Develop/Maintain the necessary infrastructure and operational systems to increase and sustain high levels of research productivity. Coordinate and participate in family-centered, holistic care; foster a consumer focus. Ensure quality customer service to the research subjects, research staff, and the industry sponsors, IRB, federal, state, and other regulatory agencies. Monitor, direct and perform day-to-day operations to ensure policies and procedures are being followed, objectives are being met, and that projects are being run efficiently and effectively. Work effectively across the organization and externally with sponsor organizations to ensure effective and efficient conduct of clinical research. Work with the CCHMC Data Management Core and Bioinformatics personnel to establish/maintain a robust informatics infrastructure in support of clinical research. Implement systems and processes associated with study initiation- acquisition of supplies, coordination between internal and external departments and sites, training and instruction of the study team and ancillary staff, research registration and billing, maintenance of source documents and study binders, ensure timeliness, availability and security of research information.
·Human Resource Management
Provide daily supervision of research personnel and support staff; perform other personnel activities including recruitment, scheduling, and educational training, administering performance appraisals and providing discipline. Determine appropriate personnel resource allocation for clinical studies based on the study parameters. 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. Implement schedules and recommend actions which will ensure that services and consultation are regularly and conveniently available to meet the needs of Cincinnati Children's patients and participants. Ensure continuing education for all staff as appropriate. Oversee the orientation and training of new staff.
·Financial Management and Resource Planning
Collaborate with the staff to develop the study budget for the clinical study and coordinate payment schedule with sponsor; negotiate fees for associated and contracted study personnel services. Manage study account and ensure that expenditures do not exceed contracted amount. Monitor for appropriate charges. Communicate with sponsors concerning budget issues, subject study-related problems, recruitment strategies and specific policies and procedures. Ensure adherence to grant sponsor, IRB, and Cincinnati Children's accounting and grant administration guidelines. Collaborate with Business Director or Business Manager to prepare, coordinate, evaluate, and manage annual fiscal operating and capital equipment budgets. Help forecast resource needs including planning for staff, space, IT support and resources necessary to provide the organizational structure to conduct effective and efficient clinical research operations.
Serve as a key resource to research participants and collaborators in resolution of complex problems. Assist in the design of patient recruitment strategies specific to the study design. Monitor enrollment goals and modify recruitment strategies as necessary. Coordinate study initiation. Provide instruction to study team for specific study assignments. Oversee the proper screening of study subjects; ensure that Informed Consent forms are explained to study participants and all required signatures are obtained prior to enrollment; ensure subject safety throughout the participation in the clinical study; monitor study team compliance with study procedures and standards. 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. Oversee the collection and maintenance of research subject clinical database and provide method of document retrieval. Conduct quality assurance checks. Schedule and coordinate pre-study site visits as well as sponsor and monitor visits if necessary. Assist in preparation and review of research proposals and grant submissions. Attend and participate in investigator's meetings with sponsor if necessary.
Act as liaison between the research staff, and the industry sponsors, IRB, federal, state, and other regulatory agencies. Oversee preparation and submission of IRB documents and other documents required by regulatory agencies. Ensure submission of application for renewal of grant/s in a timely fashion. Develop and maintain source documentation of study events. Oversee completion of case report forms. Ensure compliance with regulatory agencies, standards of nursing and research practice. Support, interpret and enforce Cincinnati Children's policies. Ensures compliance with all applicable JCAHO/ PHRP standards. Oversee the proper documentation at close-out as required by grant sponsor including study summary, evaluation of team efforts, study 'drop outs' (e.g. causes, contact efforts, etc.), and return or disposal of unused supplies, reconciliation of test article accountability if necessary,. Prepare for and respond to sponsor or regulatory audits. 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.
Administer the development of training plans for Good Clinical Practice, standard operating procedures for all staff and compliance with documentation of training. Coordinate scientific meetings and lecture series. Expand knowledge base and remain abreast of new research developments by attending continuing education meetings, lectures, training sessions and conferences. Continuously update knowledge of regulatory issues regarding the conduct of clinical studies. Provide education to personnel, patients, or family through structured presentations and unstructured interactions while performing tests or resolving technical questions.
Oversees improving organizational performance through recommending areas or approaches for improvement activities, performing new procedures, collecting data and providing input to department discussions.
Support the development and implementation of research systems and processes to improve productivity and efficiency and to facilitate sustained growth in collaboration with Principal Investigators. Organize and conduct annual research needs assessment. Participates in the planning, design, measurement, assessment and improvement of the division's services. Work with faculty, and business director/managers to provide leadership for new project development efforts including development of scope or work, budget and management of contract negotiations, and execution.
Provide a leadership role in developing and coordinating departmental policies and procedures to ensure the efficient operation of clinical studies. Develop internal processes that promote research collaboration, clarify roles and expectations, and enhance the education, development and productivity of research professionals.
Using time efficiently and productively; prioritizing multiple tasks properly to meet deadlines; recognizing time constraints and adjusting work schedule to address them.
·Good Clinical Practice
Knowledge of Good Clinical Practice (GCP)
·Pediatrics - Intermediate
Possess sound knowledge of procedures and regulations specific to the assessment and care of infants, children and adolescents
Assembling teams of high-caliber people with diverse capabilities; fostering collaboration by laying down ground rules for team members, monitoring team members' interactions, and interceding when necessary to ensure team effectiveness; creating trust, a feeling of belonging to a team, and a desire for team accomplishment by showing respect for and empowering others
Working cooperatively with others to achieve group goals; proactively adjusting one's style and efforts to complement those of others on the team; being pleasant, agreeable, and easy to work with; valuing group success as much or more than individual success
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
Setting the stage for constructive relationships by being accessible, approachable, and interpersonally engaged; developing and sustaining meaningful and productive bonds with others based on mutual respect
Knowledge of related regulatory requirements and standards
Demonstrated leadership and management skills
Strong organizational and project management skills to handle projects independently.
Demonstrates an independent work initiative, sound judgment, diplomacy, tact and professional demeanor
·Analysis - Basic
Analytical ability sufficient to evaluate data, make judgments and recommendations
·Communication - Advanced
Excellent verbal, written and interpersonal communication skills.