Research Assistant II – Safety

Job not on LinkedIn

🔥 0 minutes ago

⛰️ Colorado – Remote

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💵 $20 - $24 / hour

⏰ Full Time

🟢 Junior

🧬 Research Scientist

🚫👨‍🎓 No degree required

🦅 H1B Visa Sponsor

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Logo of CPC

CPC

51 - 200 employees

🔧 Hardware

☁️ SaaS

IT Services • Hardware • SaaS

CPC is a trusted tech partner that specializes in IT support and IT services, providing a wide range of solutions including sales and maintenance of new, used, and factory recertified computer hardware and software. Established in 1962, CPC leverages a deep bench of engineers and consultants to offer innovative and efficient IT solutions tailored to both businesses with or without internal IT departments. With a focus on value, innovation, reputation, and excellence, CPC supports various industries including remote work, healthcare, and manufacturing, ensuring businesses stay up, running, and protected. The company partners with leading tech brands such as Citrix, IGEL, LG, Nutanix, Arctic Wolf, NoMachine, Zebra Technologies, and DELL, and offers both new and refurbished equipment. CPC is committed to enhancing business operations through effective IT solutions and services.

📋 Description

• Support administrative aspects of safety management such as: Data entry and verification • Manage and respond to project related emails • Accurate and timely delivery of information to other project team members • Generate and distribute reports to relevant project team members • Assist in the preparation of Master Plans, Resource Materials, Source Documentation, Meeting Minutes, and submission of documents to the Trial Master File. • Correspond with investigational sites, CPC staff and sponsors to rectify data queries and collect outstanding documentation. • Assist in tracking receipt, entry, upload, reviews and feedback to investigational sites of endpoint testing. • Assist with the printing, collation and distribution of study materials to project team members, sponsors and sites. • Assist with query management. • Assist with User Acceptance Testing (UAT) and manage user access requests (including user reconciliation). • Work closely with other team members to ensure timely completion of deliverables and resolution of issues. • Participate in project, program, functional area and general CPC meetings as required. • Adhere to CPC SOPs, Good Clinical Practice guidelines and applicable federal, state and local regulations. • Serve as a study coordinator for select projects as needed. • Additional activities as required.

🎯 Requirements

• GED or HS Diploma required. • Nursing or bachelor’s degree preferred. • Minimum of 1 years of experience working in a clinical research (or similar) setting. • Higher degree may be considered in lieu of experience. • Medical Assistant/C.N.A background a plus! • Demonstrated ability to complete core tasks with minimal direction, while reliably escalating for guidance on less routine assignments. • Thorough knowledge of the Good Clinical Practice guidelines and the applicable FDA and ICH regulations for conducting clinical drug trials. • Good understanding of the drug development process. • Proficiency in MS Office, particularly spreadsheet databases and word-processing. • Excellent communication and organizational skills. • Great attention to detail • Ability to work with others in a manner that promotes group effort and achievement. • Ability to shift priorities quickly while ensuring accuracy and timely completion of tasks. • Ability to manage conflicts and resolve problems effectively. • Ability to discern priorities and obtain direction to accomplish day-to-day tasks.

🏖️ Benefits

• Comprehensive benefits package (medical, dental, vision, life, STD, LTD etc.) • Matching 401(k) plan (dollar for dollar up to 4% of your eligible compensation, fully vested immediately) • 10 paid holidays • 15 - 25 vacation days based on years of service • Paid sick time (2.67 hours accrued bi-weekly up to a maximum of 80 hours) • In-suite exercise and relaxation room • Monthly fun events (e.g. team building activities, games, charitable events, potlucks, picnics) • Flexible and remote work schedules

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