Start-up Specialist

This is a fully remote position, open to applicants in United States.

📋 Description

• Act as the main liaison with investigative sites throughout the study initiation and ongoing processes.

• Gather, organize, conduct quality reviews, format, compile, and archive investigator and essential study documentation.

• Coordinate applications and submissions to EC/IRB/Third parties/Regulatory Authorities within established deadlines.

• Prepare country-specific application forms, cover letters, and routine submissions such as INDs/CTAs.

• Communicate effectively with regulatory authorities, internal teams, external vendors, and investigative sites.

• Review final submission documents to ensure adherence to regulations, ICH/GCP, SOPs, quality standards, budgets, and client expectations.

• Monitor start-up, maintenance, site activation, contract, and budget-related activities and milestones.

• Identify, mitigate, and escalate study-related issues and risks to ensure deliverables are met.

• Keep systems and documentation in an audit-ready condition.

• Participate actively in team and project meetings.

• Assist in developing site activation strategies, projections, and timelines.

• Review and modify informed consent forms specific to countries and sites.

• Support the negotiation and tracking of site contracts and budgets as necessary.

• Mentor and train new employees and less experienced colleagues when appropriate.

• Execute other assigned tasks as needed.

⛳️ Requirements

• Must be a resident of the United States.

• Hold a university/college degree in a relevant field (preferably life sciences) or a certification in a related allied health profession from an accredited institution.

• Relevant and equivalent experience can be considered as a substitute for educational qualifications.

• Alternatively, a High School Diploma or equivalent plus a minimum of 2 years of clinical research experience is acceptable.

• At least 2 years of experience in clinical development or start-up/regulatory processes is required.

• Strong understanding of ICH guidelines and knowledge of RA, IRB/IEC, and other relevant regulations/guidelines.

• Familiarity with investigator start-up documents and the processes involved in contract/budget negotiation.

• Previous experience interacting with operational project teams and investigative sites.

• Proven ability to understand research protocol requirements and communicate/educate others about them effectively.

• Capable of working in a fast-paced, constantly evolving, technology-driven environment.

• Ability to remain seated for prolonged periods and operate a vehicle safely.

• Capability to perform repetitive hand movements and occasionally crouch, stoop, bend, and twist.

• Proficient in using various computer software applications.

• Able to lift and carry weights of 15–20 lbs.

• Must maintain regular and consistent attendance.

• Availability for varied hours may be required.

🏝️ Benefits

• Frequent travel to client and site locations, with occasional domestic and international travel.

• Continuous acceptance of applications.