Sr. Research Conflict of Interest Specialist

Job Description

The Research Compliance Specialist-Conflicts of Interest (COI) performs duties in support of the Research Compliance activities within the Office of Research Integrity & Compliance. The primary responsibility of the Research Compliance Specialist-COI is to manage the daily activities of the Financial Conflict of Interest (FCOI) process and support the Research Compliance Manager and the Research COI Officer in ensuring all required activities are carried out per Federal regulations, policies and procedures. Actively participates in outstanding customer service and accepts responsibility in maintaining relationships that are equally respectful to all.

ResponsibilitiesImplement processes to ensure all research team members submit and maintain current FCOI disclosures and required FCOI education and training.Receive, file, and track FCOI disclosures, Significant Financial Interests (SFIs), FCOI Management Plans and completion of required training.Review all disclosed FCOI forms and identify if there is an SFI reported.Determine which SFIs are either not related to an active research project or may be related but managed administratively per the Financial Conflict of Interest in Research policy and procedures.Determine which SFIs may be related and must be reviewed by the Research Compliance Manager and submitted to the COI Officer and Research Oversight Committee (ROC) Chair and/or Co-Chair.Review and sign all FCOI disclosures determined to have no SFIs disclosed, and/or no SFIs determined to be potentially related to an active research project of which the disclosing individual is involved.Develop, sign, and implement FCOI Management Plans for all conflicted individuals and their associated projects for SFIs reported less than $40K and determined to be related to an active research project per Financial Conflict of Interest in Research policy and procedures.Develop draft Management Plans for all SFIs greater than $40K and determined to be related to an active research project.Facilitate the review of SFIs greater than $40K and draft Management Plans by the Research Compliance Manager, COI Officer and ROC Chair and/or Co-Chair, escalating any SFIs and assigned Management Plans to the Research Oversight Committee for review and voting as determined by the COI Officer and ROC Chair and/or Co-Chair.Prepare SFI/Management Plan Summary reports for all Management Plans developed and submit to the IRB in a timely manner.Prepare aggregate COI, SFI, and Management Plan quarterly reports.Submit quarterly reports, and SFI Summary reports for all Management Plans deemed needing ROC review and approval to the ROC in a timely manner.Work with external/Central IRBs and assist the Research Compliance Manager in developing workflows and processes to communicate with them regarding FCOIs and Management Plans.Independently conduct onsite internal monitoring of assigned FCOI Management Plans to assess compliance with the assigned management plan and document findings. Onsite reviews are conducted at various campuses as needed.Assist with the management of noncompliance through preparation of reviews and corrective action plans as needed working with the Research Compliance Manager.Prepare or assist with the preparation of reports as needed for internal/external individuals and/or entities including the communication of SFIs and FCOI Management Plans to stakeholders, investigators, pertinent research team members, research department managers and/or directors as needed, the Institutional Review Board and Grants department. Prepare or assist with the preparation of reports and aggregate information for enterprise and metrics reports.Provide guidance and serve as a resource to research departments and individual research team members regarding policies and procedures and federal regulations related to FCOI. This may include assisting with content and implementation of FCOI education and training, conducting live presentations virtually and/or at multiple campuses, and ensuring effective communication and information deployment related to FCOI.Offer input in the development/revision of ORI policies and procedures related to FCOI, the ongoing risk assessment of the FH Research Institute and the ORI compliance program’s effectiveness related to FCOI issues.Manage and/or assist with special projects as assigned.Essential SkillsKnowledge of federal regulations related to FCOI.Computer skills including MS Office applications and Adobe.Bachelor’s degree in a related field, including Science, Administration, Nursing, or other related biological sciences, healthcare, or research field.At least four years of experience in clinical research or scientific setting, an institutional review board, or research administration office.Additional Skills & QualificationsCertified in Healthcare Research Compliance (CHRC)Certified in Healthcare Compliance (CHC)Work Environment

This is a remote position.

Pay and Benefits

The pay range for this position is $35.00 - $40.00

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully remote position.

Application Deadline

This position will be accepting applications until Jan 2, 2025.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

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The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

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