Main Responsibilities and Required Skills for a Clinical Research Nurse
A Clinical Research Nurse is a professional who plays a vital role in the field of medical research. They contribute to the advancement of healthcare by assisting in clinical trials and studies, ensuring patient safety, and collecting accurate data. In this blog post, we describe the primary responsibilities and the most in-demand hard and soft skills for Clinical Research Nurses.
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Main Responsibilities of a Clinical Research Nurse
The following list describes the typical responsibilities of a Clinical Research Nurse:
Act as
Act as a liaison between study sponsors, investigators, and participants.
Adhere to
Adhere to EMS management processes and foster this within the team.
Adhere to ethical guidelines and protect participants' rights and welfare.
Apply
Apply in depth knowledge of clinical research and coordinate conduct of complex studies.
Assist
Assist in design of case-report forms and / or questionnaires.
Assist in identifying, reporting and following-up on Serious Adverse Events.
Assist in the delivery of improved training program in the clinical preceptor role.
Assist in the development and implementation of research protocols.
Assist in the maintenance of study medication accountability records.
Assist in the preparation of manuscripts for publication.
Assist in the preparation of research grant proposals.
Assist PI with annual approval process and amending protocols and consents as required.
Assist the anesthesiologist during procedures related to lumbar punctures.
Assist trial Investigators in screening and review of potential study participants' eligibility.
Attend
Attend Investigator Meetings, as assigned.
Collaborate with
Collaborate, as required, with other team members involved in care.
Collaborate in the organization for certain special events.
Collaborate to develop tools and work methods (tables, documents, statistics, etc.) for staff.
Collaborate with interdisciplinary teams to ensure participant safety.
Collaborate with multidisciplinary team members.
Collaborate with research coordinators and principal investigators.
Collaborate with research teams to troubleshoot and resolve issues.
Collaborate with study monitors by ensuring good communication and providing necessary materials.
Collaborate with the Managers and the Human Resources Consultant at all time.
Collect
Collect and accurately record research data and ensure adherence to protocol guidelines.
Collect blood samples on participants (when appropriate).
Collect and enter data as necessary.
Collect and prepare documents as required by sponsoring agencies.
Collect, store and ship biological samples.
Complete
Complete Case Report Forms.
Complete the forms according to the procedures.
Conduct
Conduct informed consent discussions with potential participants.
Conduct literature reviews and assist with the development of research protocols.
Conduct protocol evaluation and feasibility assessment of proposed clinical research.
Conduct study-related physical exams and follow-up visits.
Contact
Contact person for study participants during whole study phase.
Contribute to
Contribute to the development of research-related policies and procedures.
Coordinate
Coordinate all clinical research activities with minimal supervision.
Coordinate and facilitate research meetings and conferences.
Coordinate and manage the scheduling of research visits.
Coordinate and monitor the stock levels onboard the unit and report weekly.
Coordinate clinical experiment scheduling and collection of data.
Coordinate monitoring activities with Sponsor's representative(s).
Create
Create and maintain a clear rota of daily responsibilities to be implemented by the unit team.
Create, maintain and follow-up on various inventories of supplies and medications.
Develop
Develop advertisement materials, informed consent document, Case Report Forms.
Develop and maintain positive relationships with participants and their families.
Develop an individualized timeline for each protocol.
Develop clinical quality management plans and materials.
Develop patient information, informed consent forms, and patient recruitment materials.
Develop strategies to assure compliance of study participants with protocol requirements.
Document
Document investigational product (drug / device) accountability.
Document resolution and report to appropriate individuals.
Document results of study participants in accordance with protocols.
Educate
Educate staff and patients on assigned study protocols / clinical trials.
Engage
Engage in continuous professional development and pursue relevant certifications.
Ensure
Ensure compliance with all federal and local regulations.
Ensure compliance with EMS' Environmental Policy, principles, and ethics.
Ensure patients are informed of available clinical trials.
Ensure proper management of equipment, handling, storage and shipping of biological samples.
Ensure proper storage and handling of investigational products and study supplies.
