Clinical Research Associate

4-6 years

$120,000 - $145,000 USD

San Francisco

10 Aug. 20, 2024

Job Description

Job Type: Full Time Education: B.Pharm/ M.Pharm/ B.Sc/ M.Sc/ Any Life Science Graduate Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

About QED Therapeutics & BridgeBio Pharma

QED Therapeutics, an affiliate of BridgeBio Pharma, is dedicated to developing targeted therapies for FGFR-driven skeletal dysplasias, with a special focus on Achondroplasia. Achondroplasia, the most common genetically-driven short stature condition, presents significant medical challenges for affected individuals. Our investigational therapeutic candidate, infigratinib, aims to offer a transformative option for children with Achondroplasia and their families.

Our core values drive our mission:

PUT PATIENTS FIRST
LET SCIENCE SPEAK
EVERY MINUTE COUNTS
THINK INDEPENDENTLY
BE RADICALLY TRANSPARENT

BridgeBio Pharma is a biopharmaceutical company founded to bridge the gap between cutting-edge genetic science and the development of impactful medicines. Since our inception in 2015, we have built a portfolio of over 30 drug development programs spanning multiple therapeutic areas, including genetic dermatology, precision oncology, cardiology, endocrinology, neurology, pulmonology, and renal disease. With a presence in the U.S., Canada, Switzerland, and expanding across Europe, we are committed to translating today’s discoveries into tomorrow’s medicines.

For more information about us, visit: QED Therapeutics | BridgeBio Pharma

Position Overview: Clinical Research Associate

As a Clinical Research Associate (CRA) at QED Therapeutics, you will work closely with the Clinical Operations team to ensure the efficient conduct of clinical studies in compliance with protocols, Good Clinical Practice (GCP), Standard Operating Procedures (SOPs), and applicable regulations. You will oversee quality study processes, including monitoring, communication with clinical site staff and vendors, and review of monitoring reports. Additionally, you will contribute to the training and oversight of clinical vendor monitors and site personnel and help develop standardized oversight and tracking tools.

Key Responsibilities:

Study Management: Support all aspects of clinical studies from initiation through to close-out, including site management, informed consent forms (ICFs), site activations, and study plans.
Site Relations: Act as a liaison between QED and study sites, fostering strong sponsor-site relationships.
Vendor Oversight: Monitor contract vendors and Clinical Research Organization (CRO) activities to ensure compliance with study plans, timelines, budgets, SOPs, GCPs, FDA regulations, and ICH/GCP guidelines.
Issue Resolution: Proactively identify and escalate issues, participate in problem-solving, and implement risk mitigation strategies.
Tracking Systems: Coordinate and maintain tracking systems for subject screening, enrollment, study visits, data entry, and query resolution.
Monitoring Visits: Conduct co-monitoring visits with CROs as needed, overseeing site qualification, initiation, routine monitoring, and close-out.
Document Development: Assist in the creation and review of study-related documents, including protocols, informed consent forms, and monitoring plans.
Training & Compliance: Support site training, and ensure adherence to study protocols and regulatory requirements.

Education & Experience Requirements:

Required: Bachelor’s degree in natural or health sciences (e.g., biology, pharmacology, pharmaceutical sciences) or equivalent experience. Minimum of 4-6 years in clinical operations or a similar field, with Citi training preferred.
Preferred: Experience in clinical trial documentation, regulatory requirements, and working with CROs and vendors. Familiarity with clinical trial master files is a plus.

Skills:

Excellent communication and interpersonal skills
Strong organizational and problem-solving abilities
Ability to balance multiple tasks and work in a fast-paced environment
Proficiency with MS Office Suite (Excel, Word, PowerPoint)

What We Offer:

Patient-Centric Culture: Engage with individuals directly affected by the conditions we aim to impact and learn from their experiences.
Values-Driven Environment: Embrace a culture where our values—putting patients first, thinking independently, being radically transparent, and valuing every minute—drive our work.
Decentralized Model: Focus on advancing science and patient care with minimal bureaucracy.
Career Growth: Opportunities for rapid career advancement, potential involvement in multiple BridgeBio programs, and access to extensive learning and development resources.
Compensation & Benefits: Competitive salary range ($120,000 - $145,000 USD), performance bonus, equity, comprehensive health benefits, flexible PTO, and more.

Equal Opportunity Employer:

QED Therapeutics and BridgeBio Pharma are Equal Opportunity Employers. We offer equitable employment opportunities to all qualified applicants without discrimination based on sex, sexual orientation, gender identity, race, color, national origin, disability, or any other protected characteristic.

Salary:

The anticipated salary range for this role is $120,000 - $145,000 USD. Final compensation will be determined based on factors such as experience, education, and location.

Join us at QED Therapeutics and contribute to transforming lives through innovative therapies. Apply now!

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