Clinical Trials Associate/ Sr Clinical Trials Assoc, Clinical Operations

Clinical Trials Associate/ Sr Clinical Trials Assoc, Clinical Operations

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

CTA

• 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.
• Assist in data listing review and clinical study report listing review.

Sr. CTA

• In addition to the above, will also be responsible for:
• 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.
• Actively participates in data listing and/or clinical study report listing review.
• Contributes to creation of relevant study specific plans, tools and trackers.

Job Qualifications

Education, Certifications, Experience

CTA

• 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.

Sr. CTA

• BA/BS in a relevant scientific discipline with 3+ years of experience in supporting clinical trial management for industry sponsored trials.
• An equivalent combination of education and 6+ 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.

Knowledge, Skills and Abilities

• Solid interpersonal skills and demonstrated ability to lead is required.
• Effective verbal, written, interpersonal and presentation skills are 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.

Special Working Conditions

Office environment / Domestic and International travel may be necessary (up to 20%)

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 $87,000 to $135,000. Actual pay will be determined based on experience, qualifications, geographical location 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.