·Study Conduct/ Clinical Research Practice
May be required to perform all duties of CRC I-IIIs. Serve as a resource for others for all aspects of conducting a clinical trial for complex and multi-center trials. Develop & implement associated projects related to studies under the guidance of the principal investigator. Collaborate effectively with others to ensure proper progress & completion of studies. Assist other members by educating, providing resources, & consulting on difficult protocols or projects. Indirectly (or directly) supervise other CRCs. Train new staff in preparation & conduct of clinical trials. Provide oversight and guidance as needed to research staff. Collaborate on multiple projects or studies, and support other staff or the work flow involved in research work. Provide oversight and guidance to research staff for all aspects of conducting a clinical trial for complex and multi-center trials. Collect and process specimens to meet study requirements. Work with other divisions as needed to ensure proper handling, processing, storage and tracking of specimens per study requirements.
·Regulatory Compliance and Documentation
Coordinate complex regulatory activities & periodic internal self-audit of records. May lead staff in regulatory activities. Provide oversight for the preparation, review, submission and maintenance of regulatory activities/submissions, ensure accuracy and timeliness to all collaborative parties. Provide oversight and guidance for project procurements. Coordinate and participate in monitor visits, audits, and quality reviews (internal and external) in a professional manner. Organize the review, correspondence and approval of human research protocols with all regulatory authorities, including study closeout. Determine which research protocols or issues have additional requirements, i.e. review by additional CCHMC Divisions, regulatory agencies, or consultants, and coordinate the process to meet these requirements. Act as a resource for regulatory affairs. Apply federal regulations; state and local law; and CCHMC and division policies and standard operating procedures (SOPs) to promote ethical practices in research involving human participants and to ensure compliance to those regulations. Ensure the documentation of regulatory activities in appropriate systems. Coordinate and maintain up-to-date and accurate written and electronic records and files. Develop and maintain the regulatory binder.
Prepare study staff for recruitment/enrollment for medium to large/complex complexity projects. Oversee study staff performance. Proactively take initiative to ensure recruitment stays on track with the project time-lines. Implement successful plan to identify potential participants. Engage study staff to assist in identifying and enrolling participants. Proactively identify and monitor barriers to recruitment and problem-solve or innovate to overcome them. Determine best method/s to identify potential participants for research protocol (advertisements, chart reviews, monitoring of clinic schedule, etc) and prepare accordingly. Create and maintain a detailed tracking system for participants considered for enrollment. Track progress at regular intervals and report out to PI and or management.
Compose clear, precise and detailed correspondence. Document, organize and maintain all correspondence. Oversee and follow through on questions and issues that arise during study conduct. Serve as CCHMC liaison to internal departments, clinical teams, regulatory agencies, physicians' offices, city clinics, government agencies, academic centers, and other organizations. Communicate study related issues to investigators, sponsors, coordinating centers, study coordinators, clinical team, managers and other institutions in a timely fashion. Develop a rapport with study participants.
Oversee data entry and validation to ensure accuracy, quality and compliance of data collection process. Create case report forms (CRFs) in consultation with other team members, as needed, using existing study data information to promote efficient data collection and data entry. Create Data Dictionary, as per protocol and in conjunction with principal investigator and statistician. Support the data-management process for clinical research projects, including addressing data queries from data managers, project statistician, and sponsors. Maintain and audit data, providing status and activity reports as required. Organize data to analyze, identify, and report trends. Review reports, tables, and listings. Assist in data analysis and maintain record keeping and data storage for clinical research studies. Maintain master database files for clinical research protocols. Prepare reports from validation studies of clinical research projects. Evaluate and resolve issues regarding contents of reports. Ensure quality of data submitted from study sites and assure timely submission of data. Oversee the processing of laboratory and other external data.
Train new staff in preparation and conduct of clinical trials. Assist in developing and delivering guidelines and educational materials for investigators, research support staff and the clinical team (as applicable). Complete required training. Serve as a resource to team members. Assist investigators in the development of presentations, abstracts, and manuscripts. Assist other members by educating, providing resources and consulting on difficult protocols or projects.
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)
Ability and motivation to promote continuing improvement and education
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
Ability to adapt work schedule to meet the demands of the position, possibly including nights and/or weekends
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
Ability to independently work through details of a problem to reach a positive solution
·Communication - Advanced
Excellent verbal, written and interpersonal communication skills.
Capable of utilizing research techniques in application to clinical research and serving as a resource for educational opportunities in these areas
May require a valid driver's license for making off-campus visits