Sr. Clinical Trial Associate

2+ years

$100,000/yr - $130,000/yr

Emeryville

10 May 27, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Communication Skills, CPC Certified, 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: Senior Clinical Trial Associate

Company: 4D Molecular Therapeutics

Location: Emeryville, California

About the Company:

4D Molecular Therapeutics is a clinical-stage biotherapeutics company based in Emeryville, California. They focus on developing diagnostics for neurological disorders, utilizing their platform, Therapeutic Vector Evolution (TVE), for targeted genetic medicines.

General Summary:

The Senior Clinical Trial Associate will support clinical trial activities at 4D Molecular Therapeutics. Reporting to the CTM/Sr. CTM, Clinical Operations, this role involves coordinating and overseeing the day-to-day operations of phase 1-3 clinical trials, ensuring compliance with regulations and timelines.

Responsibilities:

Coordinate tracking of clinical trial(s) under Clinical Trial Management oversight.
Collect, track, and review site regulatory documents for completeness.
Organize, maintain, and participate in audits and close-out of the Trial Master File (TMF/eTMF).
Track progress of assigned clinical trials via multiple spreadsheets.
Coordinate CRO and third-party vendor activities.
Review regulatory documents for accuracy and compliance.
Update 'Clinicaltrials.gov' with site updates/changes.
Track and route new CDAs, contracts, and Work Orders through legal approval process.
Review site and vendor invoices and assist with finance accruals.
Assist in developing site tools and clinical trial start-up activities.
Assist in creating and maintaining study materials for clinical studies.
Participate in study vendor set-up and specification process.
Communicate directly with sites, CROs, and CRA/monitors.
Assist in tracking clinical trial progress and organizing team meetings.
Utilize EDC/CTMS systems to acquire and synthesize data and reports.
Assist CTM in tracking and follow-up of monitoring visit reports.

Qualifications:

Bachelor's degree required.
Minimum of 2 years of experience supporting clinical trials.
Basic knowledge of clinical trial operations and regulatory requirements.
Proficiency in Microsoft Office Suite.
Ability to prioritize and manage competing priorities.
Team-oriented with effective collaboration skills.
Willingness to travel as required (<5% anticipated).

Base Salary Compensation Range:

Outside of Bay Area Range: $85,000/yr - $120,000/yr
Bay Area Range: $100,000/yr - $130,000/yr

Note: Actual salary offered may vary based on factors such as geographical location, relevant work experience, skills, and years of experience.

4D Molecular Therapeutics is an equal opportunity employer, providing employment opportunities to all qualified individuals without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, genetic information, marital status, status as a covered veteran, or any other category protected under applicable laws.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

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Sr. Clinical Trial Associate

Job Description

Job Title: Senior Clinical Trial Associate

Company: 4D Molecular Therapeutics

Location: Emeryville, California

About the Company:

General Summary:

Responsibilities:

Qualifications:

Base Salary Compensation Range:

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