Location

Bethesda, MD 20817 US (Primary)

Category

Medical Writing

Job Type

Full-Time

Salary Range

$57,000-$65,000

Education

Bachelor’s Degree

Travel

None

Job Description

• Assists on project management ad-hoc activities, produces reports, assists on editing of project

and trial documents, etc.

• Generates level of effort reports and assists in monitoring project status

• Drafts and submits project progress reports

• Coordinates team conference calls, generates and distributes meeting minutes from

internal/client/vendor meetings as applicable

• Prepares, revises, analyzes and reconciles project documents, including standard operating

procedures (SOPs), project management plan, risk management plan, training plan, metrics and

findings reports, etc., within specified timelines

• Assists with clarification and resolution of findings from quality assurance audits

• Maintains assigned data points within project tracking systems according to the established

conventions within specified times, including entry of findings

• Provides ad hoc support as needed

Job Requirements

• Excellent oral and written communication skills and interpersonal skills

• Detail-oriented and able to multi-task/prioritize well, with proven ability to handle multiple tasks

efficiently and effectively

• Strong working knowledge of Microsoft office and ability to obtain knowledge and master all

clinical trial database systems and technical tools; experience with AI tools a plus

• Ability to effectively analyze project specific data/systems to ensure accuracy and efficiency

• Flexibility to reprioritize workload to meet changing project timelines

• Knowledge of FDA clinical trial guidelines and regulations

• Clinical research experience preferred

This is a hybrid position with 2 days in TRI’s Bethesda, Maryland office, and 3 days working remotely.

We are equal opportunity/affirmative action employers, committed to diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status, or any other protected characteristic under state or local law.