Clinical Research Associate II - US West- Therapeutic

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Join Us as a Clinical Research Associate (Level II) – Make an Impact at the Forefront of Innovation. We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last five years.

As part of our global team, you will perform and coordinate all aspects of the clinical monitoring and site management process. You will conduct remote or on-site visits to assess protocol and regulatory compliance and manage required documentation. You will manage procedures and guidelines from different sponsors and/or monitoring environments (i.e., FSO, FSP, Government, etc.), ensuring that the trial is conducted in accordance with the approved protocol, ICH‑GCP guidelines, applicable regulations, and SOPs to guarantee subjects' rights, well-being, and data reliability.

You will ensure audit readiness and develop collaborative relationships with investigational sites. Responsibilities are outlined in the task matrix.

Bachelor’s degree in a life science related field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification.

Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 1 year as a clinical research monitor) or completion of the PPD Drug Development Fellowship.

Valid driver’s license where applicable.

1‑2 years of traveling on‑site monitoring experience is required.

Therapeutic experience in at least one of the following areas:
Oncology, Ophthalmology, Neurology, Cardiology, Rare Disease, Respiratory, Obesity, and/or Pulmonary.

Candidates must live within 60 miles of the nearest major airport. Up to 80% travel is expected.

Must be legally authorized to work in the United States without sponsorship.

Must be able to pass a comprehensive background check, including a drug screening.

• Proven clinical monitoring skills
• Demonstrated understanding of medical/therapeutic area knowledge and medical terminology
• Demonstrated ability to attain and maintain a working knowledge of ICH GCPs, applicable regulations and procedural documents
• Well‑developed critical thinking skills, including in‑depth investigation for appropriate root‑cause analysis and problem solving
• Ability to manage Risk‑Based Monitoring concepts and processes
• Good oral and written communication skills, with the ability to communicate effectively with medical personnel
• Ability to maintain customer focus through the utilization of good listening skills, attention to detail, and the ability to perceive customers’ underlying issues
• Good organizational and time management skills
• Effective interpersonal skills
• Attention to detail
• Ability to remain flexible and adaptable in a wide range of scenarios
• Ability to work in a team or independently as required
• Good computer skills: solid knowledge of Microsoft Office and ability to learn appropriate software
• Good English language and grammar skills
• Good presentation skills

• Work performed in an office, laboratory, clinical, and/or home office environment with exposure to electrical office equipment
• Frequent drives to site locations; frequent travel, generally 60‑80% but more for some individuals, may also include extended overnight stays
• Exposure to biological fluids with potential exposure to infectious organisms
• Personal protective equipment required such as protective eyewear, garments and gloves
• Exposure to fluctuating and/or extreme temperatures on rare occasions

The salary range estimated for this position based in California is $80,000.00–$.

This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:

• A choice of national medical and dental plans, and a national vision plan, including health incentive programs
• Employee…