CRA, Clinician to CRA Program

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

📋 Description

• Transition your clinical expertise into a Clinical Research Associate position within Thermo Fisher Scientific’s Clinician to CRA Program.

• Perform and coordinate activities related to clinical monitoring and site management.

• Conduct both remote and on-site visits to evaluate compliance with protocols and regulatory standards.

• Utilize risk-based monitoring, root cause analysis, critical thinking, and problem-solving skills to identify site process failures and determine corrective/preventive actions.

• Ensure data integrity through Source Data Review, Source Data Verification, and Case Report Form assessments.

• Evaluate the inventory and records of investigational products.

• Document findings in reports and letters adhering to approved business writing standards.

• Report deficiencies and issues to clinical management and follow up until resolution.

• Maintain ongoing communication with investigative sites between monitoring visits.

• Execute monitoring tasks in accordance with the approved monitoring plan.

• Take part in investigator payments and meetings.

• Identify potential investigators and initiate clinical trial sites as per established procedures.

• Conduct trial close-out activities and retrieve trial materials.

• Ensure that essential documents are complete and compliant with ICH GCP and relevant regulations.

• Perform on-site file assessments.

• Provide status tracking and progress reports for trials.

• Maintain accurate and up-to-date study systems such as CTMS.

• Facilitate communication between investigative sites, client companies, and internal project teams.

• Address company, client, and regulatory requirements, audits, and inspections.

• Complete administrative tasks such as expense reports and timesheets.

• Assist in project publications/tools and offer suggestions for process enhancements.

• Travel frequently, typically 60–80%, which may include extended overnight stays.

⛳️ Requirements

• Clinicians such as RNs, APRNs, PAs, MDs, Research Nurses, or Clinical Research Coordinators with clinician certification or equivalent formal academic/vocational training.

• At least 2 years of comprehensive experience as a clinician in a healthcare setting.

• Expertise in therapeutic areas such as Hematology/Oncology, CAR-T and Cell Therapy, Rare Disease, Endocrinology/Diabetes, Ophthalmology, Neurology, Cardiology, Infectious Disease, Respiratory/Pulmonology, Internal Medicine, ICU, or Critical Care, with a minimum of 2 years of relevant experience.

• Basic knowledge of medical/therapeutic areas and understanding of medical terminology.

• Capability to acquire and maintain a working knowledge of ICH GCPs, applicable regulations, and procedural documents.

• Strong oral and written communication skills.

• Excellent interpersonal abilities.

• Customer-focused with good listening skills, attention to detail, and the ability to identify underlying customer issues.

• Strong organizational and time management skills.

• Flexibility and adaptability in various situations.

• Proficient in critical thinking, root cause analysis, and problem-solving.

• Ability to manage Risk-Based Monitoring concepts and processes effectively.

• Capable of working independently as well as collaboratively within a team.

• Solid proficiency in Microsoft Office and the ability to learn new software quickly.

• Good command of the English language and grammar.

• Must adhere to specific sponsor/client/site requirements, which may include the disclosure of vaccination status or other personal information.

• Frequent travel to site locations, typically 60–80%; role indicates a travel requirement exceeding 75%.

🏝️ 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, incorporating commuter benefits and tuition reimbursement.

• A minimum of 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 coverage.

• Short- and long-term disability benefits in line with company policy.

• Competitive 401(k) U.S. retirement savings plan.

• Employees’ Stock Purchase Plan (ESPP) offering the opportunity to purchase company stock at a discount.

• Access to global resources, formal training programs, and dedicated support for career transitions.

• Flexible promotion cycles.

• Opportunities for professional development through exposure to therapeutic areas and innovative clinical trials.