Study Start-Up Specialist

About the Role

Primary contact with investigative site(s) during site start-up activities and maintenance, responsible for collecting required investigator and essential documents for a study. Ensures EC/IRB/Third body/Regulatory Authority and other local applications are submitted within agreed timelines and meet regulatory and sponsor specifications. Proactively interacts with regulatory bodies to provide guidance on requirements and maintains awareness of current regulatory standards. Serves as a local expert in project start-up activities for a particular country or region and acts as a knowledge resource to mentor and train new hires and less-experienced colleagues.

Responsibilities

• Maintain awareness of regulatory legislation, guidance, and practice in 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 with them regarding submission/approval.
• Liaise with internal and external vendors in the generation of Regulatory Authority submissions.
• Perform a review of final submission documents.
• Ensure all assigned start-up and maintenance activities are on track, compliant with client expectations, budget, applicable 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 depending 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, formatting and compiling them for compliant site activation and maintenance.
• Ensure high-quality documents are filed and systems are updated on an ongoing and timely basis, maintaining audit readiness.
• Participate in team and project meetings as applicable.
• 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 and protocol.
• Proactively resolve informed consent issues and other potential difficulties with study sites.
• Support negotiation of site contracts and budgets with sites, if applicable, and track progress of contract and budget milestones, intervening and escalating as appropriate.
• 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, interact with, and monitor all notifications and alerts to ensure milestones and events for the trial are met within mandated timelines (EU-specific role).
• Perform all other duties as needed or assigned.

Requirements

• University/College degree (life science preferred), or certification in a related allied health profession from an appropriate accredited institution (e.g., nursing certification, medical or laboratory technology) AND 2 years' work experience in clinical research, including a strong working 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 a strong working knowledge of ICH guidelines and RA, IRB/IEC regulations, will be considered.
• Minimum of 2 years of experience in clinical development or start-up/regulatory process.
• Working knowledge of ICH, RA, IRB/IEC, and other applicable regulations/guidelines.
• Familiarity with investigator start-up documents and contract/budget negotiation process.
• Previous interaction with operational project teams and investigative sites.
• Demonstrated understanding of research protocol requirements and proven ability to communicate/educate others about them.

Work Environment

General office environment.

Pay

$60,000 - 70,000 USD

Benefits

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

Regular, full-time or part-time employees working 20 or more hours per week are eligible for comprehensive benefits.