Research Assistant I

This is a fully remote position, open to applicants in United States.

📋 Description

• Act as a versatile resource to engage in various tasks that support the execution and management of projects and programs.

• Provide support to Research Operations, Community Health, Endpoint and Specialty Services, Site Operations, Data Management, Quality Control, and Trial Master File according to business requirements.

• Assist in the preparation of Master Plans, Resource Materials, Source Documentation, Meeting Minutes, and the submission of documents to the Trial Master File.

• Help in administering and monitoring project-specific training.

• Communicate with investigational sites, CPC personnel, and sponsors to address data inquiries and gather outstanding documentation.

• Track the receipt, entry, upload, review, and provision of feedback to investigational sites regarding endpoint testing.

• Print, organize, and distribute study materials to project team members, sponsors, and sites.

• Support query management efforts.

• Assist in User Acceptance Testing (UAT) and manage user access requests, including user reconciliation.

• Collaborate closely with team members to fulfill deliverables and resolve issues.

• Participate in project, program, functional area, and general CPC meetings as necessary.

• Comply with CPC Standard Operating Procedures, Good Clinical Practice guidelines, and relevant federal, state, and local regulations.

• Serve as a study coordinator for specific projects as required.

• Execute additional tasks as needed.

⛳️ Requirements

• GED or high school diploma is required; a nursing or bachelor's degree is preferred.

• At least 1 year of experience in a clinical research environment or equivalent experience is necessary.

• Fundamental understanding of the Good Clinical Practice guidelines and applicable FDA and ICH regulations for conducting clinical drug trials.

• Basic knowledge of the drug development process.

• Proficient in MS Office, especially in spreadsheet databases and word-processing applications.

• Strong communication and organizational abilities.

• Excellent attention to detail.

• Capable of collaborating with others in a way that fosters group effort and success.

• Ability to swiftly adjust priorities while maintaining accuracy and timely completion of tasks.

• Skilled in conflict management and effective problem resolution.

• Competent in following directions to execute daily responsibilities.

• Eligible candidates must pass a background and education verification check.

🏝️ Benefits

• Comprehensive benefits package including medical, dental, vision, life insurance, short-term disability, and long-term disability.

• Matching 401(k) plan with dollar-for-dollar matching up to 4% of eligible compensation, fully vested immediately.

• 11 paid holidays each year.

• 15 to 25 vacation days depending on years of service.

• Paid sick leave, accruing at 2.67 hours bi-weekly up to a maximum of 80 hours.

• Flexible work schedules with remote options available.