Sr. Clinical Trial Associate - Remote

4+ years

$120,000 - $135,000

Remote

12 May 17, 2024

Job Description

Job Type: Full Time Education: BS/BA in Life Sciences or equivalent. Skills: Causality Assessment, Communication Skills, ICD-10 CM, CPT, HCPCS Coding, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Sr. Clinical Trial Associate (Sr. CTA)

Employer: Apogee Therapeutics

Location: Remote

Employment Type: Full-time

Salary Range: $120,000 - $135,000 per year (Final salary depends on experience, education, and geography)

About Apogee Therapeutics

Founded in 2022, Apogee Therapeutics, Inc. (Ticker: APGE) is a well-funded, Nasdaq-listed biotechnology company dedicated to developing differentiated biologics for treating atopic dermatitis, chronic obstructive pulmonary disease, and other inflammatory and immunology indications with high unmet need. Our programs leverage advanced antibody engineering to optimize treatments, aiming to reshape the standard of care for inflammatory and immune diseases. We are committed to fostering an exceptional company culture grounded in our C.O.R.E. values: Caring, Original, Resilient, and Egoless.

Role Summary

The Sr. Clinical Trial Associate (Sr. CTA) supports 1-3 project teams by managing multiple administrative aspects of clinical trials across all stages, including study start-up, enrollment, study conduct, and close-out. This includes creating study documents, implementing trackers, coordinating vendor payments and supplies, performing quality control of clinical trial documents, and assisting with study start-up contracting and coordination activities. The role is also accountable for managing the collection, review, completeness, and quality of assigned eTMFs.

Key Responsibilities

Study Management:

Act as the central contact for clinical team communications, correspondence, and documentation.
Set up, maintain, and perform QC reviews on study-specific electronic Trial Master Files (eTMF) to ensure inspection readiness and compliance with regulations and Good Clinical Practices.
Track and report TMF health metrics and ensure documents are correctly processed and filed.
Track and report study metrics related to start-up, data management, and contracting.
Participate in GxP audits and clinical compliance activities.
Prepare and track study documents such as contracts, budgets, and IRB documentation.
Maintain databases/spreadsheets to facilitate tracking/documentation of departmental activities and ensure systems like EDC, eTMF, CTMS, and Payments are best utilized per quality standards.
Administer user access and change control within Apogee’s electronic systems.
Assist in User Acceptance Testing for EDC needs related to Data Management and Clinical Systems.
Assist with vendor management and logistics.
Contribute to the creation of presentations for project, departmental, sponsor, and business development purposes.
Collaborate with the Clinical Project Manager, Clinical Supply Unit, and QA to manage Clinical Supplies activities.
Manage study-related payment procedures and interact with external providers during study conduct.
Accompany CRAs on site visits to assist with clinical monitoring duties upon completion of required training.
Provide input for budget development and review monthly costs invoiced based on planned study activities vs. actual.
Organize and participate in meetings with CROs and ensure appropriate meeting minutes are prepared and filed in TMF.
Assist CRAs and RSU with preparation, handling, and distribution of Clinical Trial Supplies and maintenance of tracking information.
Assist in creating and implementing departmental procedures.
Assist with information gathering, literature searches, and creation of presentations.

Qualifications

BS/BA in Life Sciences or equivalent.
4+ years of experience in a similar position within the Biotech, Pharmaceutical, or CRO industry, specifically in an R&D environment.
Extensive experience managing electronic TMF, including set-up, maintenance, QC/QR, and query management, and familiarity with the DIA reference model.
Knowledge of ICH/GCP and applicable regulations.
Proficiency in written, verbal, and face-to-face communication.
Ability to manage multiple tasks and resources concurrently while maintaining attention to detail and meeting aggressive deadlines.
Proficient in MS Office (Word, Excel, Project), Adobe, and ISI Toolbox.
Strong critical thinking, organizational, and time-management skills.
Demonstrated alignment with Apogee’s C.O.R.E. values: Caring, Original, Resilient, and Egoless.
Willingness to travel up to 10%, including a minimum of 4 times per year for All Hands meetings.

What We Offer

A great culture based on our C.O.R.E. values.
Opportunity to work in a fast-paced, dynamic environment.
Market competitive compensation and benefits, including base salary, performance bonus, equity grant opportunities, health, welfare, and retirement benefits.
Flexible PTO.
Two one-week company-wide shutdowns each year.
Commitment to professional growth and access to development resources.
Regular all-team, in-person meetings to build relationships and problem solve.

E-Verify Participation: Apogee participates in E-Verify for I9 verification of authorization to work in the US. Learn more about E-Verify.

Equal Opportunity Employer: Apogee Therapeutics is proud to be an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.

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Sr. Clinical Trial Associate - Remote

Job Description

Job Title: Sr. Clinical Trial Associate (Sr. CTA)

About Apogee Therapeutics

Role Summary

Key Responsibilities

Study Management:

Qualifications

What We Offer

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