participant schedules meet study visit windows.
• Screen and consent eligible study subjects in accordance with IRB-approved procedures and sponsor eligibility criteria.
• Perform clinical procedures including blood draws, vital signs, ECG recording, IV administration, and specimen collection and shipment.
• Monitor study subjects for adverse events, document findings on protocol-required forms, and report to investigators and sponsors within required timeframes.
• Maintain source documentation, complete case report forms, and ensure 100% source document verification for data entered into study systems.
• Collaborate with the Principal Investigator and IRB on regulatory submissions, protocol modifications, and continuation review reports.
• Train and orient clinical and research staff on protocol-specific procedures, GCP standards, and data collection requirements.
• Attend site initiation visits, investigator meetings, and sponsor monitoring visits to represent site readiness and protocol compliance.

• Bachelor's degree in Nursing or equivalent work experience.
• 2 or more years of registered nursing experience, with at least one year in a clinical research or acute care setting.
• Active, unrestricted RN license in the state of employment, with BLS certification current at time of hire.
• Demonstrated knowledge of ICH/GCP guidelines, IRB submission processes, and FDA regulatory requirements for clinical trials.
• Ability to perform phlebotomy, IV placement, ECG recording, and vital sign assessment independently.
• Strong written and verbal communication skills, with capacity to document adverse events and protocol deviations accurately.
• Proven ability to manage multiple concurrent study protocols with minimal supervision and shifting priorities.
• Competency in clinical problem-solving and assessment across patient populations enrolled in interventional research studies.

• Certification through the Association of Clinical Research Professionals or the Society of Clinical Research Associates.
• Experience coordinating Phase 1 through Phase 4 trials, including familiarity with CTMS data entry workflows.
• BSN or MSN from an accredited nursing program, with prior exposure to investigator-initiated protocol development.
• Proficiency in medical record documentation within electronic health record systems used in research settings.

• Enrollment rate against target, measured monthly per assigned protocol.
• Adverse event reporting turnaround, tracked from event identification to sponsor notification.
• Source document error rate per monitoring visit, with threshold defined by sponsor agreement.
• Protocol deviation count per quarter, attributed to nursing-executed study procedures.
• Subject retention rate from consent through final study visit, per protocol retention goals.
• Typical tools: Clinical trial management systems (commonly Medidata Rave or similar); electronic health records (commonly Epic or Cerner).

• Base Salary Range: $72,000 to $95,000 annually, depending on experience and location.
• Bonus: Annual merit-based bonus of 3 to 6 percent of base salary.
• Equity: Not typically offered in hospital or academic research settings.
• Health Benefits: Medical, dental, and vision coverage; employer contributes majority of premium.
• PTO: 15 to 22 days annually, plus observed federal holidays.
• Common Perks: Continuing education reimbursement, certification exam fee coverage, and shift differential for evenings or weekends.

Figures are estimates based on general US market benchmarks and may be outdated. Adjust based on location, company size, and seniority level.

Successful completion of a background check, including criminal history and applicable drug screening, is required as a condition of employment in this patient-care setting. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, veteran status, or any other characteristic protected under applicable federal, state, and local law. Reasonable accommodations are available to individuals with disabilities throughout the application and employment process. Candidates must be authorized to work in the United States.

The Clinical Research Nurse owns the delivery of safe, high-quality trial participation by managing nursing activities, collecting and verifying clinical data, and overseeing lab duties and medicinal product storage. Reporting to the clinical trials team, the Clinical Research Nurse supports patient retention and drives quality assurance measures in line with ICH/GCP guidelines.

Key Responsibilities

• Provide a high quality and safe research environment.
• Manage nursing activities related to clinical trials.
• Work in line with ICH/GCP guidelines.
• Drive quality assurance measures.
• Collect, record, review and verify clinical data.
• Perform patient interest visits.
• Keep patients engaged in the study to ensure retention.
• Oversee lab duties and the storage of medicinal products.

Required Qualifications

• Registered Nurse with NMC Pin.
• 5+ years of post-registration experience as a minimum.
• Clinical research experience is desirable.
• Ability to work within wider MDT with minimal supervision.
• Patient-focused attitude.
• Self-motivated with excellent organisational skills.

Embedded within the Performance Improvement and clinical trials team, the Clinical Research Nurse delivers direct patient care, coordinates daily trial activities, and supports GCP compliance and regulatory document submission across all study phases. Working closely with the Clinical Trials Manager, Principal Investigator, physicians, and sponsors, the Clinical Research Nurse shapes patient safety outcomes and enrollment strategies for approved clinical trials.

