Clinical Trial Manager
CurrentWorks with the research nurse to lead the execution of trials in the clinics. Develop and communicate guidelines in the collection of clinical data and/or administration of clinical studies at designated clinics. Compiles information from the research nurses and physicians to complete reporting of SAEs, protocol waivers and protocol deviations. Proactively identifies trial-related issues and provides recommendations for resolution. Initiates improvements to enhance the efficacy and the… Show more Works with the research nurse to lead the execution of trials in the clinics. Develop and communicate guidelines in the collection of clinical data and/or administration of clinical studies at designated clinics. Compiles information from the research nurses and physicians to complete reporting of SAEs, protocol waivers and protocol deviations. Proactively identifies trial-related issues and provides recommendations for resolution. Initiates improvements to enhance the efficacy and the quality of the work performed on assignments. Provides support to the research nurses in the enrollment of patients into investigator initiations (IIT) and industry sponsored (IST) clinical trials through active screening of potential study patients charts. Assists the research nurse in reviewing the protocols and eligibility criteria with the physician. Ensures the safety and welfare of study patients. Attends staff meetings and participates in startup training for new studies. Reviews source document tools and updates source documents for amendments. Enters data for all specific tools/tests required by the protocol (i.e. oral medication forms, pill count diaries, QOL questionnaires, times of PK draws, EKG, etc. with affirmative assistance from the research nurse.. Communicates with SCRI study team to ensure compliance with protocol guidelines. Ensures that follow-up appointments, scans or any related procedures are scheduled correctly according to protocol requirements. Obtains pathology reports, scan reports, and tissue samples as required by protocol. Obtain signatures from sub-investigators per regulatory guidelines. Accurately completes all data and query requests and submits source documentation as necessary. Adheres to appropriate Standard Operating Procedures. Maintains patient confidentiality according to ethical and legal requirements. “Code of Conduct” philosophy and “Mission and Value Statement”. Show less