Experienced Clinical Research Associate (CRA II / SR CRA) - US East Region (Northeast & Southeast) - Multiple Therapeutic Areas Available

About the role

Join a global team that has 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 a Clinical Research Associate (Level II), 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 (e.g., FSO, FSP, Government). Acting as a site processes specialist, you will ensure trials are 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

• Conduct remote or on-site visits to assess protocol and regulatory compliance.
• Manage required documentation and site processes.
• Ensure trials adhere to approved protocols, ICH-GCP guidelines, applicable regulations, and SOPs.
• Maintain audit readiness and develop collaborative relationships with investigational sites.
• Manage procedures and guidelines from various sponsors and monitoring environments (e.g., FSO, FSP, Government).

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 a 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 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, root cause analysis, and problem-solving skills.
• Ability to manage Risk-Based Monitoring concepts and processes.
• Strong oral and written communication skills, including the ability to communicate effectively with medical personnel.
• Good organizational and time management skills.
• Effective interpersonal skills and ability to work in a team or independently.
• Attention to detail and ability to remain flexible and adaptable in various scenarios.
• Proficiency in Microsoft Office and ability to learn appropriate software.
• Strong 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 travel to site locations, 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 Florida is $85,000–$130,000. 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, including a competitive 401(k) U.S. retirement savings plan.
• Employees’ Stock Purchase Plan (ESPP) offering the opportunity to purchase company stock at a discount.