Clinical Research Associate II/Sr CRA, Multiple Therapeutic Areas

This is a fully remote position, open to applicants in Illinois, +4 more states.

📋 Description

• Oversee and coordinate all facets of clinical monitoring and site management.

• Perform both remote and on-site visits to evaluate adherence to protocols and regulatory requirements.

• Manage sponsor procedures, guidelines, and the monitoring environment.

• Ensure that trials comply with approved protocols, ICH-GCP guidelines, regulations, and SOPs.

• Monitor investigator sites utilizing a risk-based monitoring strategy.

• Conduct root cause analysis to identify failures in site processes and implement corrective and preventive measures.

• Ensure data integrity through thorough review of source documents, source data verification, and CRF evaluations.

• Assess inventory and records of investigational products.

• Record observations in detailed reports and correspondence.

• Escalate issues and deficiencies and ensure they are addressed until resolved.

• Maintain communication with investigative sites between monitoring visits.

• Execute monitoring activities according to the established monitoring plan.

• Participate in investigator payments and meetings.

• Identify and initiate engagement with qualified clinical trial sites.

• Conduct trial closeout activities and retrieve trial materials.

• Ensure essential documents are complete and perform on-site file reviews.

• Provide trial status updates and progress reports to the Clinical Team Manager.

• Update clinical trial management systems as needed.

• Facilitate communication among sites, the client company, and the PPD project team.

• Respond to audits and inspections from the company, clients, and regulatory bodies.

• Complete expense reports and maintain timesheets.

• Assist in project publications, tools, process enhancements, and other initiatives.

⛳️ Requirements

• 1–2 years of experience in on-site monitoring with travel.

• Therapeutic experience in at least one of the following areas: Oncology, Ophthalmology, Neurology, Cardiology, Rare Disease, Respiratory, Obesity, and/or Pulmonary.

• Must reside within 60 miles of the nearest major airport.

• Travel requirements may be up to 80% of the time.

• Must be legally authorized to work in the United States without the need for sponsorship.

• Successful completion of a comprehensive background check, including a drug test, is required.

• A Bachelor's degree in a life sciences-related field, Registered Nursing certification, or a comparable formal academic/vocational qualification.

• Previous experience equivalent to at least 1 year as a clinical research monitor or completion of the PPD Drug Development Fellowship.

• A valid driver’s license is required where applicable.

• Demonstrated clinical monitoring abilities.

• Knowledge of medical/therapeutic areas and medical terminology.

• Familiarity with ICH GCPs, relevant regulations, and procedural documents.

• Strong critical thinking, root cause analysis, and problem-solving capabilities.

• Ability to navigate Risk Based Monitoring concepts and processes effectively.

• Excellent oral and written communication skills.

• Strong organizational and time management abilities.

• Effective interpersonal skills with a keen attention to detail.

• Flexibility and adaptability in varied situations.

• Capacity to work independently or collaboratively within a team.

• Proficiency in Microsoft Office and readiness to learn necessary software.

• Strong command of the English language and grammar.

• Good presentation skills.

🏝️ Benefits

• Variable annual bonus based on the performance results of the company, team, and/or individual.

• Comprehensive national medical and dental plans.

• National vision insurance option.

• Health incentive programs available.

• Employee assistance and family support services.

• Commuter benefits provided.

• Tuition reimbursement offered.

• Minimum of 120 hours of paid time off (PTO) annually.

• 10 paid holidays each year.

• Paid parental leave, offering 3 weeks for bonding and 8 weeks for caregiver leave.

• Accident and life insurance coverage.

• Short- and long-term disability benefits.

• 401(k) retirement savings plan available in the U.S.

• Employee Stock Purchase Plan (ESPP) with a discount on company stock.