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.
This 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.
Essential Duties & Responsibilities:
. 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.
. Draft and review study documents such as informed consents, source documents, and meeting materials.
. Participate in study team meetings and contribute to study progress updates.
. 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.
. Responsible for contributing and making submissions to the Central IRB/ethical committees as applicable
. Track and monitor day to day study related activities such as patient enrolment, data entry, and regulatory document review.
. Review of monitoring reports and identify potential trends and issues that may need escalation to the management team.
. 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.
. Assist in the preparation and presentation of study materials at Investigator, Study Coordinator and ad-hoc meetings.
They are offering a competitive hourly rate for this role and requiring experience in Ophthalmology studies.
Please submit your resume if you are interested in this role.