Single IRB Liaison Assistant Regulator Manager

Relevant activities include, but are not limited to the following:

• Schedule and develop meeting agendas and minutes in collaboration with the study team, both remotely and in person, and lead meetings/calls as needed.
• Draft and submit sIRB applications, including amendments, protocol deviations, unanticipated problems, and adverse events.
• Upload and save documents to the internal shared drive, electronic data capture systems, and regulatory document systems, as applicable.
• Notify Project Management teams when cIRB submissions have been approved and documents have been uploaded.
• Provide the Project Management team with weekly updates on all sIRB studies.
• Assist with setting priorities and creating timelines for the sIRB team.
• Assist with the Reliance Agreement execution process.
• Assist with revising study documents, including informed consent forms, recruitment materials, and other study tools.
• Troubleshoot routine/non-routine problems and take measures to correct/handle issues.
• Incorporate data from existing information into spreadsheets/databases in an organized and presentable format.
• Keep current on federal, state, and local laws and regulations governing human-subject research through attendance at conferences, workshops, seminars, or lectures pertaining to human-subject protection.
• Takes on additional duties as assigned within the scope of the role.

• Demonstrated knowledge of federal regulations relating to the protection of human subjects and good clinical practice guidelines is preferred but not required.
• Attention to detail and excellent organizational skills.
• Excellent verbal and written communication.
• Excellent computer skills and proficiency with Microsoft Office are required.
• Ability to work independently as well as a team player who can take direction.
• Ability to effectively and efficiently work within an extremely fast moving, deadline-driven environment, while balancing multiple tasks simultaneously.

EDUCATION:

Bachelor's Degree

EXPERIENCE:

At least one year of experience in research or a related field

Background/familiarity with biology or other scientific disciplines is preferred but not required.

WORKING CONDITIONS:

This position can be either hybrid or remote. Must have reliable internet access. On occasion and at the discretion of the Director of QA, the Assistant Regulatory Manager may be required to be onsite for meetings, sponsor audits or regulatory inspections. Advanced notice will be given.

Physical Requirements

• Standing Frequently (34-66%)
• Walking Frequently (34-66%)
• Sitting Occasionally (3-33%)
• Lifting Frequently (34-66%) 35lbs+ (w/assisted device)
• Carrying Frequently (34-66%) 20lbs - 35lbs
• Pushing Occasionally (3-33%)
• Pulling Occasionally (3-33%)
• Climbing Rarely (Less than 2%)
• Balancing Frequently (34-66%)
• Stooping Occasionally (3-33%)
• Kneeling Occasionally (3-33%)
• Crouching Occasionally (3-33%)
• Crawling Rarely (Less than 2%)
• Reaching Frequently (34-66%)
• Gross Manipulation (Handling) Frequently (34-66%)
• Fine Manipulation (Fingering) Frequently (34-66%)
• Feeling Constantly (67-100%)
• Foot Use Rarely (Less than 2%)
• Vision - Far Constantly (67-100%)
• Vision - Near Constantly (67-100%)
• Talking Constantly (67-100%)
• Hearing Constantly (67-100%)