Senior Clinical Project Associate

Your Role:

• You will support the day-to-day operations of clinical trial execution, with a focus on site start-up, study participant enrollment, clinical monitoring, drug supply planning, defining clinical supply logistics, GCP and protocol compliance, from the clinical sites, CROs and vendors.
• You will coordinate with the CRO and the Relay Tx Clinical Operations Lead to support planning from study initiation through study closure.
• You will maintain study trackers and provide metrics as needed.
• You will review and contribute to key study documents including, but not limited to, informed consent forms, case report forms, and study plans.
• You will assist with the preparation and distribution of meeting agendas and minutes as well as actively participate in team meetings providing updates on your key responsibilities.
• You will help to ensure the Trial Master File is up-to-date and inspection ready.
• You will support inspection readiness by collaborating with CROs and providing support to clinical sites to prepare for and respond to audit/inspection findings conducted by internal QA and external regulatory agencies.
• You will actively participate in the development of department initiatives; contribute ideas to department initiatives that will make a difference to the efficiency and effectiveness of Clinical Operations.
• Your Background:
• You have 2-3 years of experience in clinical trial experience. CRO or Sponsor experience is strongly preferred.
• You are familiar with GCP and ICH Guidelines and the application to the conduct of clinical trials
• You are a motivated self-starter who is capable of flourishing in a fast-paced small company environment.
• You are a creative problem-solver with excellent communication and public speaking skills.
• You are familiar with MS Office products (MS Project, Excel and Power Point)
• You have strong interpersonal and organizational skills, with a high degree of attention to detail.
• You are pragmatic and able to manage multiple projects and needs effectively
• Estimated Salary Range: [$69,000 - $99,000].
• The range provided above is based on what we believe to be a reasonable estimate for this job at the time of posting. Actual base salary will depend on a number of factors, including but not limited to, a candidate’s education, experience, skills and location.
• #BP1
• You will support the day-to-day operations of clinical trial execution, with a focus on site start-up,
• study participant enrollment, clinical monitoring, drug supply planning, defining clinical supply
• logistics, GCP and protocol compliance, from the clinical sites, CROs and vendors.
• You will coordinate with the CRO and the Relay Tx Clinical Operations Lead to support planning from
• study initiation through study closure.
• You will review and contribute to key study documents including, but not limited to, informed
• consent forms, case report forms, and study plans.
• You will assist with the preparation and distribution of meeting agendas and minutes as well as
• actively participate in team meetings providing updates on your key responsibilities.
• You will support inspection readiness by collaborating with CROs and providing support to clinical
• sites to prepare for and respond to audit/inspection findings conducted by internal QA and external
• regulatory agencies.
• You will actively participate in the development of department initiatives; contribute ideas to
• department initiatives that will make a difference to the efficiency and effectiveness of Clinical
• Operations.
• You have 2-3 years of experience in clinical trial experience. CRO or Sponsor experience is strongly
• preferred.
• You are a motivated self-starter who is capable of flourishing in a fast-paced small company
• environment.

About Relay Therapeutics