Experienced Clinical Research Associate (CRA II/Sr CRA) - US Central - Multiple Therapeutic Areas Available

Schedule

Standard (Mon‑Fri)

Working 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%, with occasional extended overnight stays). Potential exposure to biological fluids and infectious organisms; personal protective equipment such as protective eyewear, garments and gloves is required. May encounter fluctuating or extreme temperatures on rare occasions.

Responsibilities

• Monitor investigator sites using a risk‑based approach, applying root‑cause analysis, critical thinking, and problem‑solving to identify site process failures and implement corrective/preventive actions.
• Ensure data accuracy through source data verification (SDR), source data review (SDV), and case report form (CRF) review during on‑site and remote monitoring.
• Assess investigational product inventory and records.
• Document observations in reports and letters promptly, adhering to approved business writing standards.
• Escalate deficiencies and issues to clinical management and follow through to resolution.
• Maintain regular contact with investigative sites between visits to confirm protocol adherence, issue resolution, and timely data recording.
• Conduct monitoring tasks in accordance with the approved monitoring plan.
• Participate in the investigator payment process.
• Collaborate with project team members on issue/finding resolution.
• Investigate and follow up on findings as applicable.
• Participate in investigator meetings as needed.
• Identify potential investigators in collaboration with the client to ensure qualified site selection.
• Initiate clinical trial sites per procedures to ensure compliance with protocol, regulatory, and ICH‑GCP obligations, providing recommendations when warranted.
• Perform trial close‑out and retrieve trial materials.
• Ensure essential documents are complete and in place according to ICH‑GCP and applicable regulations.
• Conduct on‑site file reviews per project specifications.
• Provide trial status tracking and progress update reports to the Clinical Team Manager.
• Update study systems per agreed conventions (e.g., Clinical Trial Management System).
• Facilitate effective communication between investigative sites, the client, and the project team via written, oral, and electronic contacts.
• Respond to company, client, and regulatory audit/inspection requirements.
• Complete administrative tasks such as expense reports and timesheets in a timely manner.
• Assist in preparation of project publications/tools and share ideas/suggestions with team members.
• Contribute to other project work and process‑improvement initiatives as required.

Requirements

• 1–2 years of on‑site monitoring experience with travel.
• Therapeutic experience in at least one of: Oncology, Ophthalmology, Neurology, Cardiology, Rare Disease, Respiratory, Obesity, or Pulmonary.
• Residence within 60 miles of the nearest 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.

Education

Bachelor’s degree in a life‑sciences related field or a Registered Nursing certification (or equivalent) and relevant formal academic/vocational qualification. Completion of the PPD Drug Development Fellowship is also acceptable. Valid driver’s license required. Equivalent combinations of education, training, and experience may be considered.

Skills

• Proven clinical monitoring skills.
• Strong understanding of medical/therapeutic areas and medical terminology.
• Working knowledge of ICH‑GCP, applicable regulations, and procedural documents.
• Well‑developed critical thinking, root‑cause analysis, and problem‑solving abilities.
• Ability to manage Risk‑Based Monitoring concepts and processes.
• Excellent oral and written communication skills for interaction with medical personnel.
• Customer‑focused listening, attention to detail, and ability to discern underlying issues.
• Strong organizational and time‑management capabilities.
• Effective interpersonal skills and adaptability to varied scenarios.
• Ability to work independently or as part of a team.
• Proficiency with Microsoft Office and aptitude for learning specialized software.
• Good English language, grammar, and presentation skills.

Pay

Salary range (Illinois): $66,800 – $125,000 per year. 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 (PTO), 10 paid holidays annually, and paid parental leave (3 weeks for bonding, 8 weeks for caregiver leave).
• Accident and life insurance, short‑ and long‑term disability in accordance with company policy.
• Retirement savings programs, including a competitive 401(k) plan.
• Employees’ Stock Purchase Plan (ESPP) offering discounted company stock purchases.