Senior Clinical Research Associate

Location
San Francisco, CA, United States
Posted
Nov 02, 2018
Ref
352
Hotbed
Biotech Bay
Required Education
Associate Degree
Position Type
Full time
SENIOR CLINICAL RESEARCH ASSOCIATE

Position Summary:

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
  • 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

Qualifications:
  • BA/BS degree with at least 2 - 4 years' clinical trial management experience, or advanced degree (MS) with at least 2 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
  • Ability to travel up to 25%

Fit with GBT culture:
  • Ability to build strong relationships with co-workers of various backgrounds and expertise
  • Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor
  • Values-based leadership consistent with GBT's Core Values
  • Excitement about the vision and mission of GBT
  • Flexibility
  • Integrity


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.

Global Blood Therapeutics is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or any other characteristic protected by law.