Clinical Research Program Coordinator - CONNECT

Overview Coordinates and manages the department/center’s research portfolio. Maintains working knowledge of projects in process as well as funded projects including grant budgets and IRB protocols. Coordinates subcontracts with other sites and the Sponsored Projects Office, develops and implements processes across multiple study sites, and maintains documents to ensure effective, efficient and compliant project progress. Essential Functions Responsible for administrative management, organization of, and participation in program meetings and teleconferences, including scientific meetings with corporate and non‑profit partners, teaching conferences, grand rounds, journal club, research seminars, and CME programs. Works with Sponsored Projects Officer to manage program and project funds and dissemination of funding to collaborating sites in addition to the subcontracts with other sites. Provides funding‑opportunity notifications to PIs. Collaborates with department/center investigators in the development of IRB protocols, grant submissions and scientific publications. Coordinates personnel needs for the program and projects; oversees and organizes training. Tracks projects and initiatives to ensure they move forward based on both timelines and budget; reports to PI when progress is lacking and identifies needed action. May be responsible for administrative management of multiple protocols; plays a central role in the communication between NCH/RI and site; will act as liaison with other departments necessary to complete program projects (e.g., Data Management, Biostats, Medical Writing, Regulatory Compliance, etc.). Manages and oversees IRB process for program projects and associated sites, ensuring accurate and timely IRB submissions and maintaining associated regulatory documents. Helps facilitate creation of source documents that ensure systematic data collection and/or aid in protocol execution and management and record keeping. Collects and controls research data and subject information from sites as needed/requested; tracks screening and enrollment data across multiple sites/multiple projects. Provides monitoring, review and tracking of clinical data and preparation of study‑specific documents according to FDA regulations QA process implementation, maintenance and documentation; data entry; and maintenance of regulatory documents for multiple sites; multiple protocols. Works with principal investigators at each site to establish multi‑site monitoring plans for investigator‑initiated projects. Education Requirement Bachelor’s degree preferred or Associate degree with two years clinical research experience or project management experience. Certifications ACRP or SOCRA certification, preferred. Skills Demonstrated leadership skills Strong organizational skills Exceptional interpersonal, written and verbal communication Ability to filter information, discern importance and initiate plan for project completion Self‑directed, results‑driven with ability to manage workload Ability to work independently and as part of a team Working knowledge of data management software Experience Two years clinical research experience or project management experience Physical Requirements Occasionally: bend/twist; lifting/carrying 0‑10 lbs; lifting/carrying 11‑20 lbs; lifting/carrying 21‑40 lbs; pushing/pulling 0‑25 lbs; pushing/pulling 26‑40 lbs; pushing/pulling 41‑60 lbs; reaching above shoulder; squat/kneel Frequently: sitting, standing, walking Continuously: audible speech, computer skills, decision making, depth perception, flexing/extending of neck, hand use: grasping, gripping, turning, hearing acuity, interpreting data, peripheral vision, problem solving, repetitive hand/arm use, seeing – far/near Disclaimer The above list of duties is intended to describe the general nature and level of work performed by individuals assigned to this classification. It is not to be construed as an exhaustive list of duties performed by the individuals so classified, nor is it intended to limit or modify the right of any supervisor to assign, direct, and control the work of employees under their supervision. Equal Opportunity EOE M/F/Disability/Vet #J-18808-Ljbffr 10 Nationwide Children's Hospital