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, 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.

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.
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.) Ensure all staff credentials and trainings are current before site activation.

Collaborate with management and sponsor/CRO representatives to facilitate budget negotiations and contract execution.
Track progress of contract and budget approvals; 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.

Maintain accurate study start-up trackers, databases, and regulatory binders (electronic or paper).
Support audits and inspections by providing complete and accurate regulatory documentation.
Bachelor’s degree in life sciences, healthcare, or related field required.
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.
~ Strong organizational and project management skills; ability to manage multiple start-up projects simultaneously.
Proficiency in Microsoft Office Suite and clinical trial management systems (CTMS, eReg, eISF, etc.).

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