The Opportunity:As Senior Clinical Project Associate, you will be accountable for providing clinical trial coordination
support, along with implementing operational plans in accordance with regulatory guidelines and
ICH/GCP standards. You will be an integrated member of the Relay Tx Clinical Development Operations
team making key contributions to the execution of clinical trials that will translate Relay's innovative
science into impactful medicines for patients.
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.
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