Description
We are seeking a Clinical Research Coordinator to serve as primary contact with investigative site(s) during site start-up activities and maintenance.
The successful candidate will be responsible for collecting required investigator and essential documents for a study, ensuring EC/IRB/Third body/Regulatory Authority and local applications are made within agreed timelines.
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 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
- Perform other duties as assigned by management
In-country specific tasks:
- Serve as primary contact for investigative sites and ensure documents required are collected in a timely manner
- Collect and track necessary documents required and perform a quality review, formatting, and compilation of final documents for 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
- May support negotiation of site contracts and budgets with sites
- Proactively identify and escalate risks to meeting deliverables
Clinical Trials Information System (CTIS) tasks:
- Assist in uploading submission documentation to CTIS and interact with and monitor notifications and alerts
- Perform other duties as needed or assigned
Qualifications:
- University/College degree (life science preferred) or certification in a related allied health profession
- 2 years' work experience in clinical research, including a strong working knowledge of ICH guidelines and RA, IRB/IEC regulations
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
- Demonstrated understanding of research protocol requirements and proven ability to communicate them/educate others about them