Position

Clinical Trial Associate

The Clinical Trial Associate will report directly to the VP of Clinical Operations and will support clinical studies from start-up to close-out. The ideal candidate will ensure designated clinical trial activities are performed in accordance with applicable SOPs, company policies, and regulatory guidelines. This is a hands-on support role assisting with documenting and reporting for the clinical development program, study sites, and clinical trial vendors. The position will work cross-functionally to ensure high quality clinical operations execution. You will be an integral member of the Context Therapeutics Clinical Operations team making key contributions to the overall execution of clinical trials.

Company

Context Therapeutics, Inc.

Responsibilities

Job Responsibilities include, but are not limited to:

• Supporting day-to-day operations of clinical trial execution, with a focus on site start-up, study participant enrollment, clinical monitoring, GCP and protocol compliance, from the clinical sites, CROs, and vendors.
• Coordinating with the CRO and the Context clinical operations leads to support planning from study initiation through study closure.
• Maintaining study trackers and providing metrics as needed.
• Reviewing and contributing to key study documents including, but not limited to, informed consent forms, study plans, and meeting minutes.
• Assisting with the preparation and distribution of meeting agendas, minutes, and agenda item tracking. You may also actively participate in department or product team meetings providing updates on your key responsibilities.
• Ensuring the Trial Master File is up-to-date and inspection ready.
• Tracking of study materials and laboratory research samples (Bioanalytical and Biomarker samples).
• Supporting audit/inspection readiness by collaborating with relevant external vendors and clinical sites to prepare for and respond to audit/inspection findings conducted by internal QA and external regulatory agencies as applicable.
• Participating actively in the development of department initiatives; contribute ideas to department initiatives that will make a difference to the efficiency and effectiveness of Clinical Operations.

Requirements

• BA/BS degree required
• 1-2 years of clinical trial experience. CRO or Sponsor experience is strongly preferred.
• Familiar with GCP and ICH Guidelines and the application to the conduct of clinical trials
• Motivated self-starter who is capable of flourishing in a fast-paced small company environment.
• Creative problem-solver with excellent communication and public speaking skills.
• Strong interpersonal and organizational skills, with a high degree of attention to detail.
• Pragmatic and able to manage multiple projects and needs effectively.
• Proficient in Microsoft Office Suite

Benefits

• 401(k)
• Dental insurance
• Health insurance
• Vision insurance

Work Location

• Greater Philadelphia, PA area
• Hybrid work model, which allows for work to be completed from home and in the office.
• Onsite presence expected two to three days per week.

About Context Therapeutics ^®

Context Therapeutics Inc. (Nasdaq: CNTX) is a biopharmaceutical company advancing T cell engaging (“TCE”) bispecific antibodies for solid tumors. Context is building an innovative portfolio of TCE bispecific therapeutics, including CTIM-76, a Claudin 6 x CD3 bispecific antibody, CT-95, a Mesothelin x CD3 bispecific antibody, and CT-202, a Nectin-4 x CD3 bispecific antibody. Context is headquartered in Philadelphia.

Context Therapeutics is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law.