Clinical Research Coordinator

Fresenius Medical Care•Kalamazoo, MI

About The Position

The Clinical Research Coordinator works under the supervision of the Principal Investigator (PI), Director, and other site personnel to apply study protocols in a clinical setting and complete assigned duties accurately and on time. The coordinator maintains study documentation and ensures studies comply with company policies and procedures and applicable state and federal regulations, including Good Clinical Practice (GCP), ICH, and FDA guidelines. The role coordinates study activities from regulatory submissions and participant identification through informed consent, visit scheduling, protocol procedures, investigational product accountability, participant monitoring, and study-record maintenance. The coordinator communicates with the PI, study sponsor, IRB, study monitors, management, participants, and facility personnel as appropriate. The position has no supervisory responsibilities.

Requirements

Bachelor’s degree or an equivalent combination of education and experience.
Graduate of a healthcare technical program, such as LVN/LPN, Medical Assistant, or Dialysis Technician; alternatively, an associate degree in Life Sciences or another health-related field.
Two to five years of healthcare experience.
Current appropriate state licensure, if applicable.
Proficiency with PCs and Microsoft Office applications.
Good communication and organizational skills.
Ability to work independently.
Willingness to pursue CCRC or SoCRA certification when eligible.

Nice To Haves

Advanced degree preferred.
Dialysis experience preferred.
Research experience preferred.

Responsibilities

Develop an in-depth understanding of each study protocol and ensure protocol adherence in accordance with FDA, GCP, and ICH guidelines.
Prepare and submit regulatory documents accurately and on time under the supervision of the PI and appropriate management.
Work with the PI to identify potential study participants according to inclusion and exclusion criteria.
Obtain informed consent according to GCP and educate participants about study particulars, updating them about relevant details as needed.
Schedule participant visits and prepare laboratory work and tests according to the protocol.
Maintain appropriate storage and accountability of study drugs and investigational products according to protocol and sponsor requirements.
Administer investigational products according to protocol and under physician direction, within applicable licensure and training requirements.
Monitor and evaluate participants’ conditions and responses to investigational products; consult the PI regarding appropriate administration and communicate observations as appropriate.
Document participant and study information according to ALCOA principles and maintain study and participant records according to GCP.
Meet with study monitors to review, verify, and correct case report form data and ensure study records are maintained appropriately.
Review laboratory results and tests with the physician in a timely manner.
Report participant progress, complaints, issues, and serious adverse events to the PI, sponsor, IRB, management, or other appropriate parties as required.
Assess study execution at the facility or practice on an ongoing basis and communicate concerns to the Director, PI, sponsor, or IRB as needed.
Collect essential pre-study documents and file them appropriately in study records.
Provide facility or practice management with a list of study participants to help prevent improper billing for services or laboratory tests covered by the research budget.
Ensure appropriate storage, access, and maintenance of investigational-product records, including documentation of products received, dispensed, and returned to the sponsor.
Complete the clinical trials management system and electronic or paper case report forms accurately and on time.
Attend Investigator Meetings as necessary.
Perform other duties as assigned.