IRB Specialist II - RI Scientific

Overview:

This position is in support of the NCH IRB Full Board.  Includes full board review lifecycle, including screening research submissions, verifying regulatory documentation, coordinating full board meetings, ensuring quorum requirements, documenting meeting minutes, and communicating IRB determinations to investigators. Includes reviewing protocols for compliance, confirming required modifications before approval, supporting researchers, and assisting with reviewer education. Candidates should have a bachelor’s degree (advanced degree preferred), experience in clinical research or regulatory affairs, and knowledge of regulations governing human subjects research. Certification such as CIP or CCRP preferred. Position requires in-office work at least 3 days/week on the NCH campus. 

Job Description Summary:

Job Description:

• Provides protocol submission related technical & administrative support to Principle Investigators (PIs).
• Coordinates across the organization and with multiple levels of faculty and staff to support the assembly, submission, review, and maintenance of regulatory protocols.
• Serves as the primary resource for investigators regarding the organizational review requirements for research protocols.
• Tracks pending applications and advises PIs on the status of submissions. Identifies and tracks approved research protocols, including implementing procedures to assist investigators in complying with conditions imposed by the regulatory committees.
• Maintains communication with PIs regarding approaching expirations of study approvals, delinquent responses, incomplete submissions, and other concerns.
• Serves as super-user for the eTRAC system and contributes to the design and implementation of process improvements and business flow changes.
• Provides training to PIs and staff regarding the use of the eTRAC system to submit new protocols or amend existing protocols.
• Collaborates cross-functionally to ensure that researchers have completed mandatory training.
• Attends and supports meetings, seminars, conferences, and workshops. Submits minutes of meetings and drafts correspondence based on committee deliberations. Issues approval notices based on conditions imposed by the committee.
• Coordinates filing of institutional accreditation applications. Maintains records for inspections. Ensure the quality, content, and format of regulatory submissions to state, federal, and international agencies.
• Contributes to the compliance management process and ensures timely completion of non-compliance reporting as required by federal and institutional regulatory agencies.
• Attends regulatory professional meetings and identifies new or modified regulations.

• Bachelor’s Degree, required.
• Master’s Degree, preferred.

(not specified)

Relevant certification, preferred.

• Ability to analyze and apply Federal, industry regulatory agencies and AWRI’s policies.
• Effective verbal and written communication.
• Working knowledge of research terminology.
• Ability to work both independently and in a team-oriented environment, under minimal direction.
• Proficiency with MS Office.

Threeyears of relevant research regulatory experience, required.

OCCASIONALLY: Bend/twist, Climb stairs/ladder, Lifting / Carrying: 0-10 lbs, Pushing / Pulling: 0-25 lbs, Reaching above shoulder, Squat/kneel, Standing, Walking

FREQUENTLY: (none specified)

CONTINUOUSLY: Audible speech, Color vision, Computer skills, Decision Making, Flexing/extending of neck, Hand use: grasping, gripping, turning, Hearing acuity, Interpreting Data, Peripheral vision, Problem solving, Repetitive hand/arm use, Seeing – Far/near, Sitting

Ability to multi-task within a demanding environment.

"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"