Cincinnati Children's Hospital Medical Center - Research Compliance Careers

Research Compliance Jobs
at Cincinnati Children's Hospital Medical Center

Full Job Title: Heart Institute - SPEC-REG AFFAIRS,HIRC

Job Number: 87953

Location: Cincinnati, OH

Date Posted: 3-6-2017



DEPARTMENT: Heart Institute Research Core

SUPERVISOR'S TITLE: Clinical Research Manager, Business Director, Medical Director, Project Manager

PURPOSE OF POSITION: To oversee the review and correspondence of research protocols to the Institutional Review Board for the Heart Institute Research Core.

Responsibilities
·Research Management
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.
·Compliance/Legal
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.
·Data/Documentation Management
Document the conduct of each protocol's regulatory activities in Oncore?. Maintain written and electronic systems to support the clinical research activities. Submit data to collaborative parties accurately and within a timely manner.
·Quality/Performance Improvement
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.
·Resource/Professional Development
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.
·Communication
Communicate the results of IRB review to investigators and study coordinators by phone, e-mail, in person, or in written correspondence in a timely fashion. Compose clear, precise, detailed and technical letters and correspondence.

Skills & Competencies
·Writing
Excellent writing, editing and related computer skills
·Interpersonal Skills - Adv
Strong interpersonal skills. Effectively communicate at all levels of the organization.
·Computer Proficiency - Basic
Working knowledge of basic computer applications
·Organization
Possess strong organization skills and attention to detail
·Problem Solving
Ability to independently work through details of a problem to reach a positive solution
·Research
Ability to analyze scientific methods and desirable research design. Familiarity with the code of federal regulations regarding human subjects' research required.

Required:
·Bachelor's Degree OR Equivalent combination of education and experience
·Three years directly related experience

Preferred:
·3 years of directly related administrative, clinical and/or research experience preferably in a biological, medical, health care, educational or research setting
·Assoc of Clinical Research OR Society of Clinical Research Associates Certification

Cincinnati Children’s is an Equal Opportunity Employer. Qualified applicants receive consideration for employment without regard to race, color, religion, sex, national origin, age, genetic information, physical or mental disability, military or veteran status, sexual orientation, gender identity/expression, or other protected status in accordance with applicable federal, state, and local laws and regulations. If you would like more information about equal employment opportunity (EEO) rights as an applicant under the law, please click here

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