The Position

The Sr. Clinical Research Associate (Sr. CRA) provides support to the Clinical Operations Manager (COM)/Study Lead(s) to manage and track key study deliverables. The primary purpose of the position is to support the COM/Study Lead in study set-up, execution, and closeout to ensure study deliverables are met and compliance with clinical protocols, their objectives and ICH and GCP guidelines. This is primarily an in-house role.

Location: San Diego, CA or Pasadena, CA office

Responsibilities

• Support Study Lead to execute study milestones against study timelines
• Tracking of key deliverables during start-up, study maintenance and close-out; generate, review and distribute reports from internal tracking at requested intervals (Site Status, Enrollment, Dosing)
• Collaborate with the Study Lead to develop/review certain study-specific plans and/or processes
• Present updates at team meetings as needed (i.e., Clinical Trial Team Meeting, Project Team Meeting, Investigator Meeting, project training, etc.)
• Collect and review essential documents from investigational sites
• Support CTAs with TMF set-up, maintenance, ongoing quality review, and final reconciliation of study documents
• Participate in study specific tasks such as investigator identification and site activation
• Contribute to the development/review of study specific Monitoring Plans; track timing/planning of site visits to ensure compliance
• Contribute to the development/review of study materials, case report forms (CRFs), informed consent documents for clinical studies
• Review monitoring visit reports and perform occasional co-monitoring visits with CRO CRAs
• Assist in the preparation and review of site reference materials (i.e., screening/enrollment logs, Delegation of Site Responsibilities form, Site Monitoring Log, etc.)
• Act as CROs’ CRA/CTA first line of contact for study related questions/issues
• Work with the CRO to arrange and prepare for Site Qualification Visits, Site Initiation Visits and Site Investigator Meetings (as applicable)
• Provide updates on study/site status as needed to ensure timely study entry and updates are reflected on ClinicalTrials.gov or EU equivalent
• Assist Study Lead with design and preparation of study related materials for the training of CRO staff
• Assist Study Lead with oversight of study vendors (CRO, Drug Supply, Central Lab) as required
• Perform remote query and data review as needed to assist CDM
• Assist clinical finance and study lead with the review, tracking and management of study specific budgets

Required:

• 4-year college degree (preferred) otherwise, candidates with a combination of education and relevant experience will be considered
• Minimum of five (5) years in clinical research
• Minimum of three (3) years onsite monitoring/site management experience
• Experience managing/supervising vendors
• Thorough understanding of all applicable FDA ICH- GCP regulations and guidelines
• Working knowledge of medical terminology
• Ability to proactively perform and complete duties with minimal supervision in an accurate and timely manner
• Proficient in MS Office (Word, Excel, and PowerPoint)
• Ability to work in a team or independently
• Effective interpersonal, written and verbal communication skills
• Able to critically evaluate job tasks and the impact on overall study execution
• Strong problem-solving capabilities
• Effectively collaborates with Study Team members
• Exceptional organizational skills with the ability to multi-task and prioritize
• Attention to detail
• Ability to work with distributed team members and outside vendors
• Occasional travel in US or overseas (<10%)

Preferred:

• CRA certification

The base salary range for this position in the selected city is $120,000 - $140,000 annually.

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