Core Functions

• Use therapeutic communication, including active listening and teaching, to provide research intervention care to clinical research patients and coordinate with interprofessional team as written in the research protocol.
• Contribute to teamwork by consistently responding positively to requests for assistance.
• Provide patient education regarding disease process and involve patient and family in decision-making processes.
• Advocate on patient and family behalf to identify and resolve clinical and ethical concerns, utilizing appropriate resources.
• Facilitate onboarding and orientation process for new staff in conjunction with Clinical Trials Manager.
• Precept new clinical research staff in clinical setting.
• Coordinate pre-site and site initiation visits and train hospital and clinic nurses and physicians on scientific aspects and protocol requirements of research studies.
• Provide comprehensive nursing assessments to develop, coordinate, implement and evaluate activities associated with all phases of clinical research projects.
• Monitor safety of all research subjects and report adverse events.
• Follow the clinical research protocol and nursing process and modify care based on continuous evaluation of the research patient's condition.
• Collect, process and ship protocol-required lab specimens and maintain supply and equipment inventory.
• Collaborate with Principal Investigator and Institutional Review Board on regulatory documents for submission assuring compliance with local and federal regulatory standards.
• Identify, recruit, and consent clinical research subjects for participation in approved clinical trials and monitor enrollment goals.
• Enter study-related data into Clinical Trials Management System in accordance with research institute policy.
• Identify and present areas for innovation, efficiency and improvement in patient care operations using evidence-based practice literature.

Qualifications & Experience

• Bachelor's degree in Nursing or higher from an accredited school of nursing.
• Texas RN license or temporary TX RN license, to be obtained within 90 days.
• American Heart Association Basic Life Support (BLS) certification.
• One year of acute care or clinical research experience.
• Demonstrated clinical problem-solving and critical thinking using an analytical approach.
• Ability to adapt to multiple ongoing priorities with minimal supervision, including organizing workflow and actively participating in problem-solving.
• Strong interpersonal and team player skills with all levels of the healthcare team.
• Basic computer knowledge with ability to operate multiple computer systems including Hospital Information Systems and Office software.
• Sufficient proficiency in speaking, reading, and writing English to perform essential job functions.

Reporting to the Principal Investigator, the Clinical Research Nurse leads all aspects of clinical trial coordination, including direct patient care, regulatory document preparation, adverse event reporting, and staff training across multiple hospital locations. Partnering with sponsors, IRB representatives, and supervising physicians, the Clinical Research Nurse builds compliant, high-quality research operations under Good Clinical Practice standards.

Primary Duties

• Facilitate, maintain, and coordinate the logistical aspects of assigned study protocols with other research staff in accordance with Good Clinical Practice, standard operating procedures, applicable nursing practices and sponsor requirements.
• Provide direct nursing patient care including inpatient admission and discharge, diagnosis, administration of medications, and performance of applicable clinical study-related tests.
• Maintain continual clinical assessment of study subjects under the direction of the principal investigator or supervising physician.
• Attend investigator's meetings and coordinate and attend pre-study site visits, study initiation visits, and all other study-related visits by monitors or sponsor representatives.
• Schedule and lead in-house protocol meetings to review study-related procedures, staffing and visit flow.
• Schedule and coordinate all medical needs and coverage for protocol-related procedures.
• Maintain and document all study-related communication including with the principal investigator, study subjects, sponsor or sponsor representatives, and IRB throughout the clinical trial.
• Provide subject instructions for study participation and serve as the primary contact for subjects to handle study-specific questions, concerns, or events.
• Obtain and document all adverse event data on appropriate forms and report to appropriate parties as outlined by the study protocol, regulations and applicable policies.
• Ensure accurate, complete and timely data entry into CRFs using 100% source documentation verification.
• Schedule, lead and assist with all study-related visits on site and remain available during visits for applicable corrections and questions.
• Maintain research files, design forms as needed, and assist in preparation or review of material for submission to an IRB.
• Train other study-specific research staff in collection and reporting of required data.
• Travel between hospital locations where research is conducted.

