Clinical Research Coordinator Lead

Benefits

Qualifications

• •Bachelor's Degree required, or equivalent combination of Associate’s degree and experience, required
• •3-5 years of relevant experience, required
• •Knowledge of blood collection procedures

Responsibilities

• •Exhibits technical and functional expertise in the area of research/clinical trials through the execution of protocols for local and networkwide research
• •Coordinates daily activities of a designated study or group of studies and maintains industry relationships
• •Guides the training of physicians, fellows, and research staff on good clinical practice, external regulatory agency requirements
• •May be required to perform venipuncture on study participants; collects, processes, and ships specimens according to protocol and training requirements
• •Adheres to good clinical practice, and complies with regulatory and grant agency requirements, and study protocol; maintains study records and collaborates with the institutional review board as necessary
• •Responsible for coordination of a designated study or group of studies for single/multisite (networkwide)
• •Evaluates trial protocols, manages the clinical research sites including, but not limited to acting as primary contact for clinical research sites for questions related to the protocol conduct protocol, regulatory document completion, study supplies, client scheduling, and electronic data capture
• •Trains, coaches, supports and mentoring, and day-to-day support of Clinical Research Coordinators and other team members
• •Keeps accurate and up-to-date records
• •Collects labels, logs, processes, and ships biological specimens for analysis according to protocol and training requirements
• •Schedules subjects for protocol-related evaluations; collaborates with physicians, investigators and other healthcare providers; promotes respect for subjects’ rights
• •Provides on-site or remote monitoring of clinical research site activities to ensure compliance with protocols, SOPs and relevant federal and state regulatory and institutional policies
• •Provides consultation during study start-up activities regarding development of study protocol, SOP or Case Report Forms (CRFs), site qualification, data collection and study conduct
• •Participates in site initiations and trainings
• •Assesses accuracy, completeness and timeliness of study records by performing source data verification, regulatory document and consent form review, adverse event reporting compliance review, and investigational product accountability
• •Performs study close-out monitoring activities
• •Provides pre-review assistance prior to regulatory inspections and submissions
• •Promotes overall compliance and quality with research conduct through participation in education and training activities for professional staff
• •Assists in developing appropriate education and training sessions for investigators and clinicians involved in research
• •May provide technical guidance and direction to support team members, contractors and/or other vendors
• •3-12 combined
• •May travel to different clinical research sites as needed
• •Performs related duties, as required
• •All responsibilities noted here are considered essential functions of the job under the Americans with Disabilities Act
• •Maintains and Models Nuvance Health Values
• •Demonstrates regular, reliable and predictable attendance
• •23 more items(s)