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Cincinnati Children's · 9 hours ago

Regulatory Affairs Specialist - Office for Clinical & Translational Research

Cincinnati, OH

Full-time

Onsite

Entry, Mid Level

$57K/yr - $72K/yr

2+ years exp

Cincinnati Children's is a renowned children's hospital committed to improving children's health. They are seeking a Regulatory Affairs Specialist to oversee research protocol compliance, conduct pre-reviews of draft documents, and ensure ethical practices in research involving human subjects.

Health Care

Responsibilities

Apply a comprehensive understanding of research regulations, ethics and guidelines, analyze research protocols submissions (new protocols, continuing review, changes to protocols, one-time use request and adverse events) to determine compliance with regulations

Oversee the review and correspondence of research protocols

Use independent judgment to interpret, analyze, and apply federal, state and CCHMC guidelines to promote ethical practices in research involving human subjects and to ensure compliance to those regulations by faculty and staff investigators

Work directly with individual faculty and staff investigators and research support staff to address human subjects issues during protocol review

Answer questions and problem solve for investigators, faculty, staff, research coordinators and students

Act as a liaison between IRB members and researchers to promote information flow

Prepare, review and submit all protocol amendments, SAE reports, and continuing reviews

Complete all reviews and submissions in a timely manner, meeting all deadlines

Under the guidance of senior staff, may assist in the development of protocol documents including but not limited to the protocol and consent forms

Upon request from investigators, conduct pre-reviews of draft documents (such as new protocol submissions, exemptions, and changes of protocol) and advise investigators and research coordinators regarding potential ethical, regulatory, editorial or content issues before they are submitted for full IRB review

Determine which research protocols or issues have additional requirements, such as the need for review by an outside expert, and coordinate the process to meet these requirements

Follow policies and procedures governing the handling of confidential information as defined by Cincinnati Children's mission and applicable laws and regulations

Review timeliness, accuracy, availability and security of information

Work daily in an audit ready manner

Organize and participate in activities to prepare for audits, surveys, quality reviews, and inspections

Participate in improving organizational performance through recommending areas or approaches for improvement activities, performing new procedures, collecting data and providing input to department discussions

Participate in staff committee, subcommittee, or special project groups

This may include research and writing, coordinating meeting schedules, preparing and distributing materials, recording minutes to document progress, and communicating the final outcome

By applying a comprehensive understanding of research and ethics, compose clear and precise memos, reports and training materials

Assist in developing written guidelines and educational materials for investigators (faculty and staff)

Contribute to planning and presenting educational programs for investigators, research coordinators, and other groups

Use creative and effective presentation skills

Participate in establishing job requirements and goals; perform duties at the desired level of competency

Act as a resource for faculty and staff regarding regulations during research protocol review

Serve as an informational and referral resource for the research community regarding regulatory, ethical and procedural issues

Maintain currency in field through cross-training, continuing education, literature and seminars

Implement this knowledge into the department

Document the conduct of each protocol's regulatory activities in an electronic regulatory system

Maintain written and electronic systems to support the clinical research activities

Submit data to collaborative parties accurately and within a timely manner

Qualification

Research regulationsProtocol analysisCompliance reviewAudit preparationDocumentation managementCommunication skillsTeam collaborationPresentation skills

Required

Bachelor's degree in a related field

2+ years of work experience in a related job discipline

Company

Cincinnati Children's

Cincinnati Children’s, a nonprofit academic medical center established in 1883, offers services from well-child care to treatment for the most rare and complex conditions.

Founded in 1883

Cincinnati, Ohio, USA

10001+ employees