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Work Shift
Job Summary:
The Clinical Research Coordinator II independently manages significant and key aspects of large clinical trials, registries and research projects for the WellStar Research Institute of the WellStar Health System. This includes determining effective strategies for promoting/recruiting research participants and retaining participants in long term clinical trials. Responsibilities include identifying potential study patients; ascertaining patient eligibility for clinical trials; coordinating, evaluating, and following patients in clinical trials; coordinating research-related visits; completing and filing necessary forms with internal and external departments and agencies as necessary; maintaining records for patients enrolled in clinical trials; and overseeing data management for research projects. The incumbent will train and provide guidance to less experienced staff. This position also participates in IRB submissions and responds to requests and questions effectively, interfaces with study sponsors, monitors, and reports SAEs; resolves study queries and periodically audits operations to ensure compliance with applicable regulations.
Core Responsibilities and Essential Functions:
Clinical & Translational Trial Management
* Utilizes coordination skills to complete all research protocols, including patient eligibility determination, recruitment, screening, scheduling and organizing of study visits, enrollment, assessments, interviews, laboratory and diagnostic studies, medication tracking and other protocol specific investigational procedures
* Records data from source documentation and/or participant interaction onto case report forms
* Participates in periodic site monitoring visits from sponsor, regulatory authorities, and others. Participates in data quality assurance reviews.
* Receives and tracks receipt and status of study specimens from multiple sites. Performs packaging and ships study specimens (blood, urine, etc.) to the sponsor or laboratory in accordance with sponsor and shipping guidelines and regulations, maintaining appropriate documentation
* Responsible for study completion processes including data lock, study closeout, reporting and archiving of study files, ensuring completeness and continuity of all study data, performing ongoing checks of clinical/translational data that has been entered on the case report forms (paper or electronic) or in reports and assuring archival of appropriate/required documentation
* Supports the development and management of study budgets, supports the maintenance of clinical trial billing compliance and provides reports to investigators, department administration and funding agencies.
Regulatory & Compliance
* Utilizes or acquires knowledge of disease processes to observe for and report adverse events in a timely and accurate manner to the principal investigator and all regulatory authorities (IRB, Sponsor, FDA, NIH, etc.) as required by protocol, policies and procedures and regulations
* Serves as an advocate for human subjects by establishing and maintaining communication with investigators, research staff, sponsors and participants to ensure protection for human participants of research
* Prepares and maintains documents required to be maintained internally and available for regulatory authorities and/or the sponsor prior to, during and after the conduct of a clinical/translational trial.
Research Advancement
* Participates at professional meetings
* Assesses for and implements process…