JUMP TO CONTENT

Senior CRA - Oncology Early Phase - Boston and Greater Northeast

  1. Boston, Portland, Providence, United States
2025-119214
  1. Clinical Monitoring
  2. ICON Strategic Solutions
  3. Home-Based

About the role

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


Roles and Responsibilities:

  • Acts as primary local company contact for assigned sites for specific trials. Trials may include both early and late phase clinical trials.
  • Develops meaningful site relationships through consistent collaborative communication and engagement.
  • May participate in site feasibility and/or pre-trial site assessment visits.
  • Attends/participates in investigator meetings as needed.
  • May serve as Lead CSM for specific study providing study level oversight and support for CSMs assigned to the study. This assignment ensure study level information is shared with assigned CSMs and has key role in establishing site monitoring strategy for study.
  • Responsible for driving activities within site initiation and start-up, preparation and conduct of site monitoring (including remote monitoring), site management (by study specific systems and other reports/dashboards) and site/study close-out according to SOPs, Work Instructions (WIs) and policies. Responsible for the implementation of risk based monitoring approaches at the site level and to work with site to ensure timely resolution of issues found during monitoring visits.
  • Ensures site staff are trained and the corresponding training records are complete and accurate at any time point during all trial phases. Responsible in close collaboration with study team for the activities during site activation phase to speed up the process and activate the site in the shortest possible
  • Ensure site compliance with study protocol, ICH-GCP, and local/country regulations.
  • Ensure ongoing adequacy of site (facilities, staff) for trial conduct.
  • Ensure source and other site documentation is adequate and in compliance with ALCOA-CCEA
  • Involved with site level recruitment strategy and prioritization and implementation in partnership with other functional areas.
  • Ensures site non-IMP study supplies are adequate for trial conduct.
  • Ensures that clinical drug supplies are appropriately used, handled, and stored and returns are accurately inventoried and detailed.
  • Oversees the appropriate destruction of clinical supplies.
  • Ensures site staff complete data entry and resolve queries within expected timelines.
  • Ensures validity and completeness of data collected at trial sites.
  • Ensures that all Adverse Events (AE) /Serious Adverse Events (SAEs) are reported within the required reporting timelines and documented as appropriate.
  • Maintains complete, accurate and timely data and essential documents in relevant systems used for trial management.
  • Fully documents trial related activities, in particular monitoring. Writes visit reports and follow-up letter in accordance with the SOPs. Promptly communicates relevant status information and issues to appropriate stakeholders.
  • Reviews study files for completeness and ensures archiving retention requirements are met, including storage in a secure area at all times.
  • Aligns with relevant training requirements. Act as local expert in assigned protocols. Develops therapeutic knowledge sufficient to support role and responsibilities.
  • Works closely with CTL to ensure Corrective Action Preventative Action (CAPA) is completed for Quality Assurance (QA) site audits and for quality issues identified at the site during routine monitoring visits.
  • Prepares trial sites for close out, conduct final close out visit.
  • Establishes and maintains good working relationships with internal and external stakeholders in particular investigators, trial coordinators and other site staff.
  • May participate in the Health Authority (HA) and IEC/IRB submission and notification processes as required/appropriate.
  • May be responsible for up to 10 sites across 2-4 protocols, dependent on complexity of protocols and site activity. Responsible for managing own travel budget within guidelines.  

Required Qualifications:

  • BA/BS degree with 5years of experience in pharmaceutical related drug development.
  • Five years site monitoring and/or site management experience.
  • Strong years of Oncology required
  • Strong working knowledge of GCP, local laws and regulations, assigned protocols and associated protocol specific procedures including monitoring guidelines.
  • Strong critical thinking and problem solving skills.
  • Strong IT skills in appropriate software and company systems.
  • Willingness to travel up to 40% with overnight stay away from home.
  • Proficient in speaking and writing English. Depending on hiring region, may also be required to be fluent in local language.
  • Good written and oral communication.

