Clinical Research Source Writer

CenExel•Hollywood, FL

2d•Onsite

About The Position

About Us: Each of CenExel’s research sites specialize in Phase I to Phase IV clinical trials. Our Centers of Excellence comprise some of the most well respected and long-standing research facilities in the country. Specialty areas of research across our sites include Psychiatry, Acute Post Op Pain, Asian Bridging, Dermatology, GI, and Neurology. Each of our Centers of Excellence has tremendous experience and expertise in complex early phase trials, and all our sites have in-patient capability. We focus on quality people, teamwork, and highly experienced clinical research managers with a history of success. Along with an exceptional work environment that promotes teamwork, positive leadership, and optimal work-life balance, CenExel Clinical Research also provides highly competitive compensation and a generous benefits package to full time employees after 30 days of employment including Health Insurance, Dental, Vision, LTD, STD, Life Ins, and 401k. Job Summary: Responsible for the creation of all source documentation needed for clinical trials for various specialty areas including but not limited to Endocrinology/Metabolic. Also includes editing and tracking of source documents as needed for protocol amendments and/or change in processes. Must observe strict adherence to ICH, GCP, protocol, and CenExel guidelines, regulations, and policies.

Requirements

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.
Essential physical requirements include sitting, typing, standing, and walking.
Lightly active position, occasional lifting of up to 20 pounds.
Reporting to work, as scheduled, is essential.
On site work arrangement.

Nice To Haves

One year clinical research experience preferred; clinical and technical writing experience is a plus.

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.