Sr. Clinical Research Associate - Early Phase Studies

Thermo Fisher Scientific•Austin, TX

About The Position

The Sr. Clinical Research Associate (CRA) independently performs and coordinates clinical monitoring and site management activities for Phase I and other Early Development studies, particularly clinical pharmacology studies. The CRA conducts remote and on-site visits to assess protocol compliance, participant safety, data integrity, and regulatory adherence, and ensures trials follow approved protocols, ICH-GCP guidelines, applicable regulations, and standard operating procedures. The position emphasizes the complexities of early-phase research, including intensive safety assessments, dose escalation, PK/PD sampling, and time-sensitive study procedures. The CRA supports audit readiness and develops collaborative relationships with investigational sites, sponsors, and cross-functional study teams. The posting gives conflicting location information: its description initially identifies Austin, Texas, while its working conditions specify Las Vegas, Nevada, as the required base and primary site. Regular travel to the primary site and possible travel to other locations, including overnight travel, are required.

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 CRA clinical monitoring experience, including site qualification, initiation, interim monitoring, and close-out visits.
Strong medical and scientific knowledge and ability to independently review and interpret source documents, including medical histories, laboratory results, concomitant medications, adverse events, and eligibility criteria.
Must be based in the Austin, TX area, according to the Education and Experience Requirements section; the Working Conditions section instead specifies Las Vegas, NV.
Valid driver's license where applicable.
Thorough knowledge of ICH-GCP, applicable regulations, SOPs, and clinical monitoring requirements.
Knowledge 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 identification and escalation.
Understanding of risk-based monitoring concepts and processes.
Strong written and verbal communication, interpersonal, and relationship-management skills for collaboration with sites, medical personnel, sponsors, and cross-functional teams.
Strong organizational skills, attention to detail, and ability to manage multiple priorities in a fast-paced, time-sensitive environment.
Ability to work independently with minimal oversight and contribute effectively to collaborative teams.
Flexibility and adaptability to changing priorities, operational needs, and complex clinical scenarios.
Proficiency in Microsoft Office and ability to learn and use clinical trial management systems and related software.
Strong English language and grammar skills.
An equivalent combination of appropriate education, training, and directly related experience may satisfy applicable educational requirements.

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 in dedicated Phase I units 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 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 protocols, 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 as applicable to ensure accuracy, completeness, and protocol compliance.
Review medical histories, laboratory results, concomitant medications, adverse events, eligibility assessments, and other clinical documentation.
Assess investigational product accountability through inventory and records review, including protocol-specific 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, accurate monitoring reports and follow-up letters according to business writing standards.
Communicate with investigational sites between visits regarding protocol adherence, outstanding issues, 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 teams, particularly about 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.