Research Assistant II – Safety

CPC

Research Assistant II supporting safety management operations for clinical trials. Handling administrative tasks and collaborating with team members to ensure smooth project delivery.

Posted 7/16/2026full-timeRemote • Colorado • 🇺🇸 United StatesJunior💰 $21 - $24 per hourWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates proficiency in clinical research support, including data management, report generation, and adherence to Good Clinical Practice guidelines. Capable of effective communication and collaboration within project teams to ensure timely completion of deliverables.

Highest-signal resume keywords

Clinical Research ExperienceGood Clinical Practice KnowledgeMS Office ProficiencyData Entry and VerificationUser Acceptance Testing (UAT)

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Data EntryReport GenerationDocument PreparationQuery ManagementEndpoint Testing Tracking

Soft Skills

Excellent CommunicationOrganizational SkillsAttention to DetailConflict ManagementTeam Collaboration

Certifications & Qualifications

GEDHS DiplomaNursing DegreeMedical Assistant CertificationC.N.A Certification

Industry Keywords

Clinical TrialsFDA RegulationsICH RegulationsDrug Development ProcessTrial Master File

About the role

Key responsibilities & impact

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

What you’ll need

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

Comp & perks

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