Human Subjects Program Manager
Ripple Effect is seeking a full-time Human Subjects Program Manager with a background in biomedical research and significant experience with human subjects protections and related policies to work within the Office of Extramural Research (OER) at the National Institutes of Health (NIH).
- Duty Location: Bethesda, MD
- Position Information: Full-Time, Regular
- Vacancies: 1 Opening
- Security Clearance: A security clearance is not required to apply. Applicants, once hired, may be subject to a security investigation and may need to meet eligibility requirements for access to classified information.
- Travel Required: This position requires occasional local travel (Washington, D.C. area) for work-related meetings.
Ripple Effect Communications is a government contractor providing professional consulting services in the areas of: Communications & Outreach; Program Management & Policy; and Research & Evaluation. For this position, we are looking for someone to support the Office of Extramural Research at the National Institutes of Health (NIH). Ripple Effect is a fast-paced, demanding, and rewarding environment where independent work, creative thinking, and solution-proposing is the norm. To learn more about working at Ripple Effect and our growing team check out the Future Rippler section of our website.
The Office of Extramural Research (OER) within the National Institutes of Health (NIH) provides leadership for the management of trans-NIH programs via the development of programs and policies, interpretation, coordination, oversight, evaluation, training and outreach for NIH extramural staff and the extramural research community. As such, OER is tasked with helping to provide oversight and direction for the implementation of initiatives aimed at enhancing the stewardship, accountability, and transparency of human subjects research. Several recent initiatives, including the NIH policy on dissemination of clinical trials information, the single IRB policy, the new 21st Century Cures bill, and the revised Common Rule necessitate major changes for NIH. Ripple Effect is seeking a full-time staff member to work with OER and other NIH components to implement this series of initiatives. This is a 1-year appointment with the possibility of an extension.
Ripple Effect attracts high-achievers who consistently attain above-average results and take responsibility for solving problems. Our clients engage us because we bring intelligence, innovation, initiative, and impact to project management. We need self-starters who get the job done, who can handle a wide range of support tasks, and who enjoy the energy of a government office with intelligent colleagues and fast-paced programs.
The ideal candidate for this role has a strong background in human subjects research, an intimate familiarity with human subjects protections and policies, has demonstrated project management experience, and is highly motivated to take on challenges within a fast-paced environment.
The Program Manager will provide program administration and subject-matter expertise by completing the following tasks:
Provide subject matter expertise
- Advise OER on optimal approaches to implementation of human subjects and privacy related policies and regulations.
- Provide technical expertise in the development of new or revised products (policies, guidance, instructions, procedures resources) needed for oversight of the NIH policies and procedures
- Provide technical expertise in the development of new or revised products (draft regulations, policies, guidance, instructions, procedures resources) for NIH privacy protections programs and/or certificates of confidentiality
- Use expertise to assess products proposed by others in OER, NIH, and the extramural research community
- Prepare reports that reflect current state-of-the-art on topics in areas of expertise to help guide OER decisions
- Use the appropriate project management processes, skills, and resources to oversee projects pertaining to human subjects regulations and data privacy.
- Employ techniques to define, plan, organize, schedule, manage and close out projects
- Oversee and manage project teams (e.g., coordinate subgroups to ensure tasks are ongoing and completed on time)
- Formulate, organize and monitor inter-connected projects
- Resolve higher scope issues
- Manage stakeholder expectations
- Represent the Human Subjects team at meetings within and external to NIH.
- Provide program support on related extramural initiatives, including trans-NIH working groups and committees.
- Possess an advanced degree Master’s degree or higher from an accredited university
- Have adept skills and knowledge of Microsoft Office tools (i.e., Word, Excel, PowerPoint, SharePoint)
- Be willing and able to work full time on the client site during core business hours
- Possess excellent problem-solving and communication skills
- Have experience in project or program management
- Have knowledge and understanding of the management and conduct of human subjects research (including clinical trials), including knowledge of privacy protection regulations and certificates of confidentiality
- Have a scientific background acquired via education, training and/or experience
- Experience with NIH preferred, particularly the extramural research programs
Our employees are rewarded in many ways for their contributions to our mission, including competitive pay, exceptional benefits, and a range of work/life programs based on employment classification. Benefit offerings may include:
- Health Benefits – Health, Dental, and Vision
- Life, long-term disability, and other insurance products
- Health and Wellness Programs
- Flexible Spending and Health Savings Accounts
- Retirement 401K program
- Profit sharing and bonus program
- Paid and unpaid leave
- Professional development
- Flexible schedules and work location
Vetting and Hiring Process
It is the policy of Ripple Effect Communications, Inc. that:
- qualified applicants will receive consideration for employment without regard to race, sex, color, religion, age, national origin, marital status, disability, veteran status, genetic information, sexual orientation, gender identity or any other reason prohibited by law in provision of employment opportunities and benefits;
- employment eligibility will be verified using E-verify;
- applicants may be asked to participate in assessments during the interview process as described in our Informed Consent Policy; and
- applicants will not be reimbursed for any expenses associated with the interview process or relocation.
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