Study Start-Up Specialist

6 days ago

Savannah GA, United States ClinLab Solutions Group Full time

Position Overview The Study Start-Up Specialist plays a key role in ensuring timely activation of clinical trials at the research site. This individual manages all start-up activities from feasibility through site initiation, ensuring that regulatory, contractual, and operational requirements are met efficiently. The ideal candidate is detail-oriented, proactive, and capable of coordinating across multiple stakeholders — including sponsors, CROs, investigators, and internal site teams — to ensure trials launch on time and in compliance with GCP, FDA, and IRB regulations. Qualifications, skills, and all relevant experience needed for this role can be found in the full description below. Key Responsibilities Feasibility & Site Activation Review study feasibility questionnaires and coordinate completion with site leadership and investigators. Evaluate protocol requirements against site capabilities, resources, and patient population. Track and manage study activation timelines, identifying and resolving barriers to start-up. Regulatory Submissions Prepare, compile, and submit regulatory documents for IRB/EC approval (initial submission, continuing reviews, amendments). Maintain essential regulatory documents (1572, CVs, licenses, financial disclosures, delegation logs, etc.) in compliance with ICH-GCP and sponsor requirements. Ensure all staff credentials and trainings are current before site activation. Contracts & Budgets Collaborate with management and sponsor/CRO representatives to facilitate budget negotiations and contract execution. Track progress of contract and budget approvals; maintain clear communication with both internal and external stakeholders. Support review of payment terms and milestone deliverables. Site Initiation Readiness Coordinate pre-study visits, SIV scheduling, and logistical setup (lab kits, supplies, systems access, training completion). Ensure completion of site activation checklists and readiness documentation prior to FPFV. Partner with Clinical Research Coordinators and Regulatory staff to ensure seamless transition from start-up to study conduct. Compliance & Documentation Maintain accurate study start-up trackers, databases, and regulatory binders (electronic or paper). Support audits and inspections by providing complete and accurate regulatory documentation. Ensure compliance with all internal SOPs, GCP, and applicable regulations. Qualifications Education: Bachelor’s degree in life sciences, healthcare, or related field required. Advanced degree (MS, MPH, PharmD, RN, or equivalent) preferred. Experience: 2+ years of experience in clinical research, preferably within a research site or site network environment. Prior experience in study start-up, regulatory affairs, or clinical trial coordination strongly preferred. Working knowledge of ICH-GCP, FDA, and IRB submission processes. Skills & Competencies: Strong organizational and project management skills; ability to manage multiple start-up projects simultaneously. Excellent written and verbal communication skills. xrczosw Proficiency in Microsoft Office Suite and clinical trial management systems (CTMS, eReg, eISF, etc.). Collaborative mindset with a proactive, solution-oriented approach.

  • Study Start-Up Specialist

    1 week ago

    Savannah, GA, United States ClinLab Solutions Group Full time

    Position Overview The Study Start-Up Specialist plays a key role in ensuring timely activation of clinical trials at the research site. This individual manages all start-up activities from feasibility through site initiation, ensuring that regulatory, contractual, and operational requirements are met efficiently. The ideal candidate is detail-oriented,...

  • Study Start-Up Specialist

    5 days ago

    Savannah, United States ClinLab Solutions Group Full time

    Position OverviewThe Study Start-Up Specialist plays a key role in ensuring timely activation of clinical trials at the research site. This individual manages all start-up activities from feasibility through site initiation, ensuring that regulatory, contractual, and operational requirements are met efficiently. The ideal candidate is detail-oriented,...

  • Study Start-Up Specialist

    2 weeks ago

    Savannah, United States ClinLab Solutions Group Full time

    Position OverviewThe Study Start-Up Specialist plays a key role in ensuring timely activation of clinical trials at the research site. This individual manages all start-up activities from feasibility through site initiation, ensuring that regulatory, contractual, and operational requirements are met efficiently. The ideal candidate is detail-oriented,...

  • Study Startup Specialist

    2 days ago

    Savannah, Georgia, United States CenExel Clinical Research Full time $40,000 - $80,000 per year

    About Us:Each of CenExel's research sites specialize in Phase I to Phase IV clinical trials. Our Centers of Excellence comprise some of the most well respected and long-standing research facilities in the country. Specialty areas of research across our sites include Psychiatry, Acute Post Op Pain, Asian Bridging, Dermatology, GI, and Neurology. Each of our...

  • Specialist Project Management and Planning

    2 weeks ago

    Savannah, GA, United States ClinLab Solutions Group Full time

    Position Overview The Study Start-Up Specialist plays a key role in ensuring timely activation of clinical trials at the research site. This individual manages all start-up activities from feasibility through site initiation, ensuring that regulatory, contractual, and operational requirements are met efficiently. The ideal candidate is detail-oriented,...

  • Work Study Student

    1 week ago

    Savannah, United States Georgia Southern University Full time

    Job Summary The Work-Study Student will support the Financial Aid Office and the United Way of Coastal Empire's 211 Program as a Call Center Specialist in the Savannah area beginning Fall 2025.Student employees cannot work more than 1300 hours in a 12-consecutive month period.Please confirm your Federal Work-Study eligibility with the Office of Financial Aid...

  • Lease-Up Specialist

    4 days ago

    Savannah, Georgia, United States ARK Homes For Rent Full time

    Position Summary:We're looking for an energetic and results-drivenLease-Up Specialistto lead the charge leasing new Build-to-Rent (BTR) communities. This role is designed for a sales-focused professional who thrives in fast-paced environments and is motivated by performance-based rewards. You will be responsible for achieving move-in goals and driving...

  • TMF Specialist

    2 days ago

    Savannah, Georgia, United States Allen Spolden Full time $75,000 - $94,000 per year

    The TMF Specialist is responsible for overseeing the overall management and quality of essential clinical trial documents to ensure compliance with applicable regulatory and local requirements. This position will provide management and oversight of Trial Master File (TMF) filing activities to ensure audit and inspection readiness for clinical...

  • Scheduling Specialist

    2 weeks ago

    Savannah, United States St. Josephs Candler Full time

    Scheduling Specialist Position Summary The Scheduling Specialist will receive requests for procedures, coordinate the exam times per protocol with convenience considered for the patients and departments. - Collect and validate high quality Patient Demographics, Guarantor Insurance info, Authorizations, Resource availability, CPT, HCPCS, ICD-9 codes ....

  • Scheduling Specialist

    2 weeks ago

    Savannah, United States St. Joseph'sCandler Full time

    Position Summary The Scheduling Specialist will receive requests for procedures, coordinate the exam times per protocol with convenience considered for the patients and departments. - Collect and validate high quality Patient Demographics, Guarantor Insurance info, Authorizations, Resource availability, CPT, HCPCS, ICD-9 codes . Practice phone etiquette and...