CLINICAL RESEARCH COORDINATOR

PRINCIPAL DUTIES AND RESPONSIBILITIES:

·         Assists with the determination of the guidelines for the collection of clinical data and coordinates and implements procedures and processes for data collection.

·         Coordinates all aspects of study subject care from pre-screening through study completion as defined by the protocol and Principal Investigator (PI) delegation.

·         Ensures thorough, individualized, protocol-based study subject education on all study process requirements including but not limited to: informed consent, study participation obligations, appropriate use of investigational product, safety, privacy, rights and responsibilities.

·         Develops processes for methodically monitoring the status of study subjects as they progress through the study’s timeline of activities.

·         Regularly evaluates the study subjects’ condition and communicates/documents concerns to PI to ensure subject safety.

·         Maintains documents according to applicable HIPAA and regulatory requirements.

·         Acts as the point of contact or lead person in a facility/practice to oversee protocol compliance.

·         Proactively addresses and acts upon adverse event or patient safety issues according to the appropriate procedure.

·         Maintains integrity of Fresenius Medical Care, practice and study-specific medical, administrative, and operational records.

·         Troubleshoots protocol, and strategizes with all participants at every level of the study in order to assure quality study outcomes.

·         Serves as primary point of contact between sponsor, Clinical Research Organization (CRO), PI and clinical staff.

·         Adheres to SOP and GCP and all regulatory practices as established by law and company policies and procedures.

·         Coordinates logistics of activity for multiple, concurrent studies at multiple study sites.

·         Other duties as assigned.

PHYSICAL DEMANDS AND WORKING CONDITIONS:

·         The physical demands and work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

·         Day to day work includes desk and personal computer work and interaction with patients, facility staff and physicians.

·         The work environment is characteristic of a health care facility with air temperature control and moderate noise levels. May be exposed to infectious and contagious diseases/materials.

·         The position requires 25% travel between assigned facilities and various locations within the community. Travel to regional, Business Unit and Corporate meetings may be required.

EXPERIENCE AND REQUIRED SKILLS:

·         2 to 4 years of nursing experience, or has successfully performed in the role of Clinical Research Coordinator I for a minimum of 3 years and demonstrated outstanding performance through performance evaluations, certification and other job performance measures.

·         Research experience preferred.

·         Critical care, nephrology and/ or cardiac nursing experience desirable.

·         Willing to pursue CCRC or CCRP certification when eligible.

·         Excellent communication and organizational skills.

·         Ability to work independently, and exhibit diplomacy and problem solving skills in the performance of this role.

·         This is NOT a remote role.

·         Locations Needed: Denver, Baltimore, Atlanta, Raleigh, Baton Rouge, Houston, LA County