Clinical Trial Associate

Overview

Black Diamond Therapeutics is a precision oncology medicine company pioneering the discovery and development of small molecule, tumor-agnostic therapies. Black Diamond targets undrugged mutations in patients with genetically defined cancers for whom limited treatment options currently exist. Black Diamond is built upon a deep understanding of cancer genetics, protein structure and function, and medicinal chemistry. The Company's proprietary technology platform, Mutation-Allostery-Pharmacology, or MAP, platform, is designed to allow Black Diamond to analyze population-level genetic sequencing data to identify oncogenic mutations that promote cancer across tumor types, group these mutations into families and develop a single small molecule therapy in a tumor-agnostic manner that targets a specific family of mutations.

The BDTX Clinical Trial Associate (CTA) role collaborates with cross-functional team members to assist the clinical research teams in ensuring the most effective and efficient conduct of clinical research studies by providing administrative and project tracking support.

Responsibilities

Key Responsibilities:

To be successful in the role, the individual must be able to perform the following:

• Provide general administrative support to the Clinical Operations Department and assistance to Project Manager(s) and Project Director(s).
• Assist the Clinical Operations teams in the completion of all required tasks to meet departmental and project goals.
• Support the Clinical Operations teams with ongoing conduct of studies.
• Provide support for TMF set up, to contribute in the development of eTMF filing and document management plan to create an inventory form for physical TMF hard files for the studies and to provide support with TMF audit observations.
• To be familiar with ICH GCP, appropriate regulations, relevant BDTX sops, and internal tracking systems.
• To be familiar with the roles of the Clinical Research Associates (CRA) including site visits, if appropriate.
• Assist project teams with study-specific documentation and guidelines as appropriate.
• Set up, organize and maintain clinical study documentation (e.g. Main Study Files, CRFs, etc.) including preparation for internal/external audits, final reconciliation, and archival.
• Process Data Collection Forms i.e. login, tracking, quality control as appropriate for the study.
• Assist in quality control audits of clinical study documentation (e.g. Main Study Files, CRF Files, Monitoring Files, etc.).
• Coordinate ordering/dispatch and tracking of trial materials (e.g. CRFs, diary cards, lab supplies, drug supplies) as appropriate.
• Assist project teams with trial progress tracking by updating the Clinical Trial Management systems.
• To copy and route incoming correspondence, internal documentation, CRFs, etc., as appropriate.
• To assist in the coordination of Investigator payments, if applicable.
• Contact clinical sites for specific requests (e.g., enrollment updates, missing documentation, meeting arrangements, etc.).
• Assist in the tracking and distribution of safety reports.
• Coordinate document translation, if required.
• Attend project team meetings and generate meeting minutes.
• Assist the Project Manager role and project team with Investigator Meeting coordination, activities preparation, and generate meeting minutes.
• Assist in the production of slides, overheads, etc., as needed for the project, departmental, sponsor, and/or business development presentations.
• Assist with the coordination of team member tracking.

Qualifications

Qualifications:

• Independent management of multiple studies
• Actively provides operational direction and/or general supervision to direct reports.
• Oversee performance of CROs, third party vendors, and field CRAs including co-monitoring, to ensure compliance with study protocol and in accordance with scope of work; identify areas of concern and escalate within Portola and/or CRO as appropriate.
• Perform clinical data review of data listings and summary tables, including query generation.
• Identify, select, and monitor performance of investigational sites for clinical studies; prepare accurate and timely visit reports from all site interaction visits.
• Develop and maintain good working relationships with investigators and study staff.
• Ensure studies are carried out according to the study protocol, SOPs, and ICH/GCP regulations and study-specific manuals and procedures.
• Track and report on progress of study including site activation, patient enrollment, monitoring visits.
• Review key study quality metrics (e.g., eligibility, primary endpoint data, etc.) and determine appropriate action in conjunction with study team (autonomy may vary with experience)
• Investigate queries, monitor discrepancies.

Work Environment:

This job operates in a professional office environment. This role routinely usues standard office equipment.

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform he essential functions of this job.

While performing the duties of this job, the employee is occasionally required to stand; walk; sit; used hands to fingers, handle, or feel objects, tools, or controls; reach with hands and arms; climb be stairs; talk or hear. The employee must occasionally lift or move office products and supplies, up to 20 lbs.

Black Diamond Therapeutics is an equal opportunity employer and welcomes and encourages all applications. Diversity and inclusion are important core values and will encourage our creativity and growth as a company. Accommodations are available on request for candidates taking part in all aspects of the selection process. We thank all applicants for their interest, however, only those selected will be invited for an interview.