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 Leader
The Clinical Trial Leader (CTL) works independently on most assignments, requiring the application of judgement in resolving issues or making recommendations to senior team members. The ability to identify tasks/issues that need to be addressed while being highly organized with the ability to multitask and adjust direction based on changing project/corporate priorities is a must. The CTL reports to the Director of Clinical Operations.
The CTL assists the study team across all investigator sites and ensures compliance with protocol and overall clinical objectives. Performing project/study management-related responsibilities by coordinating and tracking activities for clinical trials with protocol, Standard Operating Procedures (SOPs) and regulatory guidelines from the inception of the study through database lock, the successful candidate will work closely with all functional areas as well as external providers to ensure high-quality study outcomes.
- Ensure study activities are executed according to study protocol, regulatory guidelines and operational plan.
- Review Investigational Drug Brochures (IDB), Protocols, Case Report Forms (CRFs) and informed consent forms (ICFs) for 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
- Assist preparation of vendor requests for proposals and track receipt of proposals, 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.
- Assemble and distribute regulatory binders to clinical sites, if required.
- Draft and/or assist with preparation of trial-related 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 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
- Act with consistent sense of urgency with acute attention to detail
- Working knowledge and experience with Electronic Data Capture (EDC) systems and CTMS preferred
- Exceptional organizational and time management skills
Clinical Trial Manager
Duties include operational management and oversight assistance of clinical trial activities for assigned studies. The Clinical Trial Manager will be responsible for execution of clinical activities at the project level and will work closely with and report to the Director of Clinical Operations.
- Co-manage operational activities of clinical trials including training, monitoring, trial timeline, budget, resources, and vendors.
- Monitoring and reporting of study progress including site activation, target enrollment, site visits, etc.
- Ensure clinical operations deliverables are being met per study timeline.
- Assist with sponsor study start up process activities including but not limited to attendance at the trial kick-off meeting, assist with clinical site orientations, site selection and review of site and vendor Clinical Trial Agreements and budgets.
- Prepare project plans, standard operating procedures, and other clinical documents.
- Assist with preparation of site visit reports.
- Monitor the quality of vendor deliverables.
- Co-monitoring to ensure compliance with study protocol, SOPs, and ICH/GCP regulations.
- Oversee investigational product inventory and reconciliation.
- Clinical data review and validation to source records.
- Coordination of site visits and investigator meetings.
- Manage vendor invoices in collaboration with accounting teams; reconcile with study budget.
- Assist with quality assurance audits and reporting.
- TMF maintenance and archiving – ensure all project level study documentation is filed in the TMF in accordance with company SOPs and regulatory requirements.
- Provide timely, comprehensive updates and reports on all duties to Director of Clinical Operations.
- Other duties as assigned.
- Bachelor’s or Master’s Degree in Life Science discipline (or relevant field)
- Clinical operations experience in the Pharmaceutical, Biotechnology, Academic or contract research organization (CRO) setting
- Clinical project management experience in early and late phase trials (Phase I-III)
- Must have familiarity with clinical research concepts, practices, FDA regulations and ICH Guidelines regarding drug development phases, clinical research and data management methods.
- Exceptional verbal and written English language communications skills.
- Ability to travel domestically and internationally.
Please send a resume and cover letter to email@example.com