CRA (Level II) - Neuroscience Experience / Immunology - Central (IL/TX)

What You’ll Do

• Maintains a risk-based monitoring approach, applying RCA, critical thinking, and problem-solving skills to identify and address site process failures.
• Ensures data accuracy through SDR, SDV, and CRF review during on-site and remote monitoring activities.
• Assesses investigational products through physical inventory and record review.
• Documents observations promptly in reports and letters using approved business writing standards.
• Escalates observed deficiencies and issues to clinical management and ensures they are resolved.
• Maintains regular contact with investigative sites between monitoring visits to ensure protocol adherence and data integrity.
• Conducts monitoring tasks according to the approved monitoring plan.
• Participates in the investigator payment process and collaborates with the project team on issue resolution.
• Investigates and follows up on findings as needed.
• Attends investigator meetings as necessary.
• Identifies potential investigators and recommends acceptable sites.
• Initiates clinical trial sites and ensures compliance with protocols and regulations.
• Performs trial close-out and retrieval of trial materials.
• Ensures essential documents are complete and compliant with ICH-GCP and regulations.
• Conducts on-site file reviews as per project specifications.
• Provides trial status updates and maintains study systems.
• Facilitates communication between investigative sites, clients, and the project team.
• Responds to company, client, and regulatory requirements/audits/inspections.
• Completes administrative tasks such as expense reports and timesheets.
• Assists in preparing project publications/tools and shares ideas with team members.
• Contributes to other project work and process improvements.

Requirements

• Bachelor's degree in a life sciences-related field or Registered Nursing certification and relevant formal academic/vocational qualification.
• Previous experience as a clinical research monitor or completion of PPD Drug Development Fellowship.
• Valid driver’s license where applicable.

Knowledge, Skills, and Abilities

• Proven clinical monitoring skills.
• Demonstrated understanding of medical/therapeutic area knowledge and medical terminology.
• Well-developed critical thinking skills, including critical mindset and problem-solving.
• Effective oral and written communication skills.
• Good organizational and time management skills.
• Ability to remain flexible and adaptable.
• Good computer skills, including Microsoft Office.
• Strong English language and grammar skills.
• Effective presentation skills.

Working Conditions and Environment

• Office/Laboratory/clinical/home office environment.
• Frequent drives to site locations.
• Frequent travel, generally 60-80%, with more for some individuals.
• Extended overnight stays may be required.
• Exposure to biological fluids and potential exposure to infectious organisms.
• Personal protective equipment required, including protective eyewear, garments, and gloves.
• Exposure to fluctuating and/or extreme temperatures on rare occasions.

Compensation and Benefits

The salary range for this position in Illinois is estimated at $66,800.00 - $112,000.00. This role may also be eligible for a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package, including:

• A choice of national medical and dental plans, and a national vision plan, including health incentive programs.
• Employee assistance and family support programs, including commuter benefits and tuition reimbursement.
• At least 120 hours of paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy.
• Retail and savings programs, such as our competitive 401(k) U.S. retirement savings plan.
• Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount.

For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards.