BioPhase Solutions specializes in recruiting top talented professionals for San Diego's Scientific community. We are currently looking for a CRA to work for a leading San Diego biotechnology company.
CRA (with pharma experience)
Responsible for clinical activities related to clinical trials and performing or managing daily in-house and outsourced operations associated with these trials. This position should be able to independently handle various clinical study assignments.
Prepares and updates clinical protocols, instructions for use, informed consents, reports of prior investigations, bibliography, case report forms, clinical trial reports, and other study-related documents in consultation with the cross-functional project team, investigators, and data management.
Coordinates executes operational aspects of clinical studies, including study start-up, patent enrollment and follow up, study closure activities. Manages study budgets, timelines, and resource requirements. Manages internal and outsourced activities for assigned trials.
May perform site qualification, initiation, monitoring, close-out visits as well as auditing at participating sites. Liaises with CROs, Core Labs, and other collaborators to ensure compliance with the Investigational Plan and appropriate regulations, guidelines, and policies.
Conducts ongoing review of adverse events. Compiles and updates adverse event logs.
Conducts training of investigators, site staff, and internal clinical staff. Sets-up and maintain (or supervise) accurate study status and accountability logs.
Reviews data listings and tables. Educate internal/external data management on the clinical context of these documents and provide oversight of data reconciliation.
Evaluates clinical data/information. May write, and revise annual, interim, and final reports and clinical sections of regulatory submissions.
As clinical research representative, interface with representatives from other key functional groups including Research and Development, Regulatory Affairs, Marketing, Legal and other groups.
Minimum BS in biology or healthcare required.
At least 3 years experience as a CRA in device, biotech, pharma, or CRO setting, including at least 1 year as in-house CRA.
Experience in clinical trials in at least one of the following therapeutic areas: Oncology, Anti-Infectives, Infectious Disease.
Experience with international/global studies would be advantageous.
Strong knowledge of Good Clinical Practice (GCP) and US and international regulations for clinical trials
Ability to travel up to 30%, internationally and within the US
Organized and detail-oriented
Good communication/negotiation skills with clinical investigators and academic thought leaders; highly professional demeanor
Advanced written, oral, and presentation skills
Proficient knowledge of medical terminology
Strong Computer skills (MS Office products, word processing, spreadsheets, etc.)
Ability to multi-task. Strong prioritization and organizational skills
Strong problem solving skills