Preferred Qualifications:

  • Experience working cross-functionally and in matrix teams
  • Experience in executing Lead CSM role
  • Experience mentoring more junior site monitors or site managers
  • Experience working in early development studies


What ICON can offer you:


Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

  • Various annual leave entitlements
  • A range of health insurance offerings to suit you and your family’s needs
  • Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
  • Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being
  • Life assurance
  • Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others


Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits

At ICON, inclusion & belonging are fundamental to our culture and values.   We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

.
https://careers.iconplc.com/reasonable-accommodations

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
A picture of Debora Oh
How to excel as a CRA in a Clinical Research Organisation

Teaser label

Our People

Content type

Blogs

Publish date

08/29/2023

Summary

To excel as a Clinical Research Associate (CRA) in a Clinical Research Organization (CRO), you need a combination of education, skills, and the right mindset. Brazil-based CRA II Debora shares her

Teaser label

Brazil-based CRA II Debora Oh shares her tips on how to become a great CRA and provides insight into life at ICON.

Read more
View all

Similar jobs at ICON

Study Start Up Associate All Levels

Salary

Location

Brazil

Department

Clinical Monitoring

Location

Brazil

Remote Working

Home-Based

Business Area

ICON Strategic Solutions

Job Categories

Clinical Monitoring

Job Type

Permanent

Description

The Study Start Up Associate fulfills the role of Local Regulatory Affairs Lead (LRAL) and is responsible for preparing, submitting and following up on initial and amended Regulatory Agency (RA), Cent

Reference

2025-121261

Expiry date

01/01/0001

Bruna Duarte

Author

Bruna Duarte
Read more Shortlist Save this role
CRA I

Salary

Location

Poland

Department

Clinical Monitoring

Location

Poland

Remote Working

Home-Based

Business Area

ICON Strategic Solutions

Job Categories

Clinical Monitoring

Job Type

Permanent

Description

As a CRA II you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

Reference

2025-121146

Expiry date

01/01/0001

Zalkina Lomber Read more Shortlist Save this role
Senior Clinical Research Associate

Salary

Location

Beijing

Department

Clinical Monitoring

Location

Beijing

Remote Working

Office Based

Business Area

ICON Strategic Solutions

Job Categories

Clinical Monitoring

Job Type

Permanent

Description

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

Reference

2025-121388

Expiry date

01/01/0001

Allen Hao

Author

Allen Hao
Allen Hao

Author

Allen Hao
Read more Shortlist Save this role
Senior CRA

Salary

Location

Romania, Bucharest

Department

Clinical Monitoring

Location

Bucharest

Remote Working

Office or Home

Business Area

ICON Full Service & Corporate Support

Job Categories

Clinical Monitoring

Job Type

Permanent

Description

We are currently seeking a Senior Clinical Research Associate (CRA) to join our diverse and dynamic team. As a Senior CRA at ICON Plc, you will play a critical role in overseeing and managing clinical

Reference

JR133487

Expiry date

01/01/0001

Sophie Clarke

Author

Sophie Clarke
Read more Shortlist Save this role
Senior CRA

Salary

Location

United States

Department

Clinical Monitoring

Location

United States

Remote Working

Home-Based

Business Area

ICON Strategic Solutions

Job Categories

Clinical Monitoring

Job Type

Permanent

Description

As a Sr. CRA you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. One of our FSP clients is looking for a Sr. CRA with point

Reference

2025-121358

Expiry date

01/01/0001

Jamie Pruitt

Author

Jamie Pruitt
Read more Shortlist Save this role
SSU CRA

Salary

Location

United Kingdom

Department

Clinical Monitoring

Location

UK

Remote Working

Home-Based

Business Area

ICON Strategic Solutions

Job Categories

Clinical Monitoring

Job Type

Permanent

Description

Role: Study Start Up CRA (must have CRA experience or extensive SSU experience) Location: Must be based in the UK, nationwide travel  Fully sponsor dedicated As a CRA you will be joining the world’s

Reference

2025-121307

Expiry date

01/01/0001

Amani Yousef

Author

Amani Yousef
Read more Shortlist Save this role
View Jobs

Browse popular job categories below or search all jobs above