·Clinical Research Operation Management
Provide day to day oversight of the clinical research activities, including management of clinical research coordinators, regulatory affairs specialists, nursing staff, lab processors, nurses, and medical assistants. Assure that department specific standard operating procedures are up-to-date and compliant with regulatory, hospital and accrediting institutions. Prepare yearly department budget with business office staff for the research core. Negotiate fees for associated services. Manage study accounts and ensure that appropriate funds are obtained for services. Oversee preparation and submission of IRB and SAC documents and other documents required by regulatory agencies. Provide instruction to study team for specific study assignments. Train/educate the ancillary staff regarding studies. Ensure continuing education for all staff as appropriate. Oversee the orientation and training of new staff.
·Initiation and Oversight of Studies
Oversee the implementation of approved studies and recruited subjects. Ensure informed consent forms are explained to study participants and all required signatures are obtained prior to treatment. Ensure subject safety throughout the participation in the study. Monitor study team compliance with study procedures and standards as well as CCHMC policies and applicable laws and regulations. Ensure the implementation of the Principal Investigator's recommendation for adverse event intervention; ensure that serious adverse events are reported to sponsor and IRB and documented on source documents. Communicate with sponsors concerning budget issues, patient study-related problems, recruitment strategies and specific policies and procedures. Oversee the collection of data & maintenance of clinical research database, case report forms & document/report retrieval. Conduct quality assurance checks. Schedule and coordinate pre-study site, sponsor and monitor visits. Attend and participate in investigator's meetings with sponsor. Coordinate and participate in family-centered, holistic patient care for study participants. Collaborate with leadership to prepare marketing materials.
Provide daily supervision of research personnel and support staff. Perform personnel activities including recruitment, assigning work, training, administering performance appraisals and providing discipline. Provide career development guidance to research personnel and support staff; coaches and mentors staff to build knowledge and skills; creates learning opportunities for employees. Coordinate continuing education opportunities for clinical research support staff. Manage attendance at required Cincinnati Children's training sessions, including radiation safety, laboratory safety, bloodborne pathogens and OSHA. Make job requirements and goals for each position clear to employees and provide sufficient training to achieve the desired level of competency; document evidence of competence on a continuing basis. Review timeliness, accuracy, availability and security of information. Comply with and enforce compliance with Infection Control policies and procedures. Participate in establishing job requirements and goals; perform duties at the desired level of competency. Review timeliness, accuracy, availability and security of information.
Assess feasibility of implementation of newly approved, pilot, or proposed research studies (resource allocation as well as clinical preparation). Act as liaison between the research staff, and the industry sponsors, IRB, federal, state, and other regulatory agencies. Serve as a key resource to research participants and collaborators (referring institutions). Expand knowledge base and remain abreast of new research developments by attending continuing education meetings, lectures, training sessions and conferences. Implement this knowledge into the appropriate division/department within Cincinnati Children's Hospital Medical Center. Continuously update knowledge of regulatory issues regarding the conduct of clinical studies. Represent Division on hospital-wide councils/committees/working groups. Assist in the planning, design, measurement, assessment and improvement of the division's services.
Coordinate real-time preparation for sponsor monitoring, regulatory agency audits, and accreditation surveys; initiate corrective action, if needed. Provide a leadership role in developing and coordinating departmental policies and procedures to ensure the efficient operation of both clinical research studies and patient care in a clinical setting. Facilitate development of department performance improvement plans. Participate in peer-reviewed, intra-office quality assurance program that retrospectively evaluates accuracy, timeliness, and protocol violations. Participate in appropriate committees, task forces, and work groups. Participate in improving organizational performance through recommending areas or approaches for improvement activities, performing new procedures, collecting data and providing input to department discussions. Implement schedules and recommend action which will ensure that services and consultation are regularly & conveniently available to meet the needs of CCHMC's patients as determined by the medical staff.
·Pediatrics - Intermediate
Possess sound knowledge of procedures and regulations specific to the assessment and care of infants, children and adolescents
Understanding and showing respect and appreciation for the uniqueness of all individuals; leveraging differences in others' perspectives and ideas; appreciating cultural differences and adjusting one's approach to successfully integrate with others who are different from oneself
Demonstrated leadership and management skills
Strong organizational and project management skills to handle projects independently.
·Analysis - Basic
Analytical ability sufficient to evaluate data, make judgments and recommendations
·Communication - Advanced
Excellent verbal, written and interpersonal communication skills.