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

About the role

Join our global team as a Clinical Research Associate (Level II) and 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. You will perform and coordinate all aspects of the clinical monitoring and site management process, conducting 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) while acting as a site processes specialist. Your role ensures that 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. 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 various sponsors or monitoring environments.
• Act as a site processes specialist to ensure trials comply 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 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 skills, including root cause analysis and problem-solving.
• Ability to manage Risk-Based Monitoring concepts and processes.
• Strong oral and written communication skills, with 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.
• 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) is required.
• Rare exposure to fluctuating and/or extreme temperatures.

Pay

The salary range for this position based in Florida is $85,000.00–$130,000.00. 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.