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

Work Schedule

Standard (Mon‑Fri) with up to 80% travel, including frequent overnight stays.

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 exposure to biological fluids (potentially infectious) are required. Personal protective equipment such as protective eyewear, garments, and gloves is used. Occasional exposure to fluctuating or extreme temperatures may occur.

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 according to the approved monitoring plan and participate in investigator payment processes.
• Collaborate with project team members on issue/finding resolution and investigate follow‑up findings.
• Participate in investigator meetings as needed.
• Identify potential investigators in collaboration with the client company to ensure qualified site selection.
• Initiate clinical trial sites per relevant procedures, ensuring compliance with protocol, regulatory, and ICH‑GCP obligations.
• Perform trial close‑out and retrieve trial materials.
• Ensure essential documents are complete and in place per ICH‑GCP and applicable regulations.
• Conduct on‑site file reviews per project specifications.
• Provide trial status tracking and progress updates to the Clinical Team Manager.
• Update study systems according to agreed conventions (e.g., Clinical Trial Management System).
• Facilitate effective communication between investigative sites, the client company, and the project team via written, oral, or 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 process‑improvement initiatives and other project work as required.

Required Qualifications

• 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, or Pulmonary.
• Residence within 60 miles of a major airport.
• Legal authorization to work in the United States without sponsorship.
• Ability to pass a comprehensive background check, including drug screening.

Education and Experience

• Bachelor’s degree in a life‑sciences related field or a Registered Nursing certification (or equivalent) with relevant academic/vocational qualification.
• Experience comparable to at least 1 year as a clinical research monitor, or completion of the PPD Drug Development Fellowship.
• Valid driver’s license, where applicable.
• Equivalency through a combination of appropriate education, training, and/or directly related experience may be considered.

Knowledge, Skills and Abilities

• Proven clinical monitoring skills.
• Understanding of medical/therapeutic area knowledge and medical terminology.
• Working knowledge of ICH‑GCP, applicable regulations, and procedural documents.
• 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 for interaction with medical personnel.
• Customer‑focus, attentive listening, and attention to detail.
• Excellent organizational and time‑management abilities.
• Effective interpersonal skills and adaptability to varied scenarios.
• Capability to work both independently and as part of a team.
• Proficiency with Microsoft Office and ability to learn specialized software.
• Good English language, grammar, and presentation skills.

Compensation and Benefits

• Salary range (Illinois): $66,800 – $125,000 per year.
• Variable annual bonus based on company, team, and/or individual performance.
• National medical, dental, and vision plans with 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) offering discounted company stock purchases.