Float Clinical Research Coordinator II

Job Summary Must be comfortable with 80% travel. Highly prefer someone who lives in the Northeast, as they will be traveling to Michigan, Mississippi, Louisiana, Indiana and New Jersey. Responsible for the collection, accuracy and validity of clinical research data for assigned clinical studies in accordance with the study protocol and timelines. Performs a variety of complex activities to appropriately compile, document and analyze clinical research data, using the subject’s medical record as source. Negotiates differing priorities with multiple players whilst balancing a multiple number of tasks and timelines under a complex network of rules and regulations. Ensures research studies are conducted according to established company policies and procedures as well as all applicable State and Federal regulations, specifically Good Clinical Practice (GCP, ICH, and FDA guidelines). Practices cost containment strategies while ensuring appropriate enrollment of subjects in studies. Responsibilities Assist with the determination of the guidelines for the collection of clinical data and coordinate and implement procedures and processes for data collection. Coordinate all aspects of study subject care from pre-screening through study completion as defined by the protocol and Principal Investigator (PI) delegation. Protect the rights and the well‑being of subjects enrolled in studies. Ensure 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. Develop processes for methodically monitoring the status of study subjects as they progress through the study’s timeline of activities. Regularly evaluate the study subjects’ condition and communicate/document concerns to PI to ensure subject safety. Accurately document study subject activities as outlined by the protocol. Maintain documents according to applicable HIPAA and regulatory requirements. Implement study‑specific quality goals and practices. Act as the point of contact or lead person in a facility/practice to oversee protocol compliance. Proactively address and act upon adverse event or patient safety issues according to the appropriate procedure. Maintain study site environmental integrity, including safe handling of biological specimens as well as study product procurement, administration, and storage. Participate as needed in study‑related, internal or State/Federal surveys and audits. Maintain integrity of Fresenius Medical Care, practice and study‑specific medical, administrative, and operational records. Troubleshoot protocol, and strategize with all participants at every level of the study in order to assure quality study outcomes. Serve as primary point of contact between sponsor, Clinical Research Organization (CRO), PI and clinical staff. Adhere to SOP, GCP and all regulatory practices as established by law and company policies and procedures. Coordinate logistics of activity for multiple, concurrent studies at multiple study sites. Participate in the recruitment, interview process, and education of new research personnel as directed. Coordinate with facility or practice manager to educate new clinical staff on study‑specific responsibilities and protocol tasks. Maintain mandatory training requirements according to guidelines/conditions set by, for example, the International Air Transport Association (IATA), GCP, etc. Oversee performance of delegated study‑related activities by all licensed personnel, or direct patient care staff. Coordinate and resolve potentially conflicting patient care treatment protocols involving the clinic and support staff. Collaborate with appropriate management to ensure research activities are not inappropriately or illegally billed, and that research activities are minimally disruptive to clinic routine. Track and coordinate potential study site education funds and assist with disbursement. Facilitate positive relationships with Medical Director and appropriate management. Support physicians by communicating initiatives, policies and procedures; ensure attending physician receives notifications of patients’ participation. Provide the clinic Governing Body and clinic staff with appropriate study documentation. Maintain up‑to‑date knowledge regarding the operation of study‑specific equipment and technology. Implement study procedures around the parameters of the dialysis machines and dialysis process. Provide relevant information regarding the projected regional costs of treatments, projected enrollment capabilities, anticipated risks/benefits at specific study sites, logistical impediments, etc. for use in study contract and budget negotiations. Ensure study enrollment goals met, study resources are used efficiently, and the study budget is adhered to and covers the cost of research at study sites. Complete the clinical trials management system and electronic/paper case report forms in an accurate and timely manner. Ensure the appropriate maintenance of study subject payment records. Complete application documents (e.g., internal, Institutional Review Board (IRB) site submission, sponsor required) and coordinate ongoing document processing throughout the entire study. Coordinate with regulatory monitors, respond to mentoring inquiries. Complete study subject records in an accurate and timely completion of all applicable study subject records. Other duties as assigned. Physical Demands and Working Conditions 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 80% travel between assigned facilities and various locations within the community. Travel to regional, Business Unit and Corporate meetings may be required. Education and Experience Graduate of a technical program in healthcare, AA in Life Sciences or other health‑related field, preferred. 2 to 4 years of clinical research 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. Critical care, nephrology and/or cardiac experience desirable. Willing to pursue CCRC or CCRP certification when eligible. Current state licensure, if applicable. Good computer skills: Microsoft Office minimally. Excellent communication and organizational skills. Ability to work independently, and exhibit diplomacy and problem‑solving skills in the performance of this role. Equal Employment Opportunity Statement Fresenius Medical Care is an equal opportunity employer and does not discriminate on the basis of race, color, religion, sexual orientation, gender identity, parental status, national origin, age, disability, military service, or other non‑merit‑based factors. Fresenius Medical Care maintains a drug‑free workplace in accordance with applicable federal and state laws. #J-18808-Ljbffr CH01 CHE Fresenius Medical Care (Schweiz) AG