Study Start-Up Specialist

Primary contact with investigative site(s) during site start-up activities and maintenance with responsibility for collection of the required investigator and essential documents for a study. Ensures EC/IRB/Third body/Regulatory Authority and any other local applications are made within agreed timelines and that documentation meets applicable regulations and sponsor specifications. Proactively interacts with regulatory authorities to provide guidance on requirements and maintains awareness of current regulatory standards.

Responsibilities

• Maintain awareness of regulatory legislation, guidance, and practice in the assigned countries.
• Coordinate, collect, and organize data and information required by EC/IRB/Third body/Regulatory Authority, including preparation of study documentation such as country application forms and cover letters for sponsor review.
• Review and negotiate Informed Consent Forms with sites.
• Compile and prepare routine submissions to IRB/IEC/Third body/Regulatory Authorities (e.g., INDs/CTAs) and liaise regarding submission/approval.
• Liaise with internal and external vendors in the generation of Regulatory Authority submissions.
• Perform a review of final submission documents.
• Ensure assigned start-up and maintenance activities are on track, compliant with client expectations, budget, laws, guidelines, regulatory requirements, ICH/GCP, SOPs, and quality standards.
• Prevent and escalate study issues appropriately and in a timely fashion.
• Perform other duties as assigned by management based on country and situational requirements.
• Serve as primary contact for investigative sites to ensure timely collection of required documents.
• Collect, track, and perform quality reviews of necessary documents for compliant site activation and maintenance.
• Ensure high-quality document filing and system updates, maintaining audit readiness.
• Participate in team and project meetings.
• Assist in strategy definition for Site Activation and provide accurate projections and timelines to study teams.
• Review and customize country and site-specific patient informed consent forms for compliance with local requirements.
• Proactively resolve informed consent issues and other potential difficulties with study sites.
• Support negotiation of site contracts and budgets, tracking progress and escalating as needed.
• Proactively identify and escalate risks to meeting deliverables to Submission Leads.
• Notify the Submissions Lead of hours identified as Out-of-Scope or overburn.
• Assist in the upload of submission documentation to CTIS, interacting with and monitoring notifications and alerts to meet mandated timelines (EU-specific).

Requirements

• University/College degree (life science preferred) or certification in a related allied health profession (e.g., nursing, medical, or laboratory technology) from an accredited institution and 2 years' work experience in clinical research, including strong knowledge of ICH guidelines and RA, IRB/IEC regulations.
• Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
• In lieu of the above, candidates with a High School Diploma or equivalent and a minimum of 2 years' work experience in clinical research, including strong knowledge of ICH guidelines and RA, IRB/IEC regulations, will be considered.

Experience

• Minimum of 2 years of experience in clinical development or start-up/regulatory processes.
• Working knowledge of ICH, RA, IRB/IEC, and other applicable regulations/guidelines.
• Familiarity with investigator start-up documents and contract/budget negotiation processes.
• Previous interaction with operational project teams and investigative sites.
• Demonstrated understanding of research protocol requirements and ability to communicate/educate others about them.

Benefits

• Medical, Dental, and Vision coverage.
• Life, STD/LTD insurance.
• 401(K) retirement plan.
• Paid time off (PTO) or Flexible time off (FTO).
• Company bonus where applicable.

Pay

$60,000 - 70,000 USD

Physical Demands

General Office Environment.