Clinical Research Program Coordinator

 

Applicants should have a regulatory experience.

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.

 

 

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 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"