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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. 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.
Job Responsibility
Assists with determination of guidelines for collection of clinical data
coordinates all aspects of study subject care
protects rights and well-being of subjects
ensures thorough protocol-based study subject education
develops processes for monitoring study subjects
evaluates study subjects' condition and communicates concerns
accurately documents study subject activities
maintains documents according to HIPAA and regulatory requirements
implements study-specific quality goals
acts as point of contact for protocol compliance
proactively addresses adverse events
maintains study site environmental integrity
participates in surveys and audits
maintains integrity of Fresenius Medical Care records
troubleshoots protocol
serves as primary point of contact between sponsor, CRO, PI and clinical staff
adheres to SOP and GCP
coordinates logistics for multiple concurrent studies
participates in recruitment and education of new research personnel
coordinates with facility manager to educate clinical staff
maintains mandatory training requirements
oversees performance of delegated study activities
coordinates and resolves conflicting treatment protocols
collaborates with management to ensure appropriate billing
tracks and coordinates study site education funds
facilitates positive relationships
supports physicians
provides clinic with study documentation
maintains knowledge of study specific equipment
implements study procedures around dialysis machines
provides information for study contract and budget negotiations
ensures study enrollment goals are met
completes clinical trials management system and case report forms
ensures maintenance of study subject payment records
completes application documents
coordinates with regulatory monitors
completes study subject records
Requirements
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
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
excellent communication and organizational skills
ability to work independently, and exhibit diplomacy and problem solving skills
Nice to have
Northeast location
critical care, nephrology and/or cardiac experience