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Clinical Research Operations Manager
Clinical Research Operations Manager
We are currently seeking a Clinical Research Operations Manager to join our multi-disciplinary team that conducts research on behalf of NIH and other Federal clients. You will be responsible for the development, implementation, and oversight of clinical research operations for epidemiologic research studies. Responsibilities may include development of budgets, timelines, protocol and study materials development, IRB and other regulatory submissions, data collection procedures as well as quality assurance plans and field site monitoring, and overall study communications.
- Collaborates with colleagues, clients and subcontractor on matters related to the design, implementation, and management of clinical operations for epidemiologic research studies
- Leads development and oversight of clinical operations for research protocols including recruitment, screening, enrollment, informed consent, any clinical procedures required by the protocol such as physical exams, imaging, specimen collection, survey completion, participant reimbursements and tracking
- Handles the day-to-day operations of clinical or epidemiological research studies and/or staff conducting studies, including study start-up, conduct, and close-out activities
- Serves as primary contact for investigator(s), client, sponsor and/or functional area representatives in leading protocol execution
- Develops protocols and informed consent and assent forms for studies
- Provides technical mentorship to research sites and clinics on protocol related issues
- Collaborates with multi-disciplinary project team to estimate requirements, and prepare preliminary budgets
- Works with clients, study collaborators and project staff to develop data collection instruments, manuals of operations, and reports
- Develops, reviews, and maintains key study documents to ensure adequate documentation
- Develops training materials and conducts training for study implementation
- Ensures compliance with government regulations when writing and reviewing protocols, analysis plans, reports, and manuscripts
- Recommends and implements innovative process ideas to impact study operations
- Plans, coordinates, and leads resources/processes for successful completion of study goals
- Serves as the liaison with internal and external partners to ensure effective research operations
- Works with programmers to develop requirements for data and specimen management systems and for QA/QC reports
- Ensures development of quality assurance plans and procedure manuals and oversee implementation and monitoring of quality throughout study
- Writes monthly project reports and provides written and oral progress reports to clients and management
- Performs additional duties as required
- A Master's Degree in Public Health, Nursing, Advance Practice Provider (APRN or PA) with at least 5 or more years of clinical research experience or a Bachelor’s in Public Health or Nursing with 8 years of clinical research experience
- Experience with direct supervision of research project staff
Other highly desired, but not required, skillsets:
- Background in cancer research
- Experience working in the Federal space as a government contractor
Personal Skills / Experience
- Excellent oral and written communication, and organizational skills
- Demonstrated experience managing multiple projects simultaneously in a fast paced, highly collaborative environment.
- Effective interpersonal skills including the ability to provide balanced feedback, motivate and train others
- Ability to proactively identify, prevent or resolve issues
- Organized, proficient at multi-tasking with outstanding attention to detail
- Able to lead, empower, supervise and coordinate teams
- Possesses cross-cultural awareness and is able to adapt appropriately
- Proficient with MS Office (Word, Excel, PowerPoint, and Outlook)
Working at ICF
Working at ICF means applying a passion for meaningful work with intellectual rigor to help solve the leading issues of our day. Smart, compassionate, innovative, committed, ICF employees tackle unprecedented challenges to benefit people, businesses, and governments around the globe. We believe in collaboration, mutual respect, open communication, and opportunity for growth.
We can only solve the world's toughest challenges by building an inclusive workplace that allows everyone to thrive. We are an equal opportunity employer, committed to hiring regardless of any protected characteristic, such as race, ethnicity, national origin, color, sex, gender identity/expression, sexual orientation, religion, age, disability status, or military/veteran status. Together, our employees are empowered to share their expertise and collaborate with others to achieve personal and professional goals. For more information, please read our EEO & AA policy.
COVID-19 Policy: New or prospective U.S. employees must provide proof of complete vaccination on the date of their commencement of employment. If selected for employment, you will provide proof of your full vaccination status, defined as vaccinated two weeks after receiving the requisite number of doses of a COVID-19 vaccine approved or authorized for emergency use by the FDA.
Reasonable Accommodations are available, including, but not limited to, for disabled veterans, individuals with disabilities, and individuals with sincerely held religious beliefs, in all phases of the application and employment process. To request an accommodation please email firstname.lastname@example.org and we will be happy to assist. All information you provide will be kept confidential and will be used only to the extent required to provide needed reasonable accommodations. Read more about non-discrimination: EEO is the law and Pay Transparency Statement.
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