MaximaTek · 12 hours ago
Clinical Research Coordinator
Wyoming, United States
Full-time
Onsite
New Grad, Entry, Mid Level
0+ years expMaximaTek is seeking a detail-oriented Clinical Research Coordinator (CRC) to manage and oversee the daily operations of clinical trials. This role acts as the vital link between the clinical site, study sponsors, and regulatory bodies, ensuring research integrity, patient safety, and adherence to regulatory standards.
Management Consulting
Hiring Manager
Sai Teja Kothapally
Responsibilities
Coordinate the daily activities of clinical trials, including patient recruitment, screening, enrollment, and follow-up visits
Maintain comprehensive Essential Document files and ensure all study activities align with IRB/IEC requirements and SOPs
Perform accurate data entry into Electronic Data Capture (EDC) systems and ensure the 'ALCOA+' principles of data integrity are upheld
Monitor participant well-being, report Adverse Events (AEs) and Serious Adverse Events (SAEs) promptly to sponsors and regulatory boards
Author and maintain source documentation and assist in internal and external audits to ensure GxP and cGMP requirements are met
Serve as the primary point of contact for Clinical Research Associates (CRAs) during monitoring visits
Qualification
Required
Bachelor's degree in Life Sciences, Nursing, Biomedical Sciences, or a related healthcare field
0–5 years of experience in clinical research, healthcare administration, or academic laboratory environments
Strong understanding of ICH-GCP guidelines and Human Subjects Protection
Proficiency in clinical trial management software and EDC platforms
Familiarity with 21 CFR Part 11 regarding electronic records and signatures
Excellent medical writing and documentation skills
Preferred
Certification (or eligibility) for CCRC (ACRP) or CCRP (SoCRA)
Experience with medical device clinical trials (ISO 14155)
Knowledge of Phlebotomy or basic clinical assessment skills
Benefits
Targeted Placement: Direct marketing to our network of hiring managers in the Life Sciences and MedTech industries.
Technical Resume Rebuild: Optimization of your profile to highlight clinical expertise alongside regulatory documentation skills.
Interview Coaching: Guidance on behavioral interviews and regulatory compliance case studies.
Company
MaximaTek
Maxima Technologies is a privately owned, leading professional IT services firm Based in Cheyenne, WY.
51-200 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase