·Study Conduct/ Clinical Research Practice
May be required to perform all duties of CRC I-IVs. Serve in leadership role and as a resource for others for all aspects of conducting clinical trials for complex and multi-center trials. Directly (or indirectly) supervise other CRCs or support staff involved in clinical research work. Collaborate on multiple projects or studies of increased complexity. Serve as a resource for study team members and other divisions that may be involved with specimen collection, processing, storage and tracking for clinical trials. Lead activities designed to improve organizational performance such as process improvement projects. Provide input to division discussions. Work independently and look for opportunities to grow clinical research projects within assigned division. Act as a role model with a significant expertise, knowledge & experience in coordination of clinical research. Be recognized as an expert, organization-wide resource, and contributor to professional knowledge for conducting complex trials.
·Regulatory Compliance and Documentation
Manage multiple complex regulatory projects. May lead and supervise regulatory staff. Organize and manage activities for the preparation, review, submission and maintenance of regulatory activities to collaborative parties. Provide oversight of periodic internal self-audit of records. May lead monitor visits, audits, and quality reviews (internal and external). Manage 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, consultants, and data safety monitoring boards, and coordinate the process to meet these requirements. Act as an expert resource for regulatory affairs. Mentor and lead others in applying federal regulations; state and local law; and CCHMC and divisional policies, and 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. Manage the maintenance of up-to-date and accurate written and electronic records and files. Develop and maintain the regulatory binder.
Develop, implement and execute recruitment strategies to identify potential participants for large, complex projects. 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, management, and required regulatory agencies.
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 a CCHMC liaison to internal departments, clinical teams, regulatory agencies, physician's 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.
Develop and maintain data management plan and SOPs for projects. Oversee data entry and validation to ensure accuracy, quality and compliance of data collection process. Create CRFs in consultation with other team members using existing study data information to promote efficient data collection and data entry. Create Data Dictionary, per protocol and in conjunction with principal investigator and statistician. Oversee the design of auditable database, data collection forms, error checking methods, and related programs for collection, analysis, and reporting. Support the data-management process for clinical research projects, data query management 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. Perform both quantitative and qualitative analyses. Maintain data storage for clinical research studies, and master database files for clinical research protocols. Prepare reports from validation studies of clinical research projects. Evaluate and resolve discrepancies within 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 other members by educating, providing resources and consulting on difficult protocols or projects. Assist investigators in developing presentations, abstracts and manuscripts. Act as a mentor and contribute to the professional growth of others. Act as an expert, organization-wide resource and contributor to professional knowledge.
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