Sr. Clinical Research Associate
Department: Clinical Development
Reports to: Director, Clinical Development
Biotheranostics, Inc. is seeking a talented Sr. Clinical Research Associate (Sr. CRA) to join our team in San Diego, CA (see www.biotheranostics.com). The Sr. CRA will be responsible for overseeing and executing key clinical trial activities across Biotheranostics' development programs. This position provides broad scientific input and support to clinical activities including protocol development, study implementation, analysis, and reporting of results. This position offers an excellent opportunity for a highly motivated person to lead and support the clinical development program of molecular diagnostic tests.
Essential Duties and Responsibilities:
- Manage clinical studies and serve as primary liaison with principal investigators and sites to ensure adherence to protocols, GCP, ICH and SOPs.
- Responsible for all aspects of study management, including training, conduct of pre-study and initiation visits, monitoring, maintenance of study files, close-out of sites, and other duties, as assigned.
- Independently perform CRF review, query generation and resolution against data review guidelines on data management systems.
- Participate in the development of study protocols and Case Report Forms.
- Assist in the writing and review of study reports, scientific and regulatory submissions and SOPs, prepare and present clinical data at scientific/board meetings as needed.
- BS/BA in Biological Sciences, Life Sciences, or healthcare required with 5 plus years clinical operations experience in biotech, pharma or CRO setting. MS or equivalent preferred.
- Thorough knowledge of ICH Guidelines and GCP including an understanding of regulatory requirements.
- Must have strong clinical operation skills, including conducting, managing, monitoring and auditing of clinical research studies in oncology.
- Familiarity with pathology and oncology, and genomic approaches in diagnostic applications and biomarker discovery a plus.
- General familiarity with biostatistics and regulatory affairs.
- Detail oriented with good organizational and time management skills. Ability to work on multiple projects simultaneously.
- Demonstrated technical and project management capabilities are required, as well as effective verbal and written communication skills in a collaborative work environment.
- Self-motivated and passion for medical innovation and commitment to scientific rigor
If interested, please submit a copy of your CV/Resume to us to apply.E-mail