Clinical Research Nurse/Cmed
Position Number: S-3209
Type of Recruitment: External
Position Summary:
This position is comprised of both clinical responsibilities and regulatory responsibilities. Clinical responsibilities may include assisting with developing and implementing the activities of a clinical research trial which consists of selection of patients, treatment procedures, drawing blood, performing EKGs, recording adverse events, withdrawals, ethical/legal practices, monitoring 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 (Pl). Regulatory responsibilities include understanding of 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.
Required Qualifications:
Graduation from an accredited school of nursing.
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 certification.
One year nursing experience related to the duties of the position.
Strong interpersonal and communication skills required.
Ability to analyze and interpret data and maintain confidentiality required.
Preferred Qualifications:
Bachelor of Science in Nursing degree.
BLS certification.
Experience conducting single/multicenter clinical trials, human subject research or similar activities.
Duties & Responsibilities:
Acts as a liaison between hospital physicians and principal investigator (PI). Professionally interacts with physicians, hospital committees, etc.
Works collaboratively with investigator, sub-investigators, referring physicians, patients and their families, other clinical research coordinators, vendors, research organizations, and hospital staff.
Continually networks at sponsored research events as a representative for CMU College of Medicine. Develops and collaborates with research sponsors for upcoming research studies.
Acquires and maintains thorough knowledge of current research procedures, guidelines, federal regulations, and specific protocol requirements.
Recruits consent study patients and establishes a patient/coordinator relationship. The CR-RN must be attentive to patient’s specific needs and discuss them with the Pl.
Coordinates all aspects of research study exercises.
Carries out assigned work as required for specific duties related to study preparation, execution, and post-study documentation.
Performs study-specific duties, including but not limited to, completion of case report forms, coordinating/tracking patient visits, and receipts and processing of various reports generated by sponsor, site liaison for sponsor/monitors, and query resolution.
Assesses patients for consenting into clinical trials based on inclusion/exclusion criteria. Executes and conducts study visits.
Prepares documentation as required by the study sponsor and/or the Pl.
Trains study patients under direction of the Pl.
Conducts the following:
Lab set-up and take-down for study exercises.
Collection of capillary and venous blood samples.
Collection, processing and shipment of any lab specimens required per protocol to include but not limited to stool, sputum samples etc.
Plasma processing for testing and/or plasma.
Preparation for storage/shipment of lab samples supplies and study medication.
Data entry into spreadsheet or database.
Develops, prepares, and presents new project proposal packets, annual reviews, and interim study documents for submission to the Institutional Review Board. 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, presents new study information to the Institutional Review Board-New study packet, revisions, Serious Adverse Events, Protocol Deviations etc.
Provides regulatory documents to the study sponsor and maintains contact with the sponsor throughout the study regarding regulatory issues.
Creates, updates, and maintains regulatory documents.
Completes adverse event reporting, preparation for monitor visits, and internal/external audits, as necessary.
Maintains supply inventory, reorders as necessary, and receives and inspects research materials.
Performs quality control activities and initiatives.
Researches patient bills and adjustments as needed.
Develops monthly invoices for services provided related to research studies and research studies completed by other organizations, i.e. MCVI, Neurology, Orthopedics, Wound Care etc.
Collaborates with Finance for the completion of all monthly reports.
Provides training to new employees, employees in ancillary departments and volunteers.
Participates in unit conferences and continuing education activities to meet institutional and departmental requirements.
Supervision Exercised:
None.
Employee Group: Professional & Administrative -Salary
Staff Pay Level:
Pay Range: $75,000 - $90,000
Division: Academic Affairs
Department: College of Medicine
Position Status: Provisional
Position End Date: 06/30/2024
Employment Status: Full Time
FTE: 1.0
Position Type: 12 month
Weekly Work Schedule: M-F 8:00 a.m. - 5:00 p.m.; evenings and weekends as required
Location: Saginaw, Michigan
Posting Ends:
Open Until Filled: Yes
To apply and see full details, visit https://apptrkr.com/5217622
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