Senior Clinical Research Associate (CRA)
The Senior Clinical Research Associate (CRA) provides support to the Clinical Operations Manager(s)/Study Lead(s) to manage and track key study deliverables. The primary purpose of the position is to support the COM/Study Lead to ensure study deliverables are met and compliance with clinical protocols, their objectives and ICH and GCP guidelines.
This is a FULL-TIME job with a generous base salary, benefits, bonus, and stock options. It will be 100% remote for now and post-COVID would require 2-3 days a week in the office. You can work out of EITHER the PASADENA office OR the SAN DIEGO 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, recruitment, collection of regulatory documents and site activation
•Contribute to the development/review of study specific Monitoring Plans; tracks timing/planning of site visits to ensure compliance
•Contribute to the development of study materials, case report forms (CRFs), informed consent documents for clinical studies
•Review monitoring reports and perform occasional co-monitoring visits with CRO CRAs to ensure quality process
•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 (relevant discipline preferred)
• Minimum of three (3) years in clinical research, biopharmaceutical or similar industry
• Working knowledge of medical terminology
• Thorough understanding of all applicable FDA, ICH and GCP/GxP regulations and guidelines
• Solid vendor management skills
• 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
Name: Heather Brown
Email: hbrown@advancedclinical.com