Senior Clinical Scientist
Role and Responsibilities
- In collaboration with study team, writes or assists in writing of study protocols and amendments, consent forms, case report forms and ancillary study documents
- Protocol implementation including site identification and communication, attendance at investigator meetings, correspondence with sites including IRBs and interaction with Clinical Operations
- Writes or assists in writing Investigator Brochures, DSURs, INDs and other regulatory documents
- Assist other team members in Clinical Development in the implementation and conduct of clinical trial which includes but not limited to review of enrollment packets, review of adverse events and all other clinical data generated during conduct of trial
- Assist in Medical Monitor responsibilities including all aspects of trial conduct, working closely with Drug Safety, Regulatory and Data Management
- Work with Data Management to ensure that clinical data is collected in a timely manner, assist with cleaning of data listings for efficacy and safety evaluation
- Work with project and study teams around tactical deliverables related to protocol development and all supporting documents, clinical data collection and analysis, study reports, abstracts, meeting presentations and publications
- Participates in the development of clinical operating guides and maintains secure study files
- May coordinate activities of other personnel (team lead)
Qualifications and Education Requirements
- M.D., Ph.D., R.N, PharmD, Nurse Practitioner or Physician Assistant required.
- 5+ years of biotech experience in the field of oncology preferred
- Demonstrated understanding of clinical study conduct including relevant regulations such as GCP, etc
- Proficient with Microsoft Office.
- Flexibility and willingness to solve problems that fall outside of immediate area of expertise
- Clear and concise verbal and written communication skills and strong organizational and collaborative skills, with an exceptional attention to detail.
- Travel time is approximately 10%-15% including visits to investigative sites, investigator meetings and scientific meetings
- Work independently in an interdisciplinary, fast-paced, often changing environment.
- Committed to the values of integrity, accountability, agility, and drive.
*Local Bay Area Candidates Preferred*
PLEASE SEND COVER LETTER AND CV TO: firstname.lastname@example.org