US - West Coast - Sr. Clinical Research Associate

About the Position

US - West Coast - Sr. Clinical Research Associate

We are seeking a Senior Clinical Research Associate for the US West Coast region to manage clinical trials in compliance with Good Clinical Practices (GCP) and regulatory requirements. This role is a contract position with a salary range of $135,000 - $145,000 per hour.

Responsibilities

• Conduct routine site monitoring visits and participate in site selection, site initiation, and study closure activities.
• Ensure clinical trials are conducted according to the approved protocol, amendments, and in compliance with GCP, Company SOPs, and all applicable regulatory requirements.
• Serve as the primary contact for CROs/vendors, Investigators, and study coordinators for study-related questions.
• Support feasibility and site selection processes for clinical studies.
• Assist in the development and review of clinical protocols, informed consent forms, and other study-related documents.
• Manage patient recruitment strategies to increase patient randomization into the trial.
• Review all AE/SAEs and ensure appropriate documentation is in place.
• Assist and support data validation and data cleaning procedures.
• Order and coordinate study supplies for clinical studies.
• Develop and maintain tracking tools to support the management of clinical studies.
• Plan and participate in Investigator meetings and CRA trainings.
• Provide guidance, clinical trial management, and direction to other junior Clinical Research Associates.

Requirements

• Education: BA/BS or RN, preferably in the Life Sciences.
• Experience: Minimum of 5+ years of experience in the pharmaceutical/biotechnology industry as a Clinical Research Associate from study start-up to database lock.
• Specialization: Strong Oncology (liquid and solid tumor) monitoring experience in phase 1-3 pharmaceutical/biotechnology clinical trials.
• Knowledge: Good understanding of ICH guidelines, GCP, PhRMA code, FDA CFR, clinical research ethics, HIPAA, patient privacy laws, and other relevant local regulatory requirements.
• Technical Skills: Strong working knowledge of EDC, IVR, and CTMS systems.
• Abilities: Ability to handle and prioritize multiple studies and projects, work effectively in a team/matrix environment, and understand technical, scientific, and medical information.
• Travel: Ability to travel 70-80%.

We Offer

• Competitive salary range of $135,000 - $145,000 per hour.
• Remote work options.
• Comprehensive benefits package including health coverage, life insurance, disability insurance, and 401k benefits.

About the Company

At Advanced Clinical, our commitment to diversity and inclusion in every part of our organization is crucial to fulfilling our mission and demonstrating our REAL values. Advanced Clinical is committed to providing employment opportunities without regard to sex, race, color, age, national origin, religion, gender identity or expression, sexual orientation or sexual preference, pregnancy or maternity, genetic information, marital status, disability, veteran status, or any other basis protected by applicable federal, state, or local law.

Advanced Clinical complies with federal and state disability laws and makes reasonable accommodations for applicants and candidates with disabilities. If a reasonable accommodation is needed to participate in the job application or interview process, please contact [email protected].

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