Clinical Research Nurse RN

Summary

Clinical Research Nursing is the specialized practice of professional nursing focused on maintaining equilibrium between care of the research participant and fidelity of the research protocol (ANA, 2016). The Clinical Research Nurse is responsible for human subject protection, care coordination and continuity, contribution to clinical science, clinical practice and study management. (IACRN, 2012). MyMichigan Clinical Research Nurses work within a dedicated Research Department as a part of the health system focused primarily on clinical trials in multiple specialty areas. Clinical trials may include pharmaceutical and device trials and other research projects directly related to patient treatment or care. The Clinical Research Nurse works under the guidance and supervision of the Principal Investigator, ensures the integrity and quality of clinical trials are maintained and conducted with federal, state, and local regulations, IRB board approvals, and MyMichigan Health policies and procedures.


Responsibilities

(50%)* - Providing Direct Patient Care to Research Study Participants

- Ensure compliance with each study's protocol by providing through review and documentation at each study visit

- Participates in recruitment and selection of study participants by interviewing and documenting medical history to determine compliance with eligibility requirements

- Performs medical tests, including but not limited to, vital signs, lab draws and processing, and electrocardiograms

- Administers investigational medication and performs patient assessments during clinic visits to determine presence of side effects; notifies Principal Investigator of findings/issues

- Provides patient education and medical information to study participants to ensure understanding of proper medication dosage, administration, and disease treatment

- Documents medical data in patient chart to capture protocol requirements

(40%)* As a study coordinator, ensures assigned studies are conducted inaccordance with the Food and Drug Administration (FDA), Office of Research Protections (OHRP ), and Good Clinical Practice (GCP)guidelines

- Ensure site compliance with research protocols by reviewing all regulatory requirements to confirm implementation of appropriate methods, practices, and procedures for all research activities

- Develops accurate source materials to ensure compliance from all site staff

- Provides accurate and timely data collection, documentation, entry, and reporting in both sponsors, Clinical Research leadership, and overseeing IRB, as indicated

- Ensures appropriate training and credentialing for assigned protocols and associated staff

- Supports the regulatory staff in the maintenance of regulatory documents

- Communicates and collaborates specific study requirements to there search team, including internal and external parties, sponsors, monitors, PI, and study participants

- Ensures compliance with research protocols through participation in ongoing quality control audits, including maintaining ongoing investigational drug accountability

(10%)* - Complete required professional development and compliance training activities required by MyMichigan Health and as needed for the position.

- Maintain Good Clinical Practice, IATA, and other training as required

- Complete Annual Compliance Modules for position

- Participate as a part of the research team to identify and prioritize the development of systems and infrastructure to maintain research quality and compliance

- Occasional travel to attend sponsor study training meetings

- On-call for weekends/evenings - rotated among all study coordinators

- based on FTE allocation

OTHER DUTIES AND RESPONSIBILITIES:

Demonstrate excellent customer service.

Always promotes subject safety.

Contribute to the MyMichigan Health organization targets for patient satisfaction and net operating margin.

Follow ALCOA principles for research documentation.

Establish effective working relationships with participants, families, physicians, physician office staff, hospital staff, pharmaceutical company representatives, and research related visitors.

Acts as liaison between all involved clinical areas and staff of the protocol requirements.

Work collaboratively with investigators, sub investigators, referring physicians, other clinical research nurses, and hospital staff.

Provides education for patients and families regarding the protocol, including the disease process, plan of care, symptom awareness, and the need to report adverse events.

Provide in service education to the clinical staff of the hospitals (pharmacy, nursing, etc.) related to investigational drugs, devices, or procedures, including physiological effects, drug interactions, side effects, nursing care considerations, etc.

Communicate serious adverse events to all appropriate sources.

Accountable to the Manager of Cardiovascular Research.

Represent MyMichigan Health as a professional, high-quality clinical site.

Prepares, coordinates, and participates in on-site monitor visits.

Analyzes protocol and assists in the creation of source documents.

Coordinates activities related to billing, notification of appropriate departments, lab orders, etc.

Understand and contribute to the functional unit plan goals and objectives that align with the organization's strategic plan.

Follow patients and complete post-hospital follow ups, including clinical assessments.

Performs blood draws and basic lab tests as required by the protocol.

Coordinates and provides patient care and follow up to research patients as indicated per protocol and remains available 24 hours daily when on call.

Educate study participants about their rights as research subjects, answer questions, and refer these to the primary investigator.

Ascertain the adequacy of the document and obtain informed consent following the federal regulations before beginning study related procedures.

Provides a copy of signed informed consent to the participant.

Serve as a resource (along with the PI) for questions or concerns of the participant.

Maintain OSHA and Universal Precautions and associated training.

Keep participant's welfare uppermost in mind regarding emergencies, study procedures, termination of the study, etc.

Provides participants with research-related materials.

Reviews and has knowledge of Clinical Research policies and procedures.

Complete and maintain source documents.

Establishes procedures for randomization, blinding, and data collection.

Resolve all sponsor queries regarding participant information.

Per standard operating procedures, document follow up with participants about ongoing adverse events after study completion.

Maintains, closes, and archives study documents according to standard operating procedure.


Certifications and Licensures

ACLS - Advanced Cardiac Life Support

Preferred

BLS - Basic Life Support

Required Equivalent Experience - Within 1 month of hire or transfer

RN - Registered Nurse

Required Equivalent Experience - BSN is preferred.


Required Education

Education: Associates Degree

Comments: Bachelor's degree in nursing preferred.

Other Information

EXPERIENCE, TRAINING AND SKILLS:

- Valid RN license

- Two years of recent clinical nursing experience in a hospital, clinic, or similar health care setting

- Knowledge of medical terminology, drug calculation skills, clinical medicine, clinical trials, and GCP concepts

- Knowledge of federal, state and local regulations, including HIPAA policies and procedures

- Detail oriented and meticulous in all aspects of work

- Strong follow through skills and ability to proactively identify and solve problems; demonstrated initiative is imperative

- Must have a professional demeanor, strong communication skills with patients and physicians and co-workers

- Ability to work independently and as a part of a team

- Strong interpersonal, customer service, and multi-tasking skills are critical

- Must be proficient in Microsoft Office Word and EXCEL, electronic health systems and databases used in the research environment, or have the willingness to learn and demonstrate proficiency

- Ability to work well under pressure, multi-task, and manage deadlines

PHYSICAL/MENTAL REQUIREMENTS AND TYPICAL WORKING CONDITIONS:

Exposure to stressful situations, including those involving public contact, as well as, trauma, grief and death.

Able to wear personal protective equipment that includes latex materials or appropriate substitute if required for your position.

Can move freely about facility with or without an assisted device and must be able to perform the functions of the job as outlined in the job description.

Overall vision and hearing are necessary with or without assisted device(s).

Frequently required to sit/stand/walk for long periods of time. May require frequent postural changes such as stooping, kneeling or crouching.

Some exposure to blood borne pathogens and other potentially infectious material. Must follow MyMichigan Health bloodborne pathogen and TB testing as required.

Ability to handle multiple tasks, get along with others, work independently, regular and predictable attendance and ability to stay awake.

Overall dexterity is required including handling, reaching, grasping, fingering and feeling. May require repetition of these movements on a regular to frequent basis.

Physical Demand Level: Medium. Must be able to occasionally (0?33% of the workday) lift or carry 21?50 lbs., frequently 34?66% of the workday 20 lbs. and or Walk/Stand/Push/Pull of Arm/Leg controls and constantly (67?100% or the workday) 10 lbs.


Equivalent Experience and Other Comments (Education)

Other Comments