Job Description
Job Description Must have RN licensure to qualify. PURPOSE AND SCOPE: 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. 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. Protect the rights and the well-being of subjects enrolled in studies. 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. Accurately documents study subject activities as outlined by the protocol. Maintains documents according to applicable HIPAA and regulatory requirements. Implements study-specific quality goals and practices. 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 study site environmental integrity including safe handling of biological specimens as well as study product procurement, administration, and storage. Participates as needed in study related, internal, or State/Federal surveys and audits. 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. Participates in the recruitment, interview process, and education of new research personnel as directed. Coordinates with facility or practice manager to educate new clinical staff on study specific responsibilities and protocol tasks. Maintains mandatory training requirements according to guidelines/conditions set by, for example, the International Air Transport Association (IATA), GCP, etc. Oversees performance of delegated study related activities by all licensed personnel, or direct patient care staff. Coordinates and resolves potentially conflicting patient care treatment protocols involving the clinic and support staff. Collaborates with appropriate management to ensure research activities are not inappropriately or illegally billed, and that research activities are minimally disruptive to clinic routine. Tracks and coordinates potential study site education funds and assists with disbursement. Facilitates positive relationships with Medical Director and appropriate management. Supports physicians by communicating initiatives, policies and procedures; ensures attending physician receives notifications of patients' participation. Provides the clinic Governing Body and clinic staff with appropriate study documentation. Maintains up-to-date knowledge regarding the operation of study specific equipment and technology. Implements study procedures around the parameters of the dialysis machines and dialysis process. Provides 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. Ensures study enrollment goals are met, study resources are used efficiently, and the study budget is adhered to and covers the cost of research at study sites. Completes the clinical trials management system and electronic/paper case report forms in an accurate and timely manner Ensures the appropriate maintenance of study subject payment records. Completes application documents (e.g. internal, Institutional Review Board (IRB) site submission, sponsor required) and coordinates ongoing document processing throughout the entire study or Coordinates with regulatory monitors, responds to mentoring inquires. Completes study subject records in an accurate and timely completion of all applicable study subject records. Other duties as assigned.
