Assistant CRA – Northeast/Southeast

🔥 1 minute ago

🏄 California – Remote

🏄 California – Remote

💵 $58.5k - $80k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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Thermo Fisher Scientific

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1956

🏥 Healthcare

📦 Logistics

🏭 Manufacturing

Healthcare • Logistics • Manufacturing

Thermo Fisher Scientific is the world leader in serving science, with annual revenue of more than $40 billion. Their mission is to enable customers to make the world healthier, cleaner, and safer by supporting life sciences research, solving complex analytical challenges, increasing laboratory productivity, and improving patient health through diagnostics and the development of life-changing therapies. With a global team, they offer innovative technologies and pharmaceutical services through brands such as Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD.

📋 Description

• Perform remote activities on assigned projects in liaison with the CRA and study Clinical Lead • Support site preparedness and logistical monitoring processes • Assist with site management and remote monitoring according to SOPs and regulatory guidelines • Perform limited site contact activities during study start-up, site management, recruitment, and close-out • Complete study and site management activities defined in the task matrix • Complete study-specific training and orientation on study systems • Provide in-house support for pre-study assessments and waivers • Customize site ICFs with site contact details • Review EMR/EHR checklists remotely • Verify document collection, RCR submission status, site EDL, and site information • Review patient-facing materials and translations • Support vendor qualification, system access, site staff training, IM attendance, vendor trackers, and study/site supplies • Support essential document collection, review, and updating • Follow up on missing vendor data, including ECGs, lab samples, and e-diaries • Support remote review of centralized monitoring tools • Support site payment processes, system updates, reconciliations, and invoice follow-up • Perform trial reconciliations involving CRF/query status, deviations, SAEs, and safety reports • Drive action for missing, incomplete, expired, or open documents • Complete administrative tasks including expense reports and timesheets

🎯 Requirements

• Bachelor's degree in a life science discipline or related field, or Registered Nursing certification, or equivalent relevant formal academic/vocational qualification • Previous experience comparable to 0 to 2 years • Equivalency may consist of appropriate education, training, and/or directly related experience • Basic medical/therapeutic area knowledge and medical terminology • Working knowledge of ICH GCP, applicable regulations, and company procedural documents • Proficient computer skills and good knowledge of MS Office • Ability to learn and use appropriate software • Ability to extract information from study documents, electronic study data systems, CTMS, and dashboards • Excellent English language and grammar skills • Ability to handle multiple tasks efficiently and effectively • Occasional travel to clinics/hospitals may be required

🏖️ Benefits

• Variable annual bonus based on company, team, and/or individual performance • National medical and dental plans • National vision plan • Health incentive programs • Employee assistance and family support programs • Commuter benefits • Tuition reimbursement • At least 120 hours paid time off (PTO) • 10 paid holidays annually • Paid parental leave: 3 weeks for bonding and 8 weeks for caregiver leave • Accident and life insurance • Short- and long-term disability • 401(k) U.S. retirement savings plan • Employees’ Stock Purchase Plan (ESPP) with discounted company stock • Fully remote work arrangement