Skills & Qualifications

• Bachelor's degree or equivalent experience.
• Licensed as a Registered Nurse.
• Certification by the Association of Clinical Research Professionals or The Society of Clinical Research Associates preferred.
• Two years of experience in managing all aspects of clinical research trials with in-depth knowledge of protocol requirements and Good Clinical Practice.
• Three to five years of experience in clinical research trials preferred.
• Intermediate computer and internet knowledge.
• Meticulous organisational skills.
• Excellent written and verbal communication abilities.
• Excellent customer service and patient care skills.

Sitting at the intersection of clinical care and research compliance, the Clinical Research Nurse Coordinator leads protocol feasibility review, participant recruitment and screening, regulatory documentation, and data collection across assigned studies. Operating across investigator clinics, sponsor monitoring visits, and patient care teams, the Clinical Research Nurse Coordinator enables accurate, compliant execution of clinical trials from initiation through closeout.

Duties

• Participate in protocol development and review potential protocols to evaluate feasibility and implementation within standard clinical practices.
• Generate forms and prepare applications for regulatory approvals, manage regulatory processes and documentation for assigned studies.
• Recruit study participants from investigators' clinics, by referrals and advertisements.
• Screen and evaluate potential participants to ensure eligibility requirements are met, obtain informed consent, and schedule visits in accordance with study protocols.
• Perform and oversee study data collection and data entry in accordance with study protocols.
• Perform medical tests including vital signs, blood draws, and electrocardiograms.
• Schedule and coordinate required laboratory tests, imaging studies and exams.
• Evaluate and develop patient educational materials and provide patients and family members with instructions on investigational drug or device administration.
• Train, coordinate and educate patient care team in the conduct of study protocols.
• Inventory and requisition research study supplies and equipment and arrange for repair, maintenance and calibration of equipment.
• Coordinate and participate in monitoring visits with sponsors and regulatory agencies.
• Ensure clinical research is conducted in compliance with the study protocol and all applicable SOPs, laws and standards.

Education & Experience

• Bachelor's degree from a State Board of Nursing approved school of nursing and one year of professional nursing experience, OR Associate's degree or diploma in Nursing and three years of professional nursing experience.
• Two or more years of experience in the healthcare field.
• At least one year of clinical trials research experience preferred.
• Knowledge of principles, practices and techniques of clinical care.
• Knowledge of clinical research regulatory guidelines and regulations.
• Knowledge of medical practices and terminology.
• Knowledge of computer systems and applications.

A key member of the traveling clinical operations team, the Traveling Clinical Research Nurse delivers investigational product administration, adverse event assessment and management, and specimen collection across study sites in accordance with protocol requirements. Collaborating across internal teams, investigators, review boards, and study subjects, the Traveling Clinical Research Nurse leads patient scheduling, medication dispensing, and compliance monitoring to support safe and efficient trial conduct.

Functions

• Administer investigational product intravenously, including starting and monitoring IV.
• Assist physician in management of infusion reactions.
• Maintain a clean, efficient clinical area to assure the highest standards of patient care.
• Follow safety and PPE procedures and maintain proper documentation of infusion procedures.
• Provide ongoing assessment of the study subject to identify adverse events.
• Provide medical management of adverse events as appropriate.
• Communicate in a timely manner with internal teams, investigators, review boards, and study subjects.
• Prescreen study candidates by telephone and review exclusionary conditions or medications prior to scheduling screening appointments.
• Obtain informed consent per SOP.
• Administer delegated study questionnaires and collect and evaluate medical records.
• Complete visit procedures and ensure proper specimen collection, processing and shipment in accordance with protocol.
• Train others and complete basic clinical procedures such as blood draws, vital signs, and ECGs.
• Review laboratory results, ECGs, and other test results for completeness and alert values, ensuring timely investigator review.
• Schedule patients within visit windows and integrate visits with existing schedules to maximize efficient workflow and patient turnaround.
• Dispense study medication per protocol and educate patients on proper administration and importance of compliance.
• Monitor patient progress on study medication.

Requirements

• At least two years of experience as a Registered Nurse.
• Phlebotomy experience required.
• Ability to check and document vitals and perform EKG.
• Good management and organisational skills with understanding of medical procedures.
• Exceptional interpersonal skills with ability to work independently.
• Command of professional and business English, written and spoken.
• Ability to lift a minimum of 50 pounds.
• Authorization to work in the US for any employer.

Safe and effective execution of investigator-initiated clinical trials depends on the Clinical Research Nurse C, who independently coordinates trial enrollment, administers novel research medications, monitors patient progress, and develops SOPs and internal budgets across all study phases. Based within the clinical research unit, the Clinical Research Nurse C serves as a resource for junior staff and working groups while ensuring compliance with all relevant regulatory standards.

