Clinical Research Regulatory Specialist I, Department of Neurology & Rehabilitation Services, Stroke

Clinical Research Regulatory Specialist I, Department of Neurology & Rehabilitation Services, Stroke

Tags

72

GOOD MATCH

Experience Level

100

Skill

Industry Exp.

42

Education

Higher Education

Universities

Insider Connection @University of Cincinnati

2 email credits available today

Responsibilities

Prepares and submits protocol specific documentation to regulatory agencies and internal or external stakeholders including: research protocols, informed consent forms, or other similar documents necessary for research start-up or maintenance or close-out

Serve as liaison for questions/issues for designated research protocols and performs submissions to Institutional Review Boards (IRBs) including initial submissions, continuing reviews, amendments, reportable events, and/or closure

Address all regulatory issues involving research protocols; interpret, analyze and apply federal, state, and local regulations, along with University rules and regulations, to ensure ethical research practices are followed; report suspected or known instances of noncompliance with University or federal regulations

Maintains all regulatory documentation within existing systems (i.e., Complion) and secure document storage, including those that are complex in nature (e.g., procedural and interventional studies)

Comprehends, interprets, and applies regulations and legislation regarding the protection of human subjects. These include regulations under federal policies, FDA, and other compliance agencies or directive

Assist with activities related to development and execution of research agreements relating to the conduct of research activities

Prepares for, coordinates, and actively participates in site visits; communicates effectively with sponsors and/or contract research organizations (CROs)

Interacts with IRB and sponsor contacts with close supervision

Prepares and submits documentation to regulatory agencies with close supervision

Perform related duties based on departmental need

Benefits

Tuition remission covering tuition costs for nearly all undergraduate and graduate programs offered by the university for you and your eligible dependents; eligibility may vary by position and FTE status.

Choose between state pension plans (OPERS, STRS) or an Alternative Retirement Plan (ARP); UC contributes 14–18% of your salary based on position.

Generous time-off policy, including vacation and sick time, 11 paid holidays, additional end-of-year paid time off (Winter Season Days), and 6 weeks of paid parental leave for new parents.

Comprehensive health coverage (medical, dental, vision, prescription).

Flexible spending accounts and wellness programs.

Professional development and mentorship opportunities.

The position can be considered a hybrid role; weekly time spent on site is near University of Cincinnati main medical campus in Clifton, Ohio.

Glassdoor

3.9

The University of Cincinnati offers students a balance of educational excellence and real-world experience.

Cincinnati, Ohio, USA

http://www.uc.edu/

Late Stage

Total Funding

$38.17M

Key Investors

U.S. Department of Education

National Institutes of Health

2024-12-24

Grant

2024-06-06

Grant· $1.8M

2023-04-11

Grant· $1.6M

Leadership Team

Sahaja Ampolu

Co-Founder & Vice President of External Relations for the UC Bearcats Food Recovery Network

Bharath Prabhakaran

Vice President and Chief Digital Officer

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Qualifications

Bachelor's Degree

1-2 years of relevant experience

Required skills

Represents the skills you have, click on the tags, Bachelor’s Degree, Relevant Experience

Experience

1-2 years