Clinical Research Associate II – FSP

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $91.5k - $137.3k / year

⏰ Full 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

Precision Medicine Group

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 2012

💼 Consulting

🏥 Healthcare

📦 Logistics

💰 $35.2M Venture Round on 2021-03

Consulting • Healthcare • Logistics

Precision Medicine Group is a global team of experts that specializes in precision medicine, which combines advanced lab sciences, translational informatics, regulatory affairs, payer insights, and marketing communications. The company focuses on overcoming product development and commercialization challenges for pharmaceutical and life sciences clients. Their services include biomarker-driven research and development, as well as commercialization support for life science organizations from launch to product maturity. Precision Medicine Group operates through two main arms: Precision for Medicine and Precision AQ, specializing in clinical and commercial solutions respectively.

📋 Description

• Oversee all aspects of study site management to protect patient safety and ensure high-quality data • Provide guidance on audit readiness and support audit preparation and follow-up actions • Maintain study-specific trial management tools, systems and status reports • Manage site start-up procedures, including investigator feasibility and recruitment, EC/IRB submissions, regulatory document collection, informed consent review, notifications, translations and meetings as required • Assist with study budget negotiations and investigator contract execution • Verify informed consent processes and assess subject safety, protocol deviations and pharmacovigilance issues • Independently conduct pre-study, qualification, initiation, routine monitoring and close-out site visits • Prepare timely monitoring reports and maintain confirmation letters, follow-up letters, trip reports and communication logs • Support subject recruitment, retention and awareness strategies • Review Investigator Site Files and reconcile them with Trial Master Files • Communicate protocol and study issues to site personnel and Precision project and clinical trial management teams • Maintain effective relationships with investigators and study staff • Manage investigational product inventory, reconciliation, storage, security, dispensing and administration verification • Perform remote EDC CRF and patient profile reviews, resolve queries and assist with data discrepancy resolution • Identify and process Serious Adverse Events according to study procedures • Identify site risks, escalate them and own timely resolution with minimal support • Attend investigator, sponsor, global monitoring and clinical training meetings • Travel as required by project needs • Perform other duties assigned by management

🎯 Requirements

• 4-year college degree or equivalent experience in a scientific or healthcare discipline • Two (2) years or more as a CRA in a CRO or equivalent, relevant experience and/or demonstrated competencies • Site management or equivalent experience in clinical research • Excellent communication and organizational skills • Client-focused approach • Experience using computerized information systems, electronic spreadsheets, word processing and electronic mail • Ability to travel overnight, up to 60% on average based on regional requirements • International travel as needed • Fluency in English and, for non-English-speaking countries, the local language of the country where the position is based • Graduate or postgraduate degree preferred • Lupus monitoring experience preferred • Experience monitoring in rare and complex therapeutic areas preferred • Experience monitoring EDC trials and EHR records preferred • Experience in biopharma or relevant therapeutic area preferred • Relevant site start-up experience preferred • Ability to monitor study sites according to protocol monitoring guidelines, SOPs, GCP and ICH guidelines preferred • Ability to resolve project-related problems and prioritize workload to meet deadlines with minimal management support preferred • Candidates must be legally authorized to work in the country of employment without employer sponsorship

🏖️ Benefits

• Paid time off • Volunteer time off • Robust medical offerings • Non-vested 401(k) with company match • Paid parental leave • Discretionary annual bonus • Health insurance • Retirement savings benefits • Life insurance • Disability benefits • Paid time off for sick leave and vacation