Accountabilities

• Independently coordinate clinical trials including consenting, screening and enrolling eligible subjects, with support of the study team.
• Manage patient treatment throughout study participation including education about potential adverse effects.
• Provide oversight and coordination of research testing and follow-up, and directly administer novel research medications where applicable.
• Monitor the care and progress of patients, treatment of side effects, and patient status throughout study participation.
• Provide patient and family education and support.
• Assist in writing and development of investigator-initiated protocols and participate in or lead working groups within the clinical research unit.
• Develop SOPs and educate and train clinical and research staff.
• Provide input into the development of efficient workflows and attend meetings related to studies.
• Develop and institute internal strategies for meeting and exceeding trial enrollment and assuring compliance with all relevant regulatory standards.
• Help develop internal budgets for sponsored trials and assist in the development of investigator-initiated trials.

Minimum Qualifications

• RN license without restriction or limitation required.
• BSN or MSN preferred.
• At least 2 to 3 years of experience in a clinical setting or equivalent combination of education and experience.
• At least two years of research experience preferred.
• Recent experience with venipuncture for phlebotomy and IV infusions preferred.
• Excellent communication and interpersonal skills.
• Strong attention to detail.

As the Clinical Research Nurse, this role coordinates clinical trial activities across study teams, investigators, ancillary departments, and external institutions, performing clinical procedures and maintaining regulatory documentation for FDA-regulated investigational product research. The clinical trials team relies on this work to ensure protocol compliance, accurate adverse event reporting, and safe implementation of study requirements for patients, families, and collaborating physicians.

Operational Focus

• Coordinate clinical trial activities with study team and investigators to ensure appropriate staffing levels and participant coordination for daily trial activities.
• Determine patient study eligibility, ensure informed consent, and monitor patient's clinical course.
• Perform clinical procedures including blood draws, vital signs, drug administration, and specimen collection as outlined in the protocols.
• Place peripheral IVs proficiently.
• Act as a clinical liaison for protocols with clinical teams, patients, other institutions, and drug companies.
• Educate clinical teams, ancillary departments, patients, and families about protocols to ensure safe and accurate implementation in compliance with protocol requirements.
• Assist in maintaining regulatory documentation related to patient care and adverse events.
• Assist in preparing continuation review reports, protocol modifications, and other study reports.
• Maintain appropriate source documentation and complete case report forms.
• Compile and present status reports to the principal investigator, research team, sponsors, regulatory bodies, nursing staff, and physicians as requested.
• Identify, assess, and report adverse events in accordance with protocol, regulatory guidelines, and institutional policy.

Professional Experience

• BSN or BA/BS in related field required.
• Current, active Washington State Registered Nursing license required.
• Minimum 2 years as a Registered Nurse.
• Minimum 2 years of experience in clinical practice working with FDA-regulated investigational products in a research setting.
• Strong written and verbal communication skills.
• Proficiency in basic computer skills including EMR, Word, Excel, PowerPoint, and Outlook.
• Ability to work under pressure related to work and time deadlines.

Clinical Research Nurse manages data and sample collection, nursing assessment of physiologic response to drug administration, cardiac monitoring, and emergency interventions across all assigned study activities in accordance with scientific, medical, and ethical principles. The work directly supports volunteer and patient safety and ensures full regulatory compliance throughout every phase of the clinical research process.

Key Deliverables

• Ensure clinical trials are conducted in accordance with scientific, medical, and ethical principles, within regulatory requirements and guidelines.
• Ensure volunteer and patient safety throughout the study.
• Execute and maintain accurate data and sample collection according to protocol requirements and document electronic and written data.
• Perform self-check on data collected during daily activities.
• Execute multiple study activities including nursing assessment of physiologic response to drug administration, administration of study medications, cardiac monitoring, basic nursing care, and emergency interventions.

Background & Experience

• Bachelor's degree in Nursing.
• Minimum of 1 year of general medical-surgical nursing experience including competency in phlebotomy, venipuncture techniques, and performing electrocardiograms.
• Clinical nursing and emergency intervention skills demonstrating excellent assessment and standard of care.
• Working knowledge of computers and laboratory data handling acquisition systems.
• Ability to work effectively in multifunctional, interdepartmental management teams.
• English, Dutch, and/or French language proficiency.
• Available to work in various shifts including weekends, evenings, and nights.