Clinical Trial Associate, Clinical Operations

The Clinical Trial Associate, Clinical Operations will support the oversight of clinical studies from concept to close-out.  The ideal candidate will ensure all clinical trial activities are performed in accordance with applicable SOPs, company policies, and regulatory guidelines. The primary focus of this role is to support the oversight of CROs and other 3rd party vendors to ensure study milestones are achieved and high-quality clinical data are delivered in a timely manner to support Context’s drug development program.

This position is based out of our headquarters in Philadelphia, PA with at least 2 days per week in the office.

Responsibilities

Job Responsibilities include, but are not limited to:

  • Supports the clinical operations project teams under the supervision of Clinical Trial Managers.

  • May contact clinical trial sites, vendors, CROs, and partners as needed.

  • Performs administrative tasks to support clinical project teams.

  • Maintains the Trial Master File (TMF).

  • Prepares meeting agendas, meeting minutes, and tracking logs.

  • Tracks clinical trial progress, including enrollment tracking, status update reports, and other reports as needed for assigned clinical trials.

  • Submits applicable documents to the Trial Master File (TMF).

  • Follows applicable Standard Operation Procedures (SOPs)

  • Assists with the creation and maintenance of documentation for assigned clinical trials. Documents may include, but not limited to: presentations, pharmacy manuals, regulatory binders, lab manuals, and training materials.

  • Partners with external vendors for accurate distribution of all clinical trial-related materials to clinical trial sites or clinical team members.

  • Responsible for scheduling internal meetings and meetings with external collaborators

  • Responsible for meeting minutes.

  • Assists with creation and distribution of study-level communication to stakeholders

  • Supports the study team by proactively identifying, resolving, and/or escalating issues to assigned staff.

  • Under general supervision collects, processes and tracks investigator sites and regulatory documents required by the FDA, and other regulatory authorities, as necessary across multiple studies.

  • Coordinates, processes, and tracks shipments (i.e., supplies, study-related materials, etc.)

  • Serves as a point of contact for clinical supplies, document collection and preparation for close-out.

  • Prepares and maintains documents and files such as clinical study files, regulatory binders, and operations manuals for clinical sites (i.e., informed consent form, protocol and investigators brochure).

  • Assists with the quality review of documentation e.g., ICFs, regulatory green light packages.

  • Attends study and Departmental meetings

  • Capable of handling additional tasks with little supervision.

Requirements

  • BA/BS in equivalent field with 2+ years of experience in Clinical Operations or equivalent experience without degree.

  • Oncology experience preferred

  • Knowledge of applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH)

  • Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint.

  • Ability to establish and maintain effective working relationships with coworkers, managers, and clients.

  • Excellent written and verbal communication skills.

  • Ability to multitask.

  • Significant attention to detail, time management and organizational skills.

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.