Research Assistant I
CPC Clinical Research - Aurora, CO
posted 1 day ago
About the position
We are looking for a Research Assistant I to join our team! In this position you will 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, you may provide assistance to the following functional areas: Research Operations, Community Health, Endpoint and Specialty Services, Site Operations, Data Management, Quality Control, and Trial Master File. You will assist in the preparation of Master Plans, Resource Materials, Source Documentation, Meeting Minutes, and submission of documents to the Trial Master File. Additionally, you will assist in the administration and tracking of project-specific training, correspond with investigational sites, CPC staff and sponsors to rectify data queries and collect outstanding documentation, and assist in tracking receipt, entry, upload, reviews and feedback to investigational sites of endpoint testing. You will also assist with the printing, collation and distribution of study materials to project team members, sponsors and sites, manage query management, assist with User Acceptance Testing (UAT) and manage user access requests, and work closely with other team members to ensure timely completion of deliverables and resolution of issues. Participation in project, program, functional area and general CPC meetings as required is also expected. You will adhere to CPC SOPs, Good Clinical Practice guidelines and applicable federal, state and local regulations, and serve as a study coordinator for select projects as needed. Additional activities may be required.
Responsibilities
- Serve as a floating resource to perform a variety of activities in support of the execution and management of projects and programs.
- Assist in the preparation of Master Plans, Resource Materials, Source Documentation, Meeting Minutes, and submission of documents to the Trial Master File.
- Assist in the administration and tracking of project-specific training.
- 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.
- 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.
- Perform additional activities as required.
Requirements
- GED or HS Diploma required; Nursing or bachelor's degree preferred.
- Minimum of 1 year of experience working in a clinical research setting or commensurate experience.
- Basic knowledge of the Good Clinical Practice guidelines and the applicable FDA and ICH regulations for conducting clinical drug trials.
- Basic understanding of the drug development process.
- Proficiency in MS Office, particularly spreadsheet databases and word-processing.
- Good 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 follow 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)
- 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)
- In-suite exercise and relaxation room
- Monthly fun events (e.g. team building activities, games, charitable events, potlucks, picnics)
- Flexible and remote work schedules
