Sr. Clinical Research Associate - Early Phase Studies

Job description

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Join Us as a Clinical Research Associate – Make an Impact at the Forefront of Innovation We have 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. As part of our global Early Development team, you'll have the opportunity to 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. This position will primarily support an investigational site in Austin, Texas, and candidates must be based in the Austin area. While the primary focus will be the Las Vegas site, travel to additional investigational sites in other locations may be required based on business and study needs. This role requires strong clinical knowledge, independent monitoring expertise, and an understanding of the unique complexities of early-phase research, including intensive safety assessments, dose escalation, pharmacokinetic/pharmacodynamic (PK/PD) sampling, and time-sensitive study procedures. Acting as a site processes specialist, you will ensure that clinical trials are conducted in accordance with approved protocols, ICH-GCP guidelines, applicable regulations, and standard operating procedures (SOPs), while safeguarding participant rights, safety, and well-being. You will also ensure audit readiness and develop collaborative relationships with investigational sites, sponsors, and cross-functional study teams. What You'll Do 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. Education and Experience 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. An equivalency consisting of a combination of appropriate education, training, and directly related experience may be considered sufficient to meet applicable educational requirements. Preferred Qualifications The following experience is highly desirable and may differentiate candidates: 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). Knowledge, Skills and Abilities 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 ea