Remote Clinical Research Scientist

The Clinical Research Scientist (CRS) will support and work predominately with the Clinical Scientist and Medical Monitor for assigned protocols and/or projects, partnering with vendors and cross-functional teams. The CRS will provide scientific support to clinical development and operations, regulatory and quality assurance teams, as well as overall program support, ensuring the adherence to all standard operating procedures (SOPs).

• Participate in cross-functional teams to develop and implement Clinical Study protocols within the clinical program(s)

• Collaborate with internal teams, CROs and external vendors to prepare, review and finalize clinical protocol documents

• Contribute to scientific and operational aspects and stages of the protocol development and execution from study design planning through final reporting of the result

• Provide scientific input and review of protocol data to ensure a clean database, support in assessing medical monitoring reports, study integrity/conduct, and protocol oversight

• Collaborate with CROs and investigational sites in the follow-up of clinical and protocol implementation queries related to the conduct of the study

• Support preparation of abstracts, manuscripts, presentations, and materials for meetings as it related to the protocol(s) and program

• Provide a protocol-level scientific review of information to support the development

• Collaborate with team members in the review and development of Data Management activities, including eCRF edit checks, report development, and database lock processes

• Participate in activities related to review of data review, database lock, medical monitoring, and query resolution for the protocol

• Work with clinical scientists, medical monitors, and drug safety vendor(s) to provide support and scientific review of adverse events

Requirements:

• Bachelor's Degree; advanced degree preferred

• Minimum of 3 years of Clinical Science experience at a pharmaceutical, biotech, or CRO company

• Strong clinical/medical writing and presentation skills

• Strong understanding of data management and data review process

• Basic understanding of biostatistics

• Excellent written and oral communication skills

• Ability to succeed in a fast-paced work environment

• Ability to work successfully in a matrix team environment

• Time management and organizational skills required