Clinical Research Associate
HDT Global
full-time
Posted on:
Location Type: Office
Location: Rockville • Maryland • 🇺🇸 United States
Visit company websiteSalary
💰 $90,000 - $120,000 per year
Job Level
JuniorMid-Level
Tech Stack
Google Cloud Platform
About the role
- Support and coordinate logistical aspects of clinical trials (start-up, conduct, close-out)
- Assist in the development and editing of study-related materials (consent forms, study binders, site study aids)
- Assist with preparation of training workshops, Investigator/Advisory Board meeting materials
- Develop study tracking tools (site lists, enrollment tracking, vendor spreadsheets) and maintain tracking spreadsheets/databases
- Provide routine reports/dashboards to study team members
- Request purchase orders independently and assist in invoice review with CPM oversight
- Track essential documents and maintain/review the eTMF under guidance of CPM
- Assist with management of investigational product and study supplies, ensuring accuracy of shipments and collection of regulatory documents for IP release
- Attend co-monitoring visits or other site visits based on experience and CPM guidance
- Assist CPM with clinical database review and facilitate resolution of queries
- Collect, review and file regulatory and other essential documents from clinical personnel and sites
- Distribute meeting agendas and prepare/distribute meeting minutes with action items
- May assume specialized administrative roles (e.g. SOP Administrator)
- Travel up to 5% of the time
Requirements
- Bachelors degree required; scientific discipline or related healthcare field is strongly preferred
- Minimum 1 years clinical research experience (e.g. pharmaceutical, biotechnology, CRO healthcare setting)
- Knowledgeable of clinical research operations, including interpretation and implementation of FDA regulations, GCP/ICH R2
- Demonstrate core understanding of medical terminology or clinical trial activities
- Must have working knowledge and understanding of clinical protocols, and all other associated study related documents
- Advanced knowledge of MS Office including Word, Excel and Power Point and Outlook
- Knowledge of the principles and practices of computer applications in database management
- Must have a high degree of customer focus toward internal and external stakeholders
- Must display strong analytical and problem-solving skills
- Strong interpersonal and relationship management with the cross-functional team and external vendors skills
- Clear and concise verbal and written communication skills
- Strong attention to detail and organizational skills required
- Ability to establish priorities, excellent sense of urgency to manage multiple tasks and deadlines
Benefits
- market-competitive base salary
- Annual performance-based bonus program
- Stock grants at all levels
- Health insurance
- Dental insurance
- Vision insurance
- Retirement plan with 401(k) match
- Summer hours
- Professional development opportunities and access to development resources
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
clinical research experienceFDA regulationsGCPICH R2medical terminologyclinical protocolsdatabase managementMS OfficeExcelPowerPoint
Soft skills
customer focusanalytical skillsproblem-solving skillsinterpersonal skillsrelationship managementcommunication skillsattention to detailorganizational skillsability to establish prioritiessense of urgency