Clinical Research Associate

🔥 7 minutes ago

🍂 Massachusetts – Remote

🍂 Massachusetts – Remote

⏱ Part Time

🟢 Junior

🟡 Mid-level

🧪 Clinical Research

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 11%

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 to ensure compliance and quality • 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 as needed • 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 • Assist with ethics document collection and site contract negotiation • Provide monthly billing information to finance • 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 and verify source documents and CRF data • Perform quality control and verification of eTMF/TMF documents • Conduct investigational product accountability • Review site regulatory binders • Maintain contact with study sites regarding protocol/GCP compliance, patient accrual, and sponsor requests • Ensure compliance with ICH GCP, FDA regulations, and company/sponsor SOPs • Participate in internal, client/sponsor, scientific, and other meetings • Facilitate adverse event reporting and reconcile SAE reports with source documentation and CRFs • Collaborate with in-house CRAs/CTC and data management to resolve discrepant data queries • Identify site issues and develop problem-solving strategies • Conduct audit preparation at study sites as needed • Collaborate with other CRAs to maintain consistency and teamwork • Assist with CRA new hire training and onboarding • Mentor CRAs • Collaborate on Clinical Trial Management System (CTMS) development and maintenance • Manage conflicting priorities and deliver commitments • Perform additional assigned duties

🎯 Requirements

• EU: Graduation in a scientific health field • EU (Italy): Certified Monitor in compliance with Italian CRO decree dated 15Nov2011 • Ability to establish and maintain positive relationships with Sponsor, Site and Project Team members • Ability to autonomously manage monitoring activities • Quality focused; Proven ability to be careful, thorough, and detail-oriented • Strong organizational skills and the ability to multi-task and work effectively in a fast-paced environment • Able 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 Local language, both written and verbal, in the country where monitoring activities are performed • Excellent communication and interpersonal skills with customer service orientation • Good computer skills, with ability to use clinical trial management systems, clinical trial databases and electronic data capture • Self-starter who thrives in a collaborative, yet less structured team environment • Knowledge of clinical research, ICH GCP and local regulations • Knowledge of Regulatory and Ethical requirements • EU: Adequate English • Bachelor of Science (BS) in Biology or Life Sciences

🏖️ Benefits

• Remote work arrangement • Part-time employment • Contingency Workforce contract type