Clinical Research Strategies is Growing!
We’re seeking new team members. Work with a growing team in the life sciences sector with positive work culture.
Preference is location in the Metropolitan Pittsburgh region or East Coast. Attractive compensation and benefits program with remote work environment.
We offer competitive compensation, a great team, and work-from-home environment. Apply by emailing your CV, 3 professional references, and salary requirements to firstname.lastname@example.org.
Clinical Research Strategies, LLC
6400 Brooktree Court
Wexford, PA 15090
CRS Career Opportunities
Clinical and Regulatory Affairs Scientist (PhD or Equivalent)
The Clinical and Regulatory Affairs Scientist is an integral part of the CRS clinical trials and management consulting teams. Under the supervision of the Director of Clinical and Regulatory Affairs and executive leads of the consulting business, the Clinical and Regulatory Affairs Scientist will support complex drug, biotechnology, and device writing assignments.
The Clinical and Regulatory Affairs Scientist brings specialized technical knowledge about the intersection of drug discovery, clinical research, and regulatory affairs to prepare clinical protocols, IND/IDE documents, grants, Investigator Brochures, annual reports (DSUR, PSUR), safety reviews, patient narratives, regulatory document submissions, and other clinical documents. The Clinical and Regulatory Affairs Scientist plays a critical role in liaising among staff supporting emerging clinical research programs, subject matter experts, and regulatory bodies. The Clinical and Regulatory Affairs Scientist translates scientific discovery into clinical practice by supporting researchers to develop study protocols and regulatory documents for treatments based upon work conducted at CRS. The Clinical and Regulatory Affairs Scientist also contributes to Regulatory Pathway Assessments (RPAs), abstracts, literature reviews, publications, and ad hoc writing assignments from time-to-time. The Clinical and Regulatory Affairs Scientist maintains adherence to ICH Good Clinical Practices, FDA guidelines, ISO standards, internationally-recognized biomedical writing standards, local regulations, and CRS Standard Operating Procedures.
Clinical Research Associate (CRA)
The CRA performs and coordinates all aspects of clinical monitoring and site management in accordance with ICH Good Clinical Practices, FDA guidelines, ISO standards, local regulations, and CRS SOPs. Both on-site and remote monitoring techniques may be used based upon project-specific requirements. The CRA conducts site visits to assess protocol and regulatory compliance and manages required documentation. The CRA is responsible for ensuring that data will successfully pass international quality assurance audits. The CRA develops and maintains collaborative relationships with investigational sites. The CRA works closely with project management functions to identify and escalate risks of patient safety and data integrity to clients during a study. The CRA often works remotely from their home office.