Sr. Clinical Research Associate
South San Francisco, CA | Contract
Bayside Solutions is seeking a highly motivated, Sr. Clinical Research Associate to be a part of our partner’ s team in the South San Francisco Area. This is a unique opportunity to join a growing company dedicated to developing novel therapeutics to treat under-treated blood-based disorders.
The Sr. Clinical Research Associate will work in close collaboration with the Clinical Operations & Regulatory Affairs leadership team. The Sr. CRA will work to manage and monitor clinical trial sites and will function as the Sr. CRA for clinical trials. The ideal candidate will have a BA/BS degree, 2-4+ years’ of clinical trial management experience, and experience assisting in managing or leading day-to-day operations of assigned studies to ensure goals are met and in compliance with applicable GCP/ICH guidelines and other regulatory requirements.
Our Company Bio: Bayside Solutions was founded in 2001, Bayside was recognized as one of the fastest growing professional staffing companies in Northern California. The numbers tell the story: We have close to a 100% client retention rate, 700% growth in four plus years and over 95% repeat business. Our dedication to building partnership relationships with both our clients and our recruits is the key to our phenomenal success.
You can find additional information on our company website at www.baysidesolutions.com.
Sr. Clinical Research Associate:
- Work for a company that is local to the bay area and recognized as a leader of innovation.
- Competitive compensation commensurate with experience.
- This position is eligible for medical, vision, dental benefits, paid sick time, and 401K.
Summary of Responsibilities:
- Participate in and may facilitate cross-functional study teams, liaise with other functional areas (preclinical development, pharmaceutical sciences, safety, and regulatory affairs) to accurately coordinate clinical study activities.
- Coordinate clinical study timelines with Project management to meet critical milestones; escalate issues that may jeopardize timelines and deliverables.
- Provide monitoring oversight by reviewing monitoring schedules, metrics and reports.
- May oversee or manage clinical documentation and reports.
- Accurately updates and maintains clinical systems within project timelines.
- Provide regular updates of study progression to CTM, Clinical Development Lead, Program Management, and other stakeholders; proactively identify and resolve issues that arise during study conduct; manage escalation of study-related issues.
- Participate in developing study plans and system set-up; participate in preparation and ensure operational excellence of protocol, CRF, CSR and other key study team deliverables.
- Implement appropriate systems, standards and processes to ensure quality at the level of investigative sites, vendors and data; maintain clinical study files per ICH guidance.
- Participate in preparation of vendor requirements and project scope and selection of study vendors; effectively manage interactions with vendor study team.
- Work on study feasibility assessments and selection of countries and sites for study conduct.
- Create and conduct training sessions including investigator meetings and team training.
- Provide oversight and direction to study team members, including vendors, for study deliverables.
- Ensure all work adheres to ICH Good Clinical Practice (GCP) guidelines and comply with company SOP’ s.
- **Only local SF Bay Area, CA candidates will be considered**.
- BA/BS degree with at least 2 - 4 years’ of clinical trial management experience, or advanced degree (MS) with at least 2 years’ of clinical trial management experience.
- Must have strong knowledge of ICH/GCP guidelines.
- Must have strong knowledge of protocol and clinical drug development processes, clinical study design, study planning and management, and monitoring.
- Strong experience in management of CROs and other vendors.
- Requires proven project management skills and study leadership ability.
- Must have excellent interpersonal, written and verbal communication skills, administrative skills and computer ability.
- Excellent computer skills in the following programs: MS Word, PowerPoint, Excel and Project.