Description
We are seeking a Clinical Research Coordinator to join our team. As a Clinical Research Coordinator, you will be responsible for performing feasibility, site identification, site contract negotiation, and other study start-up activities. You will also provide country-specific study start-up expertise to study start-up team leads and project teams.
Responsibilities:
- Perform feasibility, site identification, site contract negotiation, and other study start-up activities, as assigned
- Distribute and collect CDAs for potential study sites
- Provide country-specific study start-up expertise to study start-up team leads and project teams
- Create study start-up document templates
- Prepare and coordinate submissions to regulatory, ethics, and other bodies
- Develop, finalize, and review master and country-specific subject information sheets (SIS)/ICFs
- Review and translate drug labels
- Perform independent quality review of submission packages
- Coordinate and translate documents required for submission
- Perform timely and accurate data entry of all relevant study start-up activities into the appropriate CTMS
- Copy and route incoming correspondence, internal documentation, etc, as appropriate
- Follow-up for queries made by EC/competent authority (CA)
- Coordinate and create documents and material needed to support SIV
- Collect critical documents required for IP release
- Dispatch, negotiate, execute, and track contracts with sites and other sites, as appropriate
- Attend study team meetings as required, including Kick-Off Meeting
- Collect and maintain current regulatory/CA and EC submission information and similar information for other related organizations in the assigned countries
- Update relevant information system
- Familiarize yourself with ICH GCP, relevant country regulations/guidelines, and SOPs
- Demonstrate competent communication and influencing skills to ensure timely follow-up, issue resolution, and report updates
- Perform regulatory document maintenance; amendments, periodic updates, and safety letters, where applicable
- Develop and maintain effective relationships with local, regional, and country authorities
- Comply with all department requirements regarding information provision and status updating and reporting
- Undertake other reasonably related duties as may be assigned from time to time
Requirements:
- Bachelor’s Degree in life sciences or a related field and 3 years’ clinical research or other relevant experience; or equivalent combination of education, training and experience
- In-depth knowledge of clinical systems, procedures, and corporate standards
- Good negotiating and communication skills with ability to challenge, if applicable
- Effective communication, organizational, and interpersonal skills
- Ability to work independently and to effectively prioritize tasks
- Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines
- Knowledge of applicable regulatory requirements, including local regulations, SOPs and company’s Corporate Standards
- Understanding of regulated clinical trial environment and knowledge of drug development process
- Ability to establish and maintain effective working relationships with coworkers, managers and clients