Title: Clinical Research Monitor Location: USA MD Fort Detrick - Fort Detrick (MDC001) Job Description: Type of Requisition: Regular Clearance Level Must Currently Possess: None Clearance Level Must Be Able to Obtain: None Public Trust/Other Required: NACI (T1) Job Family: Ancillary Health Job Qualifications: Skills: Clinical Research, Data Compilation, Research Protocols Certifications: None Experience: 4 + years of related experience US Citizenship Required: Yes Job Description: GDIT's Military Health team is hiring a Clinical Research Monitor to support the Office of Regulated Activities (ORA) under the DoW located at Ft. Detrick in Frederick, Maryland. The Office of Regulated Activities (ORA) is a multidisciplinary team of regulatory affairs, compliance, and clinical support professionals dedicated to supporting the USAMRDC mission of developing Food and Drug Administration regulated medical products for the Warfighter. The ORA provides full-service, oversight, and consultation for regulatory, clinical, non-clinical, manufacturing, data management, biostatistics, product technical, safety monitoring. ORA operates in a high-paced environment and seeks individuals who can work independently and take initiative in completing tasks. The CRA will provide clinical trial monitoring to ensure all sponsor required trial monitoring is conducted and all deliverables are provided according to 21 CFR 312 and ICH. ***This is a hybrid position and will report onsite 2 days a week at Ft. Detrick in Frederick, Maryland. Must reside within commuting distance. Must be able to travel CONUS and OCONUS (potentially working on emergency use products). HOW YOU WILL MAKE AN IMPACT: - Develop a Clinical Monitoring Plan and monitor single site and multicenter clinical studies both inside and outside the continental United States; when required, conduct centralized monitoring activities. - Remote review of electronic source documents, electronic Case Report Forms (CRFs), trends, and metrics in order to identify and mitigate safety and data quality risk issue(s), prepare Clinical Monitoring Reports and file in the sponsor’s regulatory file. The monitoring reports shall include the date of activities, description of the activities, and any findings from the activities-Prepare protocol deviations and violation and non-compliance reports - Provide remote evaluation of the study data, carried out by a team including central monitors, medical reviewers at a location other than the sites at which the clinical investigation is being conducted and annotate in monitoring reports for the sponsor’s regulatory file. - Prepare/review calibration and maintenance records, which are records kept at the clinical site that document the calibration and maintenance of all applicable equipment utilized during the execution of the clinical trial including laboratory equipment, and ensure equipment is adequate, current, accessible and annotate this information in monitoring reports for the sponsor’s regulatory file. - Prepare and/or review shipment records, which include shipping documentation for investigation products, biological samples, and if applicable, other study supplies provided to the clinical sites. - Prepare and/or review laboratory sample analysis reports WHAT YOU’LL NEED TO SUCCEED: - Bachelors degree, 4+ year’s experience supporting clinical research - Experience reviewing electronic source documents, electronic Case Report Forms (CRFs), prepare Clinical Monitoring Reports and file in the sponsor’s regulatory file. - Experience providing remote evaluation of the study data - Experience preparing/reviewing calibration and maintenance records to ensure equipment is adequate, current, accessible and annotate this information in monitoring reports for the sponsor’s regulatory file. - Experience preparing and/or reviewing shipment records, documentation for investigation products, biological samples, and other study supplies provided to the clinical sites. - ORA operates in a high-paced environment and seeks individuals who can work independently and take initiative in completing tasks. - Must be a US Citizen with the ability to obtain a favorable NACLI T1 security investigation prior to start date. - TRAVEL: Must be able to travel CONUS and OCONUS (working on emergency use products) WHAT GDIT CAN OFFER YOU: - Challenging work that makes a real impact on the world around you - Internal mobility team dedicated to helping you own your career - 401K with company match - Diverse, highly collaborative teams - Professional development, education assistance, certification and training opportunities #GDITHealth #militaryhealth #GDITLabScienceJobs #GDITFedHealthJobs #GDITPriority The likely salary range for this position is $73,965 - $86,250. This is not, however, a guarantee of compensation or salary. Rather, salary will be set based on experience, geographic location and possibly contractual requirements and could fall outside of this range. Scheduled Weekly Hours: 40 Travel Required: 10-25% Telecommuting Options: Hybrid Work Location: USA MD Fort Detrick Additional Work Locations: Total Rewards at GDIT: Our benefits package for all US-based employees includes a variety of medical plan options, some with Health Savings Accounts, dental plan options, a vision plan, and a 401(k) plan offering the ability to contribute both pre and post-tax dollars up to the IRS annual limits and receive a company match. To encourage work/life balance, GDIT offers employees full flex work weeks where possible and a variety of paid time off plans, including vacation, sick and personal time, holidays, paid parental, military, bereavement and jury duty leave. To ensure our employees are able to protect their income, other offerings such as short and long-term disability benefits, life, accidental death and dismemberment, personal accident, critical illness and business travel and accident insurance are provided or available. We regularly review our Total Rewards package to ensure our offerings are competitive and reflect what our employees have told us they value most. We are GDIT. A global technology and professional services company that delivers consulting, technology and mission services to every major agency across the U.S. government, defense and intelligence community. Our 30,000 experts extract the power of technology to create immediate value and deliver solutions at the edge of innovation. We operate across 50 countries worldwide, offering leading capabilities in digital modernization, AI/ML, Cloud, Cyber and application development. Together with our clients, we strive to create a safer, smarter world by harnessing the power of deep expertise and advanced technology. Join our Talent Community to stay up to date on our career opportunities and events at gdit.com/tc. Equal Opportunity Employer / Individuals with Disabilities / Protected Veterans

