My client a well funded biotech is looking for an experienced In-House Clinical Research Associate with 3 -5 years experience, in a full-time, 40 hour per week contract role.
\n \nThis position is unique in that it does not involve on-site monitoring. Instead, the focus is on vendor management, oversight, and collaboration with cross-functional teams to ensure high-quality clinical trial delivery and reviewing monitoring reports.
\n \nEssential Duties & Responsibilities:
\n. Develop and maintain metrics through clinical study completion to support the Clinical Study Manager to ensure study is executed per protocol, within timelines and in compliance with regulatory requirements.
\n. Draft and review study documents such as informed consents, source documents, and meeting materials.
\n. Participate in study team meetings and contribute to study progress updates.
\n. Assist with training of site study team regarding the monitoring plan, recording & maintenance of essential documents, and startup and site initiation activities under the guidance of the Study Manager.
\n. Responsible for contributing and making submissions to the Central IRB/ethical committees as applicable
\n. Track and monitor day to day study related activities such as patient enrolment, data entry, and regulatory document review.
\n. Review of monitoring reports and identify potential trends and issues that may need escalation to the management team.
\n. Collaborate with data management teams during the data review process to ensure timely resolution of data-related issues. Reach out to Regional Monitors and sites for complex or outstanding queries and identify query resolution issues.
\n. Assist in the preparation and presentation of study materials at Investigator, Study Coordinator and ad-hoc meetings.
\n \nThey are offering a competitive hourly rate for this role and requiring experience in Ophthalmology studies.
\n \nPlease submit your resume if you are interested in this role.
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