Clinical Trial Coordinator I/II

🕒 July 31

🌲 North Carolina, Ohio, +1 more states – Remote

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💵 $20 - $27 / hour

⏰ Full Time

🟢 Junior

🚫👨‍🎓 No degree required

🦅 H1B Visa Sponsor

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👻 Ghost score 20%

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Logo of Thermo Fisher Scientific

Thermo Fisher Scientific

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

• Maintain up-to-date participating center information, including contact details, contracts and reports • Prepare Investigator and Sponsor files with essential documents for site initiation • Assist Client study staff with maintaining Sponsor files throughout studies • Archive study documentation at study end according to SOPs, policies and local regulatory requirements • Input and oversee clinical study tracking systems • Identify issues proactively and escalate them for corrective action • Assist with planning, logistics and preparation of local Investigator meetings, including travel arrangements and presentation materials • Manage study materials and IMP/non-IMP supplies, including distribution, ordering, tracking, storage, reconciliation and destruction through an external vendor • Participate in local study meetings and complete assigned tasks • Organize study meetings, schedule travel, produce meeting minutes, assemble training/study materials and update contact details • Maintain study documentation and assist with document preparation and other study-related activities • Keep current with ICH GCP, Client standards and required training • Support multiple studies simultaneously and prioritize work to meet business needs • Communicate and work effectively with senior medical staff, physicians and scientists

🎯 Requirements

• High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification • Bachelor's degree preferred • CTC I: previous experience comparable to 1+ years • CTC II: previous experience comparable to 2+ years • Equivalency may consist of a combination of appropriate education, training and/or directly related experience • Excellent technical/IT skills • Knowledge of relevant operational procedures, systems and quality guidelines regarding clinical studies • Excellent English language and grammar skills and proficient local language skills as needed • Proficient in MS Office (Word, Excel, and PowerPoint) • Ability to obtain knowledge and master clinical trial database systems • Ability to successfully complete the organization’s clinical training program • Basic medical/therapeutic area and medical terminology knowledge • Basic knowledge of local health systems • Working knowledge of ICH GCP, applicable country regulations, and organization/Client SOPs and WPDs • Strong organizational, planning, negotiation, presentation, interpersonal, oral and written communication, analytical, customer-focus, flexibility, adaptability, relationship-building, independent-thinking, and risk-management skills • Ability to work in a matrix environment, independently or in a team

🏖️ Benefits

• Variable annual bonus based on company, team, and/or individual performance results • National medical, dental, and vision plans, including 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 in accordance with company policy • 401(k) U.S. retirement savings plan • Employees’ Stock Purchase Plan (ESPP) with opportunity to purchase company stock at a discount • Reasonable accommodation for individuals with disabilities

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