WMU Homer Stryker M.D. School of Medicine

Clinical Research Coordinator

Job Locations US-MI-Kalamazoo
Posted Date 2 weeks ago(9/8/2021 4:12 PM)
Job ID
2021-1757
# of Openings
3
Category
Research
Target Salary
N/A

Overview

Western Michigan University Homer Stryker M.D. School of Medicine is seeking a Clinical Research Coordinator within the Center for Clinical Research Program. The Clinical Research Coordinator, in collaboration with other members of the Center for Clinical Research, supports, facilitates and coordinates clinical research activities.  The position will coordinate the conduct of the clinical research including the planning, implementation and follow through for industry-sponsored clinical trials, government-funded clinical research and investigator-initiated clinical research drug/device studies conducted by the Principal Investigator (PI).

Responsibilities

Study Preparation and Review

  • Assist the PI in the identification of clinical studies and completion of study feasibility assessments
  • Collaborate with the PI and management in the preparation of a categorized budget and confirm accuracy and completeness of budgeted costs
  • Collaborate with the PI and Regulatory Document Specialist to request IRB approval of protocol, consent forms, and other regulatory submission documents
  • Ensure preparation and appropriate use of study materials including informed consent documents, case report forms, enrollment logs, etc.
  • Schedule and coordinate site selection and site initiation visits with the sponsor

Conduct of the Research (Clinical/Subject Management)

  • Review and develop a familiarity with the protocol such as study proceedings and timelines, inclusion and exclusion criteria, confidentiality and privacy protections
  • Assist PI in communication of study requirements to all individuals involved in the study
  • Provide appropriate training and tools for study team members
  • Work with the PI and Recruiter to develop and implement recruitment strategies in accordance with IRB requirements and approvals
  • Conduct and participate in the informed consent process
  • Screen subjects for eligibility criteria
  • Coordinate participant tests and procedures as required by study protocol
  • Collect data as required by the protocol and assure timely completion of Case Report Forms
  • Maintain study timelines
  • Work with the PI to manage day to day activities of the study

Conduct of Research (Administrative and Regulatory)

  • Coordinate with the PI to help ensure that clinical research and related activities are performed in accordance with Federal Regulations, sponsoring agency requirements and institutional policies and procedures
  • Review and develop a familiarity with the contract or award terms and conditions. Work with the PI to assure that the study is in compliance with all terms and conditions, including education, IRB approval, conflict of interest disclosure, health and safety protections for participants and staff and any financial terms or conditions
  • Maintain master study files (MSF), subject/patient files, study supplies, and any other materials or documentation
  • Assist the PI with scientific and compliance reporting requirements in accordance with federal regulations, sponsoring agency, and institutional policies and procedures
  • Coordinate the timely payments to participants
  • Complete effort reports if applicable
  • Assist the PI in the prompt reporting of unanticipated problems involving risk to research participants

Project Closeout

  • Assist PI in submission of accurate and timely study closeout documents
  • Arrange for secure storage of study documents and adhere to all Federal Regulations, and institutional policies and procedures to safeguard protected health information
  • Availability to work occasional overtime on weekends or evenings to complete time sensitive projects.
  • Acquires knowledge for new technology and policy/procedure revisions.
  • All other duties as assigned.

 

Qualifications

  • RN with 3 years of clinical experience; or Bachelor’s degree in health related field with 1 year of clinical experience; or Associate’s degree in health-related field with a minimum of 3 years of experience directly in clinical research; or LPN with 4 years of clinical experience. Previous experience or education in the protection of human research subjects and Good Clinical Practices (GCP) preferred. Clinical research certification desired. 
  • Licensed in State of Michigan if a registered nurse
  • BCLS certification required
  • IATA certification or willingness to obtain
  • High level of communication skills to effectively interact with faculty, staff, students, patients and families
  • High level of organizational skills and ability to concurrently manage multiple tasks
  • Ability to effectively communicate with others verbally and in writing
  • Ability to manage multiple priorities and deliver results to meet assigned deadlines
  • Ability to interpret complicated and detailed data accurately, and develop insightful reports
  • Meticulous attention to detail and data integrity

About Western Michigan University Homer Stryker M.D. School of Medicine

 

Western Michigan University Homer Stryker M.D. School of Medicine (WMed) is an exciting environment to pursue and academic career. The medical school is a collaboration of Western Michigan University and Kalamazoo's two teaching health systems, Ascension Borgess and Bronson Healthcare. The medical school is a private 501(c)(3) nonprofit corporation supported by private gifts, clinical revenues, research activities, tuition, and endowment income. Building upon the $100 million foundational gift in 2011, WMed received a philanthropic commitment of $300 million to support the mission of the medical school in June 2021. WMed contributed to the creation of 1,600 new jobs and an economic impact of $353 million in Kalamazoo and Calhoun counties in 2020.

 

WMed is fully accredited by the Liaison Committee on Medical Education and the Higher Learning Commission. WMed offers a comprehensive, innovative four-year Doctor of Medicine degree program and two Master of Science degree programs in Biomedical Sciences and Medical Engineering. There are more than 200 residents and fellows in 10 residencies and five fellowships accredited by the Accreditation Council for Graduate Medical Education. To support its mission to educate and inspire lifelong learners, WMed has Joint Accreditation for interprofessional continuing education, which incorporates accreditation by the Accreditation Council for Continuing Medical Education.

 

WMed Health is the clinical practice of the medical school with more than 300 providers offering comprehensive primary care and specialty services in several locations throughout Kalamazoo, Portage, and Battle Creek. The Department of Pathology faculty serve as the Office of the Medical Examiner for counties throughout Michigan and northern Indiana.

 

The W.E. Upjohn M.D. Campus located in downtown Kalamazoo serves as the primary educational facility with faculty and administrative offices, student study and social spaces, team-based learning halls, a state-of-the-art Simulation Center accredited by the Society for Simulation in Healthcare, basic science research labs, as well as toxicology and forensic pathology labs.

 

WMed is building upon Kalamazoo’s century-long foundation of drug discovery and medical device development with a strategic investment in clinical, laboratory, community, and educational research. The Center for Immunobiology, Center for Clinical Research, WMed ForenTox, Research Histology Lab, Innovation Center, Division of Epidemiology and Biostatistics, and Human Research Protection Program contribute to the medical school’s advancement of knowledge through innovation and discovery. 

 

Western Michigan University Homer Stryker M.D. School of Medicine is an Equal Employment Opportunity/Affirmative Action employer of females, minorities, individuals with disabilities, and protected veterans, and actively strives to increase diversity within its community. We provide a drug- and tobacco-free workplace. 

 

EEO Minorities/Women/Disabled/Protected Veterans.

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