Ensure quality patient care, safety, and adherence to GCP principles.
Ensure that the teams have the paperwork and consumables to carry out each aspect of the study.
Ensure the maintenance and proper functioning of health care materials and equipment.
Ensure the medical safety of volunteers.
Ensure the preparation and smooth running of visits related to the research programs.
Ensure the proper destruction of unused laboratory equipment.
Ensure the quality of the database and supervising database cleaning.
Facilitate
Facilitate pre-study, site qualification, study initiation, and monitoring visits.
Facilitate study close out activities.
Follow
Follow Good Clinical Practice (GCP) guidelines and study protocols.
Follow Good Clinical Practice guidelines and federal regulations (IHC, April 1996).
Follow the established procedures of the various research programs on the techniques to be applied.
Gather
Gather, compile, organize, analyze and report research information and study results.
Identify
Identify own learning needs and pursues appropriate learning activities.
Identify personal goals.
Infuse
Infuse study drugs and monitor patients.
Keep abreast of
Keep abreast of regulations and policies governing clinical research.
Liaise with
Liaise with and organise where necessary the daily collection of samples with couriers.
Maintain
Maintain case report forms, charts and documentation.
Maintain Clinical Trial.gov /.
Maintain competency in skills as required.
Maintain compliance with regulatory requirements and institutional policies.
Maintain confidentiality and privacy of participant information.
Maintain delegation logs.
Maintain equipment log & calibration records.
Maintain multiple study databases.
Maintain NIH and CITI training in accordance with local IRB policy.
Maintain proper documentation.
Maintain thorough and organized documentation of study-related activities.
Maintain up-to-date records and transcripts at all times.
Make
Make recommendations related to equipment or nursing tasks as needed.
Manage
Manage CIF's document control system and maintain a tracking system of SOPs.
Manage expired medications.
Manage infection control and sterilization of health care equipment.
Manage study finances including sponsor invoicing & resolving study subject billing issues.
Mentor
Mentor new clinical research coordinators.
Monitor
Monitor budget plans and management.
Monitor daily usage and maintain adequate levels of clinical supplies.
Monitor participants' progress and identify any adverse reactions or side effects.
Monitor serious adverse events or reactions and reporting immediately to PI.
Participate in
Participate in data analysis and contribute to research findings.
Participate in internal and / or external meetings according to the employer's needs.
Perform
Perform and record physical measurements including vital signs and body measurements.
Perform data quality checks and ensure accuracy and completeness.
Perform physical assessments and administer investigational treatments or medications.
Perform the required tasks in the various computer portals.
Perform timed blood samples.
Prepare
Prepare and administer parenteral solutions.
Prepare and submit reports to regulatory authorities and ethics committees.
Prepare clinical specimens for shipment to central laboratories.
Provide
Provide and direct nursing care in a research environment.
Provide education and support to participants regarding the study procedures and their role.
Provide ethical oversight in support of the clinical study.
Provide ethical, safe, and holistic nursing care of clinical research participants.
Provide guidance, advice, and support for the team during the daily operation of the study.
Provide guidance and mentorship to junior staff or new researchers.
Provide instructions and assistance to clinical research volunteers.
Provide support to other research team members, where necessary.
Record
Record adverse events with referral to medical providers for evaluation & treatment.
Recruit
Recruit eligible participants for clinical trials.
Recruit and enroll clinical study participants.
Report
Report adverse events to the nursing assistant and physician when necessary.
Report any sickness related absences to the Clinical Service Manager.
Research
Research and prepare equipment and supplies in accordance with institutional procedures.
Respect
Respect the internal policies and procedures in effect.
Respond to
Respond to follow-up requests following monitor visits.
Respond to sponsor queries, prepares for audits by sponsor, IRB and / or the FDA / DHHS.
Review
Review and adheres to assigned research study protocol.
Review, comprehends, and adheres to assigned study protocol.
Review data output on a daily basis to ensure the highest level of quality and accuracy.
Review lab results, imaging reports, and other study-specific reports.
Screen
Screen and enroll patients for studies.
