CenExel · 1 month ago
Clinical Research Source Writer
Hollywood, FL
Full-time
Onsite
Entry Level
1+ years expCenExel is a leading organization specializing in Phase I to Phase IV clinical trials across various specialty areas. The Clinical Research Source Writer is responsible for creating and maintaining source documentation for clinical trials, ensuring adherence to guidelines and regulations while supporting process improvement initiatives.
Clinical TrialsHealth CarePharmaceutical
Responsibilities
Creates and maintains source documentation according to timelines established by CenExel
Produces timely revisions of source documentation as needed
Performs clinical and technical writing as required by CenExel site, Sponsors, and CROs
Creates and maintains tracking tools used for version control
Assists with various tasks related to Process Improvement and writing of processes and procedures as needed
Maintains documentation software
Assumes other duties and responsibilities as assigned
Qualification
Required
Bachelor's degree or equivalent experience
Ability to complete paperwork with precision and attention to detail
Advanced knowledge and utilization of grammar and writing skills
Demonstrated knowledge and understanding of protocols and study assessments
Knowledge of various clinical research data collection methods
Knowledge of psychiatry and various medical conditions
Knowledge and ability to effectively utilize ICH, GCP, ALCOA, GDP and the protocol to create meticulous source documentation
Knowledge and routine utilization of advance-level Microsoft Office and Adobe operations and functions; basic form-building with edit-check controls; database building and maintenance skills
Skilled in organization and record maintenance
Skilled in developing and maintaining effective working relationships with Quality and Operations Management at all sites
Ability to react calmly and effectively in emergency situations
Ability to interpret, adapt and apply guidelines and procedures
Ability to work independently as well as functioning as part of a team
Must be able to effectively communicate verbally and in writing
Preferred
One year clinical research experience preferred; clinical and technical writing experience is a plus
Benefits
Health Insurance
Dental
Vision
LTD
STD
Life Ins
401k
Company
CenExel
CenExel is a clinical research site network supporting phase I-IV clinical trials. It is a sub-organization of Webster Equity Partners.
1001-5000 employees
Funding
Current Stage
Late StageTotal Funding
unknown2025-04-12Acquired
2023-04-01Private Equity
Leadership Team
Patrick McLaughlin
Chief Operating Officer
Recent News
Venture Capital Firms
2025-10-16
Company data provided by crunchbase