Sr. Clinical Research Associate
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Sr. Clinical Research Associate - Belgium (French & Dutch Fluency)
Site Monitoring activities (55-60%)
• Independently conduct and document onsite and remote activities, including site monitoring and close-out visits. Ensure that all activities are documented in accordance with applicable SOPs and study guidance.
• Collaborate with site staff to review and ensure that the data reported in the applicable study system(s) is consistent with the source documents and compliant with study requirements.
• Monitor, resolve and/or facilitate resolution of data queries and escalate issues as appropriate.
• Coordinate the shipment of clinical supplies, including but not limited to, investigational product, laboratory supplies, ePROs and study documents.
• Ensures site staff is trained in all aspects of the study including but not limited to the protocol, study plans, systems and ICH-GCP.
• Participate in routine study progress meetings, teleconferences, and Investigator’s meetings.
• Routinely review ISF and TMF for accuracy, timeliness, and completeness. Request documents from the site, as required.
Site Management activities (15-20%)
• Act as a primary contact for any questions or issues that arise from investigational sites.
• Oversee overall integrity of the study and promote positive working relationships with the site staff and study team members.
• Facilitate and support site staff with access to study systems and ensure sites are compliant with project specific training requirements.
• Ensure all site related issues are followed until resolution, including action items and protocol deviations.
• Coordinate delivery of clinical sites communications, collaborating with project teams, to ensure investigational sites are provided accurate ongoing data, updates, information and feedback on project/regulatory guidelines and objectives throughout the project lifecycle.
• Regularly review the study related systems remotely to ensure compliance, accuracy and completeness.
• Translate site documents for TMF filing when applicable.
• Routinely review the TMF for accuracy, timeliness, and completeness. Request documents from the site, as required.
• Coordinate the shipment of clinical supplies, including but not limited to, investigational product, laboratory supplies, ePROs and study documents.
• Participate in audits/inspections and follow-up on issues and implement actions, when required.
• Participate in routine study progress meetings and teleconferences.
Site Recruitment and Setup (15-20%)
• Coordinate the shipment and delivery of clinical supplies, including but not limited to laboratory supplies, study documents and investigational product.
• Responsible for all site management activities related to site activation and work with the sites to meet clinical project timelines and milestones.
• Support the study Start-up team by following up on pending documents, as needed.
• Support the Regulatory team by reviewing, localizing and translating site documents, as required.
• Optimize patient recruitment providing guidance and support to site teams to meet the site recruitment milestones.
• Participate in Investigator’s meetings.
Mentoring and Internal Initiatives (5-10%)
• Mentor and support CRA I and II.
• Perform CRA Assessment Visits, co-monitoring visits or visit sign-off process, providing feedback.
• Assist the MSM hiring Manager by participating in interviews with candidates for the CRA position, as requested.
• Participate in process improvement initiatives and contribute to the development of best practices.
QUALIFICATIONS
MINIMUM EXPERIENCE REQUIREMENTS
4 - 6 years of related experience
PREFERRED EXPERIENCE REQUIREMENTS
7 – 9 years of related experience
MINIMUM EDUCATION REQUIREMENTS
(Honors) Bachelor’s degree
