Clinical Research Associate

🔥 7 minutes ago

🍂 Massachusetts – Remote

🍂 Massachusetts – Remote

💵 $100k - $130k / year

⏰ Full Time

🟢 Junior

🟡 Mid-level

🧪 Clinical Research

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 1%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

Apply Now

Find Similar Remote Jobs

Set Up Email Alert For New Jobs

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume

Alira Health

WebsiteLinkedInAll Job Openings

501 - 1000 employees

🏥 Healthcare

🏭 Manufacturing

⚕️ Healthcare Insurance

💰 $58M Venture Round on 2023-01

Healthcare • Manufacturing • Healthcare Insurance

Alira Health is a global consulting firm that partners with life sciences companies to develop innovative solutions in healthcare. The company specializes in a wide range of services including research and clinical development, regulatory compliance, and management consulting. Alira Health focuses on patient engagement, market access, and providing real-world solutions to improve patient outcomes. They are committed to environmental sustainability and actively participate in community involvement and ESG initiatives. Alira Health also provides technology solutions with a focus on improving life sciences research through empathy and scientific excellence.

📋 Description

• Conduct site monitoring responsibilities for clinical trials • Provide oversight, leadership, and guidance in the management and execution of clinical trials • Ensure protocol compliance and quality • Work with Lead CRAs, Senior CRAs, in-house CRAs, Associate Director of Clinical Monitoring, and Project Managers • Provide guidance, oversight, and feedback to the CRA team regarding project scope, SOPs, timelines, and budgets • Review monitoring visit reports and conduct co-monitoring and evaluation visits • Ensure appropriate and timely investigator site visits • Coordinate cross-functional departments to resolve clinical trial monitoring issues • Assist with study-specific Monitoring Plans and training presentations • Set up and collect site-specific ethics documents and assist with site contract negotiation • Provide monthly billing information to the finance team • Manage study budgets and act as sponsor referent for stand-alone projects • Perform qualification, initiation, interim, and close-out visits remotely and onsite • Prepare accurate and timely monitoring visit reports • Review source documents and verify CRF data integrity • Perform quality control and verification of eTMF/TMF documents • Conduct investigational product accountability • Review site regulatory binders • Maintain contact with study sites, assess patient accrual, and respond to sponsor requests • Ensure compliance with ICH GCP, FDA regulations, and company/sponsor SOPs • Facilitate adverse event reporting and reconcile SAE reports with source documentation and CRFs • Resolve discrepant data queries with in-house CRAs/CTC and data management • Identify site issues and develop problem-solving strategies • Conduct audit preparation at study sites • Assist with CRA onboarding, training, and mentoring • Collaborate on the development and maintenance of the Clinical Trial Management System (CTMS) • Manage conflicting priorities and perform additional assigned duties

🎯 Requirements

• 2+ years monitoring experience required • Ability to establish and maintain positive relationships with Sponsor, Site and Project Team members • Ability to autonomously manage monitoring activities • Quality focused; careful, thorough, and detail-oriented • Strong organizational skills and ability to multi-task in a fast-paced environment • Ability to manage priorities, organize time, and solve problems • Strong analytical, negotiation, meeting management, cross-functional team, and leadership skills • Ability to travel • Ability to manage stress • Professional, trustworthy, and disciplined • Ability to problem-solve unstructured or ambiguous challenges • Strong command of the local language, written and verbal, in the country where monitoring activities are performed • Excellent communication and interpersonal skills with customer service orientation • Good computer skills, including clinical trial management systems, clinical trial databases, and electronic data capture • Self-starter able to thrive in a collaborative, less structured team environment • Knowledge of clinical research, ICH GCP, and local regulations • Knowledge of regulatory and ethical requirements • English language • Bachelor of Science (BS) in Biology or Life Sciences

🏖️ Benefits

• Remote and onsite work options for monitoring visits • Regular employment contract • Global, collaborative work environment • Opportunities for CRA mentoring and training • Professional development through participation in internal, client/sponsor, scientific, and other meetings