CLINICAL RESEARCH NURSE / COLLEGE OF MEDICINE

CLINICAL RESEARCH NURSE / COLLEGE OF MEDICINE

This position is comprised of both clinical and regulatory responsibilities. Clinical responsibilities may include assisting with developing and implementing the activities of a clinical research trial which consists of pre-screening patients for study eligibility and performing delegated study tasks including but not limited to: treatment procedures, drawing blood, performing EKGs, administration and accountability of study medication/study devices, recording adverse events, monitoring patient retention, withdrawals, ethical/legal practices, and audit preparation. This position may be expected to act as the primary contact with the sponsor's study monitoring individual(s), be a resource for developing operational plans, become an expert regarding the study plan, and maintain awareness of all ongoing activities, ensuring proper handling of all paperwork. Depending upon the type and complexity of a given trial, these roles and responsibilities may be shared with or assigned to other research staff at the discretion of the director of clinical research or principal investigator (PI). Regulatory responsibilities include understanding compliance with federal, state, and local laws as they relate to the performance of human patient's research, as well as preparation and maintenance of all regulatory documentation for assigned studies. This position may be responsible for presenting the study to the Institutional Review Board (IRB) and/or other departments. It is the responsibility of the position to schedule and conduct study specific training for any additional staff within the research department as well as ancillary departments. Travel may be required between clinical sites for training or study related patient visits mainly throughout the Saginaw/Tri-Cities area.

Required Qualifications - Bachelor's degree from an accredited school of nursing with passage of an RN licensure exam. Four years of nursing experience related to the duties of the position. Current registration with the State of Michigan Board of Nursing as a Registered Nurse (RN). Certificate of completion for CITI training or willingness to obtain training upon hire. Ability to analyze and interpret data and maintain confidentiality. Strong interpersonal and communication skills.

Preferred Qualifications - Two years of experience conducting single/multicenter clinical trials, human subject research, or similar activities. Clinical research certification. BLS certification.

Duties & Responsibilities - Acts as a liaison between hospital physicians and the principal investigator (PI). Professionally interacts with physicians, hospital committees, etc. Works collaboratively with investigators, sub-investigators, referring physicians, patients and their families, other clinical research coordinators, research sponsors and research organizations, vendors, and ancillary hospital/clinical staff. Networks at sponsored research events as a representative for the Covenant Healthcare College of Medicine at Central Michigan University. Works in a team environment to facilitate and execute study protocol requirements. Acquires and maintains training and certifications to perform delegated research procedures. Follows state and federal regulations, specific protocol requirements, and Good Clinical Practice Guidelines. Provides training for new employees, ancillary departments, and volunteers. Participates in unit conferences and continuing education activities to meet institutional and departmental requirements, as required. Develops and collaborates with research sponsors for upcoming research studies. Recruits study patients and establishes a patient/coordinator relationship, remaining attentive to patient's specific needs and discussing them with the PI. Coordinates all aspects of research study requirements. Carries out assigned work as required for specific duties related to study preparation, execution, and post-study documentation. Assists with the coordination and execution of the study feasibility assessment, site qualification visits, and site initiation visits. Performs study-specific duties, including but not limited to, completion of case report forms, coordinating/tracking patient visits and receipts, and processing various reports generated by sponsors/site liaisons for sponsors/monitors, and query resolution. Trains study patients under direction of the PI. Assesses patients for consenting into clinical trials based on inclusion/exclusion criteria. Executes and conducts study visits as protocol is written, ensuring that safety related deviations are promptly reported to the sponsor and regulatory bodies, as required. Documents study procedures in source worksheets or dedicated database. Prepares documentation as required by the study sponsor and/or the PI. Creates, updates, and maintains regulatory documents and provides regulatory documents to the study sponsor, maintaining contact with the sponsor throughout the study regarding regulatory issues. Completes adverse event reporting, preparation for monitor visits, and internal/external audits as necessary. Maintains supply inventory, completing reorders as necessary, and receives and inspects new research materials. Performs quality control activities and initiatives. Maintains accurate receipts and inventory of investigational or approved study medications and/or devices. Follows Michigan State, local, and federal laws and Michigan Licensing guidelines to administer study medications as described in the Investigator's Brochure, study protocol, or Instructions For Use. Oversees laboratory set-up, monitoring and inventory of study supplies, and the dissolution process for studies. Collects blood or biological samples as described in the protocol, laboratory manual, or standard operating procedure. Processes and ships any lab specimens as required per protocol, including but not limited to blood, stool, sputum samples, etc. Prepares lab samples, supplies, and study medication for storage/shipment. Develops and maintains IATA Training. Develops, prepares, and presents new project proposal packets, annual reviews, and interim study documents for submission to the Institutional Review Board(s). This may include the following: creation of drafts for informed consent forms, abstracts, communications with sponsors and/or committees, determination of consent form changes per protocol, amendments, presentation of new study information to the Institutional Review Board-New Study packet, revisions, serious adverse events, protocol deviations, etc. Completes required documentation for visit billing in a timely manner. Collaborates with the Finance Department for the completion of all monthly reports. Reviews patient billing and works with the proper departments to correct any disputes or adjustments as needed. Develops and reviews invoices for services provided related to internal research studies and research studies completed by other organizations (i.e. Professional Billing, Hospital Departments, Independent Physician Offices, Institutional Review Boards, Vendors, Sponsor, etc.). Performs other duties as delegated and assigned.