FirstString Research is a clinical stage biotechnology company founded on a vision to deliver clinically relevant and effective solutions for inflammation-based medical conditions through an understanding of the molecular and cellular contexts that define the underlying pathology. Our focus is on diseases with unmet medical needs associated with dysregulation of inflammatory processes and an impaired injury response.
FirstString is a high growth, fast paced organization that offers competitive salary and benefits including 401k to employees at all levels. We are currently seeking highly motivated, self-driven individuals to join our team. The ability to be productive and successful in an intense work environment is critical.
Clinical Trial Lead
The Clinical Trial Lead (CTL) works independently on most assignments. The ability to multitask, prioritize, and identify tasks/issues that need to be addressed while being highly organized is a must. The CTL reports to the Director of Clinical Operations.
The CTL assists the study team across all study sites and ensures compliance with protocol and overall clinical objectives. This position incorporates project/study management-related responsibilities by coordinating and tracking activities for clinical trials and regulatory functions/reporting from the inception of the study through database lock. The successful candidate must be able to work closely with all functional areas as well as external providers to ensure high-quality study outcomes.
- Initiate, provide guidance, and ensure study activities are executed according to study protocol, regulatory guidelines and operational plan.
- Create and review protocols, case report forms, informed consent forms, and other study materials that reflect a thorough understanding of the study drug and procedures.
- Keep abreast of SOPs, Good Clinical Practice (GCP) and ICH guidelines as well as state and federal laws and ethical standards
- Participate in study start-up, conduct and closeout activities
- Initiate vendor requests for proposals and track receipt of proposals, coordinate proposal presentations and demonstrations, and preparation and review of MSAs and SOWs
- Collect and review site regulatory documents for accuracy and completion (i.e. 1572, Financial Disclosure documents, CLIA waivers, etc.), if not delegated to CRO.
- Create, assemble, and distribute regulatory binders and lab manuals to clinical sites, if required.
- Draft and/or assist with preparation of trial-related documents and procedure manuals, source documents, tools and templates (start-up forms, study logs)
- Support project management activities including taking meeting minutes, providing agendas to the clinical team, tracking screening/enrollment across all sites and maintaining study-status trackers.
- Maintain/monitor the Trial Master File for all clinical projects
Skills and Requirements:
- Bachelor’s Degree in health sciences related field, RN, or related discipline required
- Minimum 3-5 years relevant experience in the pharmaceutical, biotechnology, academic or contract research organization (CRO) setting
- Excellent written and verbal communication skills
- Strong PC skills (MS Word, MS Excel, MS Project)
- Sound analytical and problem-solving skills
- Acute attention to detail
- Working knowledge and experience with Electronic Data Capture (EDC) systems and CTMS preferred
- Exceptional organizational and time management skills
Please send a resume and cover letter to firstname.lastname@example.org