Source Writer (Contract)

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.

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. 

Essential Responsibilities and Duties:

• 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.

Education/Experience/Skills:

• Bachelor’s degree or equivalent experience.
• One year clinical research experience preferred; clinical and technical writing experience is a plus.
• 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.

Working Conditions

1. Indoor, Office environment.
2. Essential physical requirements include sitting, typing, standing, and walking.
3. Lightly active position, occasional lifting of up to 20 pounds.
4. Reporting to work, as scheduled, is essential.
5. On site work arrangement.

CenExel Clinical Research is an Equal Opportunity Employer. All applicants will be considered for employment without regards to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or status.