Sr. Clinical Research Associate - Early Phase Studies

Thermo Fisher Scientific•Las Vegas, NV

About The Position

The Senior Clinical Research Associate (CRA) supports Early Development studies, primarily Phase I and clinical pharmacology trials. The role independently performs and coordinates clinical monitoring and site management, conducting remote and on-site visits to assess protocol compliance, participant safety, data integrity, and regulatory adherence. The position primarily supports an investigational site in Las Vegas, Nevada; candidates must be based in the Las Vegas area. Travel to other investigational sites may be required according to study and business needs, including 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 participant rights, safety, and well-being. The role supports complex early-phase research, including intensive safety assessments, dose escalation, PK/PD sampling, and time-sensitive study procedures. It also promotes audit readiness and collaborative relationships with sites, sponsors, and cross-functional study teams.

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 site qualification, initiation, interim monitoring, and close-out visits.
Strong medical and scientific knowledge, including the ability to independently review and interpret 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 able 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 trial conduct, including dose escalation, intensive safety monitoring, stopping criteria, dosing procedures, PK/PD sampling, and high-volume source data review.
Ability to independently manage monitoring activities, prioritize competing requirements, and exercise sound clinical judgment.
Critical thinking, risk assessment, root cause analysis, and problem-solving skills, including appropriate issue escalation.
Understanding of risk-based monitoring concepts and processes.
Excellent written and verbal communication skills and ability to collaborate with sites, medical personnel, sponsors, and cross-functional teams.
Strong interpersonal, relationship-management, organizational, and attention-to-detail skills; ability to manage priorities in time-sensitive environments.
Ability to work independently with minimal oversight and contribute effectively to collaborative teams.
Flexibility and adaptability to changing study priorities and operational needs.
Proficiency in Microsoft Office and ability to learn and use CTMS 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; candidates with less Phase I 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 studies.
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 with complex routes of administration, including intravenous, subcutaneous, or other injectable therapies.
Monitoring experience within dedicated Phase I or clinical pharmacology units.
Experience as a Lead CRA, mentoring junior CRAs, or taking on additional senior-level monitoring responsibilities.
Experience working independently in lean or cross-functional project structures, including studies without a designated Clinical Trial Manager.

Responsibilities

Independently monitor investigational sites using a risk-based approach, identifying compliance gaps and risks and supporting 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 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 medical histories, laboratory results, concomitant medications, adverse events, eligibility assessments, and other clinical documentation.
Assess investigational product accountability through physical inventory and records review.
Identify, document, and escalate safety concerns, protocol deviations, data discrepancies, and study risks; partner with sites and project teams on resolution and follow-up.
Prepare timely and accurate monitoring reports and follow-up letters.
Communicate regularly with investigational sites between visits regarding protocol adherence, outstanding issues, and data entry.
Participate in investigator meetings and collaborate on site identification, qualification, initiation, monitoring, and close-out activities.
Ensure essential documents are complete, accurate, and maintained in accordance with ICH-GCP, applicable regulations, and project requirements; conduct on-site file reviews as required.
Maintain study tracking and monitoring records in CTMS and other applicable platforms.
Facilitate communication among sites, sponsors, and cross-functional teams, particularly about time-sensitive activities and emerging risks.
Support audit and inspection readiness and respond to sponsor, company, and regulatory requirements.
Complete administrative responsibilities such as expense reports and timesheets.
Contribute to project initiatives, process improvements, and knowledge sharing.
Provide guidance or mentoring to less experienced CRAs as appropriate.