Clinical Research Source Writer jobs in United States
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CenExel · 1 month ago

Clinical Research Source Writer

CenExel is a company specializing in Phase I to Phase IV clinical trials with a focus on quality and teamwork. They are seeking a Clinical Research Source Writer responsible for creating and maintaining source documentation for clinical trials in various specialty areas, ensuring adherence to guidelines and regulations.

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. The above responsibilities are a general description of the level and nature of the work assigned to this classification and are not to be considered as all inclusive

Qualification

Clinical research experienceICHGCPTechnical writingAdvanced Microsoft OfficeAdobe operationsAttention to detailOrganizational skillsEffective communicationTeamwork

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

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CenExel is a clinical research site network supporting phase I-IV clinical trials. It is a sub-organization of Webster Equity Partners.

Funding

Current Stage
Late Stage
Total Funding
unknown
2025-04-12Acquired
2023-04-01Private Equity

Leadership Team

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Patrick McLaughlin
Chief Operating Officer
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Company data provided by crunchbase