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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates proficiency in clinical research operations, including adherence to Good Clinical Practice guidelines and effective communication with investigational sites and sponsors. Capable of managing project-specific training and documentation while ensuring compliance with federal and state regulations.
Highest-signal resume keywords
Clinical Research ExperienceGood Clinical Practice KnowledgeMS Office ProficiencyProject CoordinationData Management
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Clinical ResearchData ManagementUser Acceptance TestingDocumentation PreparationQuery Management
Soft Skills
Communication SkillsOrganizational SkillsAttention to DetailConflict ResolutionTeam Collaboration
Certifications & Qualifications
GEDHS DiplomaNursing DegreeBachelor's Degree
Industry Keywords
Good Clinical PracticeFDA RegulationsICH RegulationsDrug Development ProcessTrial Master File
About the role
Key responsibilities & impact- Serve as a floating resource to perform a variety of activities in support of the execution and management of projects and programs
- Provide assistance to Research Operations, Community Health, Endpoint and Specialty Services, Site Operations, Data Management, Quality Control, and Trial Master File based on business needs
- Assist in preparing Master Plans, Resource Materials, Source Documentation, Meeting Minutes, and submitting documents to the Trial Master File
- Assist in administering and tracking project-specific training
- Correspond with investigational sites, CPC staff, and sponsors to rectify data queries and collect outstanding documentation
- Track receipt, entry, upload, review, and feedback to investigational sites of endpoint testing
- Print, collate, and distribute 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 team members to complete deliverables and resolve 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
What you’ll need- 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
- Viable applicants will be required to pass a background and education verification check
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)
- 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