Set-up
Set-up and assign protocol procedures and preclinical (bench or animal) experiments.
Stay updated with
Stay updated with current research trends and advances in the field.
Support
Support any other duties / activities required for the efficient running of the facility.
Support for data management and study data entry.
Support, participate in, and host regulatory inspections.
Undertake
Undertake regular liaison with the Clinical Services Manager.
Utilize
Utilize EHR systems to generate day-to-day study needs such as volunteer badges and study rosters.
Utilize evidence-based practice methods to improve patient care.
Utilize therapeutic communication skills.
Work with
Work with clinical research coordinators.
Most In-demand Hard Skills
The following list describes the most required technical skills of a Clinical Research Nurse:
Proficiency in data collection and management software.
Knowledge of medical terminology and healthcare practices.
Familiarity with electronic health record (EHR) systems.
Ability to operate medical devices and equipment.
Competence in administering investigational treatments or medications.
Understanding of statistical analysis and data interpretation.
Experience with clinical trial protocols and regulatory requirements.
Knowledge of research ethics and regulatory guidelines (e.g., ICH-GCP).
Ability to analyze and interpret research data accurately.
Proficiency in Microsoft Office Suite for data analysis and reporting.
Skill in conducting literature reviews and synthesizing evidence.
Competence in clinical assessment and physical examinations.
Understanding of research methodologies and study design.
Knowledge of adverse event reporting and safety monitoring.
Experience with clinical research documentation and record-keeping.
Familiarity with medical coding and classification systems (e.g., ICD-10).
Proficiency in using specialized research software or databases.
Ability to perform protocol-specific laboratory tests.
Knowledge of clinical research regulations and guidelines (e.g., FDA).
Skill in maintaining accurate and organized research records.
Most In-demand Soft Skills
The following list describes the most required soft skills of a Clinical Research Nurse:
Effective Communication: The ability to communicate clearly and effectively with participants, healthcare professionals, and research team members is crucial in ensuring accurate information exchange and maintaining collaborative relationships.
Empathy and Compassion: Demonstrating empathy and compassion towards participants helps create a supportive and trusting environment, enabling them to feel comfortable and valued throughout the research process.
Attention to Detail: Being detail-oriented is essential for accurately collecting and documenting research data, ensuring adherence to protocol guidelines, and identifying any discrepancies or errors.
Critical Thinking: Clinical Research Nurses must possess strong critical thinking skills to assess complex situations, make sound judgments, and solve problems effectively. This skill is particularly valuable when dealing with unexpected situations or adverse events.
Time Management: Effective time management skills are necessary for balancing multiple responsibilities, meeting deadlines, and efficiently coordinating research visits and procedures.
Flexibility and Adaptability: Clinical research environments can be dynamic and subject to changes. Being adaptable and flexible allows Clinical Research Nurses to navigate evolving circumstances, adjust protocols, and provide seamless support to participants and the research team.
Collaboration and Teamwork: Working collaboratively with interdisciplinary teams, such as physicians, research coordinators, and laboratory personnel, is essential for successful clinical research. Strong teamwork skills promote effective coordination, information sharing, and problem-solving.
Ethical Conduct: Upholding high ethical standards and demonstrating integrity in research practices is fundamental for protecting participant rights, ensuring confidentiality, and maintaining public trust.
Leadership: Clinical Research Nurses may be responsible for supervising and mentoring junior staff members. Possessing leadership skills allows them to provide guidance, foster professional growth, and promote a positive research culture.
Continuous Learning: Clinical research is a rapidly evolving field. Having a growth mindset and a commitment to continuous learning enables Clinical Research Nurses to stay updated with emerging research techniques, technologies, and best practices.
Conclusion
Clinical Research Nurses play a critical role in advancing medical knowledge and improving patient care through their involvement in clinical trials and research studies. This blog post has outlined the primary responsibilities of Clinical Research Nurses, emphasizing the importance of a diverse set of hard and soft skills. From technical proficiency to effective communication and ethical conduct, possessing the right skills equips Clinical Research Nurses to excel in their roles and contribute to the success of clinical research endeavors.
