Start-Up Specialist - FSP

Fortrea•Durham, NC

6d•Remote

About The Position

The Study Start Up Specialist serves as the primary contact for investigative sites during study start-up and maintenance, collecting required investigator and essential documents and coordinating submissions to ethics committees, institutional review boards, third bodies, regulatory authorities, and other local bodies. The specialist ensures applications are submitted within agreed timelines and that documents meet applicable regulatory and sponsor requirements. The role proactively engages with review bodies to clarify requirements, maintains awareness of current regulatory standards, and serves as a local start-up resource for a country or region. The specialist may mentor and train new or less-experienced colleagues when appropriate. The position involves coordinating and quality-reviewing start-up and maintenance documentation, preparing and compiling routine regulatory submissions, communicating with internal and external vendors and review bodies, and keeping systems and files accurate and audit-ready. The specialist works with project teams and investigative sites to support site activation, informed consent compliance, and, when applicable, site contract and budget progress. The role also identifies and escalates risks, issues, and out-of-scope work. Work is performed in an office environment, with frequent travel to client or site locations and occasional domestic and international travel. The role requires comfort with changing priorities, tight timelines, teamwork, and electronic data environments. Target pay range: $50,000–$70,000.

Requirements

University or college degree, preferably in life sciences, or certification in a related allied health profession from an appropriate accredited institution; relevant equivalent experience may be considered in lieu of education.
At least 2 years of work experience in clinical research, including a strong working knowledge of ICH guidelines and regulatory authority and IRB/IEC regulations.
Alternatively, a high school diploma or equivalent and at least 2 years of clinical research experience with strong working knowledge of ICH guidelines and regulatory authority and IRB/IEC regulations will be considered.
At least 2 years of experience in clinical development or start-up/regulatory processes.
Working knowledge of ICH, regulatory authorities, IRB/IEC, and other applicable regulations and guidelines.
Familiarity with investigator start-up documents and the site contract and budget negotiation process.
Previous interaction with operational project teams and investigative sites.
Demonstrated understanding of research protocol requirements and ability to communicate and educate others about them.
Must reside in the United States.
Ability to sit for extended periods and operate a vehicle safely.
Ability to perform repetitive hand movements and fast, simple, repeated movements of the fingers, hands, and wrists.
Ability to occasionally crouch and stoop, and frequently bend and twist the upper body and neck.
Ability to use a variety of in-house and off-the-shelf computer software.
Ability to lift or carry light to moderate objects, including luggage and a laptop, up to 15–20 pounds.
Regular and consistent attendance; varied hours may be required.

Nice To Haves

Life science degree preferred.
Experience serving as a local expert in start-up activities for a particular country or region.
Experience mentoring or training new hires and less-experienced colleagues, when appropriate.

Responsibilities

Maintain awareness of regulatory legislation, guidance, and practices in assigned countries.
Coordinate, collect, and organize information required by ethics committees, IRBs, third bodies, and regulatory authorities; prepare study documents such as country application forms and cover letters for sponsor review, as applicable.
Compile and prepare routine regulatory submissions, including INDs and CTAs, and liaise with review bodies regarding submissions and approvals.
Liaise with internal and external vendors involved in regulatory authority submissions, as applicable.
Review final submission documents, as applicable.
Keep assigned start-up and maintenance activities on track, aligned with client expectations and budget, and compliant with applicable laws, guidelines, regulatory requirements, ICH/GCP, SOPs, and quality standards.
Prevent and promptly escalate study issues and risks to deliverables.
Serve as the primary contact for investigative sites and collect required documents in a timely manner.
Track required documents and perform quality review, formatting, and compilation for site activation and maintenance.
File high-quality documents and update systems promptly to maintain audit readiness.
Participate in team and project meetings, as applicable.
Assist with site activation strategy and provide accurate projections and timelines to study teams when needed.
Review and customize country- and site-specific patient informed consent forms for compliance with local requirements and protocol; proactively resolve consent issues and other potential difficulties with sites.
Support site contract and budget negotiations, when applicable, track related milestones and developments, and intervene or escalate as appropriate.
Notify the Submissions Lead of hours identified as out of scope or overburn.
Perform other duties assigned by management or as needed, with proper supervision where applicable.
Mentor and train new hires and less-experienced department colleagues when suitable.