The posting
Independently performs, coordinates and oversees all aspects of the clinical site monitoring services, assessing protocol and regulatory compliance as per Alimentiv’s and sponsor’s standard processes, ICH/GCP guidelines and local regulation. Serves as the primary liaison between the sponsor/Alimentiv and investigative sites by playing a critical role in the execution of clinical study plans. Provides guidance and mentoring CRA I and II, collaborating effectively with cross-functional stakeholders in a dynamic, results-driven and high-accountability environment. Perform CRA Assessment Visits and participate in audits/inspections, when required.
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.
- Monitoring visits in Portugal and Spain
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%)
- Identify and advise on site investigators selection, independently conduct and document onsite and remote activities, including site qualification and initiation visits. Ensure that all activities are documented in accordance with applicable SOPs and study guidance.
- 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
ADDITIONAL KNOWLEDGE / SKILLS
Working Conditions
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