Country Study Specialist
South San Francisco, CA 94080
Bayside Solutions is seeking a Country Study Specialist to be part of our client’ s team in South San Francisco. This is an opportunity to work with the largest privately held pharmaceutical corporation in the world and ranks among the world' s 20 leading pharmaceutical corporations.
Our Client’ s culture is highly collaborative, offers an environment that encourages employees to expand their knowledge in order to make a profound impact on patients’ lives. This could explain why their company has been recognized as one of the “ Top Twenty Employers” in biotechnology and pharmaceuticals by Science Careers.
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.
Country Study Specialist
- An opportunity to join a patient-focused organization that is driven to develop, manufacture and commercialize medicines to treat life threatening conditions.
- 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:
- Development and/or writing study documents (protocols, protocol amendments, CRFs, investigational brochures, annual report, study guidelines, etc.)
- Qualifying, monitoring and managing sites including co-monitoring with the CRO
- Management of various CROs and vendors involved in the study (e.g. monitoring, data management, central labs, etc)
- Implementation of operational activities and project management tasks associated with clinical studies (eg. central lab coordination, SAE tracking/reconciliation, etc.) to ensure they are conducted in a successful, timely manner and within budget
- Responsible for all start-up activities including but not limited to: site selcetion, drug preparation, enrollment, data collection, etc.
- Proactively identifying solutions when issues arise
- Organization of investigator, steering committee, and data monitoring committee meetings
- Assist with CRO and vendor identification and selection process
- Management of key study parameters (e.g. start-up activities, drug preparation, enrollment, data collection, etc)
- Implementation and management of operational plans
- Data review (patient profiles, line listings, patient narratives, etc.)
- Preparation of study updates
- May take on timelines and budget management, as applicable
Summary of Qualifications:
- BS/RN degree or equivalent in the scientific or health care field (e.g. Nursing, Pharmacy, etc.)
- 4-5 years in the pharmaceutical industry including in-house experience
- Solid, hands-on clinical trial experience including site monitoring
- Strong organizational and oral and written communication skills
- Solid experience developing/writing study documents (protocols, annual reports, etc.)
- Ability to work as a team player and the ability to work in a fast-paced environment
- Must be flexible, detail-oriented and have an interest in professional growth
- Energetic, self-starter, able to multi-task and be proactive
- Some travel required