Sr CRA/Principal CRA - Chicago Metro Area

$66,800 - $120,000/Yr

Life Technologies - Chicago, IL

Full-time - Entry Level

Hybrid - Chicago, IL

10,001+ employees

Miscellaneous Manufacturing

About the position

The Clinical Research Monitor position at Thermo Fisher Scientific involves overseeing and coordinating all aspects of clinical monitoring and site management processes. The role is crucial in ensuring compliance with protocols and regulations, enhancing the quality of clinical trials, and improving health outcomes globally. The position requires a blend of clinical knowledge, critical thinking, and effective communication skills to manage relationships with investigational sites and ensure the integrity of clinical data.

Responsibilities

• Perform and coordinate all aspects of the clinical monitoring and site management process.
• Conduct remote or on-site visits to assess protocol and regulatory compliance and manage required documentation.
• Manage procedures and guidelines from different sponsors and/or monitoring environments.
• Act as a site processes specialist to ensure trials are conducted in accordance with approved protocols and regulations.
• Ensure audit readiness and develop collaborative relationships with investigational sites.
• Monitor investigator sites using a risk-based monitoring approach and apply root cause analysis to identify and resolve issues.
• Ensure data accuracy through review of source data and case report forms during monitoring activities.
• Document observations in reports and letters in a timely manner using approved business writing standards.
• Escalate observed deficiencies and issues to clinical management and follow through to resolution.
• Maintain regular contact with investigative sites to confirm protocol adherence and issue resolution.
• Conduct monitoring tasks in accordance with the approved monitoring plan and participate in investigator payment processes.
• Perform trial close out and ensure essential documents are complete and compliant with regulations.
• Provide trial status tracking and progress update reports to the Clinical Team Manager.

Requirements

• Bachelor's degree in a life sciences related field or Registered Nursing certification or equivalent.
• Previous experience comparable to 2 years as a clinical research monitor.
• Proven clinical monitoring skills and understanding of medical/therapeutic area knowledge.
• Ability to attain and maintain knowledge of ICH GCPs and applicable regulations.
• Well-developed critical thinking skills and problem-solving abilities.
• Good oral and written communication skills, with the ability to communicate effectively with medical personnel.
• Strong organizational and time management skills.

Nice-to-haves

• Experience in Cell and Gene Therapy, Hematology/Oncology, or Rare Disease therapeutic areas.
• Knowledge of risk-based monitoring concepts and processes.

Benefits

• Choice of national medical and dental plans, and a national vision plan.
• Employee assistance and family support programs, including commuter benefits and tuition reimbursement.
• At least 120 hours paid time off (PTO) and 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.
• Competitive 401(k) U.S. retirement savings plan.
• Employees' Stock Purchase Plan (ESPP) allowing purchase of company stock at a discount.