Clinical Research Nurse Job Description

Clinical Research Nurse Job Description

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Clinical research nurse provides direct care to research patients, including drug administration, lab draws, coordination of appointments, follow-up and management of side effects.

Clinical Research Nurse Duties & Responsibilities

To write an effective clinical research nurse job description, begin by listing detailed duties, responsibilities and expectations. We have included clinical research nurse job description templates that you can modify and use.

Sample responsibilities for this position include:

Ensure that studies are implemented in full compliance with FDA Regulations and Guidelines, Good Clinical Practices (GCP) and Department of Defense (DoD) and Department of the Army (DA) regulations, guidelines, and practices
Maintain study files, provide copies of forms to study sponsor, IRB, general clinical research center, FDA including reporting of SAEs, AEs per regulatory and institutional guidelines
Will provide direct nursing services (care) using the nursing process in support of a clinical research trial
Evaluating and enrolling patients in clinical research studies
Performs study procedures (e.g., start intravenous lines, venipunctures, obtain biological specimen samples, obtain ECG recordings, vital signs, safety assessments, ) as required by study protocol under the supervision of the Clinical Research Coordinator, Principal Investigator, and Sub-Investigators
Provide as an integral member of the clinical research team provide direct nursing care to research study participants
Participate in an individualized training/orientation program geared to teaching or reinforcing the principles of Clinical Nursing Research practiced at MSKCC
Participates in direct patient care only within the scope of assigned clinical research protocols
Facilitate and participate the execution of study-related activities of a Phase I clinical research study conducted at the Phase 1 Unit in relation to areas of responsibility
Collaborates closely with Principal Investigator (PI) and clinical research team to ensure that key federal/state/local regulatory requirements are followed

Clinical Research Nurse Qualifications

Qualifications for a job description may include education, certification, and experience.

Licensing or Certifications for Clinical Research Nurse

List any licenses or certifications required by the position: ACLS, BLS, ACRP, OCN, ONS, CPR, CCRP, CCRC, AHA, BLCS

Education for Clinical Research Nurse

Typically a job would require a certain level of education.

Employers hiring for the clinical research nurse job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Associate Degree in Nursing, Education, Science, Communication, Associates, Oncology, Nursing Program, Health, Life Science, Registered Nursing

Skills for Clinical Research Nurse

Desired skills for clinical research nurse include:

Excel
Dosage ranges
Indications
Principles
Side effects
Clinical research
Medical terminology
Outlook
Practices
Microsoft Office with keen attention to detail

Desired experience for clinical research nurse includes:

Leading the Nurse Scholar's program
Developing educational programs for the nursing staff
Implementing scholarly activities related to research nursing (e.g., journal clubs, distribution of reprints, identifying speakers for in-service education)
Leading the effort to have Research Nursing recognized as an advanced practice specialty and developing educational materials, such as manuals, textbooks, and scholarly papers to establish the core information and competencies for Research Nursing at the national level
Participating in the International Society for Research Nursing and leading cross-cultural international training programs in Research Nursing
Conducting original research on Research Nursing and Research Nurse Education and disseminating the findings via presentations at professional meetings and peer-reviewed publications

Clinical Research Nurse Examples

1

Clinical Research Nurse Job Description

Job Description Example
Our growing company is searching for experienced candidates for the position of clinical research nurse. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for clinical research nurse
  • Adhering to trial protocols and legislation
  • Dose investigational product via– oral, topical, inhalation, IM, SC, intranasal, and IV route
  • Perform standard nursing care like vital signs, ECG and holter monitoring in a controlled and timed environment
  • Collecting trial data
  • Participate in development, review and evaluation of study contracts and agreements including identifying resources needed to conduct and evaluate study procedures and data
  • Extract data from source documents and complete Case Report Forms (CRF) or database entries
  • Aid with administrative duties for the clinical program including but not limited to
  • Providing direct patient care involving diagnosis, administration of medications, and performance of tests under the direction of the principal investigator or supervising physician
  • Oversees and monitors the well-being and safety of study participants by active assessment by serving as a visible point of contact at all times
  • Works with CSM and Training Manager to provide protocol training to the clinical study team, to communicate on-the-spot performance direction
Qualifications for clinical research nurse
  • At least an associate's degree in nursing
  • Successful completion of a full 4-year course of study in nursing from an accredited college or university leading to a bachelor's or higher degree
  • Showing a flexible attitude with respect to work assignments, new learnings and willingness to work on shift
  • Interfacing with the study PIs, Lead Research Coordinator, and Child Psychology Specialist on a regular basis to develop, implement, and monitor adherence to research protocols and standard operating procedures for the research study
  • Following up with research participants in accordance with established protocols, which may involve coordinating staffing or scheduling encounters
  • Maintain research records, which may include entering data into research data bases
2

