Clinical Research Nurse/CMED - Mount Pleasant, United States - Central Michigan University

Description

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Please see Special Instructions for more details.

Central Michigan University is dedicated to fostering a broadly diverse and inclusive campus that respects all social identities, experiences, and perspectives.

In an effort to further this initiative, we are especially interested in candidates who will advance and promote an inclusive and supportive environment for every member of our university community.

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.

If there is another document you wish to include that is not required, please utilize Other Document (1).

Position will remain open until filled. The university reserves the right to close the recruitment process once a sufficient applicant pool has been identified. For best consideration, please submit application materials before Sunday, January 28, 2024.

Position Information

Position Information

Posting Number S-3209 Position Number 72215 Type of Recruitment External Position Title CLINICAL RESEARCH NURSE/CMED 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.

Message to Applicants

Central Michigan University is dedicated to fostering a broadly diverse and inclusive campus that respects all social identities, experiences, and perspectives.

In an effort to further this initiative, we are especially interested in candidates who will advance and promote an inclusive and supportive environment for every member of our university community.

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.

If there is another document you wish to include that is not required, please utilize Other Document (1).

Position will remain open until filled. The university reserves the right to close the recruitment process once a sufficient applicant pool has been identified. For best consideration, please submit application materials before Sunday, January 28, 2024.

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 About the Department 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.

EEO Statement

CMU, an AA/EO institution, strongly and actively strives to increase diversity and provide equal opportunity within its community.

CMU does not discriminate against persons based on age, color, disability, ethnicity, familial status, gender, gender expression, gender identity, genetic information, height, marital status, national origin, political persuasion, pregnancy, childbirth or related medical conditions, race, religion, sex, sex‐based stereotypes, sexual orientation, transgender status, veteran status, or weight (see ).

If you wish to see "EEO is the Law" posters, please click here.

CMU does not discriminate on the basis of sex in the education program or activity that it operates, including admission and employment, and is required by Title IX of the Education Amendments of 1972 not to discriminate in such a matter.

Inquiries about the application of Title IX can be made to CMU's Title IX Coordinator, the US Department of Education's Assistant Secretary, or both.

CMU's Title IX Coordinator can be reached at:

Phone:
Office: 103 E. Preston St.

Bovee University Center, suite 306

Mount Pleasant, MI 48858


Email:
Posting Ends Open Until Filled Yes

Supplemental Questions

Required fields are indicated with an asterisk (*).

• How did you first learn of this job opportunity? Please list the specific advertising source or indicate if it was word of mouth.

(Open Ended Question)

• Are you currently an internal employee of CMU according to the university's definition?
• Yes
• No
• If yes, to which employee group do you belong? (If not applicable, select "Not Applicable").
• No

t Applicable

• Dispatcher
• Medical Faculty
• Office Professional
• P&A, SO or Faculty
• Police
• Public Broadcasting
• Sergeant
• Service Maintenance
• Supervisory/Technical
• Are you a graduate of an accredited school of nursing and currently are registered with the State of Michigan Board of Nursing?
• Yes
• No
• Do you have a certificate of completion for CITI training or willingness to obtain certification?
• Yes
• No
• Do you have at least one year nursing experience related to the duties of the position?
• Yes
• No

Optional & Required Documents

Required Documents

• Resume/Curriculum Vitae
• Cover Letter

Optional Documents

• Other Document (1)