Clinical Regulatory Specialist

Responsibilities Maintains current and accurate protocol documentation. Ensures that patients are appropriately registered/enrolled on study; maintains documentation of registration/enrollment. Compiles and submits data on appropriate case report forms according to protocol requirements and within protocol-specified time lines. Ensures protocol compliance with intense oversight of specific study requirements. Works with physicians, nurses, and imaging center staff to see that protocol related tests and visits are ordered per protocol guidelines. Play active role in recruitment of participants to studies. Performs protocol specific clinical duties as required per the research study. Assures confidentiality of patient information. Identifies and communicates important protocol and data management issues or problem areas to supervisor. Monitors external sites and imaging centers for accuracy of data submitted by comparison with source documents; monitors compliance with execution of protocol requirements by comparison of source documents with protocol document; monitors completeness and accuracy of AE reporting; and monitors compliance with regulatory requirements. Writes detailed monitoring report s and works with Principal investigator and site personnel to develop resolution plan. Reports findings to management. Participates in the management of all study startup activities for all research protocols for the department. Trains and instructs staff and clinical and imaging center offices in implementation of protocol changes that encompass, clinical activities, patient participation, drug safety, IRB and or FDA updates. Manages all correspondence from Research Sites, Sponsors, CRO’s, IRB’s and state and federal regulatory agencies. Responsible for the oversight of research required training for study related activities, the protection of human subjects, GCP, across all clinical research sites and imaging centers. Responsible for the creation and review of work flows and source documents assist in standardization and compliance for all study activities. Responsible for updating and current documentation of investigator and sub-investigators licensure and qualifications for participation in clinical research. Ensures work environment and imaging centers are organized and function efficiently. Provides educational training and mentoring to other staff. Attends and participates in meetings as required. Maintains current knowledge of GCP and FDA guidelines through attendance at meetings, seminars, other training. Maintains educational training and certification in peer professional organizations for clinical research and regulatory professionals. Performs other duties as assigned or directed to meet the goals of the department. Candidate Qualities Passionate about patient care and exercise sound judgement and an ability to remain professional in all situations. You demonstrate effective and professional communication, interpersonal skills and respect with patients, guests & colleagues. You have a structured work-approach, understand complex problems and you are able to prioritize work in a fast-paced environment. Qualifications BS/BA degree or higher in life science or related field. Degree could be substituted with 5 years of more clinical research experience. Able to be certified by either ACRP or SoCRA within 1 year. 3 years experience in research setting Read, identify and extract pertinent data from medical records. Ability to read, write and comprehend medical terminology. Good written and oral communication skills. Must be able to multi-task and handle rapidly changing priorities. Must meet deadlines and regulatory time frames for submission and maintenance of protocols. Benefits Comprehensive Medical, Dental and Vision coverages. Health Savings Accounts with employer funding. Wellness dollars 401(k) Employer Match Free services at any of our imaging centers for you and your immediate family. Pay Range: $80,000 - $97,000 per year #J-18808-Ljbffr