Date Posted: 2026-03-24Country: United States of AmericaLocation: Florida - Remote WHY JOIN FCS At Florida Cancer Specialists & Research Institute, we believe our people are our strength and we invest in them. In addition to having a positive impact on the people and communities we serve, associates benefit from significant professional opportunities, career advancement, training and competitive wages. Offering competitive salaries and comprehensive benefits packages to include tuition reimbursement, 401-K match, pet and legal insurance. A LITTLE BIT ABOUT FCS Since 1984, Florida Cancer Specialists & Research Institute & Research Institute (FCS) has built a national reputation for excellence. With over 250 physicians, 220 nurse practitioners and physician assistants and nearly 100 locations in our network. Utilizing innovative clinical research, cutting-edge technologies, and advanced treatments, we are committed to providing world-class cancer care. We are recognized by the American Society of Clinical Oncology (ASCO) with a national Clinical Trials Participation Award, FCS offers patients access to more clinical trials than any private oncology practice in Florida. Our patients have access to ground-breaking therapies, in a community setting, and may participate in national clinical research studies of drugs and treatment protocols. In the past five years, the majority of new cancer drugs approved for use in the U.S. were studied in clinical trials with FCS participation prior to approval. Through our partnership with Sarah Cannon, we are one of the largest clinical research organizations in the United States. Often, FCS leads the nation in initiating research studies and offering ground-breaking new therapies to patients. Come join us today! Summary: The Director of Clinical Research Administration provides strategic and administrative leadership for the planning, management, and execution of clinical research business and operational activities supporting the clinical research program at Florida Cancer Specialists & Research Institute. This role ensures studies are conducted in accordance with regulatory requirements and sponsor expectations while driving operational performance, program growth, and team development across the clinical research enterprise. PRIMARY TASKS AND RESPONSIBILITIES: - Program Management: - Provide strategic and operational leadership for clinical research activities across the organization, ensuring studies are conducted in accordance with regulatory requirements, sponsor expectations, and institutional policies. - Monitor operational performance across the research program, including study activation timelines, enrollment performance, key performance indicator (KPI) monitoring, and operational efficiency, implementing process improvements as needed. - Sponsor & Alliance Management: - Support alliance management activities with key industry partners to maintain strong sponsor relationships and promote continued research collaboration and portfolio growth. - Ensure alignment on study execution, operational expectations, and performance metrics across sponsor and CRO partnerships. - Vendor Oversight: - Direct vendor strategy and oversight for clinical research operations, including selection, contracting support, performance monitoring, and relationship management for vendors supporting clinical trial execution (including CTMS, eRegulatory platforms, imaging providers, and specialty service vendors). - Contracts & Grants Management: - Lead the preparation, negotiation, and management of clinical trial agreements, confidentiality agreements, and related research contracts in collaboration with sponsors and internal stakeholders. - Provide hands-on grant management, including preparing budgets, submitting applications, tracking award progress, and preparing required progress reports. - Support contract and study budget negotiation activities to ensure study budgets appropriately reflect operational costs and resource utilization. - Research Compliance & Billing: - Support research billing compliance processes, including research billing determinations and coordination with compliance and revenue cycle teams. - Read and interpret Medicare Coverage Analysis and Code and Coverage determinations to support appropriate setup of research-related billable procedures. - Investigator Engagement & Research Growth - Cultivate strong partnerships with physician investigators to advance clinical research participation, supporting study feasibility, portfolio growth, and enrollment performance. - Partner with the VP of Clinical Research, Medical Directors, investigators, and research staff to identify opportunities to improve patient screening, study awareness, and enrollment in clinical trials. EDUCATION/CERTIFICATIONS & LICENSES: - Masters degree in Healthcare, Research, or related field - CCRC/CCRP certification (preferred) - Valid Driver’s License in state of residency for travel to clinics and must comply with the Company Driver Safety Operations and Motor Vehicle Records Check Policy EXPERIENCE: - Minimum of 8 years of clinical research experience. Required. - Oncology clinical trials experience required, therapeutic clinical trial experience preferred. - Demonstrated leadership and/or management experience required. - Working knowledge of federal, state, and local regulations governing clinical research, including IRB requirement and research compliance. - Working knowledge of research billing determinations and coverage analysis processes. CORE COMPETENCIES, KNOWLEDGE/SKILLS/ABILITIES: Essential competencies and KSAs targeted to successfully performing in role: - Clinical Research Expertise: - Comprehensive knowledge of clinical research operations, including study start-up, regulatory submissions, patient recruitment, and trial execution. - Strong understanding of Good Clinical Practice (GCP), FDA regulations, and human subject protection requirements governing clinical trials. - Familiarity with the clinical trial lifecycle, including feasibility assessment, study activation, enrollment management, and study closeout. - Research Compliance and Billing: - Knowledge of research billing compliance requirements, including coverage analysis and billing determinations. - Understanding of clinical trial financial workflows, including budgeting, invoicing, sponsor payments, and reconciliation. - Contract & Grant Management: - Knowledge of clinical trial agreements, confidentiality agreements, and research contracting processes. - Familiarity with grant management processes, including proposal submission, award tracking, and reporting requirements. - Ability to support or lead study budget development and contract negotiations. - Operational & Leadership Skills - Strong analytical and critical thinking skills. - Strong project management and operational planning skills. - Ability to analyze operational and financial data and track program performance metrics. - Demonstrated ability to lead and develop multidisciplinary research teams. - Ability to manage competing priorities, drive operational efficiency, and support organizational growth - Communication & Collaboration: - Strong interpersonal and communication skills with the ability to effectively collaborate with investigators, research staff, sponsors, and organizational leadership. - Ability to facilitate physician engagement and promote participation in clinical research activities. - Technical Systems Knowledge - Familiarity with clinical research technology platforms, including CTMS, eRegulatory, and electronic data capture systems. VALUES: - Patient First – Keeping the patient at the center of everything we do - Accountability – Taking responsibility for our actions - Commitment & Care – Upholding FCS vision through every action - Team – Working together, one team, one mission *It is remote but you must be located in Florida* #LI-TZ1 SCREENINGS – Background, drug, and nicotine screens Safeguarding our patients and each other is an important part of how we deliver the best care possible to the communities we serve. All offers of employment at Florida Cancer Specialists & Research Institute are contingent upon clear results of a thorough background screening. Additionally, as a condition of employment, FCS requires all new hires to receive various vaccinations, including the influenza vaccine, barring an approved exemption. In addition, FCS is a drug-free workplace, and all new hires will be subject to drug/ nicotine testing. Medical Marijuana cards are not recognized. EEOC Florida Cancer Specialists & Research Institute (FCS) is committed to helping individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at FCS, please email FCS Recruitment (Recruiter@FLCancer.com) for further assistance. Please note this email address is intended to request an accommodation as part of the application process. Any other correspondence will not receive a response. FCS is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

Company Description All Care Therapies company is at the forefront of utilizing cutting-edge technology to deliver in-home speech, occupational, and physical therapy services for a diverse clientele, spanning children to adults with various disorders and conditions. As a leading provider of virtual in-home therapy, we excel in addressing the unique needs of each client within the familiar comfort of their environment. Job Description Are you Interested in Teletherapy? Join our OT team! We are hiring in all 50 states to provide services for clients in California. We are also offering reimbursement for California licensure! As a Remote Certified Occupational Therapy Assistant (COTA), you will provide occupational therapy services to clients remotely. You will collaborate with licensed Occupational Therapists to assess and implement appropriate treatment plans, monitor progress, and provide guidance to clients through virtual platforms. Your primary goal will be to help clients achieve their occupational therapy objectives and improve their functional abilities in a remote setting. What You Will Do - Intervention: Provide remote occupational therapy services, including exercises, activities, and interventions to help patients achieve their goals and improve their functional abilities. - Education: Educate patients and their caregivers on techniques and strategies to enhance their independence and well-being. - Documentation: Maintain accurate and up-to-date patient records, including progress notes and other necessary documentation. - Compliance: Adhere to relevant ethical and legal standards and regulations, including patient privacy and confidentiality (e.g., HIPAA compliance). - Technology: Utilize telehealth platforms and tools effectively to conduct remote therapy sessions. - Continuing Education: Stay current with the latest developments in occupational therapy and engage in ongoing professional development. Why Join Us - We are a therapist-owned and operated organization - Career Advancement - We believe in recognizing high-performing teams - Efficient web-based documentation system - Growing company in a new model of service delivery - Monthly team meetings - Supportive collaboration with the Clinical team and Supervisors - Training and materials provided Compensation W2 | $27.00 - $46.00 per hour commensurate with experience, qualifications, and bilingualism. Qualifications - Valid certification as a Certified Occupational Therapy Assistant (COTA) - Active CA State Certified Occupational Therapy Assistant License or ability to apply - Experience in a clinic, private practice, hospital, or home health setting - Technical proficiency to conduct teletherapy through our all-inclusive platform - Should be comfortable working with pediatrics (18 months+) - Prefer strong experience in feeding, sensory, hand, emotional regulation and neurodiverse clients Additional Information All your information will be kept confidential according to EEO guidelines. All Care Therapies is an equal opportunity employer. All aspects of employment, including the decision to hire, promote, discipline, or discharge, will be based on merit, competence, performance, and business needs. We do not discriminate based on race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law. - Department: Provider Network

• Reporting to the Director of Clinical Operations, this individual contributes to the development and implementation of strategic direction of clinical trials, acts as study team lead for Clinical Operations and is responsible for delivery of all clinical trial operational activities, across one or more studies. • Accountable for overall management of clinical trials, including providing strategic direction to the study team, to meet corporate goals and timelines • Collaborate with the Clin Development to assess study progress, ensure proper study conduct and adherence to the protocol • Central role maintaining relationships with other internal functions, strategic partners and CROs • Oversee functional deliverables to support program objectives, identify risks to study timelines, propose mitigations, and implement solutions with team and management support • Communicate program status, cost, and issues to senior management • Monitor global regulatory intelligence for international industry practices for operational efficiency and compliance • Responsible for the coordination of team meetings, as assigned, with both internal and external partners • Serve as a clinical trial lead for one or more trials and responsible for implementation, planning, and execution of clinical trial activities • Cultivate and maintain strong relationships with investigators, and trial site managers and other site staff, as applicable • Participates in the selection of vendors and manages their activities. • Organize investigator meetings, as needed • Coordinate timely data review to identify trends and discrepancies • Responsible for all aspects of site management from feasibility, selection, start-up, maintenance, and close out • Select, assess, and approve sites for activation • Contribute to study budget, including regular forecasting and internal reporting • Review invoices against scope of work and work completed to date, and to identify and communicate variances • Responsible for management of CRO and vendors to support clinical operations contracted for the assigned study/studies

Start-Up Manager 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 What you will be doing - The Study Start-up/Site Activation Lead is responsible at country level for managing and conducting start-up activities in compliance with the client procedures, documents, local and international guidelines such as ICH – GCP and relevant regulations. - The Study Start-up/Site Activation Lead will prepare, review, track and manage site regulatory documentation at country and site level, and will maintain, review and report on site performance metrics. - The Study Start-up/Site Activation Lead works in close collaboration with the CRAs and the Local Study Team/Local Study Associate Director to ensure that study start-up activities and milestones are achieved in a timely and efficient manner - Typical Accountabilities: - Contribute to ensure that clinical and operational feasibility assessment of potential studies is performed to the highest quality. - Accountable for study start-up and regulatory maintenance being in charge with collection, preparation, review and tracking of documents for the application process; - Accountable for submission of proper application/documents to Regulatory Authorities and/or IEC/IRB during start-up period. - Actively participates in Local Study Team (LST) meetings. - Update CTMS and other systems with data from study sites as per required timelines during the start-up period. - Follow up on outstanding actions with study sites during start-up period to ensure resolution in a timely manner. - Ensure timely collection/uploading of essential documents into the eTMF in accordance with ICH-GCP, client SOPs and local requirements. Support QC checks performed by Trial Manager or delegate to ensure that all country and site level trial essential documents required by ICH-GCP prior to study start have been collected and verified for correctness, prior to setting sites ready to enroll, and in line with client SOPs. - Provide regular information to Line Managers at country level on study and planned study milestones/key issues during the start-up period. Your profile - Bachelor’s Degree, preferably in life sciences. - Minimum of 5 years of experience in a Clinical Research environment, focusing on Start-Up. - Strong project management skills, with a deep understanding of regulatory and submission processes - Excellent written and verbal communication abilities. - Proven ability to work efficiently to tight deadlines and manage multiple priorities. 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