Research Compliance Senior Manager

Dartmouth Health • Lebanon, NH

91d

About The Position

Reporting directly to the Dept Director of Research Operations, provides coordination for the administration, support, quality assurance, and management of research compliance functions for the Office of Clinical Research (OCR). This position participates in the essential aspects of research compliance activities, educates stakeholders on research compliance topics, and supports policy and procedure development.

Requirements

• Bachelor's degree in business or healthcare administration, requisite professional training and experience in healthcare/clinical research compliance and quality assurance.
• Minimum of three (3) years of management experience in a clinical research compliance environment; 10 years of research experience.
• Knowledge of the code of regulations and GCP for human subjects.
• Strong competency in Microsoft Office programs (Word, Excel, and PowerPoint).
• Ability to assess and resolve unprecedented problems that require research and review of policy, procedures.

Nice To Haves

• Certification in healthcare compliance or clinical research compliance.
• Clinical research experience.
• Effective organizational skills and a strong attention to detail.
• Effective professional written and oral communications skills.
• Strong interpersonal skills.

Responsibilities

• Manages OCR compliance initiatives by interpreting and applying federal (US, EMA, or other) regulatory laws and guidance during the monitoring and education of the performance of complex clinical research operations.
• Interprets the requirements of ICH GCP, the approved study protocol, and sponsor study related SOPs.
• Demonstrates an understanding of current events that have influenced guidelines and regulatory processes with regards to FDA regulations and guidelines as well as those on a global scale.
• Mentors and educates research teams in the planning and conduct of clinical trials.
• Provides study and study team preparation assistance for an audit/inspection conducted by a sponsor or regulatory authority.
• Provides comprehensive regulatory guidance to the DH research community.
• Oversees, where appropriate, creation and planning of study-specific monitoring plans that assure sufficient resources are allocated to ensure timely review of data while maintaining established standards for study participant safety and data integrity.
• Oversees, where appropriate, the writing and dissemination of reports (i.e. monitoring / auditing).
• Assesses new investigator-initiated studies for investigational drug / investigational device exemption applicability.
• Analyzes, creates, and modifies strategies, policies and procedures to ensure regulatory compliance for studies conducted at DH and implementation of new industry-wide initiatives.
• Develops and revises research compliance policies, SOPs, and educational opportunities in response to audit/inspection findings or requests from study teams.
• Conducts and coordinates human subject research educational initiatives.
• Initiates and manages compliance initiatives relating to the protection of the rights, safety, welfare of subjects.
• Serves as OCR's Collaborative Institutional Training Initiative (CITI) Administrator.
• Identifies internal control and research compliance risks to the organization, designs and executes related audits / quality assurance assessments, reports findings and results and recommends interventions to mitigate risks identified through the work.
• Presents and discusses research compliance related issues and findings with all levels of management and prepares reports and presentations for the OCR.
• Identifies and facilitates the activities of the key contacts essential to ensuring effective team operations during a clinical trial.
• Demonstrates an understanding of the cross functional team in developing a communication.
• Performs other duties as assigned.

What This Job Offers

• Industry: Ambulatory Health Care Services
• Education Level: Bachelor's degree