Clinical Trial Coordinator II

This is a fully remote position, open to applicants in Mexico.

📋 Description

• Offers both administrative and technical assistance to the Project Team.

• Aids in ensuring audit readiness by reviewing files in accordance with organizational SOPs and departmental guidelines.

• Provides administrative assistance for activities related to site activation.

• Contributes to the development of the critical path for site activation to facilitate swift site activations.

• Represents the organization within the global medical research community.

• Cultivates collaborative relationships with investigators and site staff as appropriate.

• Gains insights about sites within the relevant market by collaborating with company personnel.

• Serves as a buddy during onboarding as necessary.

• Assists in training new employees and engages in departmental process enhancement initiatives.

• Coordinates, manages, and finalizes assigned trial activities based on specific Central or Local roles.

• Conducts department, internal, country, and investigator file reviews, documenting findings in the appropriate systems.

• Ensures assigned tasks are completed punctually, within budget, and to a high-quality standard; communicates potential risks to project leads and line managers.

• Analyzes and reconciles study metrics, aiding in the clarification and resolution of site documentation issues.

• Provides both technical and administrative project support in collaboration with internal departments and team members.

• Keeps accurate records of trial status in databases.

• Establishes and maintains relationships with local client affiliates where applicable.

• Advocates for the inclusion of Strategic Collaboration sites in the process.

• Trains new staff on processes and systems.

• Maintains study documentation and offers global support with study lists, training trackers, system access management, and activity plans as necessary.

• Sends documents to clients and centralized IRB/IEC as needed.

• Participates in kick-off meetings and takes notes when required.

• Assists in scheduling and organizing client and internal meetings, including taking meeting minutes.

• Collaborates with internal departments to synchronize site start-up activities with the site activation critical path.

• Aids in the preparation of regulatory compliance review packages and regulatory submissions.

• Collects site-selection documents directly from sites when necessary.

• Works alongside teammates and clinical staff to meet deadlines and resolve site-related issues and risks.

• Ensures a streamlined site contact and follow-up plan, monitors compliance, and escalates any concerns or non-compliance to management.

⛳️ Requirements

• No specific job requirements, qualifications, experience, education, certifications, software proficiency, language requirements, or work authorization requirements are outlined in the posting.

🏝️ Benefits

• Details regarding benefits are not provided in the posting.