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About the Role

Support complex, early-phase clinical trials that advance innovative therapies through critical stages of drug development. As a Clinical Research Associate (CRA) supporting Early Development studies, you will independently perform and coordinate clinical monitoring and site management activities, with a focus on Phase I and clinical pharmacology studies. You'll conduct remote and on-site visits to assess protocol compliance, participant safety, data integrity, and regulatory adherence.

Responsibilities

Independently monitor investigational sites using a risk-based monitoring approach, applying critical thinking, root cause analysis, and problem-solving skills to identify compliance gaps, mitigate risks, and implement corrective and preventive actions.
Conduct site qualification visits, site initiation visits (SIVs), interim monitoring visits (IMVs), and close-out visits (COVs) in accordance with approved monitoring plans, study protocols, and applicable regulatory requirements.
Support Phase I and Early Development studies, including complex clinical pharmacology protocols such as First-in-Human (FIH), Single Ascending Dose (SAD), Multiple Ascending Dose (MAD), and PK/PD studies.
Monitor early-phase study activities with particular attention to participant safety, dose escalation procedures, protocol-defined stopping criteria, dosing requirements, time-sensitive sample collection, and intensive clinical data review.
Perform source data review (SDR), source data verification (SDV), and case report form (CRF) review, as applicable, to ensure data accuracy, completeness, and protocol compliance.
Review relevant clinical documentation, including medical histories, laboratory results, concomitant medications, adverse events, and eligibility assessments.
Assess investigational product accountability through physical inventory and records review, ensuring compliance with protocol-specific dosing and administration requirements.
Identify, document, and escalate safety concerns, protocol deviations, data discrepancies, and other study risks in a timely manner.
Partner with investigational sites and project teams to ensure appropriate resolution and follow-up.
Document monitoring observations through timely, accurate reports and follow-up letters in accordance with approved business writing standards.
Maintain regular communication with investigational sites between monitoring visits to confirm protocol adherence, resolution of outstanding issues, and timely data entry.
Participate in investigator meetings and collaborate with sponsors and internal teams to support site identification, qualification, initiation, ongoing monitoring, and study 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 accurate and timely study tracking, monitoring documentation, and updates within clinical trial management systems (CTMS) and other applicable platforms.
Facilitate effective communication among investigational sites, sponsors, and cross-functional study teams, particularly regarding time-sensitive clinical activities and emerging study risks.
Support audit and inspection readiness and respond to applicable sponsor, company, and regulatory requirements.
Maintain administrative responsibilities, including expense reports, timesheets, and other required documentation.
Contribute to project initiatives, process improvements, and knowledge sharing across the clinical operations team.
May provide guidance or mentoring to less experienced CRAs as appropriate.

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 demonstrated experience conducting site qualification, initiation, interim monitoring, and close-out visits.
Previous Phase I / Early Development clinical monitoring experience is strongly preferred, particularly experience supporting complex early-phase or clinical pharmacology studies.
Approximately 3+ years of Phase I monitoring experience is ideal; however, candidates with less Phase I experience and substantial hands-on exposure to complex early-phase protocols will also be considered.
Direct monitoring experience with multiple early-phase study designs is highly preferred, particularly First-in-Human (FIH), Single Ascending Dose (SAD), and Multiple Ascending Dose (MAD) studies.
Experience with PK/PD, Drug-Drug Interaction (DDI), Food Effect, or Bioavailability/Bioequivalence (BA/BE) studies is also valuable.
Strong medical and scientific knowledge, with demonstrated ability to independently review and interpret clinical source documentation, including medical histories, laboratory results, concomitant medications, adverse events, and eligibility criteria.
Must be based in the Austin, TX area to support the primary investigational site, with flexibility to travel to additional locations as needed.
Valid driver's license where applicable.
Experience monitoring additional clinical pharmacology studies, including 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 (IV), subcutaneous (SC), 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 (CTM).

Skills

Strong clinical and medical terminology knowledge, including the ability to review complex clinical data and identify potential safety, eligibility, and protocol compliance concerns.
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.
Demonstrated ability to independently manage monitoring activities, prioritize competing study requirements, and exercise sound clinical judgment.
Well-developed critical thinking, risk assessment, root cause analysis, and problem-solving skills, with the ability to identify and escalate issues appropriately.
Strong understanding of risk-based monitoring concepts and processes.
Excellent written and verbal communication skills, with the ability to collaborate effectively 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 clinical 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 the ability to learn and effectively utilize clinical trial management systems and other relevant software.
Strong English language and grammar skills.

Location

Austin, Texas area
Las Vegas, NV area

Work Type

Office
Remote
On-site visits
Travel may be required

Experience Level

3-5+ years of independent clinical monitoring experience as a CRA
Approximately 3+ years of Phase I monitoring experience

Education Level

Bachelor's degree in life sciences, nursing, pharmacy, or a related medical/scientific discipline
Equivalent combination of education, training, and relevant experience

About the Company

Successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years.