Clinical Research Associate

Reports to

Associate Director, Clinical Operations

Exempt

This position will work with the Coherus clinical team to support execution of global clinical studies for Coherus’ various products. Depending on project complexity and level of experience, this may include supporting one or more clinical studies and/or managing a multi-national region for multiple global clinical studies.

This position will assist in supporting the lead CPM in the oversight of contract research organizations, clinical laboratories, and other vendors, including clinical sites; collaborate with clinical development partners, as well as other internal departments to ensure that the clinical studies are conducted on time and within budget. This position will also assist with the development of processes and infrastructure within clinical operations.

• Collaborate with other Coherus functional areas and consultants, such as Clinical Supply, Project Management, Data Management, Clinical Development, Biostatistics, Quality Systems, Regulatory Affairs, and others, in order to successfully coordinate assigned clinical study/program.
• Provide support to CROs and vendors for assigned clinical study/programs, providing Coherus representation and ensuring adherence to project scope, deliverables and timelines.
• Assist with study start up with CROs and clinical sites as necessary, including, working closely with CRO to complete template clinical documents, such as, ICF, CRF specifications and development, clinical site agreements, and other study documentation.
• Review and track CRO monitoring visit reports to identify issues and trends and follow-up, as needed, to ensure resolution. Ensure adherence to all documentation requirements and process at the CRO(s), all other vendors and within Coherus.
• Ensure adherence to all documentation requirements and process at the CRO(s), all other vendors and within Coherus.
• Support the CTM with vendor management activities for Coherus managed vendors, such as central labs, to ensure work is being performed within scope and timelines.
• Track active study sites and provide FDA required site documents to Regulatory on an ongoing basis for submission to the IND.
• Monitor the maintenance of the clinical trial master files per SOPs and GCP, at the CRO(s) and vendors. Review clinical study files for completeness periodically throughout and at the completion of clinical trials and prior to archiving. Set-up and manage necessary portions of the trial master file in-house for assigned clinical study/program.
• Maintain protocol amendment checklists, as appropriate, to ensure compliance with Coherus SOPs
• Maintain internal study trackers for team contacts and vendor contacts and database access requests
• Track internal team training and collaborate with Quality Systems to assign trainings in Master Control
• Participate in clinical study team meetings and teleconferences and assist with agenda and minute preparation, as needed.
• Maintain internal Action Item and Decision Log
• Support study logistics and monitoring activities to ensure that milestones and deliverables are well defined and achieved; recognize and elevate issues that may jeopardize timelines and deliverables or lead to out-of-scope expenses.
• Liaise with cross-functional teams and Legal to perform quality reviews of ICFs and site contracts and budgets.
• Assist with start-up document reviews and Regulatory package green light approval and drug release.
• May support team with study drug tracking and ordering and/or lab kit order requests
• Tracking of bioanalytical and biomarker sample collection per the Lab Manual.
• In collaboration with other Coherus clinical staff and departments ensure the clinical studies are conducted in compliance with Federal, State and local regulations, Good Clinical Practice regulations and internal Standard Operating Procedures.
• Contribute to the review of Standard Operating Procedures (SOPs), standard forms and study-specific guidelines to support clinical operations.
• Travel as required to domestic and international development partners, CROs, vendors, and clinical sites, as needed.
• Provide additional…