Clinical Trial Associate

Planet Pharma; Cambridge (MA); On-site; USD 70,000 - 88,000; Full time

Job summary

Planet Pharma is seeking a Clinical Trial Associate to support administrative aspects of study management from start-up through closeout.

Responsibilities include minute-taking, scheduling virtual meetings, filing essential documents, TMF maintenance, and metric reporting. Travel up to 15% may be required; a bachelor’s degree is preferred.

Qualifications

• Excellent computer skills including Excel, Word, PowerPoint and Lotus Notes.
• Database skills required.
• Good communication skills, both verbal and written.
• Excellent time and priority management and organizational abilities.

Responsibilities

• Take and distribute meeting minutes for internal and external meetings.
• Schedule activities and set up virtual meetings with materials.
• Review vendor meeting minutes and documents for accuracy.
• Filing and routing of agreements related to Clinical Operations.
• Prepare and track essential document packets for review.
• Create and update trackers for metric reporting.
• TMF and file maintenance.
• Distribute, collect and track large amounts of documentation.
• Assist with preparation of reports and publications as required.
• Travel up to ~15%, including international travel.

Skills

Excel

Word

PowerPoint

Lotus Notes

Database skills

Communication skills

Interpersonal skills

Time management

Organizational skills

Education

Bachelor’s degree preferred

Job description

Target PR Range: 51-64/hr DOE

JOB DESCRIPTION

Summary of Position:

This role represents a great opportunity to be a part of a growing clinical organization.? The Clinical Trial Associate will support all administrative aspects of study management from start-up through closeout.? ?

Responsibilities:

• Responsible for taking and distributing meeting minutes for both internal and external meetings, in the office and via teleconferences.

• Scheduling activities and setup virtual meetings, including compilation of materials and overseeing presentations

• Review study vendor meeting minutes and documents for accuracy.

• Filing and routing of agreements related to Clinical Operations.

• Preparing and tracking green light packets/ essential document packets for review.

• Creating and updating trackers for metric reporting

• TMF and file maintenance

• Distributes, collects, and tracks large amounts of documentation accurately and within project timelines.

• Assists with preparation of reports and technical or scientific publications, as required.

• Minimal Travel, including international travel, required (~15%)

Requirements:

• Bachelor’s Degree Preferred

• Experience in a CRO, Sponsor or clinical research administration function, including hands on experience relating to the essential documentation of a clinical trial.? Experience supporting Drug or Biologics trials strongly preferred.

• Excellent computer skills including knowledge of Excel, Word, PowerPoint, and Lotus notes. Database skills a requirement

• Good understanding of the policies and procedures of Clinical Operations and ICH-GCP, particularly relating to essential documentation

• Excellent time and priority management, able to work efficiently under pressure

• Excellent organizational and problem-solving skills

• Thrives in a fast-paced and evolving environment

• Self-motivated, shows initiative, is proactive and able to work on his/her own as well as in a team

• Good communication skills – both verbal and written

• Good interpersonal skills and ability to deal with people at all levels with sensitivity and tact