Source Document Writer - Clinical Research

JOB TITLE – Source Document Writer

GENERAL SUMMARY OF DUTIES – Responsible for the creation of all source documentation needed for clinical trials conducted. 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 ACMR guidelines, regulations and policies.

MANAGER – Vice President and General Manager

DUTIES INCLUDE, BUT ARE NOT LIMITED TO:

• Creating and maintaining of source documentation according to timelines established by ACMR
• Timely revision of source documentation as needed
• Clinical and technical writing as required by CenExel sites, Sponsors, and CROs
• Creating and maintaining of tracking tools used for version control
• Maintenance of documentation software
• Other duties as assigned.

KNOWLEDGE, SKILLS & ABILITIES – This position requires the following minimal requirements:

• Ability to complete paperwork with precision and attention to detail (Required)
• 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
• Assist with various tasks related to Process Improvement and writing of processes and procedures as needed
• 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
• Skill in organization and record maintenance
• Skill 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
• Ability to communicate clearly both written and verbally

The ideal candidate will be an independent, critical thinker who is well organized and has a strong attention to detail. They should be able to perform the above duties in a fast-paced environment in a manner consistent with company goals. They must also be willing to adhere to the 7 guiding principles of our company.

Service Excellence: We believe all relationships with co-workers, sponsors, and subjects are partnerships. We demonstrate service excellence through a personal commitment to producing high quality, high value work, and delivering on time and on target results for every partner.

Safety: We believe that physical and psychological safety are foundational for a healthy organization. We proactively identify and mitigate safety risks as part of our daily work and value those who speak up for safety.

Resilience: We believe resilience is critical for doing our best work. We demonstrate resilience by remaining flexible, adapting to sudden change, and bouncing back from difficult situations with grace and confidence.

Team Orientation: We believe that having a team orientation leads to individual and organizational success. We demonstrate team orientation by working collaboratively and leveraging collective knowledge, ideas, and strengths to achieve a common goal.

Ethical Behavior: We believe the pillars of ethical behavior are integrity, honesty, respect, courtesy, and caring. We demonstrate ethical behavior by modeling professional standards of conduct.

Mutual Respect: We believe that mutual respect cultivates a supportive workplace. We demonstrate mutual respect by embracing diverse perspectives, sharing ideas, and trusting in each other’s abilities.

Open Communication: We believe that open communication results in a rich and rewarding dialogue that allows for the flow of energy and creativity. We demonstrate open communication by listening for understanding, speaking up without fear, freely sharing experiences, and soliciting ideas and opinions from others.

EDUCATION – Minimum BA/BS required

EXPERIENCE – At least two years of clinical research experience preferred; clinical and technical writing experience is a plus

CERTIFICATE/LICENSE – CPR training provided

PHYSICAL DEMANDS/WORKING CONDITIONS – Standard operating hours are Monday through Friday, 8:00a.m. to 4:30p.m. May be required to complete job-related tasks outside of that time frame, in excess of a standard 40-hour work week. Requires prolonged walking, standing, some bending, stooping and stretching. Requires hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator and other office equipment. Requires normal range of hearing and eyesight to record, prepare and communicate appropriate reports. Requires occasional lifting of boxes up to 50 pounds. Work is performed in a medical office environment and includes exposure to blood-born pathogens and bio-hazardous materials. This role requires the ability to work with a broad range of personalities, situations, medical conditions, and psychiatric disorders; therefore, candidates must possess the ability to resolve conflicts immediately and diffuse potentially escalating events before they occur.

Experience

• 1 - 2 years: Clinical Research experience
• 1 - 2 years: Clinical and Technical writing experience

Education

• Bachelors or better