Clinical Research Associate II/Senior CRA – Multiple Therapeutic Areas

This is a fully remote position, open to applicants in Illinois, +3 more states.

📋 Description

• Oversees investigator sites utilizing a risk-based monitoring strategy, employing root cause analysis (RCA), critical thinking, and problem-solving abilities to pinpoint failures in site processes and implement corrective/preventive measures to ensure compliance and mitigate risks.

• Guarantees the accuracy of data through SDR, SDV, and CRF reviews as necessary via both on-site and remote monitoring activities.

• Evaluates investigational products through physical inventory assessments and records reviews, documenting findings in reports and correspondence promptly while adhering to approved business writing standards.

• Promptly escalates identified deficiencies and issues to clinical management and ensures follow-up until resolution. May require maintaining regular communication between monitoring visits with investigative sites to verify compliance with the protocol, resolution of previously identified issues, and timely data recording.

• Executes monitoring responsibilities in alignment with the sanctioned monitoring plan. Engages in the investigator payment process and shares responsibility with other project team members in resolving issues/findings. Investigates and follows up on findings as necessary.

• Attends investigator meetings as required. Collaborates with the client company to identify potential investigators, ensuring the suitability of qualified investigative sites. Initiates clinical trial sites following relevant procedures to guarantee compliance with the protocol, regulatory, and ICH GCP obligations, and makes recommendations as needed. Conducts trial close-out and retrieval of trial materials.

• Ensures that essential documents are complete and compliant with ICH-GCP and applicable regulations. Conducts on-site file reviews as specified by the project.

• Provides trial status tracking and progress updates to the Clinical Team Manager (CTM) as needed. Ensures study systems are updated according to agreed study conventions (e.g., Clinical Trial Management System).

• Promotes effective communication among investigative sites, the client company, and the PPD project team through written, verbal, and electronic interactions.

• Addresses company, client, and relevant regulatory requirements/audits/inspections.

• Completes and maintains administrative duties such as expense reports and timesheets promptly.

• Contributes to the project team by assisting in the development of project publications/tools and sharing insights/suggestions with team members.

• Participates in other project initiatives and process improvement efforts as necessary.

⛳️ Requirements

• 1–2 years of onsite monitoring experience involving travel.

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

• Candidates must reside within 60 miles of the nearest major airport, with up to 80% travel anticipated.

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

• Must successfully pass a comprehensive background check, which includes a drug screening.

🏝️ Benefits

• A selection of national medical and dental plans, along with a national vision plan, including health incentive programs.

• Employee assistance and family support programs, which encompass commuter benefits and tuition reimbursement.

• At least 120 hours of paid time off (PTO), 10 paid holidays each year, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability according to company policy.

• Retirement and savings options, such as our competitive 401(k) U.S. retirement savings plan.

• The Employees’ Stock Purchase Plan (ESPP) provides eligible colleagues the chance to buy company stock at a discounted rate.