Study Start-up Specialist
South San Francisco, CA | Contract
Bayside Solutions is seeking a Study Start-up Specialist to be part of our client’ s team in South San Francisco. This is an opportunity to work with one of the largest Biopharmaceutical companies in the world developing innovative medicine to save patients’ lives.
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.
Study Start-up Specialist
The Study Start-up (SSU) Specialist functions as a subject matter expert on all SSU-related activities in the country/region, oversees and leads SSU activities in collaboration with other clinical research stakeholders and serves as a leader for local/global SSU process improvements and patient recruitment strategies.
- 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:
- Coordinates, guides and assists with all start up activities prior to site activation, including but not limited to:
- Site Informed Consent Form (ICF) localization and guidance in line with regulatory / health authority requirements
- Ethics Committee information, meeting dates & costs
- Ethics applications & associated online systems
- Ethics & Governance submission processes
- Clinical Trial Health Authority application and regulatory submission process
- Contracts & Indemnity request process
- Localize global Informed Consent Form (ICF) with country requirements
- Other materials and documentation used by the study requiring local governance approval
- Maintains up to date knowledge, ensure adherence and compliance with local regulatory requirements and associated documentation
- Review, analyze and collate metrics to ensure processes are in place that drive efficiency and reduction of timelines across start up and contracts negotiation
- Ensures all start up information & requirements are kept up to date in a central repository for project teams
- Assists with label preparation and approval (local label representative) for studies in collaboration with local regulatory department
- Tracks metrics and study start-up timelines to identify trends and opportunities for improvement
- Liaises and collaborates with relevant authorities / bodies to further enhance clinical trial processes, government policies / laws, via innovative approaches
- Maintains up-to-date understanding of Start Up processes by liaising with key stakeholders, and looks for emerging trends across government, hospital, industry and other stakeholders to evolve the unit and to resolve any issues
- Proactively responds to information survey requests by government, health regulatory authorities and industry bodies
- Provides continuous and proactive communication with ECs / hospital administration / industry bodies to obtain accurate and up to date information on clinical trial status and activities
- Maintains communication with local legal/regulatory/medical affairs departments to ensure input is sought and all internal/external requirements are met
- Provides guidance to CSMs on regulatory/ethics, track & drive site activations by regular review and monitoring status of submissions/activations
- In collaboration with vendor management and procurement, provide input as required into vendor identification, selection, and RFI/RFP process.
- Liaises and shares best practices with other SSUs within CCO
Summary of Qualifications:
- University Degree or Equivalent preferably in a medical/science-related field
- Prior work experience demonstrating knowledge and understanding of clinical trials, such as that obtained in a clinical trial monitor capacity, and experience managing projects.
- Demonstrated knowledge and understanding of ICH-GCP, the regulatory, ethics and contractual requirements for starting clinical trials in relevant country
- Demonstrated competence in analysis, planning and problem solving.
- Excellent communications skills including the ability to state opinions clearly, ask questions, seek clarification, communicate facts objectively, challenge when appropriate, and pursue issues to resolution
- Ability to present clear messages from complex information/data to all levels in the organization in both written and spoken English
- Experience working as part of a team with a proven ability to make an active contribution to the team' s performance and teamwork
- Able to make effective decisions, self-motivated, assertive, and displays initiative
- Proven project management and organizational skills and the ability to prioritize and manage multiple tasks with flexibility
- Demonstrated computer literacy, usage of MS Office software, web-based systems and databases.
- Availability to travel domestically and internationally if required.