DEPARTMENT:Cancer and Blood Diseases Institute
SUPERVISOR'S TITLE: Varies: Clinical Research Director, Institute Director, AVP, Sr. Business Director, Business Director
TITLES SUPERVISED: Research Nurses, Clinical Research Coordinators, Nurse Practitioners, Data Management Specialist, Data Coordinators, Clerks, Clinical Lab Specialists, Medical Writer, Project Specialists, Project Managers, Research Assistants, Administrative Assistants, Students, Volunteers
TOTAL NUMBER OF FTEs DIRECTLY SUPERVISED: 16-17
TOTAL NUMBER OF FTEs INDIRECTLY SUPERVISED: 2
PURPOSE OF POSITION: To assist in the design, development, and implementation of clinical research projects. To coordinate and administer clinical trials under the direction of the Principal Investigator. To provide budgetary and fiscal management, and to oversee quality assurance, maintenance of databases and other clinical data management systems, and proper documentation. To plan direct, organize, control and improve the assigned functions within the Division in order to meet the fiscal, patient care, research and teaching needs of Cincinnati Children's and as determined by the Division Director.
·Study Design and Preparation
Prepare budget for the clinical trial and payment schedule with sponsor. Negotiate fees for associated services. Manage study account and ensure that expenditures do not exceed contracted amount. Monitor for appropriate charges. Design patient recruitment and retention strategies. Monitor enrollment goals and modify recruitment strategies as necessary. Prepare marketing materials, search for potential referral services within the community, and contact and network with sponsors. Oversee preparation and submission of IRB and SRC documents and other documents required by regulatory agencies. Provide instruction to study team for specific study assignments. Train/educate the ancillary staffs regarding the clinical trial. Ensure continuing education for all staff as appropriate. Oversee the orientation and training of new staff.
·Initiation and Oversight of Studies
Oversee screening of study subjects. Ensure informed consent forms are explained to study participants & all required signatures are obtained prior to treatment. Ensure subject safety throughout the participation in the trial. Monitor study team compliance with study procedures & standards as well as CCHMC policies and applicable laws & regulations. Ensure the implementation of the Principal Investigator's recommendation for adverse event intervention; ensure that serious adverse events are reported to sponsor & 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. Oversee the proper documentation at close-out as required by grant sponsor including return or disposal of unused supplies, reconciliation of test article accountability, study summary, evaluation of team efforts and study 'drop outs'. Coordinate & participate in family-centered, holistic patient care for study participants.
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.
Participate in new clinical trial protocol critique and development. Assess feasibility of implementation (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 trials 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.
Skills & Competencies
·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.
·Bachelor of Science OR Bachelor's Degree in a health care related field
·5 years related experience Preferred:
·Assoc of Clinical Research OR Soc of Clinical Research Assoc OR equivalent