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 duties accurately and on time. The coordinator maintains documentation for assigned clinical studies and ensures studies comply with company policies and procedures, applicable state and federal regulations, Good Clinical Practice (GCP), ICH, and FDA guidelines. The role involves coordinating study activities and participant care, maintaining regulatory and study records, handling investigational products, completing clinical trial management systems and case report forms, and communicating with the PI, study monitors, sponsors, IRBs, participants, and facility management. The position includes desk and computer work and interaction with patients, staff, and physicians in a healthcare facility. It requires 10–15% travel between assigned facilities and community locations; travel to regional, Business Unit, and Corporate meetings may also be required. Exposure to infectious and contagious diseases or materials is possible.

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 AA 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.

Nice To Haves

Advanced degree preferred.
Dialysis experience preferred.
Research experience preferred.
Willingness to pursue CCRC or SoCRA certification when eligible.

Responsibilities

Develop an in-depth understanding of each study protocol and ensure compliance with the protocol, FDA requirements, 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 based on inclusion and exclusion criteria.
Obtain informed consent according to GCP.
Schedule subject visits and prepare laboratory work and tests according to the protocol.
Store study drugs and maintain drug accountability according to the study protocol and sponsor requirements.
Administer investigational products according to the protocol and under physician direction, within applicable licensure and training requirements.
Monitor and evaluate patients’ condition in relation to the investigational product and consult with the PI about its administration.
Assess subjects’ responses to investigational products and communicate observations to the PI, sponsor, and IRB as appropriate.
Educate subjects about study particulars and provide updates on pertinent study details as needed.
Document study-related subject information according to ALCOA principles.
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 subject progress, complaints, and issues to the PI, sponsor, or IRB as needed and in a timely manner.
Assess overall study execution at the facility or practice and communicate concerns to the Director, PI, sponsor, or IRB as needed.
Notify appropriate management and external parties of serious adverse events according to the protocol.
Collect essential pre-study documents according to GCP and file them appropriately in the study record.
Maintain study files and subject participant records according to GCP.
Provide facility or practice management with a list of study participants to help avoid improper billing for research-funded laboratory tests or services.
Ensure appropriate storage, access, and maintenance of investigational product records.
Document investigational product received, dispensed, and returned to the study sponsor according to GCP.
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.