Research Assistant II

CPC Clinical Research

Aurora, CORemote OKFull time
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Pay
$21 to $24
an hour
Location
Aurora, CO
Work style
Remote OK
Job type
Full time
Posted
Oct 23
1 day ago
Career path

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About the company

CPC Clinical Research

Research Services · 51 to 200 employees

Founded in 1989 by the University of Colorado, CPC has two divisions. CPC Clinical Research is an academically led, non-profit, clinical research organization offering Phase 1 - 4 clinical research leadership and management services to sponsors around the world. CPC Clinical Research specializes in innovative research including a proprietary program, the Endpoint Quality Intervention Program (EQuIP), that helps reduce variability in the collection of endpoint data, allowing more definitive answers to the study objectives.

CPC Community Health creates innovative and educational programs to implement established cardiovascular prevention national guidelines and best evidence in Colorado communities resulting in improved cardiovascular health.

CPC is affiliated with the University Of Colorado School Of Medicine, Denver Health and the National Jewish Health. CPC is also the clinical trials arm of the University of Colorado Charles C Gates Center for Regenerative Medicine & Stem Cell Biology whose goal is to understand the biology of stem cells in order to develop new therapies for debilitating diseases such as heart diseases and vascular diseases.

CPC CLINICAL RESEARCH MISSION

To unite academic leadership with operational expertise to optimize the quality of clinical research and improve health.

CPC COMMUNITY HEALTH MISSION

Our mission is to improve the health of all Coloradans by creating innovative community health programs that deliver evidence-based interventions.

Visit us at www.cpcmed.org and www.communityhealth.org

CPC Clinical Research on LinkedIn

What you'll do

  • The Research Assistant II serves as a floating resource to support project execution, including data management, quality control, and Trial Master File maintenance.
  • They act as a primary point of contact for investigational sites, managing documentation, data queries, and study close-out activities.

What you need

  • Candidates must have a GED or high school diploma, with a nursing or bachelor's degree preferred.
  • A minimum of one year of experience in a clinical research setting and knowledge of Good Clinical Practice (GCP) guidelines are required.
  • Education: a high school diploma or a bachelor's degree

Key skills

Clinical researchData managementQuality controlTrial master fileALCOA+ documentationQuery managementData reconciliationUser acceptance testingGood clinical practiceFDA regulationsICH regulationsMS OfficeCommunication skillsOrganizational skillsAttention to detailConflict resolution

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Perks

  • Medical insurance
  • Dental insurance
  • Vision insurance
  • Life insurance
  • Short-term disability
  • Long-term disability
  • 401(k) matching
  • Paid holidays
  • Paid vacation
  • Paid sick time
  • Flexible work schedules
  • Remote work

See full description on company page, apply now

Read the full posting here
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 October 28, 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 at careers@cpcmed.org.

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