Sr. Clinical Research Associate - Early Phase Studies

Thermo Fisher Scientific•Austin, TX

About The Position

The Senior Clinical Research Associate (CRA) independently performs and coordinates clinical monitoring and site management activities for Early Development studies, with a focus on Phase I and clinical pharmacology trials. The role involves remote and on-site monitoring to assess protocol compliance, participant safety, data integrity, and regulatory adherence. It supports complex early-phase studies involving intensive safety assessments, dose escalation, PK/PD sampling, and time-sensitive procedures. As a site processes specialist, the CRA ensures trials are conducted in accordance with approved protocols, ICH-GCP guidelines, applicable regulations, and standard operating procedures, while safeguarding participant rights, safety, and well-being. The position also supports audit readiness and collaborative relationships with investigational sites, sponsors, and cross-functional study teams. The posting contains conflicting location details: it initially states that the primary investigational site is in Austin, Texas and candidates must be Austin-based, while later sections identify the primary site as Las Vegas, Nevada and require candidates to be based in the Las Vegas area. Travel to additional sites may be required, including overnight travel. Work may take place in office, laboratory, clinical, and/or home-office environments.

Requirements

Bachelor's degree in life sciences, nursing, pharmacy, or a related medical or 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 and the ability to independently review and interpret clinical source documentation, including medical histories, laboratory results, concomitant medications, adverse events, and eligibility criteria.
Based in the required site area; the posting identifies both Austin, Texas and Las Vegas, Nevada as the required location in different sections.
Flexibility 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, safety monitoring, stopping criteria, dosing procedures, PK/PD sampling, and high-volume source data review.
Ability to independently manage monitoring activities, prioritize requirements, and exercise sound clinical judgment.
Critical thinking, risk assessment, root cause analysis, and problem-solving skills, including appropriate escalation of issues.
Understanding of risk-based monitoring concepts and processes.
Strong written and verbal communication, interpersonal, relationship management, and customer-focused skills.
Excellent organizational skills, attention to detail, and ability to manage multiple priorities in fast-paced, 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 clinical trial management systems and other relevant software.
Strong English language and grammar skills.

Nice To Haves

Phase I or Early Development monitoring experience, particularly with complex early-phase or clinical pharmacology studies; approximately 3+ years of Phase I monitoring experience is ideal.
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 in 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 to identify compliance gaps and risks, conduct root cause analysis, and implement corrective and preventive actions.
Conduct site qualification, site initiation, interim monitoring, and close-out visits in accordance with monitoring plans, study 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 in early-phase studies.
Perform source data review, source data verification, and case report form review, and review clinical documentation including medical histories, laboratory results, concomitant medications, adverse events, and eligibility assessments.
Assess investigational product accountability through physical inventory and records review.
Identify, document, and escalate safety concerns, protocol deviations, data discrepancies, and other study risks; coordinate their resolution and follow-up.
Prepare timely and accurate monitoring reports and follow-up letters.
Communicate regularly with investigational sites between visits to confirm protocol adherence, issue resolution, and 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 in accordance with ICH-GCP, regulations, and project requirements; conduct on-site file reviews as needed.
Maintain study tracking and monitoring documentation in clinical trial management systems and other applicable platforms.
Facilitate communication among sites, sponsors, and cross-functional study teams, especially regarding time-sensitive activities and emerging risks.
Support audit and inspection readiness and respond to sponsor, company, and regulatory requirements.
Complete administrative tasks 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.