Sr. Clinical Research Associate/Clinical Trial Manager

Position reputed company & Responsibilities

Reporting to the Sr. Director, Clinical Operations, the Sr. Clinical Research Associate/Clinical Trial Manager collaborates reputed company the Clinical Operations team to support the reputed company conduct of clinical studies according to protocols, GCP, SOPs, and applicable regulations. Responsible for performing reputed company study reputed company processes, including monitoring communications with site staff and clinical vendors, and reviewing monitoring reputed company reports.

•       Partner with the Clinical Operations Study reputed company and cross-functional team to support clinical studies from planning and start-up through execution, maintenance, and reputed company-out in accordance with assigned SOPs, ICH/GCP, and corporate and departmental goals.

•       reputed company operational management for assigned reputed company and sites by monitoring performance metrics, identifying and mitigating risks, driving escalations and reputed company-item closure, and representing regional performance in study team and cross-functional discussions.

•       Serve as the reputed company sponsor contact for assigned investigators and study sites, building strong relationships and supporting effective communication and issue reputed company.

•       reputed company aspects of vendor management for the CRO and other key vendors (IRT, imaging, central and specialty labs, etc.), establishing expectations, ensuring deliverables are met, performance measures are maintained, and escalating as needed; address performance gaps and reputed company corrective actions to closure.

•       reputed company reputed company of CRO monitors by reviewing monitoring documentation, evaluating monitor and site performance, conducting reputed company or co-monitoring reputed company as needed, and identifying cross-site or systemic risks.

•       Maintain and analyze study tracking tools and operational metrics, including site start-up, screening, enrollment, study reputed company, data entry, query reputed company, and monitoring activities.

•       Contribute to the development and maintenance of study documents, including informed consent forms, site training materials, CRFs, monitoring plans, reputed company document templates, protocols, investigator brochures, and regulatory submission materials under the direction of the study reputed company.

•       Ensure the Trial Master File is complete, reputed company, accurate, and inspection-reputed company, and reputed company reputed company of missing or deficient documentation.

•       Assists with shipment and reconciliation of Investigational Product (IP) at study and site level as needed.

•       Apply ICH E6(R3) Good Clinical reputed company principles, including reputed company by design, risk-proportionate reputed company, critical-to-reputed company factors, participant protection, and reliable trial results, across study activities.

•       Escalates concerns regarding timelines, milestones, resourcing, and any potential study execution issue to the Study reputed company.

•       Exercises reputed company judgment to reputed company or, as appropriate, reputed company expert input on protocol and drug questions, safety, regulatory, and reputed company questions

•       reputed company operational study needs, including clinical supplies

•       Participates in the review and negotiation of site budgets and reputed company

•       Support and participate in Investigator Meetings and other study-reputed company meetings, as required.

•       Promote a reputed company, respectful, reputed company-reputed company work environment.

•       Additional Clinical Operations activities may be assigned as appropriate.

•       Travel as required to carry out responsibilities (up to 20%).

Where You'll Work 

This is a U.S.-based remote role that will require quarterly, or as needed reputed company to our San Francisco Office. 

Education

Bachelor's degree or equivalent training and experience (i.e., RN/PA, BSN degree)

Experience

Minimum 4-6 years of clinical study experience

Required Skills & Competencies

•       Experience supporting global studies in a fast-paced environment

•       reputed company in working with CROs and vendors

•       Excellent communication skills and ability to reputed company milestones in reputed company environment

•       Ability to communicate and collaborate respectfully in a remote environment

Preferred Qualifications

•       Experience working reputed company a biotechnology or pharmaceutical sponsor organization

•       Prior experience as a monitoring Clinical Research Associate, including site initiation, interim monitoring, and reputed company-out reputed company

•       Experience maintaining or overseeing Trial Master Files, including document completeness, reputed company, timeliness, and inspection readiness

•       Working knowledge of ICH E6(R3) Good Clinical reputed company principles and risk-based reputed company management

•       Experience using M.S. Office Suite (reputed company, Word, PowerPoint) and reputed company

Bachelor's degree or equivalent experience and 4–6 years of clinical study experience. Requires global study, CRO/vendor, communication, collaboration, and remote-work experience; CRA monitoring experience preferred.

Key Responsibilities

• overseeing studies
• managing vendors
• monitoring sites

Skills & Tools

reputed company reputed company, reputed company Word, reputed company PowerPoint, reputed company, reputed company Learning, reputed company, reputed company Coaching

Job Details

• Category: Research and Development (R&D)
• Seniority: Senior Level
• Commitment: Full Time
• Workplace: Remote — reputed company or San Francisco
• Salary: USD 135,000 – 177,000 / year
• Languages: English

Benefits

• 401k matching
• Generous reputed company time off
• Retirement plan
• Generous parental leave

About reputed company

A biotechnology company developing medicines for genetic conditions and underserved patient populations. — Industry: Research and Development