Clinical Research Nurse Job Description

Job Description Example
Our innovative and growing company is looking to fill the role of clinical research nurse. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for clinical research nurse
  • Assist in the design of recruitment strategies
  • Recruit participants according to IRB approved methodologies
  • Coordination of visits, Schedule participant visits with support services, perform interviews and clinical assessment to collect data required by the protocol
  • Attend and participate in investigator meetings and calls with the sponsors
  • Order and receive drug/device supplies
  • Oversee proper documentation of close-out as required by grant sponsors including return of unused supplies, reconciliation of test/drug accountability forms, study summary, evaluation of team effort and subject enrollment
  • Work involves organizing and executing a phase 3 clinical protocols to compare the safety and immunogenicity of two smallpox vaccines
  • Ensure appropriate and accurate documentation of patient care in the medical record and in designated electronic case report forms and specific computer programs
  • Advise, perform, and instruct staff, research participants and/or others about protocol-specific procedures and treatments, equipment, policies, adverse medication reactions, and follow-up instructions appropriate to the research study
  • Perform and/or assist in participants’ briefings and screenings, to include obtaining of informed consent
Qualifications for clinical research nurse
  • Successful completion of a full 4-year course of study in an accredited college or university leading to a bachelor's or higher degree in nursing from an accredited nursing program
  • Experience working with toddlers and preschool age children, including performing developmental assessments of and obtaining venous blood samples from toddlers and preschool age children
  • Bachelor’s degree in Nursing AND current RN licensure in the state of Maryland
  • Must possess basic skills in clinical nursing including drawing blood with butterfly needles and IV catheters
  • Must possess and maintain certification to conduct human research such as HIPAA and CITI training
  • Based on guidance from Lead Principal Investigator, Site Principal Investigator and Nurse Protocol Coordinator, will update research investigators of relevant issues, concerns, and progress of study
3

Clinical Research Nurse Job Description

Job Description Example
Our innovative and growing company is hiring for a clinical research nurse. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for clinical research nurse
  • Assist research investigators in collecting study data and statistics
  • Assist PI in submitting annual Continuing Review Reports (CRRs) and annual report for the study
  • Write and review Standard Operating Procedures (SOP) and Study Specific Procedures (SSP) and guidelines
  • Quality Control (QC) of tracking and filing of all protocol laboratory test results and samples
  • QC the preparation of study charts, source documents, labels and laboratory and other test results
  • QC of test article (vaccine) accountability
  • QC of regulatory study file to include filing of necessary documents per protocol SOP, Food and Drug Administration (FDA) and DA requirements
  • Prepare regulatory files and study records for QA audits, monitoring, and assists in responses to audits and monitoring visits
  • Reviewing medical records
  • Preparing materials for submission to the IRB and participating in protocol development by drafting study protocols and/or reviewing potential protocols to evaluate their effect on standard nursing procedures
Qualifications for clinical research nurse
  • Must possess and maintain a license as a registered nurse in a state or US territory that license nurses
  • Have a current BLS certification
  • Must be GCP (Good Clinical Practice) trained or willing to complete such training
  • Have completed HIPAA training and will comply with proper handling of proprietary information
  • None required beyond that described above
  • Or Associate’s degree from an accredited institution in Nursing plus 3 years clinical nursing experience
4

Clinical Research Nurse Job Description

Job Description Example
Our growing company is hiring for a clinical research nurse. We appreciate you taking the time to review the list of qualifications and to apply for the position. If you don’t fill all of the qualifications, you may still be considered depending on your level of experience.
Responsibilities for clinical research nurse
  • Perform patient assessment, offer patient education and patient/family support
  • Assists with grant and budget preparation
  • Develops, implements, and supports research process by assisting investigators in study design, completion of approval process, and management of clinical trials specific to the Peds ID VTEU
  • The NIH/DMID VTEU contract for multiple current and upcoming clinical trials requires that nurse coordinators be available to conduct study visits, make appropriate safety assessments, and document all activities as required by each protocol
  • Study product administration, obtaining samples (serum, urine, stool) using appropriate techniques, and obtaining individual clinical assessments (EKG, Vital signs, BMI, health history) are critical to the success of DMID sponsored trials
  • Mandated training will be required per DMID, NIH, Emory IRB, EHSO and credentialing healthcare entities (EHC, CHOA, Grady)
  • Maintain safety and confidentiality of study subjects throughout the study
  • Study organization and documentation
  • Collection of study data, CRF completion, maintaining source documentation
  • Performing patient study visits
Qualifications for clinical research nurse
  • Or LPN or Diploma in Nursing plus 4 years clinical nursing experience
  • Involved in external professional organizations
  • Preferred oncology nursing experience (at least 1-2 years)
  • Preferred research and/or oncology research experience
  • Registered nurse with a current, active Colorado license, preferred certification in oncology nursing
  • Acts as a professional role model in all aspects of performance
5

Clinical Research Nurse Job Description

Job Description Example
Our company is looking to fill the role of clinical research nurse. We appreciate you taking the time to review the list of qualifications and to apply for the position. If you don’t fill all of the qualifications, you may still be considered depending on your level of experience.
Responsibilities for clinical research nurse
  • Coordination of visits, Schedule participant visits with support services, perform interviews and clinical assessment to collect data required by the grant
  • Assist adult hematology physicians with sickle cell patients 18-21 transition to their service
  • Assist in community programs for patient population including off site workshops, conferences as needed and creating/updating educational materials
  • Participate in team meetings and calls with the collaborating physicians and ancillary support staff
  • Recruit, screen, enroll, and follow study participants over the course of a study as outlined in assigned cardiovascular research protocols
  • Coordinates the implementation of clinical protocols at Northwestern and subsites
  • Responsible for ongoing data collection and maintenance of confidential records
  • Complete protocol specific nursing assessments for study participants with appropriate documentation in the source record or case report form
  • Coordinates with study staff to ensure proper documentation and timing of research-related procedures
  • Perform clinical procedures such as IV placement, blood draws from peripheral sites
Qualifications for clinical research nurse
  • Willingness and ability to learn and perform a variety of technical procedures such as drawing blood, processing and harvesting lab specimens, taking vital signs, performing ECGs
  • Prior experience in outpatient medical practice with women’s health and/or osteoporosis a plus
  • VA RN license
  • Minimum three (3) years of practical work experience in healthcare, five (5) years preferred
  • While not required, individuals with Advanced Practice Nursing degree will also be strongly considered for this role
  • May be expected to sit for CCRP or CCRC certification exam upon eligibility

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