Sr. Clinical Research Associate - Early Phase Studies

Thermo Fisher Scientific•Las Vegas, NV

About The Position

The Senior Clinical Research Associate (CRA) supports global Early Development studies, primarily Phase I and clinical pharmacology trials. The role independently performs and coordinates clinical monitoring and site management activities, including remote and on-site visits, to assess protocol compliance, participant safety, data integrity, and regulatory adherence. The primary investigational site is in Las Vegas, Nevada, and the candidate must be based in the Las Vegas area. Travel to additional sites may be required based on study and business needs, including potential overnight travel. The CRA serves as a site processes specialist, ensuring trials follow approved protocols, ICH-GCP guidelines, applicable regulations, and standard operating procedures while protecting participants’ rights, safety, and well-being. The role supports audit readiness and collaborative relationships with sites, sponsors, and cross-functional study teams. Early-phase work may involve intensive safety assessments, dose escalation, PK/PD sampling, and time-sensitive study procedures. The position works in office, laboratory, clinical, and/or home office environments. Potential conditions include exposure to electrical office equipment, biological fluids, and infectious organisms; personal protective equipment may be required. Rare exposure to fluctuating or extreme temperatures is possible.

Requirements

Bachelor’s degree in life sciences, nursing, pharmacy, or a related medical/scientific discipline, or an equivalent combination of education, training, and relevant experience.
3–5+ years of independent clinical monitoring experience as a CRA, including experience conducting site qualification, initiation, interim monitoring, and close-out visits.
Strong medical and scientific knowledge, including the ability to independently review and interpret clinical source documentation such as medical histories, laboratory results, concomitant medications, adverse events, and eligibility criteria.
Must be based in the Las Vegas, Nevada area and be flexible to travel to additional locations as needed.
Valid driver’s license where applicable.
Thorough understanding of ICH-GCP, applicable regulations, SOPs, and clinical monitoring requirements.
Strong understanding of early-phase clinical trial conduct, including dose escalation, intensive safety monitoring, stopping criteria, dosing procedures, PK/PD sampling requirements, and high-volume source data review.
Ability to independently manage monitoring activities, prioritize competing study requirements, and exercise sound clinical judgment.
Strong critical thinking, risk assessment, root cause analysis, and problem-solving skills, including the ability to identify and escalate issues appropriately.
Strong understanding of risk-based monitoring concepts and processes.
Excellent written and verbal communication skills and ability to collaborate with investigational sites, medical personnel, sponsors, and cross-functional project teams.
Strong interpersonal and relationship management skills with a customer-focused approach.
Excellent organizational skills, attention to detail, and ability to manage multiple priorities in fast-paced, time-sensitive research environments.
Ability to work independently with minimal oversight while contributing effectively to collaborative study teams.
Flexibility and adaptability to changing study priorities, operational needs, and complex clinical scenarios.
Proficiency in Microsoft Office and ability to learn and effectively use clinical trial management systems and other relevant software.
Strong English language and grammar skills.

Nice To Haves

Previous Phase I or Early Development clinical monitoring experience, particularly with complex early-phase or clinical pharmacology studies; approximately 3+ years of Phase I monitoring experience is ideal, though candidates with less experience and substantial hands-on exposure to complex early-phase protocols may also be considered.
Direct monitoring experience with First-in-Human, Single Ascending Dose, and Multiple Ascending Dose study designs.
Experience with PK/PD, Drug-Drug Interaction, Food Effect, or Bioavailability/Bioequivalence studies.
Experience monitoring QT/QTc, ADME/mass balance, renal impairment, hepatic impairment, MASH, or other specialty-population studies.
Experience supporting studies involving complex routes of administration, including intravenous, subcutaneous, or other injectable therapies.
Previous monitoring experience within dedicated Phase I units or clinical pharmacology units.
Experience serving as a Lead CRA, mentoring junior CRAs, or assuming additional senior-level monitoring responsibilities.
Experience working independently within lean or cross-functional project structures, including studies without a designated Clinical Trial Manager.

Responsibilities

Independently monitor investigational sites using risk-based monitoring, critical thinking, root cause analysis, and problem-solving to identify compliance gaps, mitigate risks, and implement corrective and preventive actions.
Conduct site qualification, site initiation, interim monitoring, and close-out visits in accordance with monitoring plans, protocols, and regulatory requirements.
Support Phase I and Early Development studies, including First-in-Human, Single Ascending Dose, Multiple Ascending Dose, and PK/PD studies.
Monitor early-phase activities with particular attention to participant safety, dose escalation, stopping criteria, dosing requirements, time-sensitive sample collection, and clinical data review.
Perform source data review, source data verification, and case report form review as applicable; review clinical documentation such as medical histories, laboratory results, concomitant medications, adverse events, and eligibility assessments.
Assess investigational product accountability through inventory and records review, ensuring compliance with dosing and administration requirements.
Identify, document, and escalate safety concerns, protocol deviations, data discrepancies, and other study risks; partner with sites and project teams on resolution and follow-up.
Prepare timely and accurate monitoring reports and follow-up letters in accordance with business writing standards.
Communicate regularly with sites between visits to confirm protocol adherence, resolve outstanding issues, and support timely data entry.
Participate in investigator meetings and collaborate with sponsors and internal teams on site identification, qualification, initiation, monitoring, and close-out.
Ensure essential documents are complete, accurate, and maintained according to ICH-GCP, regulations, and project requirements; conduct on-site file reviews as required.
Maintain study tracking, monitoring documentation, and updates in CTMS and other applicable platforms.
Facilitate communication among sites, sponsors, and cross-functional teams, particularly regarding time-sensitive activities and emerging risks.
Support audit and inspection readiness and respond to applicable sponsor, company, and regulatory requirements.
Complete administrative responsibilities, including expense reports, timesheets, and other required documentation.
Contribute to project initiatives, process improvements, and knowledge sharing; provide guidance or mentoring to less experienced CRAs as appropriate.