Clinical Research Program Coordinator

Nationwide Children's Hospital

1d•Hybrid

About The Position

Overview: This is a hybrid position with an expectation of at least 12 onsite hours each week. The selected candidate will be required to attend in person monthly onsite meetings as well as any additional onsite meetings requested by their supervisor or leadership. Job Description Summary: 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. Job Description: 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 collaborations sites in addition to the subcontracts with other sites. Provides funding opportunity notifications to PI’s. 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. Track projects and initiatives to ensure they move forward based on both timelines and budget; report 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 (i.e., Data Management, Biostats, Medical Writing, Regulatory Compliance, etc.). Manages and oversees IRB process for program projects and associated sites, ensuring sites are submitting accurate and timely IRB submissions, and maintain 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. Work 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 the 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 Additional Physical Requirements performed but not listed above: (not specified) "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. EOE M/F/Disability/Vet" The moment you walk through our doors, you feel it. When you meet our patient families, you believe it. And when you talk with anyone who works here, you want to be part of it. Welcome to Nationwide Children’s Hospital, Where Passion Meets Purpose. Here, Diversity, Equity and Inclusion are integrated into our core values and practices. We are passionate about building, sustaining and evolving an inclusive and equitable environment. We are seeking individuals who live these values and want to share their experiences and efforts in support of our collective mission. We’re 15,000 strong. And it takes every one of us to improve the lives of the kids we care for, and the kids around the world we’ll never meet. Kids who live healthier, fuller lives because of the knowledge we share. We know it takes a Collaborative Culture to deliver on our promise to provide the very best, innovative care and to foster new discoveries, made possible by the most groundbreaking research. Anywhere. Ask anyone with a Nationwide Children’s badge what they do for a living. They’ll tell you it’s More Than a Job. It’s a calling. It’s a chance to use and grow your talent to make an impact that truly matters. Because here, we exist simply to help children everywhere. Nationwide Children’s Hospital. A Place to Be Proud.

Requirements

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 the ability to manage workload.
Ability to work independently and as part of a team.
Working knowledge of data management software.
Two years clinical research experience or project management experience.
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

Nice To Haves

ACRP or SOCRA certification, preferred.
Bachelor’s degree preferred or Associate degree with two years clinical research experience or project management experience.

Responsibilities

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 collaborations sites in addition to the subcontracts with other sites.
Provides funding opportunity notifications to PI’s.
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.
Track projects and initiatives to ensure they move forward based on both timelines and budget; report 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 (i.e., Data Management, Biostats, Medical Writing, Regulatory Compliance, etc.).
Manages and oversees IRB process for program projects and associated sites, ensuring sites are submitting accurate and timely IRB submissions, and maintain 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.
Work with principal investigators at each site to establish multi-site monitoring plans for investigator-initiated projects.