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

Responsibilities

• Conduct remote or on‑site monitoring visits to assess protocol and regulatory compliance.
• Manage required documentation for each site visit.
• Apply sponsor‑specific procedures and guidelines (e.g., FSO, FSP, Government).
• Ensure trials are conducted in accordance with the approved protocol, ICH‑GCP guidelines, applicable regulations, and SOPs.
• Guarantee subjects’ rights, well‑being, and data reliability.
• Maintain audit readiness for each investigational site.
• Develop and sustain collaborative relationships with investigational sites.
• Follow the detailed task matrix outlining site‑process responsibilities.

Education and Experience Requirements

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

Knowledge, 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 and root‑cause analysis abilities.
• Experience with Risk‑Based Monitoring concepts and processes.
• Excellent oral and written communication skills for interaction with medical personnel.
• Customer‑focused listening, attention to detail, and issue‑resolution skills.
• Strong organizational and time‑management abilities.
• Effective interpersonal skills and adaptability to varied scenarios.
• Ability to work independently or as part of a team.
• Proficiency with Microsoft Office and ability to learn specialized software.
• Good English language, grammar, and presentation skills.

Working Conditions and Environment

• Office, laboratory, clinical, and/or home‑office settings with exposure to standard electrical equipment.
• Frequent travel to site locations (generally 60–80 % travel, with occasional extended overnight stays).
• Potential exposure to biological fluids and infectious organisms; required use of personal protective equipment (protective eyewear, garments, gloves).
• Occasional exposure to fluctuating or extreme temperatures.

Schedule

Standard work schedule: Monday – Friday. Up to 80 % travel required.

Compensation and Benefits

Salary range (Florida): $85,000 – $130,000. Eligible for a variable annual bonus based on company, team, and/or individual performance.

• 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 (PTO), 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) with discounted stock purchase opportunity.