JUMP TO CONTENT

TMF Clinical Trial Associate - Remote, US

  1. United States
2023-104942
  1. Clinical Trial Support
  2. ICON Strategic Solutions

About the role

This vacancy has now expired. Please click here to view live vacancies.

As a TMF Clinical Trial Associate you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.


Job Duties will Include:

  • Ensures a complete, accurate and high quality Trial Master File (TMF) as the subject matter expert through proper, consistent documentation and proactive partner relationship with the study team
  • Provides feedback, support and training to study teams in order to build knowledge and awareness of good, quality documentation management practices for clinical trials.
  • Clinical study team member: works closely with the Clinical Trial Manager (CTM) and is responsible for coordination, logistics, tracking and administrative tasks in support of clinical trials.
  • Responsible for tracking study budgets, including invoice and PO
  • management/reconciliation, and accruals in support of the CTM and Finance.
  • Tracks study status, enrollment, regulatory documentation, and site start-up status for assigned clinical projects.
  • Responsible for set-up, filing, maintenance, reconciliation, and archiving of electronic and paper Trial Master Files.
  • Responsible for data entry into Clinical Trial Management Systems.
  • Supports and/or tracks external access rights to Clinical Trial Management Systems.
  • Interacts with CROs, vendors, investigators, monitors and other external partners to provide information and resolution for specific requests and issues.
  • Manage and track clinical and non-clinical supplies.
  • Assists CTM with agendas and meeting minutes for clinical sub-team meetings.
  • Assists CTM with logistics coordination for investigator meetings and external vendor meetings.
  • Responsible for routing, tracking, and coordinating site and CRO/vendor Confidential Disclosure Agreements (CDAs) and contracts with Sr. Manager Clinical Operations, legal, and finance departments.
  • Responsible for facilitating site advertisement review and approval with CCC Committee.
  • Responsible for special projects supporting operations/departmental initiatives such as ClinicalTrials.gov, SOPs, GCP, process enhancements, outsourcing, Sunshine Act etc.

Qualifications:

  • Bachelor’s degree or equivalent undergraduate degree with science or healthcare experience preferred 
  • Experience: 1-2 years clinical research experience in a pharmaceutical/biotech, CRO setting preferred
  • Basic knowledge and understanding of GCP/ICH Guidelines for conducting clinical trials
  • Strong interpersonal, organizational, and multi-tasking skills
  • Excellent attention to detail and problem solving skills
  • Self-motivated and displays initiative
  • Perform job duties with minimal supervision and guidance
  • Ability to work effectively work in a team setting

 


Why ICON?

Our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

List #1

Day in the life

A picture of chemists on a superimposed periodic table
5 reasons why you should consider a career in Clinical Research

Teaser label

Inside ICON

Content type

Blogs

Publish date

01/17/2025

Summary

Five Reasons Why You Should Work at a Contract Research Organization Contract research organisations (CROs) play a pivotal role in advancing medical science, offering career opportunities that are

Teaser label

If you’re seeking a rewarding and fulfilling work environment, a career at a CRO might be the perfect fit.

Read more
Man with headphones on looking at a laptop
Tips to make a lasting impression in a video interview

Teaser label

Career Progression

Content type

Blogs

Publish date

05/10/2024

Summary

Although many employers are returning to the office, we’re still seeing a mix of both video and in-person interviews in application processes. Early in 2020, the number of companies using video interv

Teaser label

Ace your virtual job interview with these proven video interview tips.

Read more
EPIC Interns
ICONs EPIC Internship Program

Teaser label

Career Progression

Content type

Blogs

Publish date

07/20/2023

Summary

Unlocking your Potential: The Benefits of ICON’s EPIC Internship Program  Internship programs have become a vital stepping stone for students and young professionals seeking to gain practic

Teaser label

Read more about ICON plc's EPIC (Entry-level Professionals in CRO (Contract Research Organization)) internship program.

Read more
View all

Similar jobs at ICON

GCP Strategy Lead

Salary

Location

Canada

Department

Clinical Operations Roles

Location

Canada

Remote Working

Home-Based

Business Area

ICON Strategic Solutions

Job Categories

Clinical Trial Support

Job Type

Permanent

Description

As a Clinical Quality Compliance Lead you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

Reference

2025-120615

Expiry date

01/01/0001

Melissa Benner Read more Shortlist Save this role
Senior Study Start Up Associate

Salary

Location

Israel

Department

Clinical Operations Roles

Location

Israel

Remote Working

Home-Based

Business Area

ICON Strategic Solutions

Job Categories

Clinical Trial Support

Job Type

Permanent

Description

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotech

Reference

2025-120870

Expiry date

01/01/0001

Salome Kankia

Author

Salome Kankia
Read more Shortlist Save this role
Clinical Documentation Coordinator I

Salary

Location

United Kingdom

Department

Clinical Operations Roles

Location

UK

Remote Working

Home-Based

Business Area

ICON Strategic Solutions

Job Categories

Clinical Trial Support

Job Type

Permanent

Description

As a Clinical Data Coordinator I you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

Reference

2025-118468

Expiry date

01/01/0001

Jonathan Cunliffe Read more Shortlist Save this role
CTA

Salary

Location

Poland

Department

Clinical Operations Roles

Location

Poland

Remote Working

Home-Based

Business Area

ICON Strategic Solutions

Job Categories

Clinical Trial Support

Job Type

Permanent

Description

As a global (Sr) CTA,  you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

Reference

2025-120800

Expiry date

01/01/0001

Dagmara Drozdowska Read more Shortlist Save this role
GCP Strategy Lead

Salary

Location

Canada

Department

Clinical Operations Roles

Location

Canada

Remote Working

Home-Based

Business Area

ICON Strategic Solutions

Job Categories

Clinical Trial Support

Job Type

Permanent

Description

As a Clinical Quality Compliance Lead you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

Reference

2025-120616

Expiry date

01/01/0001

Melissa Benner Read more Shortlist Save this role
GCP Compliance Oversight Project Manager

Salary

Location

United States

Department

Clinical Operations Roles

Location

United States

Remote Working

Home-Based

Business Area

ICON Strategic Solutions

Job Categories

Clinical Trial Support

Job Type

Permanent

Description

As a Clinical Quality Compliance Lead  you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

Reference

2025-120614

Expiry date

01/01/0001

Melissa Benner Read more Shortlist Save this role
View Jobs

Browse popular job categories below or search all jobs above