Clinical Research Associate
Concentric Analgesics is searching for a Clinical Research Associate (CRA), based in the San Francisco Bay Area. The Clinical Research Associate participates in all aspects of clinical operations for the Concentric Analgesics clinical programs. This position is based in San Francisco with 40 – 60% travel time.
Key Roles & Responsibilities:
Assist Clinical Operations in training CRO CRAs and creating the CRA training materials
Attend co-monitoring visits as required per the Sponsor Oversight Plan and/or Monitoring Plan
Review Monitoring Visit Reports from the CRO, escalating monitoring trends or findings as applicable
Attend study qualification and initiation visits
Track metrics related to Sponsor Oversight and the Monitoring Plan
Review study data for trends, anomalies or protocol violations
Assist in start-up activities of clinical research studies including Investigator Meetings, site initiation visits, enrollment planning, and Investigator selection
Collaborate closely with Concentric study management, CRO study managers, and CRO staff; review site/patient activity tracking, prepare study updates and proactively identify and solve study-related issues
Regularly communicates with Investigators to identify and resolve clinical study conduct issues and ensures site compliance with Good Clinical Practice, and federal and applicable local regulatory requirements;
Review and provide input to study plans and guidelines, including study monitoring plans, data management plans, etc.
Participate in new database User Acceptance Testing
Assist in development of study documents, such as informed consent forms, study logs, and study manuals
Provide overall tactical support for the study
Manage central labs, including timely ordering of supplies and management of sample shipment and tracking
Prepare IP release forms and work closely with CMC to ensure adequate and timely delivery of IP to study centers
Lead or assist with TMF processes: set-up, training, QC, management and delivery of TMF from CROs
Knowledge and Skill Requirements:
BS/BA/RN degree or equivalent and 4+ years’ experience in clinical development and operations, at least 2 of which have been in a CRA role (field or HQ)
Previous experience with a startup/small company
At least 3 years’ experience performing on-site monitoring conducting SIVs, IMVs, and COVs for IND regulated clinical research studies.
Must have thorough understanding of GCP and ICH regulations, clinical trial monitoring, and regulatory compliance
Co-monitoring experience required
Strong communication and interpersonal/team skills
Proficient in MS Excel, Word and PowerPoint
Established ability to prioritize and manage multiple tasks simultaneously, demonstrated ability to identify and resolve issues, and effectively manage timelines.
Strong organizational skills, proven effectiveness in a quick-changing, fast-paced environment, excellent people skills, and a proven record as a team player
This role will require 40 – 60% travel (US based currently)
Click here to apply.