Sr. Clinical Trial Associate

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At DICE Therapeutics, we design and develop innovative therapies in immunology for patients with debilitating disease. Seeking to create a future where convenient oral medicines with biologic-like efficacy are available to patients with serious medical conditions, we are developing oral alternatives to medicines currently limited to injectable forms. We foster an inclusive and collaborative workplace where everyone feels welcome, respected and valued.

Essential Functions:

In this role, you will provide direct support to clinical study teams. You must have a positive, proactive, creative mindset and be open to navigating ambiguity. The Sr. CTA independently identifies tasks/issues that need to be addressed while being highly organized with the ability to multitask and adjust direction based on changing project priorities. The Sr. CTA will work closely with the CTM and cross-functional representatives to ensure successful completion of all clinical activities and project deliverables with agreed upon project priorities, timing, budget, and quality requirements. You will facilitate the creation of meeting agendas and minutes, track study activities and documents using a variety of tools and systems, assist with reviewing clinical data, and provide support for the filing and oversight of the Trial Master File (TMF). The Sr. CTA will support oversight of CROs and other third-party vendors on assigned studies. You will be responsible to assure adherence to GxP in conduct of DICE clinical trials, the quality and integrity of generated data, and the rights and welfare of participants /patients.

Key Responsibilities:

  • Contributes to study management efforts under the guidance of the CTM to ensure that delegated components of clinical trials are executed according to study protocol/manuals, ICH/GxP and DICE quality standards
  • Assists with development of study related and essential documents/plans and documents
  • Primary Clinical Operations support role; facilitates the creation of meeting materials and takes precise minutes for study team meetings
  • Contributes to the set-up, oversight and close out of vendors, as requested
  • Assists with planning of Investigator Meetings; may lead presentations at Investigator Meetings
  • Coordinates development, procurement and management of study-specific training materials and supplies, as required; tracks operational data (supplies, lab samples), as needed
  • Develops study specific TMF Plan and oversees collection, tracking, reconciliation and archiving of TMF throughout the trial
  • Assists with project scoping, invoice reconciliation and change orders for clinical trial vendors
  • Participates in the review of clinical data in the EDC, data cleaning activities; ensures that all study data and documentation meet FDA/GCP/ICH regulations
  • Participates in the review, approval, and tracking of clinical monitoring visit reports in conjunction with the CTM and ensures that follow up items are closed out in a timely manner
  • Maintains day-to-day contact with counterpart at CRO and/or trial site; responsible for identification of potential issues or problems with the sites and communicates/escalates to CTM
  • Represents DICE in interactions with clinical sites to resolve issues and/or obtain documentation
  • Expands knowledge of clinical trial operations /scientific principles under minimal direction and recognizes when to escalate issues with solid communication skills  
  • Maintains and updates study trackers/metrics on an ongoing basis, and provides timely study-level KPI updates to Leadership
  • Contributes to key or interdepartmental initiatives/projects e.g., system or process improvements
  • Assists in preparing for and responding to audit findings in collaboration with GCP QA
  • Travel required: potential domestic and international travel

Preferred Education, Experience, Skills and Behaviors:

  • Bachelor’s degree or equivalent training and experience
  • Minimum of 5 years of experience in Clinical Operations (2 years in Sponsor setting)
  • Minimum 2 years direct experience managing eTMF and clinical trial databases /systems
  • Prior experience as a Study Coordinator or CRA is a plus
  • Early Development experience required. Start-up experience a plus
  • Well-versed in Good Clinical Practices (GCP), International Council for Harmonization (ICH) guidelines and regulatory requirements for clinical development
  • Proven ability to manage multiple projects while maintaining high quality
  • Solution-oriented mindset
  • Highly motivated self-starter
  • Exceptional organizational and time management skills
  • Acts with consistent sense of urgency with acute attention to detail
  • Respectful of others and is a team player
  • Proficiency in MS Office (Word, PowerPoint, MS Project), expertise in Excel  

Position is based in South San Francisco, with potential for flexible work arrangement

 Salary range 108,000 – 120,000

The pay range for this position that we reasonably expect to pay. Individual compensation is based on various factors including, experience, education, skillset, and geographic location. This range is for the Bay Area, California location and may be adjusted to the labor market in other geographic areas.

DISCLAIMER

The above information in this description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job.

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