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CenExel · 6 hours ago

Clinical Research Coordinator Sr.

Marlton, NJ

Full-time

Onsite

Senior Level

$35/hr - $41/hr

5+ years exp

CenExel is a leading organization specializing in Phase I to Phase IV clinical trials across various specialty areas. The Clinical Research Coordinator Sr. is responsible for coordinating all aspects of complex clinical trials, ensuring compliance with regulations and protocols while managing patient involvement and data integrity.

Clinical TrialsHealth CarePharmaceutical

Responsibilities

Coordinates all aspects of patient involvement for complex and/or multiple studies from study initiation until study completion

Organizes research information for clinical trials

Observes subjects and assists with data analysis and reporting

Oversees study protocol scheduling and collection of data

Identifies, reviews, and reports adverse events, protocol deviations, and other unanticipated problems appropriately

Manages, monitors, and reports research data to maintain quality and compliance

Performs administrative and regulatory duties related to the study as appropriate

Participates in other protocol development activities

Works collaboratively with internal departments, sponsors and investigators to ensure protocols are understood and assists in training staff members

Ensures site receives accurate information and supplies from sponsors (i.e.: source, protocol, scales, supplies, approvals, contacts, etc.)

Educates potential participants and caregivers on protocol specific details and expectations

Performs safety and efficacy assessments per protocol (vital signs, EKGs, blood draws and other assessments as assigned)

Assists senior management with site qualification visits by knowledge of staff credentials, equipment, calibrations, and enrollment capabilities

Assesses and delegates daily tasks to research staff, ensuring goals of accuracy and timeliness

Trains, mentors, and/or manages Research Assistants and lower level Clinical Research Coordinators

Assumes other duties and responsibilities as assigned. The above responsibilities are a general description of the level and nature of the work assigned to this classification and are not to be considered as all inclusive

Qualification

Clinical Research CoordinationGCP ComplianceFederal Regulations KnowledgeCCRC CertificationLeadership SkillsCrisis ManagementProblem SolvingEffective Communication