Summary:

Clinical Trials Associate (CTA), Clinical Operations, is responsible for supporting clinical study team(s) to manage various aspects of the operational execution and delivery of quality studies and quality processes according to protocols, SOPs, and Gossamer policies and procedures, applicable regulations and principles of GCP. The CTA will prioritize and handle multiple tasks effectively in a fast-paced Research and Development (R&D) environment.  Either under the guidance of Clinical Operations management for the CTA or independently the Sr CTA, the individual will coordinate, track, and manage daily activities for multiple clinical studies to support both the internal project team(s) and the CRO(s).

Essential Duties and Responsibilities 

  • Assist in the tracking and oversight of all start-up activities (site and country study submissions, clinical trackers and essential documents status) and oversight of third-party vendors.
  • Assist the Clinical Operations Manager(s)/Project Team to prepare and maintain eTMF, ensuring tracking of essential study documents and periodic review to assure accuracy and completeness.
  • Support the Clinical Operations Manager(s) coordinating project meetings, including scheduling and drafting, distribution, and filing of meeting agendas and minutes.
  • Communicate effectively with clinical study administration vendors (Functional Service providers etc.).
  • Assist in coordination of Investigator and Vendor payments, tracking of invoices and accruals, if applicable.
  • Independently tracks and oversees study start-up activities and oversight of third-party vendors.
  • Communicating key issues and mitigations to relevant cross-functional stakeholders.
  • Leads the coordination of Investigator and Vendor payments, tracking of invoices and accruals, if applicable.
  • May participate in data listing and/or clinical study report listing review.
  • Contributes to creation of relevant study specific plans, tools and trackers.

JOB QUALIFICATIONS

  • BA/BS in a relevant scientific discipline with 2+ years of experience in supporting clinical trial management for industry sponsored trials. 
  • Equivalent combination of education and 5+ years of experience in relevant clinical operations roles may be considered.
  • Experience being part of a Phase 3 global trial or Phase 2/3 rare disease programs is an asset.
  • Solid interpersonal skills and demonstrated ability to lead is required.
  • Effective verbal, written, interpersonal and presentation skills are required.
  • Bilingual preferred but not required
  • Working knowledge and experience with Word, PowerPoint, SharePoint and Excel.
  • Strong attention to detail and dedication to accurate and high-quality work.
  • Focus on results, highly collaborative cross functionally, and proactive.
  • Effective time management skills and ability to manage competing priorities.
  • Knowledge of FDA and/or EMA Regulations (or relevant local regulations), ICH Guidelines, and GCP governing the conduct of clinical studies.
  • This position can be hybrid based in San Diego, CA or remote. 

Gossamer Bio is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants and complies with all applicable national, state and local laws governing nondiscrimination in employment.

The expected salary range for this position is $85,000 to $130,000. Actual pay will be determined based on experience, qualifications, and other job-related factors permitted by law.  This position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. This position also qualifies for the benefits as listed below:

Gossamer Bio offers highly competitive benefit plans and programs, including medical, dental and vision insurance, 401(k) and 401(k) matching , long-term incentive plan, disability plan, vacation pay, sick time, holiday pay, and work, personal and family time off in accordance with the terms of the applicable plans. For additional general information on Company benefits, please visit https://www.gossamerbio.com/work-at-gossamerbio/

Vaccination Policy:  Gossamer Bio is committed to complying with federal, state and local law on vaccinations.  Job candidates and employees should be aware that some roles may require full vaccination against COVID-19 . Gossamer Bio is an equal opportunity employer, and will provide reasonable accommodation to those unable to be vaccinated where it is not an undue hardship to the company to do so as provided under federal, state, and local law.

California Consumer Privacy Act (CCPA) Notice for California Residents:
This notice is to notify you that personal data about you has been collected by Gossamer Bio (“Controller”), which is located at 3013 Science Park Road, Suite 200, San Diego CA 92121 and can be contacted by emailing privacy@gossamerbio.com, because Controller wishes to evaluate your candidacy for employment at Controller.

Your personal data was either obtained from publicly available sources (e.g. LinkedIn) or provided to Controller by someone who referred you for potential employment.  Controller’s Privacy team can be contacted at privacy@gossamerbio.com.  

Your personal data will be processed for the purposes of managing Controller’s recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes.  Such processing is legally permissible under Art. 6(1)(f) of Regulation (EU) 2016/679 (General Data Protection Regulation) and the California Consumer Privacy Act (CCPA) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment.

Your personal data has been shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller’s behalf.   

Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment.  Under the GDPR and CCPA, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted.  You also have to right to data portability.  In addition, you may lodge a complaint with a supervisory authority.

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