Assistant CRA – Northeast, Southeast US

🔥 0 minutes ago

🏖️ New Jersey, New York, +2 more states – Remote

🏖️ New Jersey – Remote 🗽 New York – Remote 🦀 Maryland – Remote 🌴 South Carolina – Remote

💵 $58.5k - $75k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

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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

• Complete study and site management activities as defined in the task matrix • Complete and document study-specific training and learn study-specific systems • Provide in-house support during pre-study assessments and waivers • Customize site ICFs with site contact details as needed • Perform remote EMR/EHR checklist reviews and support assessments • Verify document collection and RCR submission status; update site EDL and site information • Review patient-facing materials and translations • Support vendor-related qualification processes for site staff • Ensure system access is requested, granted, and revoked for relevant site staff • Follow up on site staff training • Coordinate logistics for IM attendance and maintain vendor trackers • Coordinate study/site supply management • Support essential document collection, review, and updating in systems • Follow up on missing vendor data, including ECGs, lab samples, and e-diaries • Support ongoing remote review of centralized monitoring tools • Support site payment processes, system updates, reconciliations, and site invoice follow-up • Perform reconciliation tasks for CRF and query status, deviations, SAEs, and safety reports • Verify document collection status and drive action for missing, incomplete, expired, or open documents • Perform other assigned site management tasks and client-requested FSP role profiles • Complete administrative tasks such as expense reports and timesheets

🎯 Requirements

• Completed Bachelor's degree in a life science discipline or related field, or Registered Nursing certification or equivalent relevant formal academic/vocational qualification • Previous experience providing knowledge, skills, and abilities comparable to 0–2 years • Minimum 6 months of clinical trials/clinical research exposure preferred • Candidates must live within 60 miles of a major airport due to future travel requirements • Basic medical/therapeutic area knowledge and medical terminology • Working knowledge of ICH GCP, applicable regulations, and company procedural documents • Effective oral and written communication skills • Excellent interpersonal and customer service skills • Good organizational and time management skills and strong attention to detail • Ability to handle multiple tasks efficiently and effectively • Flexibility and adaptability • Ability to work in a team or independently • Well-developed critical thinking, root cause analysis, and problem-solving skills • Proficient computer skills and good knowledge of MS Office • Ability to learn and use appropriate software and leverage modern technology • Ability to extract pertinent information from study documents, electronic study data systems, CTMS, and dashboards • Excellent English language and grammar skills

🏖️ Benefits

• Variable annual bonus based on company, team, and/or individual performance results • 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 opportunity to purchase company stock at a discount • Fully remote work arrangement