What are the responsibilities and job description for the Clinical Scientist position at Advanced Clinical?
Clinical Research Scientist
12 Month Contract, Renewable
Fully Remote
*Respiratory experience preferred.
Position Summary:
The Clinical Research Scientist (CRS) will support and work predominately with the Clinical Trial/Indication Lead(s) and Medical Monitor(s) for assigned protocols and/or projects, partnering with vendors and cross functional teams. The CRS will provide clinical and scientific support to clinical development and operations, regulatory, medical affairs, drug safety, and quality assurance teams, as well as overall program support ensuring the adherence to all standard operating procedures (SOPs)
Responsibilities:
- Participate in cross functional teams to develop and implement clinical studies within clinical program(s). Responsibilities include but are not limited to:
- Collaborate with internal teams, contract research organizations (CROs), and external vendors to prepare, review and finalize clinical study documents and plans
- Contribute to scientific and operational aspects and stages of the protocol development and study execution, from study design planning through final reporting of results
- Provide scientific input and review of clinical study data, support in assessing medical monitoring reports, study integrity/conduct, and study oversight
- Support preparation of abstracts, manuscripts, presentations, and materials for meetings as it related to the protocol(s) and program
- Provide protocol level scientific review of information to support the development and updates for regulatory documents (i.e., IND submissions, IND Annual Updates, DSUR, and Investigator Brochures)
- Support enrollment projections and assist with the development and implementation of subject recruitment and retention strategies
Provide scientific support to the study teams, including:
Collaborate with team members in the review and development of Data Management activities including eCRFs, edit checks, report development, and database lock processes
Participate in activities related to data review, database lock, medical monitoring, and query resolution for the protocol
Work with other clinical scientist(s), medical monitors, and drug safety to provide support and scientific review of safety data
Provide scientific review of study plans
Support corporate objectives:
Development, review, and revision of departmental and corporate SOPs and processes
Support regulatory activities at the protocol level to develop, prepare and respond to regulatory authorities
Position Requirements:
- Requires a Pharm.D., Ph.D., or M.D. (or M.D. equivalent) with a minimum 1-3 years of drug development experience
- Experience with EDC systems (i.e., RAVE) and data analysis tools (i.e., J-Review) required
- Strong medical writing and presentation skills
- Basic understanding of biostatistics and data management
- Ability to read, analyze and interpret common scientific and technical journals, financial reports, and legal documents
- Excellent written and oral communication skills
- Ability to succeed in fast-paced work environment
- Ability to work successfully in a matrix team environment
- Meeting management, conflict management, and cross-functional team leadership skills required
- Time management and organizational skills required
