Clinical Research Associate

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $112.2k - $168.2k / year

⏰ Full Time

🟢 Junior

🟡 Mid-level

🧪 Clinical Research

👻 Ghost score 0%

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AstraZeneca

WebsiteLinkedInAll Job Openings

10,000+ employees

💊 Pharmaceuticals

🧬 Biotechnology

🏥 Healthcare

Pharmaceuticals • Biotechnology • Healthcare

AstraZeneca is a global biopharmaceutical company focused on discovering, developing and manufacturing prescription medicines. The company emphasizes scientific research and innovation, with large-scale R&D and global business operations aimed at transforming healthcare for people, society and the planet.

📋 Description

• Serve as AstraZeneca’s representative at investigative sites • Qualify and select investigators • Manage study start-up activities, document preparation, ethics/regulatory submissions, and site initiation • Ensure site teams complete required training and remain inspection-ready • Plan and conduct remote and onsite monitoring visits • Perform source data verification/review and remote data checks • Use Site Quality Risk Assessments to adjust monitoring intensity • Maintain accurate entries in CTMS and other systems • Resolve data queries with data management • Prepare monitoring reports and follow-up letters • Collect and quality-check essential documents in the eTMF • Ensure prompt and accurate Serious Adverse Event reporting and follow-up • Verify protocol adherence and safeguard participant rights, privacy, and wellbeing • Track and drive enrollment and retention • Identify risks and issues, implement corrective and preventive actions, escalate concerns, and follow through to resolution • Manage study supplies and the Investigator Site File • Oversee investigational product accountability and preparation for destruction where applicable • Adhere to ICH-GCP, local regulations, and AstraZeneca procedures • Prepare sites for and collaborate during audits and regulatory inspections • Engage with the Local Study Team and investigators • Contribute to investigator meetings and communicate progress and insights • Share site intelligence that informs strategy • Collaborate with cross-functional colleagues • Champion efficient, cost- and time-optimized delivery of quality clinical trials

🎯 Requirements

• Bachelor’s degree in a related discipline, preferably in life science, or equivalent qualification • Knowledge of the drug development process • Knowledge of international ICH-GCP guidelines • Knowledge of relevant country regulations • Medical knowledge and ability to learn relevant AstraZeneca therapeutic areas • Knowledge of clinical study management, including monitoring, study drug handling, and data management • Fluency in written and spoken business-level English • Ability to work effectively in person and virtual team settings • Cultural awareness • Ability to identify and champion efficient clinical-trial delivery with optimized cost and time • Ability to travel nationally/internationally as required • Valid driving license, if a country employment requirement • Risk-based thinking, strategic thinking, problem solving, critical thinking, decision making, and issue management • Ability to interpret and implement clinical study protocols • Ability to adhere to participant rights, privacy, and wellbeing requirements • Knowledge of clinical study operations, GCP, and quality management • Audit and inspection readiness knowledge • Risk-based quality management, monitoring-plan implementation, and source data verification/review • Recruitment and retention planning and execution

🏖️ Benefits

• Short-term incentive bonus opportunity • Equity-based long-term incentive program eligibility for salaried roles • Retirement contribution for hourly roles • Qualified retirement program (401(k) plan) • Paid vacation and holidays • Paid leaves • Medical coverage • Prescription drug coverage • Dental coverage • Vision coverage • Flexible benefits offering • Opportunities for personal development and career growth • Modern tools • Inclusive and equitable work environment • Disability and special-needs accommodations