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

About the role

As a Clinical Research Associate (Level II) you will perform and coordinate all aspects of clinical monitoring and site management. 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 the approved protocol, ICH‑GCP guidelines, applicable regulations, and SOPs. You will also ensure audit readiness and develop collaborative relationships with investigational sites.

Responsibilities

• Conduct remote or on‑site monitoring visits to assess protocol adherence and regulatory compliance.
• Manage and maintain required trial documentation.
• Apply sponsor‑specific procedures and guidelines (e.g., FSO, FSP, Government).
• Act as a site processes specialist to guarantee subject rights, well‑being, and data reliability.
• Maintain audit readiness and support audit activities.
• Develop and sustain collaborative relationships with investigational sites.
• Follow detailed tasks and responsibilities outlined in the task matrix.

Requirements

• Bachelor’s degree in a life‑science field, Registered Nursing certification, or equivalent academic/vocational qualification.
• Comparable experience to at least 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 on‑site monitoring experience with travel.
• Therapeutic experience in at least one of the following areas: Oncology, Ophthalmology, Neurology, Cardiology, Rare Disease, Respiratory, Obesity, Pulmonary.
• Residence within 60 miles of a major airport.
• Up to 80 % travel expected, including extended overnight stays.
• Legal authorization to work in the United States without sponsorship.
• Ability to pass a comprehensive background check and drug screening.

Skills and Abilities

• Proven clinical monitoring skills.
• Strong understanding of medical/therapeutic area knowledge and medical terminology.
• Working knowledge of ICH‑GCP, applicable regulations, and procedural documents.
• Critical thinking, root‑cause analysis, and problem‑solving abilities.
• Experience with Risk‑Based Monitoring concepts and processes.
• Excellent oral and written communication, especially with medical personnel.
• Customer‑focused listening, attention to detail, and ability to perceive underlying issues.
• Strong organizational and time‑management skills.
• Effective interpersonal skills and ability to work independently or in a team.
• Proficiency with Microsoft Office and ability to learn specialized software.
• Good English language, grammar, and presentation skills.

Working Conditions

• Office, laboratory, clinical, and/or home‑office environments with exposure to electrical equipment.
• Frequent drives to site locations; travel generally 60‑80 %.
• Potential exposure to biological fluids and infectious organisms; required personal protective equipment (eyewear, garments, gloves).
• Occasional exposure to fluctuating or extreme temperatures.

Pay

The salary range for this position in Florida is $85,000 – $130,000. The role may also be eligible for a variable annual bonus based on company, team, and/or individual performance.

Benefits

• Choice of national medical, dental, and vision plans, including health incentive programs.
• Employee assistance and family support programs, commuter benefits, and tuition reimbursement.
• At least 120 hours paid time off, 10 paid holidays, paid parental leave (3 weeks bonding, 8 weeks caregiver), accident and life insurance, short‑ and long‑term disability.
• Retirement savings options, including a competitive 401(k) plan.
• Employees’ Stock Purchase Plan (ESPP) allowing purchase of company stock at a discount.

Schedule

Standard Monday‑Friday work schedule; up to 80 % travel, which may include extended overnight stays.