CLINICAL RESEARCH COORD C
Duties: Oversees all regulatory compliance to human subject research and management of clinical trials carried out in the Multiple Sclerosis (MS) Division of the Neurology Department. The scope of this job includes independently initiating and executing research projects to operational close out of 10+ clinical trials. Managing all clinical visit activity and recruitment, creating and negotiating clinical trial budgets, developing and managing standard operating procedures (SOPs) and monitoring plans, training CRC staff and overseeing all experimental drug and deliverable logistics and allocation. Key components of this job include, IRB/Regulatory Compliance, clinical trial management and clinical assessment of study participants.
Responsible for management of all clinical trial aspects from start-up to operational close-out including but not limited to the implementation of clinical trial requirements for the MS Division. Key duties will include overseeing all clinical visit activities for assigned protocols, acting as a primary liaison between enrolled patients, primary physicians and members of multi-disciplinary care team and study sponsors. Creates and negotiates clinical trial budgets, oversees all trial related invoicing and reviews monthly financial reports. Independently manages clinical supplies and vendor logistics including maintaining inventory, ordering and proper storage of all biological kits and ancillary material sourcing for clinical trials (eg.: testing supplies, lab manuals, certifications, source documents, calibrations etc.). Additionally, be responsible for processing, packaging and routing all clinical trial biological samples as well as necessary documents (1572s, FDFs etc).
Develops and manages internal SOPs and clinical trial monitoring plans. Trains all CRC staff on current protocols and research SOPS. Generates, reviews and edits appropriate study-related documentation in line with internal and external regulatory requirements. Oversees clinical trial drug allocation and deliverables. Ensures data queries, study reporting to all external regulatory authorities, and archiving are completed in a timely manner. Hosts periodic site initiation and site monitoring visits with study sponsors and manages audit preparation. Processes and ships all bio-specimen samples. It is expected they will promote organizational values of patient and visitor satisfaction by demonstrating courtesy and respect for patients and their families, visitors and other employees. Providing care for patients in all age groups, demonstrates competence in the assessment, treatment and care of patients served and will be expected to exhibit a professional and compassionate demeanor in performance of duties and to be unfailingly responsive to the needs of patients.
Qualifications: A Bachelor's Degree is required, a Master's Degree is preferred, and 3 years to 5 years of experience, or equivalent combination of education and experience is required.
Reference Number: 40-26708
Salary Grade: 027
Employment Type: Exempt
Special Requirements: Background check required after a conditional job offer is made. Consideration of the background check will be tailored to the requirements of the job.
Job Family: I-Technical/Professional Research