This position will work closely with a cross-functional team to ensure that clinical trials are conducted in a timely fashion and in a manner compliant with SOPs, ICH/GCP/regulatory guidelines, company goals, and budgets.
Developing sample prep methodology from various matrices (e.g. biological fluids, blood spots, etc.) compatible with LC-MS including protein precipitation, liquid-liquid extraction, solid phase extraction and affinity enrichment.
In this position you will teach and precept residents, fellows, and medical students as part of your faculty responsibilities and may be assigned other duties and responsibilities as necessary (e.g. committee memberships, laboratory section oversight etc.).
Contribute to clinical development plans, clinical sections, stat
istical analyses plans, PK/PD analyses, clinical study
reports and review of other study related documentation (Investigators Brochure, Scientific Rationales/Justification,
Regulatory agency briefing documents and responses to questions
In this role, the selected candidate must have a hands-on experience using molecular biology techniques including PCR and real-time PCR to evaluate clinical samples in a hospital, CRO, reference laboratory, or similar environment.
Assists with PowerPoint training of investigative personnel on human subject protection, principal investigator obligations, GCP and local regulations to ensure sites are conducting clinical research according to protocol and regulatory requirements. Training may take place either at investigator meetings or at the investigative site.