Contract – Senior Clinical Research Associate
CONTRACT – SENIOR CLINICAL RESEARCH ASSOCIATE
The Senior Clinical Research Associate (Sr. CRA) is a critical position within Global Blood Therapeutics' clinical team. In close collaboration with the Clinical Trial Manager, Clinical Operations & Regulatory Affairs leadership, the Sr. CRA will work to manage and monitor clinical trial sites and will function as the Sr. CRA for clinical trials. The Sr. CRA will partner with GBT's Medical Monitor and other internal and external constituents to ensure clinical trial activities and deliverables are completed on-time and within budget.
Assist in managing and or leading the day-to-day operations of assigned studies to ensure completion per established project team goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements.
Essential Duties and Responsibilities:
- Participate in and may facilitate cross-functional study teams, liaise with other functional areas (preclinical development, pharmaceutical sciences, safety, 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 update and maintain 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
- Oversight of vendor management activities and deliverables
- Work on study feasibility assessments and selection of countries and sites for study conduct
- Create and conduct training sessions including investigator meetings and team trainings
- Provide oversight and direction to study team members, including vendors, for study deliverables
- All work must adhere to ICH Good Clinical Practice (GCP) guidelines and comply with company SOP's
- BA/BS degree with at least 6 - 8 years of relevant monitoring and vendor oversight experience, or advanced degree (MS) with at least 4 years 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
- Proven project management skills and study leadership ability required
- Must have excellent interpersonal, written and verbal communication skills, and administrative skills
- Excellent computer skills in the following programs: MS Word, PowerPoint, Excel and Project
- Ability to “roll up your sleeves” and individually contribute results to a research and development effort
NOTE: This position summary is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization.
The Company complies with all laws respecting equal employment opportunity and does not discriminate against applicants with regard to any protected characteristic as defined by federal, state, and local law. This position may require you to work onsite or interact in person with customers of the Company and/or work onsite from time to time at the Company's facilities. The Company requires all employees working in its facilities (including attending in-person meetings and events) to be fully vaccinated from COVID-19 (except as required by applicable law). Therefore, this position requires you to be fully vaccinated from COVID-19, subject to reasonable accommodations for a disability/medical condition or sincerely-held religious belief, and/or as otherwise required by applicable law. The Company considers you fully vaccinated once 14 days have passed since you received either the second dose in a two-dose COVID-19 vaccine series or a single-dose COVID-19 vaccine. This position requires you to maintain a fully-vaccinated status against COVID-19, subject to reasonable accommodations required by applicable law. The vaccine must have been FDA approved, have emergency use authorization from the FDA, or, for persons fully vaccinated outside of the U.S., be listed for emergency use by the World Health Organization.