Clinical Trial Associate

The Clinical Trial Associate provides administrative support to Clinical Operations. The primary focus of the position is to facilitate efficient clinical trial planning and execution.

You will work in a nimble, dynamic, matrix environment with Clinical Trial Teams (CTT), investigative site staff and a variety of vendors and consultants to ensure trial delivery in accordance with SOPs, applicable regulations and guidelines. This individual will report directly to the Associate Director, Clinical Operations.

location: Cambridge, Massachusetts
job type: Contract
salary: $45 - 50 per hour
work hours: 9 to 5
education: Bachelors

responsibilities:

• Develop and maintain study tools including trackers, spreadsheets, and filing systems for multiple studies
• Manage sample shipments to central/reference laboratories
• Set-up and maintain eTMF in compliance with SOPs/WIs and TMF plans
• May function as subject matter expect for one or more clinical systems (e.g., eTMF, CTMS)
• Provide documents required for regulatory submission (e.g., FDA Form 1572) to Regulatory Affairs

qualifications:
Required Experience:

• 2 years experience as a Clinical Trial Associate
• Prior experience working with Confidental Disclosure Agreements (CDA)
• Prior experience QC'ing a TMF (Trial Master File)
• Prior experience overseeing a CRO

Preferred:

• Experience working as a Clinical Trial Associate on an Oncology Clinical Trial

skills: TMF

Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact ....

Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).

This posting is open for thirty (30) days.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.