Clinical Trial Associate

Randstad USA; Cambridge (MA); On-site; USD 61,992 - 68,880; Full time

Benefits offered by this job

Health Insurance

401K Contribution

Incentive and Recognition Program

Job summary

An established industry player is seeking a Clinical Trial Associate to provide essential administrative support to Clinical Operations. This role focuses on facilitating efficient clinical trial planning and execution in a dynamic environment. You will collaborate with Clinical Trial Teams, investigative site staff, and various vendors to ensure trial delivery aligns with regulations and guidelines. The ideal candidate will have a Bachelor's degree and relevant experience, particularly in managing TMF and overseeing CROs. Join this forward-thinking company to make a significant impact in clinical research.

Qualifications

• 2 years experience as a Clinical Trial Associate is required.
• Prior experience with Confidential Disclosure Agreements is preferred.

Responsibilities

• Develop and maintain study tools for multiple studies.
• Manage sample shipments and set-up eTMF in compliance with SOPs.

Skills

Clinical Trial Management

TMF (Trial Master File)

Confidential Disclosure Agreements (CDA)

Education

Bachelor's Degree

Tools

eTMF

CTMS

Job description

job summary:
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 Confidential 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 [e-mail].

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.