Clinical Research Associate - II

Job Title: Clinical Research Associate II

Department: Clinical Operations

Location: Menlo Park, CA / Miami, FL / Remote

Overview of Role:

Highly autonomous and experienced clinical operations professional responsible for Supporting all aspects of Clinical Trial Management for complex, global studies from study planning and start up through study close out.

Coordinates Summit functional team members, CROs and vendors to successfully deliver clinical studies under direction from Clinical Trial Manager and/or Director. Responsible for all performance metrics and quality of deliverables in the clinical trial.

Role and Responsibilities:

• Oversees and reports on study scope, quality, timelines with the internal Summit clinical operations team, CRO and vendors to ensure that overall project objectives are met
• Responsible for reviewing CRO and vendor contracts/work orders and specifications to enable study objectives to be met.
• Review/approve/track vendor invoices and manage accruals and payment process for all assigned clinical trial vendors including investigational sites
• Initiates and builds solid professional relationships with investigators and clinical site staff
• Partners with the CRO to ensure robust ongoing data monitoring strategies are developed and carried out effectively to ensure delivery of high-quality data
• Proactive identification and management of study related risks
• Responsible for the development and management of clinical trial documents including (but not limited to), consent documents, study plans, etc
• Responsible for reviewing and managing study related plans, processes, Investigator agreements (CTA), CRFs, CRF guidelines, monitoring plan, data management, safety monitoring
• Reviews and approves essential document packages to enable timely site activations
• Conducts and tracks Monitoring Report Review to ensure compliance with procedures across duration of study and documentation is complete
• Provides close oversight on the findings on the monitoring reports and loops back with broader team to provide updates as needed
• Guide investigator performance and adherence to protocol, and proactively addresses conduct issues and enrolment problems, as necessary
• Responsible for oversight on the maintenance of the TMF and completeness at the end of the study. Perform periodic QC of the TMF
• Oversee the execution of clinical trial activities in accordance with Good Clinical Practices
• Ensures compliance of clinical trials with national regulatory requirements
• Co-monitoring the assigned clinical trial sites following company SOPs
• Ensures the study is “inspection ready” contemporaneously
• Responsible for oversight of the functional activities of Clinical Trial Associates allocated to the project
• All other duties as assigned

Experience, Education and Specialized Knowledge and Skills:

• Bachelor’s degree or equivalent in life science, nursing, pharmacy, medical laboratory technology, or other health/medical related area preferred.
• A minimum of 3 years of clinical research / clinical trial management experience in conducting clinical trials in Pharma/Biotech organization
• Prior phase II and III experience required
• A solid understanding of the recruitment methods, drug development process, ICH guidelines/GCP and specifically, each step within the clinical trial process
• Experience with clinical studies oncology and / or rare diseases a plus
• Sophisticated understanding and skillful utilization of Microsoft Apps such as Outlook, Word, Excel, and Teams
• Ability to travel internationally to visit clinical sites and for study meetings. Amount will vary upon project needs (up to 20%).
• Proven proficiency in overseeing management and supporting large complex studies being managed internally and by a CRO
• Tenacity to work in a fast-paced team environment
• Experienced and enjoys building relationships with KOLs and site personnel. Willing to travel to establish relationships
• Ability to successfully engage and work collaboratively with global team members/colleagues
• Demonstrated ability to build and deliver on patient enrollment strategies
• Excellent interpersonal and decision making skills. Demonstrates innovation, possesses drive, energy and enthusiasm to deliver the program objectives.
• Ability to comprehend complex scientific concepts and data
• Proficient in reviewing and assessing clinical data
• Possesses excellent planning, time management & coordination skills
• Ability to problem solve and use clear judgment in relation to regulatory requirements, interactions with external parties, timelines, and complex clinical programs.
• Experience in working in a small organization a plus
• Excellent written and oral communication skills

The pay range for this role is $115,000 to $130,000 annually. Actual compensation packages are based on several factors that are unique to each candidate, including but not limited to skill set, depth of experience, certifications, and specific work location. This may be different in other locations due to differences in the cost of labor. The total compensation package for this position may also include bonus, stock, benefits and/or other applicable variable compensation.

Summit does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Summit’s human resources department to obtain prior written authorization before referring any candidates to Summit.