Clinical Research Associate

Overview:

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.

Responsibilities and Duties:

• 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 escalate 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 support across clinical studies as needed by members of the Clinical Operations team.

Qualifications:

• BS in life sciences.
• 3-5 years of experience of biotech/pharmaceutical clinical operations experience
• Strong experience in CRO and vendor management to support global clinical trials
• Understanding of FDA/EMEA regulations and GCP/ICH guidelines regarding clinical trial management.
• Demonstrated skills in writing/reviewing clinical study protocols, CRF designs, CSRs, regulatory documents (including IND/CTA, marketing application documents and annual/periodic updates) and developing study documentation.
• Understanding of data management, statistics and medical writing processes for clinical development.
• Ability to “roll up your sleeves” and individually contribute results to clinical operations and company-wide goals
• Significant attention to detail, time management and organizational skills with the ability to multi-task and prioritize
• Ability to deal with time demands, incomplete information and unexpected events
• Proactive self-starter with the ability to take responsibility for tasks and execute them successfully with little supervision
• Comfortable in a fast-paced small company environment and able to adjust workload based on changing priorities
• Team-oriented with excellent communication and interpersonal skills, including a positive and professional attitude to tasks and projects.
• Demonstrated ability to meet short-term deadlines and multi-task in a very fast-paced work environment with little direct supervision.
• Demonstrated computer skills using MS Office Suite (MS Word, Excel, PowerPoint, MS Outlook, and MS Project) software
• Perform other related tasks as requested.

The Base Salary Range for this position is $90,000 to $110,000. Coherus considers various factors, including professional background and work experience, when determining base pay. These considerations mean actual compensation will vary.

Coherus provides equal employment opportunities to all employees and applicants for employment and prohibits unlawful discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. We also prohibit discrimination based on the perception that anyone has any of these characteristics or is associated with a person who has or is perceived as having any of these characteristics.