Description
We are seeking a Study Start Up Specialist with 2+ years of start-up experience residing in the U.S.
As a Study Start Up Specialist, you will serve as the primary contact with investigative sites during site start-up activities and maintenance. Your responsibilities will include collecting required investigator and essential documents for a study, ensuring EC/IRB/Third body/Regulatory Authority and other local applications are made within agreed timelines, and that documentation meets applicable regulations and sponsor specifications.
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
- Compile and prepare routine submissions filed to IRB/IEC/Third body/Regulatory Authorities
- Liaise with internal and external vendors in generating Regulatory Authority submissions
- Perform a review of final submission documents
- Ensure all assigned start-up and maintenance activities are on track, in accordance with client expectations and budget, and in compliance with applicable laws and guidelines
- Prevent and escalate study issues appropriately and in a timely fashion
- Serve as primary contact for investigative sites and ensure documents required are collected in a timely manner
- Collect and track all necessary documents required and perform a quality review, formatting, and compilation of final documents for effective and compliant site activation and maintenance
- Ensure high-quality documents are filed and systems are updated on an ongoing and timely basis
- 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
- Support the negotiation of site contracts and budgets with sites, if applicable
- Proactively identify and escalate risks to meeting deliverables
Qualifications:
- University/College degree (life science preferred), or certification in a related allied health profession from an appropriate accredited institution
- 2 years' work experience in clinical research, including a strong working knowledge of ICH guidelines and RA, IRB/IEC regulations
- Relevant and equivalent experience in lieu of educational requirements may be considered
Experience:
- 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
Work Environment:
- Work is performed in an office environment with exposure to electrical office equipment
- Frequent travel to clients/site locations with occasional travel both domestic and international
Physical Requirements:
- Ability to sit for extended periods and operate a vehicle safely
- Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists
- Occasional crouching, stooping, with frequent bending and twisting of upper body and neck
- Ability to access and use a variety of computer software developed both in-house and off-the-shelf
- Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs
- Regular and consistent attendance
- Varied hours may be required
Target Pay Range: $50-70k