Clinical Research Associate Contactor

Responsibilities:

• Closely collaborate with Clinical Project Management to ensure study is conducted according to Standard Operating Procedures, international (ISO14155 / ICH-GCP) and local regulations and the Clinical Investigation Plan (CIP)
• Identify when site informed consent forms need updates and collaborate with the clinical management team and site personnel to make the updates and submit them to the Ethics Committee/Investigational Review Boards, Competent Authorities (as applicable).
• ·Prepare and submit documents for Ethics Committee/Investigational Review Boards, Competent Authorities (as applicable) initial and follow-up submissions (incl. amendments, renewals, safety and compliance reporting, end of study)
• Collaborate with the project management team to meet data cleaning deadlines (such as database lock) and implement contingency plans, as needed.
• Ensures smooth operational execution of allocated clinical studies by coordinating with cross-functional teams, managing timelines, overseeing site activities, ensuring compliance with regulatory requirements, and addressing any operational challenges that arise.
• Independently implement complete site management, including on-site and remote monitoring visits (incl confirmation, report writing follow-up letters) in accordance with the Clinical Investigation Plan (CIP), Monitoring Plan, SOPs, international regulations and guidelines (ISO 14155/GCP), and applicable local regulatory requirements.
• Verify compliance with the Informed Consent Process
• Conduct Source Data Verification and Source Data Review of clinical site reported data entries (compare subject and study records with the case report form) to ensure recorded data are accurately represented, complete, verifiable from the source documentation and timely reporting (including adverse event and device deficiency reporting)
• Ensure timely and accurate query resolution.
• Confirm accuracy and maintenance of Investigator/site regulatory documents file.
• Ensure reliability, integrity and traceability of all study documentation, including all Clinical Study Site staff are properly (re-)trained and training is documented, and all Clinical Study Site task delegations are documented on appropriate logs.
• Conduct device accountability to ensure proper storage, dispensation and accountability of investigational products (as applicable).
• Administer CIP and study related training to (new) study site staff during the study.
• Identify potential risks to study timelines and quality, and develop mitigation strategies.
• Ensure sites are audit-ready at all times by maintaining thorough and organized documentation.
• Maintain and collect good quality essential documents for the Trial Master File (TMF).
• Collaborate with Clinical Project Management team and Safety team to ensure timely and accurate safety reporting.
• Identify problems at sites; document action items and protocol deviations, timely resolve issues and escalate as appropriate.
• Prepare and implement site close-out activities (incl confirmation, report writing, follow-up letters and end of study communications) as per Monitoring Plan.
• Provide feedback on site performance for future trial site feasibility/selection.

Requirements:

• Bachelor's degree (or equivalent combination of education and experience) or higher in a health profession, life sciences or biomedical field.
• Current CRA certification (or working towards certification) preferred.
• 3 years of field clinical monitoring experience, experience in medical device studies is a plus; multiple therapeutic areas considered.
• Experience with electronic data capture and clinical trial management systems preferred.
• Experience with post-market studies is a plus.
• Strong organizational, attention to detail, interpersonal and problem-solving skills.
• Excellent verbal and written communication skills (correspondence, reports, etc.).
• Verbal and written proficiency in English.
• Proficient use of Microsoft Office Suite applications.
• Good knowledge of international regulations and guidelines (ISO 14155/GCP), applicable US Federal (CFR) regulations and local regulatory requirements.
• Ability to develop and maintain strong professional relationships.
• Ability to travel up to 80%

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