Research Assistant II

CPC Clinical Research; Aurora (CO); Remote; USD 45,000 - 65,000; Full time

Benefits offered by this job

Comprehensive benefits package

Matching 401(k) up to 4%

11 paid holidays

15-25 vacation days based on service

Paid sick time

Flexible and remote work schedules

Job summary

CPC Clinical Research is seeking a proactive Clinical Research Support professional in Colorado to assist across research operations, data management, and trial documentation. You will upload documents to the eTMF, perform ALCOA+ checks, and help prepare Master Plans and Meeting Minutes for Trial Master File submissions.

You will coordinate with investigational sites and CPC staff, manage data queries, and support user testing and access requests.

Qualifications

• GED or HS Diploma required; Nursing or bachelor’s degree preferred.
• Minimum of 1 year of experience in a clinical research (or similar) setting.
• Thorough knowledge of Good Clinical Practice guidelines and FDA/ICH regulations.
• Proficiency in MS Office, particularly spreadsheets and word-processing.
• Excellent communication and organizational skills.
• Great attention to detail.
• Ability to shift priorities quickly while ensuring accuracy.
• Ability to manage conflicts and resolve problems.
• Ability to discern priorities and obtain direction for day-to-day tasks.

Responsibilities

• Serve as a floating resource to perform activities in support of projects and programs.
• Provide assistance to Research Operations, Endpoint and Specialty Services, Site Operations, Data Management, Quality Control, and Trial Master File as needed.
• Work with team members to ensure timely deliverables and issue resolution.
• Perform general administrative tasks and prepare shipments for projects.
• Upload essential documents into the eTMF system and perform ALCOA+ checks.
• Participate in CPC meetings as required.
• Assist in Master Plans, Resource Materials, Source Documentation, and Meeting Minutes submissions to the Trial Master File.
• Coordinate and track receipt of project supplies to study sites.
• Assist in tracking endpoint testing data, training, and email reconciliation.
• Manage user access requests and perform data review in EDC systems.

Skills

Attention to detail

Excellent communication

Organizational skills

Team collaboration

Prioritization

Conflict resolution

Direction seeking

Education

HS Diploma

Bachelor or nursing degree preferred

Tools

MS Office

Job description

Responsibilities

• Serve as a floating resource to perform a variety of activities in support of the execution and management of projects and programs.
• Based on business needs, may provide assistance to the following functional areas:

• Research Operations
• Endpoint and Specialty Services
• Site Operations
• Data Management
• Quality Control
• Trial Master File

• Work closely with other team members to ensure timely completion of deliverables and resolution of issues.
• Perform a variety of general administrative tasks such as filing, copying, and preparation of shipments for assigned projects.
• Upload essential documents into eTMF system.
• Perform quality control reviews of project-specific documentation and support submission of documents to the Trial Master File.
• Perform ALCOA+ checks of documents uploaded into eTMF system.
• Participate in project, program, functional area and general CPC meetings as required.
• Assist in the preparation of Master Plans, Resource Materials, Source Documentation, Meeting Minutes, and submission of documents to the Trial Master File.
• Coordinate and track receipt of project supplies to study sites
• Assist in tracking receipt, entry, upload, reviews and feedback to investigational sites of endpoint testing.
• Assist in the development, administration, and tracking of project specific training.
• Manage email reconciliation and export at study close-out.
• Collect and review investigational site documentation and process as directed.
• Correspond with investigational sites, CPC staff and sponsors to rectify data queries and collect outstanding documentation.
• Serve as one of the primary points of contact for investigational sites.
• Perform query management, report generation, and data reconciliation tasks.
• Assist with User Acceptance Testing (UAT)
• Manage user access requests (including user reconciliation).
• Perform general data review of study data in EDCs

Qualifications

• 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.
• 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.

Posting deadline: This posting will remain open until filled. For best consideration, please apply by September 29, 2026.

CPC offers

• 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)
• 11 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)
  
• Flexible and remote work schedules

An Equal Opportunity Employer

CPC is dedicated to the principles of equal employment opportunity (EEO). CPC prohibits unlawful discrimination against applicants or employees on the basis of age 40 and over, race (including traits historically associated with race, such as hair texture and length, protective hairstyles), sex, sexual orientation, gender identity, gender expression, color, religion, creed, national origin, ancestry, disability, military status, genetic information, marital status, or any other status protected by applicable state or local law. It is our intention that all qualified applicants are given equal opportunity and that selection decisions be based on job-related factors.

Applicants with disabilities may be entitled to reasonable accommodation under the Americans with Disabilities Act (ADA) and certain state or local laws. If you need assistance, please email our Human Resources team [e-mail].