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
Associate’s degree from an accredited school of nursing with passage of an RN licensure exam.
Current registration with the State of Michigan Board of Nursing as a Registered Nurse (RN).
One year of nursing experience related to the duties of the position.
Certificate of completion for CITI training or willingness to obtain certification upon hire.
Strong interpersonal and communication skills.
Ability to analyze and interpret data and maintain confidentiality.
Preferred Qualifications
Bachelor’s degree in nursing.
BLS certification.
Experience conducting single/multicenter clinical trials, human subject research, or similar activities.
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.
Supervision Exercised
None.
Message to Applicants
Central Michigan University is dedicated to fostering an environment that is reflective of the communities we serve. We are especially interested in highly qualified candidates who will advance and promote CMU’s mission, vision, and leadership standards.
You must submit an on-line application in order to be considered as an applicant for this position.
Cover letters may be addressed to the Hiring Committee.
Employee Group
Professional & Administrative -Salary
Pay Range
$70,000 - $90,000 per year
Division
Academic Affairs
Department
College of Medicine
Position Status
Provisional
Position End Date
06/30/2027
Employment Status
Full-Time
Weekly Work Schedule
Mon-Fri, 8:00 a.m. - 5:00 p.m. / weekends and evenings as needed
About CMU
Central Michigan University has a more than 125-year legacy of preparing students to become leaders and changemakers in their communities and in their personal and professional lives.
We serve nearly 15,500 students on our Mount Pleasant campus, in satellite locations around the state and throughout the country, and through flexible online programs. Many of our approximately 300 undergraduate, master’s, specialist and doctoral programs in the arts, media, business, education, human services, health professions, liberal arts, social sciences, medicine, science and engineering are nationally ranked for excellence.
CMU leads the nation in leadership development programming through our Sarah R. Opperman Leadership Institute, and we are proud to be among only 5% of U.S. universities in the top two Carnegie research classifications. Our faculty work with graduate and undergraduate students in areas such as Great Lakes research, medical innovation, engineering technology and more.
Central is home to 17 men’s and women’s Division 1 sports including football, basketball, gymnastics, baseball, wrestling and more. Our student-athletes achieve great success in competition and in the classroom, capturing Mid-American Conference championships and maintaining an average cumulative GPA of 3.17.
CMU is located in Mount Pleasant, a community that blends the best of small-town living with big-city amenities. It’s part of the culturally varied and vibrant Great Lakes Bay Region that also includes Saginaw, Bay City, Midland and the state’s largest Native American community, centered on the Saginaw Chippewa Isabella Reservation in Mount Pleasant.
Area residents enjoy the mix of outdoor activities, cultural events, shopping and dining options, and family attractions. Other major Michigan destinations and attractions — Lansing, Grand Rapids, Detroit, Traverse City, wineries, beaches, golf and ski resorts, and many more — are within easy reach of the city’s central location in Michigan’s Lower Peninsula.
CMU employees enjoy access to a nationally recognized wellness program along with health care and benefits that exceed regional, state and national norms.
CMU Leadership Standards
Central Michigan University is a place where we value students and work for their success, where we act as family, and where employees are engaged, appreciated and have extraordinary opportunities to make a difference.
We intentionally maintain and strengthen the hallmark CMU culture that sets us apart from our peers by expecting CMU leaders and employees to model the following Leadership Standards and develop them within their teams.
Please review the Leadership Standards before applying for this position.
