• Oversight of monitoring effectiveness • Implements various types of oversight encounters and activities • Completes Sponsor Oversight Visit reports consistently • Utilizes a risk-based approach to review critical to quality items • Creates Study Specific Oversight Plans (SSOPs) for aligned trials • Troubleshoots and uses alternative and innovative approaches to solve problems • Builds relationships with investigators and site staff in region

• As a Senior CRA, you will work on the frontline of communication with project stakeholders, ensuring timelines, targets and standards of clinical research projects in a variety of therapeutic indications. • You will build and maintain relationships with clinical sites and investigators. • Your focus will be on subjects’ rights, safety and well-being and quality of data compliance. • Responsibilities will include conducting and reporting all types of onsite monitoring visits, driving the study startup phase, performing CRF reviews, source document verification and query resolution.

• Serve as main CTI contact for assigned study sites • Conduct site visits (pre-study [PSV], site initiation [SIV], interim monitoring [IMV], and close-out [COV]) and complete site visit deliverables with quality and within given timelines in Monitoring Plan while adhering to all applicable regulatory requirements, SOPs and ICH GCP • Assist with study start-up activities, including feasibility, pre-study activities and site selection • Collect, review and track essential/regulatory documents • Participate in and complete all general and study specific training as required • Participate in investigator, client and project team meetings • Create and implement subject enrollment strategies for assigned study sites • Ensure proper storage, dispensation and accountability of all Investigational Product (IP) and trial-related materials • Perform site management activities and provide ongoing updates of site status to Clinical Project Manager • Conduct remote monitoring and complete the related activities in accordance with study specific Monitoring Plan • Utilize systems and reports to track subject status, subject case report form (CRF) retrieval / source document review (SDV), regulatory documents, and IP • Assist with project-specific activities as member of Project Team • May support in development of CRFs and other study related documents (subject worksheets, Monitoring Plan, etc.) • May support in the translation, customization, and review of Patient Information sheet and Informed Consent, protocol synopsis and other study applicable documents as per required procedures • Where applicable, provide support to Regulatory Affairs Study Start-up Team in the preparation or revision of documentation for submission to Ethics Committee(s), Institutions Ethics Committees, Regulatory Authorities, Competent Authorities or Institutions Administration Boards, and follow-up the evaluation process until approval is available. • Provide regular updates to Sponsor/ Client • Where applicable, support in contract negotiation with study sites, Investigator payments and tracking of site payments • Manage ISF and TMF for all assigned study sites in accordance with SOPs or study-specific Monitoring Plans • Identify site issues and implement corrective actions or escalate as appropriate • Liaise with Clinical Data Management for data cleaning activities • Assist in preparing and coordinating Investigator and client meetings and attend meetings as necessary

Role Description ICF is looking for multiple Research Specialists to support a multi-year, large-scale systematic literature review project on physical activity for a federal client. Candidates will report to the Project Manager and/or Research Methodologist and will be primarily responsible for supporting literature screening and data extraction processes. They may also participate in various aspects of reporting results. The successful candidate will possess: - A strong understanding of exercise science concepts - The impacts of physical activity on health outcomes - The ability to critically evaluate scientific literature - Familiarity with the systematic literature review approach - Strong attention to detail This is a remote position; however, the job must be performed in the United States. ICF monitors employee work locations and blocks access from foreign locations/foreign IP addresses, and prohibits personal VPN connections. As an on-call/freelancer, you might work zero to 30 hours per week, depending on our workload. Work volume will fluctuate across the lifespan of the project. The weekly number of hours assigned to each Research Specialist will be dependent on project needs and the Research Specialist’s availability. Research Specialists should be available to provide at least 5-10 hours of support per week; however, some weeks may have 0 hours assigned. Our core work hours are 10am - 4pm Eastern Time with the option to start earlier or work later depending on your time zone. Research Specialists may work outside of core work hours but must be able to attend and participate in regularly scheduled team meetings during ICF core work hours. Work schedules will be coordinated with the project leaders. Qualifications - Master’s degree in Exercise Science, Kinesiology, Physical Education, Public Health, or Health Science - 1+ year of experience conducting physical activity-related research - Ability to read, interpret, and critically evaluate scientific literature related to physical activity, public health, and health behavior and outcomes - Experience conducting systematic literature reviews Requirements - Familiarity with the 2nd Edition of the Physical Activity Guidelines for Americans - Experience with systematic literature review management platforms (e.g., DistillerSR, Covidence, Rayyan, etc.) - Basic understanding of the meta-analysis approach as demonstrated through past job experience, coursework, and/or publication history - Basic understanding of umbrella reviews (review of reviews) as demonstrated through coursework or publication history Professional Skills - Strong attention to detail - Demonstrated ability to work collaboratively with multidisciplinary teams - Ability to prioritize and work on multiple projects under strict deadlines in a fast-paced environment Benefits - Equal opportunity employer - Reasonable accommodations available for disabled veterans, individuals with disabilities, and individuals with sincerely held religious beliefs - Confidential handling of accommodation requests Pay Range The pay range for this position based on full-time employment is: $74,090.00 - $125,954.00