Clinical Research Coordinator Registered Nurse

JOB SUMMARY

The Clinical Research Nurse role is a specialized practice of professional nursing focused on maintaining equilibrium between the care of the research participants and fidelity to the research protocol. Utilizing Good Clinical Practice, the Clinical Research Nurse ensures assigned studies are conducted following the Food and Drug Administration (FDA), Office for Human Research Protections (OHRP), local regulations, Institutional Review Board Approvals, and Memorial Healthcare policies and procedures under the guidance and supervision of the Principal Investigator (PI). The Clinical Research Nurse will be responsible for facilitating research studies, providing knowledgeable information regarding each research protocol to Memorial Healthcare staff, evaluating the eligibility of potential candidates for research studies, assisting in the informed consent process, monitoring research study compliance, collecting and submitting data; coordinating required study procedures to meet protocol requirements and data management. Additionally, this position will provide clinical support for improved practice and patient outcomes and collaborate with other healthcare professionals to provide care, health promotion, and education.

PRIMARY JOB RESPONSIBILITIES

1. Ensures human subject protection via diligence in research participant screening, recruitment, consenting, enrollment, randomization, treatment monitoring, follow-up procedures, and ongoing risk assessment related to research interventions and protocol activities.
2. Ensures ongoing research informed consent, addresses participant questions throughout study participation, and supports their goal for participating or terminating study participation.
3. Coordinates research activities to minimize participant risk and ensure participant safety.
4. Distributes study articles (drugs, devices), administers study drugs, and maintains study article accountability documentation.
5. Provides patient education and medical information to study patients to ensure understanding of proper medication dosage, administration, and disease treatment.
6. Performs medical tests, including but not limited to vital signs, sample collection, and electrocardiograms.
7. Collects, prepares, processes, and ships biological samples per study protocols and International Air Transport Association (IATA) requirements.
8. Provides care coordination and continuity, integrating research and clinical activities to meet the clinical needs of research participants, coordinates and completes research protocol activities, and communicates with referring providers when necessary.
9. Ensures appropriate credentialing and training of the Memorial Healthcare staff regarding research and protocol requirements.
10. Ensures scientific data integrity and maintains participant privacy, confidentiality, and safety of patients enrolled in clinical trials.
11. Develops source documentation forms and tools per study protocol requirements.
12. Documents all study-related procedures/events via electronic data capture systems, case report forms, etc.
13. Communicates effectively with research participants and their families, the research team, principal investigators, external study sponsors, primary care providers (e.g., clinical nurses, physicians, etc.), ancillary staff, and the IRB to ensure protocol adherence, participant safety, and Regulatory compliance.
14. Participates in study site activation activities, including regulatory documentation training of the research team and impacted departments.
15. Participates in clinical study planning for investigator-initiated Initiated Trials sponsored research agreements.
16. Prepares and conducts training activities for assigned trials. The number of trials depends on the phase, number of enrolled subjects, and study complexity.
17. Assists with internal and external site audits.
18. Supports regulatory efforts in maintaining regulatory documents following Memorial Healthcare Standards of Practice and applicable regulations.
19. Assists in maintaining clinicaltrials.gov information for investigator-initiated Initiated Trials and Sponsored Research Agreements.
20. Promotes research revenue cycle best practices by communicating protocol coverage as outlined in the study's Medicare Coverage Analysis (modifier codes, secondary diagnosis, etc.).
21. Maintains accurate documentation of study stipend and reimbursement per study protocol, informed consent, and budget.
22. Acts as a liaison between site, investigators, principal investigator, Memorial Healthcare, IRBs, and study sponsors.
23. Creates study-related reports as requested.
24. Participates in meetings and provides information regarding applicable clinical trials.
25. Participates in continuing education activities related to research to improve knowledge for job performance.
26. Ensures compliance with research protocols by providing ongoing quality control audits, including ongoing investigational drug accountability.
27. Participates with the PI and study team to identify and prioritize the development of systems and infrastructure to maintain research quality and compliance.
28. Maintains IATA, Good Clinical Practice, and other certifications as required.
29. Occasional travel to satellite sites and to attend sponsor study training meetings as required
30. Performs other duties as assigned.

JOB SPECIFICATIONS

EDUCATION

1. BSN required, or a registered nurse with a BA/BS degree in an applied science field (biology, psychology, or other clinical research area or equivalent education) experience required.
2. Clinical Research Certification CCRC/CCRP is preferred but not required.

EXPERIENCE

1. Current Registered Nurse (RN) with licensure in the State of Michigan is required.
2. Minimum two years prior clinical experience as a registered nurse or equivalent clinical trial experience.
3. Minimum of 1-2 years experience with research-related activities with clinical practice, ICH guidelines, FDA and OHRP regulations, IND and SAE reporting, and protection of human research participant standards, regulations, and laws preferred.
4. Current phlebotomy and ECG skills preferred
5. MS Word, Excel, Outlook, and EMR experience required
6. BLS

ESSENTIAL PHYSICAL ABILITIES/MOTOR SKILLS/SENSORY REQUIREMENTS

These physical requirements are not exhaustive and additional job related physical requirements may be added on an as needed basis. Corrective devices may be used to meet physical requirements.

1. Sedentary Work: Frequently required to stand, kneel and crouch. On a daily basis may be required to move about, sit, climb stairs and bend. Is frequently required to lift and carry up to 20 lbs. May be required to push/pull/carry items between 20-100 lbs.
2. Vision: Requires the ability to perceive the nature of objects by the eye. Near acuity: Clarity of vision at 20 inches or less. Midrange Acuity: Clarity of vision at distances of more than 20 inches and less than 20 feet.
3. Motor Coordination: While performing the duties of the job, it is required to regularly perform functions that include using hand and finger movement, handle or feel objects, be able to use tools or equipment that requires reaching with hands and arms. Must be able to travel independently throughout hospital; access patients/families including areas confined by space and/or equipment.
4. Speaking/Hearing: Ability to give and receive information through speaking and listening skills.

ESSENTIAL TECHNICAL ABILITIES

1. Able to navigate computer systems and enter data into database.
2. Use of Microsoft Office Products
3. Computer and basic office equipment proficiency required.

ESSENTIAL MENTAL ABILITIES

1. Motivated "self-starter" with ability to exercise initiative.
2. Detailed oriented with strong written and verbal communication skills.
3. Able to problem solve. Identifies and resolves problems in a timely manner. Gathers and analyzes information skillfully.
4. Analytical, prioritization and planning of work activities.
5. Adapts for changing conditions.
6. Ability to manage multiple priorities.

INTERPERSONAL SKILLS

1. Can apply effective interpersonal skills to provide service. Comfortable working in a team environment as well as independently.
2. Adapts to changes in the work environment.