Job Information
Actalent Project Manager, IRB Reliance & Cede Process Review in New Brunswick, New Jersey
Job Title: Project Manager – IRB Reliance & Cede Process Review
Job Description
This role leads an independent, time‑bound review of Cede Application and Reliance Agreement processes within a high‑volume clinical research environment. You will evaluate the end‑to‑end cede workflow, identify operational risks and inefficiencies, and deliver clear, data‑driven recommendations that support leadership decision‑making and improve overall IRB reliance operations.
Responsibilities
Lead and manage the full project over an anticipated 6–8 week timeline, ensuring milestones and deliverables are met on schedule.
Plan, organize, and facilitate weekly meetings with HRPP leadership and key stakeholders to review progress, validate findings, and align on next steps.
Conduct a comprehensive assessment of the Cede Application, including its content, structure, and usability, and recommend improvements.
Review related instructions, education materials, policies, and workflows that support reliance and cede processes.
Evaluate the end‑to‑end cede process from submission through agreement to cede, mapping current workflows and decision points.
Identify operational risks, gaps, and inefficiencies within reliance and IRB review workflows, including areas that may delay review or create confusion.
Conduct stakeholder interviews with HRPP leadership, IRB staff, research operations, and other institutional partners to understand current practices and pain points.
Perform benchmarking against relevant best practices and peer institutions to inform recommendations.
Develop detailed process maps that clearly depict current and proposed future‑state reliance and cede workflows.
Prepare a comprehensive document review summary that synthesizes findings from policies, SOPs, education materials, and application content.
Produce a structured findings and recommendations report that highlights key issues, proposed solutions, and expected impact on regulatory and operational performance.
Create a practical implementation plan that outlines priorities, timelines, responsibilities, and change‑management considerations.
Partner with Reliance and HRPP staff to support execution of approved changes and ensure alignment with institutional policies and federal regulations.
Support revisions to the Cede Application to enhance clarity, usability, and alignment with reliance requirements.
Contribute to the development and refinement of education materials, including portal content, checklists, standard operating procedures (SOPs), and other tools to guide users.
Help outline reliance and IRB processes clearly for stakeholders, setting realistic expectations for timelines, roles, and responsibilities.
Identify and recommend specific process revisions that can shorten review time while maintaining regulatory compliance and institutional standards.
Assist with rolling out updated processes, including communication, training support, and documentation to facilitate adoption and sustainability.
Provide leadership with data‑driven insights and concise summaries that support strategic decisions related to IRB reliance and cede processes.
Essential Skills
Extensive experience as a Senior‑level IRB professional with deep familiarity in IRB reliance and cede processes.
Demonstrated expertise in IRB reliance agreement workflows, including evaluation of cede applications, assessment of reliance appropriateness, coordination with reviewing IRBs, and alignment with institutional HRPP policies and federal regulations.
Strong project management skills with a track record of independently leading time‑bound initiatives, managing timelines, and delivering defined outputs within 6–8 week windows or similar.
Proven ability in process assessment and improvement, including evaluating end‑to‑end workflows, identifying operational risks and gaps, and developing actionable, data‑driven recommendations.
In‑depth knowledge of IRB applications and IRB review workflows in a clinical research setting.
Solid understanding of federal regulations and Good Clinical Practice (GCP) as they relate to IRB oversight, reliance models, and institutional compliance frameworks.
Strong analytical skills with the ability to synthesize complex regulatory and operational information into clear findings and recommendations.
Excellent written and verbal communication skills, including the ability to create clear documentation, reports, and education materials.
Proven stakeholder engagement skills, with the ability to partner effectively with HRPP leadership, IRB staff, research operations, and other institutional stakeholders.
Experience creating process maps, written assessments, summary reports, SOPs, and implementation support tools.
Demonstrated experience in project management and process improvement within clinical research or a related regulated environment.
Ability to work independently in a remote setting while maintaining regular communication and responsiveness during business hours.
Additional Skills & Qualifications
Background in clinical research operations or oversight, with familiarity with high‑volume protocol environments.
Experience supporting or working within an HRPP or IRB office in an academic medical center or similar institution.
Prior involvement in designing or refining Cede Applications, reliance portals, or related user‑facing tools.
Experience contributing to or leading the development of education materials such as portal content, checklists, and SOPs for research stakeholders.
Comfort presenting findings and recommendations to leadership and cross‑functional teams in a clear and concise manner.
Ability to translate complex regulatory requirements into practical, user‑friendly processes and documentation.
Strong organizational skills, including the ability to balance multiple workstreams, stakeholder meetings, and documentation efforts within a defined project period.
Work Environment
This is a 100% remote role supporting a high‑volume clinical research program with approximately 3,000 active protocols. The project is anticipated to run for 6–8 weeks. The ideal commitment is 40 hours per week, but part‑time arrangements of approximately 20 hours per week are possible, provided you are available during standard business hours for team and stakeholder meetings. Work is highly collaborative and involves frequent virtual interaction with HRPP leadership, IRB staff, and research operations, using common remote communication and documentation tools. The environment is fast‑paced, detail‑oriented, and mission‑driven, with a strong focus on regulatory compliance, operational efficiency, and clear, well‑structured documentation.
Job Type & Location
This is a Contract position based out of New Brunswick, NJ.
Pay and Benefits
The pay range for this position is $55.00 - $65.00/hr.
Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • 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 is anticipated to close on May 4, 2026.
Diversity, Equity & Inclusion
At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I is embedded into our culture through:
Hiring diverse talent
Maintaining an inclusive environment through persistent self-reflection
Building a culture of care, engagement, and recognition with clear outcomes
Ensuring growth opportunities for our people
Actalent is an equal opportunity employer.
About Actalent
Actalent is a global leader in engineering and sciences services. For more than 40 years, we’ve helped visionary companies advance their goals. Headquartered in the United States, our teams span 150 offices across North America, EMEA, and APAC—with four delivery centers in India led by 1,000+ extraordinary employees who connect their passion with purpose every day.
Our Bangalore, Hyderabad, Pune, and Chennai delivery centers are hubs of engineering expertise, with core capabilities in mechanical and electrical engineering, systems and software, and manufacturing engineering. Our teams deliver work across multiple industries including transportation, consumer and industrial products, and life sciences. We serve more than 4,500 clients, including many Fortune 500 brands. Learn more about how we can work together at actalentservices.com.