Preclinical Protocol Writer

BASIC SUMMARY: To independently facilitate and oversee the coordination, assembly, writing, editing and quality control of protocols, which accurately reflect the study data and fulfill all protocol and GLP requirements. Additionally, involved in the development of working with Principal Investigators and Contributing Scientists, ensuring they are in receipt of our signed Protocols/Amendments and have acknowledged they have read/understood.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

· Coordinate with and assist Study Director in the compilation of our study protocols, following regulations and contractual agreements.

· Organize the overall layout of study protocol to follow our company template and type of study.

· Ability to work within established timelines

· Prepare protocol/amendments and electronic files for submission to the DSU.

· Participate in study-specific pre-initiation meetings; anticipate reporting issues and suggest courses of action for data collection enhancements or protocol edits.

· Assist in responding to Quality Assurance Audits

· Proofread/copy edit study protocols prior to submission for Study Director signature.

· Coordinate and communicate with participating departments, sponsors and outside vendors to help ensure timely delivery, organization and generation of the protocols and/or amendments.

· Assist in development of formats, templates, and general guidelines for documentation.

· Participate in departmental or interdivisional process improvement and training initiatives.

· Perform all other related duties as necessary/assigned.

QUALIFICATIONS:

Education: Bachelor's or Master's degree in biological sciences, technical writing or equivalent field (with significant course work in biological sciences)

· Exceptional experience in a related field could substitute for the education requirement.

Experience: Minimum of one to three years experience in a regulatory pre-clinical or clinical testing environment with involvement in medical writer related activities

· Exceptional experience in related preclinical/clinical areas could substitute (e.g., study coordination or data coordination)

Certification/Licensure: Driver’s license

Other:

· Knowledge of domestic and foreign GLP regulations as they relate to reporting requirements and to study conduct

· Proficiency with Windows-based word processing, spreadsheets and presentation software

· Ability to multi-task with good communication, interpersonal, and organizational skills

· Ability to adjust priorities in order to adhere to stringent deadlines.

· Ability to perform under pressure in a fast-paced, multi-task, deadline oriented environment.

· Advanced working knowledge of Microsoft Word, Excel, and Adobe Reader

· Must be skilled in using and developing document templates.

PHYSICAL DEMANDS: NA

WORK ENVIRONMENT:

• General office working conditions, with generally quiet noise conditions

• Exposure to laboratory areas with mild noise/odors.

Job Type: Full-time

Pay: From $24.00 per hour

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Parental leave
• Professional development assistance
• Referral program
• Tuition reimbursement
• Vision insurance

Schedule:

• 8 hour shift

Work Location: One location