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

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

About the Role

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'll have the opportunity to perform and coordinate all aspects of the clinical monitoring and site management process.

Responsibilities

• Conduct remote or on-site visits to assess protocol and regulatory compliance and manage required documentation.
• Manage procedures and guidelines from different sponsors and/or monitoring environments (i.e., FSO, FSP, Government, etc.).
• Act as a site processes specialist, ensuring 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.
• Ensure audit readiness and develop collaborative relationships with investigational sites.

Requirements

• 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 years 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 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.

Qualifications

• 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 but not limited to: critical mindset, 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.
• Good organizational and time management skills.
• Effective interpersonal skills.
• Attention to detail.
• Ability to remain flexible and adaptable in a wide range of scenarios.
• Good computer skills: solid knowledge of Microsoft Office and the ability to learn appropriate software.
• Good English language and grammar skills.
• Good presentation skills.

Skills

• 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 but not limited to: critical mindset, 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.
• Good organizational and time management skills.
• Effective interpersonal skills.
• Attention to detail.
• Ability to remain flexible and adaptable in a wide range of scenarios.
• Good computer skills: solid knowledge of Microsoft Office and the ability to learn appropriate software.
• Good English language and grammar skills.
• Good presentation skills.

Benefits

Compensation And Benefits
The salary range estimated for this position based in California is $80,000.00–$125,000.00. 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 assistance and family support programs, including commuter benefits and tuition reimbursement
At least 120 hours paid time off (PTO), 10 paid holidays annually, 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
Retail and savings programs, such as our competitive 401(k) U.S. retirement savings plan
Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount

For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards