Clinical Trial Associate

14 Nov 2024

Vacancy expired!

Description:

Transforming what patients can expect from cancer therapy takes passion and a strong dedicated team. When you join ADC Therapeutics, you will join a group of talented people who share this mission.

We are seeking a Clinical Trial Associate to join ADCT’s Clinical Operations team.

Why ADC Therapeutics

ADC Therapeutics (NYSE: ADCT) is a rapidly growing commercial-stage biotechnology company that is improving the lives of cancer patients with its next-generation, targeted antibody drug conjugates (ADCs) for patients. ADC Therapeutics’ CD19-directed ADC ZYNLONTA™ (loncastuximab tesirine-lpyl) was approved by the FDA on April 23, 2021 for the treatment of adult patients with relapsed and refractory diffuse large B-cell lymphoma.

To learn more about ADC Therapeutics, please visit us at https://adctherapeutics.com/ and follow us on Twitter and LinkedIn.

What You’ll Do:

The Clinical Trial Associate will be responsible for supporting the clinical operations team in all aspects of global clinical trial operations from planning to execution and data delivery.

  • Compiles and tracks study metrics and other critical information using study trackers, databases, data forms, and reports

  • Assists with the tracking and review of safety events

  • Assists in coordinating site enrollment and reviewing site enrollment ready documents for initial supply release and subsequent supply requests

  • Supports in reviewing regulatory documents and preparing ad hoc reports

  • Assists in the development of critical study documents, including clinical protocols, ICFs, operational documents, study reference documents, study newsletters, site materials, and other study related documents

  • Coordinates with vendors on patient recruitment material

  • Provides vendor management support

  • Assists in the financial tracking of clinical trials, including tracking site and vendor contracts and invoices

  • Provides support for overall site management to ensure appropriate study execution

  • Assists in obtaining site confidentially agreement, feasibility and with other site recruitment activities

  • Assists with completion, submission, and maintenance of site IRB/EC documents and reports

  • Ensures all Trial Master File related documents are properly obtained and filed in the electronic system and manages ongoing audits of the Trial Master File including completion of CAPAs, as applicable and reconciliation of Sponsor/CRO TMFs

  • Compiles, tracks and sends study supplies to clinical sites, including drug supply related requests such as tracking drug accountability expiry lots, temperature excursion follow up and shipping requests

  • Supports training of clinical sites to the protocol and other study-specific documents

  • Assists in the coordination of investigator meetings or trainings (SIV, re-training, study coordinator meetings, ad-boards, etc.)

  • Assists with clinical sample receipt, shipment, and tracking

  • Assists with the coordination, preparation, and execution of clinical project meetings, safety meetings and any other study-specific committee meetings and associated minutes

. Requirements:

Who You Are:

  • Bachelor’s degree or equivalent from an accredited college or university preferred (life Sciences degree preferable).

  • 2+ years of experience in Clinical Trials in a Pharmaceutical /Bio-tech company or clinical setting, or health sciences experience (pharmaceutical industry or related clinical operation experience supporting clinical trials and associated documents and trackers is preferred) required.

  • Knowledge of the pharmaceutical business and ability to anticipate environmental changes and trends and implement changes accordingly; familiarity with medical terminology is necessary

  • Ability to develop and track a variety of diverse project budgets and identify key performance indicators, in a fast-paced, changing global environment.

  • Proficiency using Microsoft Word, Excel, Outlook, and PowerPoint; Microsoft Project is a plus.

  • Excellent oral and written English communication skills.

  • Ability to present technical information in a concise and clear manner.

  • Ability to work in cross-functional teams and in a highly matrixed manner

  • Willingness to travel 10-20%

ADC Therapeutics is proud to be an Affirmative Action/EEO Employer. EOE Minorities/Females/Protected Veterans/Disabled. We are committed to building diverse teams and fostering an inclusive, professional and respectful work environment where employees are empowered for success.

Full-time