This role is 100% remote. It is required to reside and hold a state license in TX or GA. Availability: This position requires at least 40 hours of availability, and all scheduling options include some afternoon and evening availability to best support client needs. About Expressable At Expressable, our mission is to expand access to family-led online occupational therapy, empowering caregivers to be active participants in their loved one’s journey. Certified by The Joint Commission and backed by 3,000+ 5-star reviews, Expressable is redefining how occupational therapy is delivered. Our secure telehealth platform and clinician-built AI assistant, Scout, streamline documentation and administrative tasks—allowing OTs to spend more meaningful time connecting with clients and delivering high-quality care. We know that exceptional care starts with exceptional clinicians—and we’re committed to creating an unmatched experience for our remote therapists nationwide. About the Role: The Clinical Supervisor role is a full time, exempt position and serves as a first-line clinical and operational leader for a team of treating Occupational Therapists. They provide day-to-day coaching, support, and supervision to ensure quality of care, therapist success, and client satisfaction. This role is also inclusive of oversight of clinical quality, and active involvement in performance improvement, client satisfaction, and strategic cross-functional initiatives. Clinical Supervisors are directly accountable for monitoring, managing, and driving key performance indicators (KPIs) to ensure team success and alignment with organizational goals. This role is also accountable for direct treatment commiserate with the needs of the organization, including recurring treatment, evaluation, and PTO coverage. This position is highly dedicated to increasing and maintaining clinical excellence, while prioritizing bidirectional communication to ensure organizational priorities are successfully implemented. Responsibilities Supervisor Duties (35%): OT Management: - Manage a team of OTs through regular one-on-one meetings focused on clinical coaching, skill refinement, mentorship, and career development. - Ensure the OT team is confident and effective in navigating Expressable tools (Cue, Slack, Reach, Guru, etc.) and identify areas for improvement or training. - Ensure team’s timely completion of Expressable internal/external training and compliance. - Serve as a guide for navigating the knowledge-base for his or her team of OTs on Expressable’s policies, procedures and best practices. - Manage and resolve clinical escalations in partnership with other organizational leaders as needed. - Effectively communicate organizational information, ensuring comprehension and transmission of key messages for OT awareness and action. - Host monthly team meetings to facilitate engagement and collaboration among OT base, with an emphasis on clinical excellence and the implementation of Expressable’s model of client care. - Foster a positive and supportive environment by building strong relationships with treating OTs, and promoting a culture of collaboration, growth, and bidirectional feedback Performance and KPI Ownership - Own and track key performance indicators (KPIs) for assigned team members, including OT efficiency, quality of care, documentation compliance, and client satisfaction/engagement - Analyze trends at the individual level to identify performance strengths and areas for improvement, collaborating with leadership based on data insights - Identify and implement data-driven performance intervention, inclusive of standards goals, intervention plans, and counseling records Communication and Team Engagement - SServe as the primary contact for OTs on change communication, and encouraging productive feedback and improvement opportunities while simultaneously ensuring effective information comprehension and transmission. - Engage in interdepartmental collaboration in support of Expressable strategy and initiatives - Conduct first-round interviews of OT candidates to aid in continued growth of provider base Direct Clinical Care (65%): - Conduct evaluations and sessions with appropriate clinical caseload, flexibly with the needs of the organization. - Model clinical excellence and maintain updated knowledge of best practices in the field Qualifications: - Experience in pediatric and/or school-based setting - Experience with pediatric assessments - Previous leadership experience required Licenses and Certifications: - Full licensure in state of residence - Individual NPI number Benefits and Perks: - Day-1 health, dental, and vision insurance options for employees and families - 401(k) with employer match - 12 weeks of company-paid parental leave - Generous and flexible PTO policies promoting work-life balance - Reimbursement for state license renewal fees - Company-provided hardware for clinical care - Dedicated support teams to minimize administrative burden - Clinician-built telehealth platform with our proprietary AI assistant, Scout, streamlining documentation and administrative tasks - Access to an active therapist community

Clinical Trial Liaison, Sponsor Dedicated ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development As a Clinical Trial Liaison at ICON, you will design and analyse clinical trials, interpreting complex medical data, and contribute to the advancement of innovative treatments and therapies. What You Will Do: Your role will involve delivering clinical research work to a high standard, working closely with your team and stakeholders. Key responsibilities include: - Collaborate with cross-functional teams to design and implement effective clinical trial enrollment strategies. - Analyze and interpret clinical trial data, ensuring accuracy and compliance with regulatory standards. - Foster strong relationships with study sites and investigators to enhance patient recruitment and retention. - Act as a liaison between sponsors, investigators, and study participants, providing support and guidance throughout the enrollment process. - Contribute to the continuous improvement of enrollment processes and strategies to optimize trial outcomes. Your Profile: You will bring relevant