Experienced Clinical Research Associate (CRA II / SR CRA) - US West- Multiple Therapeutic Areas Available

About the role

Join our global team as a Clinical Research Associate (Level II) and 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, manage required documentation, and ensure trials are conducted in accordance with approved protocols, ICH-GCP guidelines, applicable regulations, and SOPs. This role involves managing procedures and guidelines from various sponsors or monitoring environments (e.g., FSO, FSP, Government) and acting as a site processes specialist to guarantee subjects' rights, well-being, and data reliability. You will ensure audit readiness and develop collaborative relationships with investigational sites. Detailed tasks and responsibilities are outlined in the task matrix.

Responsibilities

• Conduct remote or on-site visits to assess protocol and regulatory compliance.
• Manage required documentation and ensure adherence to procedures and guidelines from different sponsors or monitoring environments (e.g., FSO, FSP, Government).
• Act as a site processes specialist to ensure trials are conducted in accordance with approved protocols, ICH-GCP guidelines, applicable regulations, and SOPs.
• Guarantee subjects' rights, well-being, and data reliability.
• Ensure audit readiness and develop collaborative relationships with investigational sites.

Requirements

• Bachelor's degree in a life science-related field, Registered Nursing certification, or equivalent and relevant formal academic/vocational qualification.
• Previous experience comparable to 1 year as a clinical research monitor or completion of PPD Drug Development Fellowship.
• Valid driver's license where applicable.
• 1-2 years of traveling on-site monitoring experience.
• Therapeutic experience in at least one of the following areas: Oncology, Ophthalmology, Neurology, Cardiology, Rare Disease, Respiratory, Obesity, and/or Pulmonary.
• 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.

Skills

• Proven clinical monitoring skills.
• Demonstrated understanding of medical/therapeutic area knowledge and medical terminology.
• Working knowledge of ICH GCPs, applicable regulations, and procedural documents.
• Well-developed critical thinking skills, including 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.
• Strong organizational and time management skills.
• Effective interpersonal skills and ability to work in a team or independently as required.
• Attention to detail and ability to remain flexible and adaptable in various scenarios.
• Solid knowledge of Microsoft Office and ability to learn appropriate software.
• Good English language and grammar skills.
• Good presentation skills.

Environmental Conditions

• Work is performed in an office, laboratory, clinical, and/or home office environment with exposure to electrical office equipment.
• Frequent drives to site locations and travel, generally 60-80% but may exceed this for some individuals, including extended overnight stays.
• Exposure to biological fluids with potential exposure to infectious organisms; personal protective equipment (e.g., protective eyewear, garments, gloves) required.
• Rare exposure to fluctuating and/or extreme temperatures.

Pay

The salary range for this position based in California is $80,000.00–$125,000.00. This position may also be eligible for a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy.

Benefits

• A choice of national medical, dental, and vision plans, including health incentive programs.
• Employee assistance and family support programs, including commuter benefits and tuition reimbursement.
• At least 120 hours of paid time off (PTO), 10 paid holidays annually, and paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave).
• Accident and life insurance, and short- and long-term disability in accordance with company policy.
• Retirement and savings programs, such as a competitive 401(k) U.S. retirement savings plan.
• Employees’ Stock Purchase Plan (ESPP) offering the opportunity to purchase company stock at a discount.