clinical research experience, along with the following qualifications and skills. Required qualifications and experience: - Bachelor's degree in a relevant field, such as life sciences or healthcare. - Oncology experience is required - Proven experience in clinical trial enrollment or related roles. - Strong analytical and problem-solving skills with the ability to interpret complex medical data. - Excellent communication and interpersonal skills to build and maintain effective relationships with stakeholders. - Detail-oriented with a commitment to ensuring accuracy and compliance in all aspects of clinical trial enrollment. What ICON can offer you: Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: - Various annual leave entitlements - A range of health insurance offerings to suit you and your family’s needs. - Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. - Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being. - Life assurance - Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others. Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here. Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles. Are you a current ICON Employee? Please click here to apply

Associate Decentralized Clinical Trial Study Lead (aDCTL) / Decentralized Clinical Trial Lead (DCTL) are an integral part of clinical trial delivery to improve patients’ lives and bring therapies to the market faster. The aDCTL / DCTL roles requires strong project management skills, customer and site facing engagement experience, creativity/innovation and the ability to thrive in a dynamic setting. The aDCTL / DCTL may oversee studies ranging from fully decentralized trials to hybrid studies which require liaising with traditional project delivery teams. Critical to the success of DCT is the ability to collaborate across multiple teams and stakeholders including but not limited to technology & IT , mobile nursing, site support services, regulatory, site startup, etc. aDCTL / DCTL’s also follow established SOP and policies focused on project delivery, productivity and quality resulting in strong project financial performance and customer satisfaction. Essential Functions • Accountable for the strategic development and delivery of DCT studies in line with agreed upon contracts while optimizing speed, quality and cost of delivery, ensuring consistent use of study tools and training materials and compliance with system updates, standard processes, policies and procedures. • Serve as DCT project oversight and/or contact with customers and own relationship with the project’s key customer contact(s) • Set objectives and manage for the DCT project team according to agreed upon contract, strategy and approach for operational delivery, effectively communicate and assess performance, providing feedback and leadership. • Collaborate with other functional groups within the company where necessary, including the core study team, to develop and/or support the preparation of integrated study management plans, support milestone achievement and manage study issues and obstacles. • Monitor progress against contract and prepare/present project information proactively to all stakeholders internally and externally. • Supervise Foresee problem solving and resolution efforts to include management of risks, and manage contingencies and issues. Take accountability for proactive contingency plans to mitigate risks. • Achieve project quality by identifying and proactively managing quality risks and issues, responding to issues raised by project team members and /implementing appropriate corrective and preventative action plans. Take ownership, understand the budget and drive optimal project financial management from initial load to study closeout • Ensure the financial success of the project including optimal management and assignment of resources to achieve project goals and profitability. • Actively work on preserving DCT scope and Forecast and identify opportunities to accelerate activities to bring milestones and revenue forward and implement appropriate actions to achieve. • Identify changes in scope and manage change control process, including securing customer agreement to financial and milestone updates as necessary. • Identify and communicate lessons learned and best practices to promote continuous improvement. Other Functions May Include • Participate in bid defense preparations. Lead bid defense presentations in partnership with Business Development for 100% Virtual studies or as a component of the larger team for integrated hybrid DCTs studies. Understand project strategy and operationalize the agreed upon approach. • Adopt corporate initiatives and changes and serve as a change advocate when necessary. • Provide input to line managers on their project team members’ performance relative to project tasks. Support staff development. Mentor less experienced project team members on assigned projects to support their professional development. • Educate and train other teams and partners on the processes, capabilities and structure of the DCT organization. • Communicate/collaborate with IQVIA business development representatives as necessary. • May participate in executive committees as part of program leadership. Qualifications • Bachelor's Degree Life sciences or related field • Requires +4 years relevant clinical research experience plus around 3 years of experience in project management experience. • Requires advanced knowledge of and experience implementing Project Management methodologies, ideally within the clinical research space. • Broad knowledge of DCT (current challenges and opportunities to improve clinical trial delivery) and other related job areas, typically obtained through advanced education combined with experience. • Knowledge of clinical trials - Knowledge of clinical trial conduct, and skill in applying applicable clinical research regulatory requirements i.e. ICH GCP and relevant local laws, regulations and guidelines, towards clinical trial conduct. • Technology Savvy – You have an affinity for learning and leveraging technology. Prior experience with set up or implementation of new platform/systems is a plus. • Communication - Strong written and verbal communication skills including good command of English language. Strong presentation, negotiation and customer management skills. • Finances - Good understanding of project financials including experience managing financials (budget), contractual obligations and implications. #LI-NRJ #LI-Remote IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.