CRA II-BIOTECH

Posted 3 Hours Ago
Be an Early Applicant
Hiring Remotely in United States
Remote
Mid level
Healthtech • Biotech • Pharmaceutical • Manufacturing
The Role
The Clinical Research Associate will independently coordinate activities for clinical studies in phases II - IV, ensuring compliance with regulations. Responsibilities include submitting protocol for ethics approval, preparing study documentation, managing queries, and potentially mentoring less experienced CRAs. Travel for site monitoring is required.
Summary Generated by Built In

CRA II Biotech - United States-Remote

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development

We are currently seeking a Clinical Research Associate to join our diverse and dynamic Biotech team that is therapeutically aligned in our Gen Med space. As a Clinical Research Associate , you’ll work within a large-scale, fast-paced environment alongside a close-knit team of highly qualified CRAs to identify, select, initiate and close-out investigational sites for clinical studies in phases II – IV, ensuring adherence to applicable regulations and principles of ICH-GCP. We pride ourselves on our amazing company culture, where We work as one team to achieve industry-leading results.

What You Will Be Doing:

  • Working independently and actively to coordinate activities to set up and monitor a study, completing accurate study status reports and maintaining study documentation

  • Submission of protocol, consent documents for ethics/IRB approval and assist in preparing regulatory submissions as requested

  • Participate in preparing and reviewing study documentation and feasibility studies for new proposals as required

  • Balancing sponsor generated queries efficiently and responsible for study cost-effectiveness

  • Dependent on level of experience you may assist in training and mentoring less expert CRA’s and/or lead CRA’s working on international projects

Your Profile:

  • 2-3 years+ of Independent monitoring experience in phase I-III trials as a CRA at a CRO

  • Knowledge of ICG GCP guidelines and expertise to review and evaluate medical data

  • You will possess excellent written and verbal communication in English

  • Ability to produce accurate work to tight deadlines within a pressurized environment

  • Remote except for Monitoring in which you will travel as per below

  • You will be asked to travel at least 8-10 Days onsite and 2-3 overnights a week (international and domestic -fly and drive) and should possess a valid driving license

Current Therapeutic need:

Infectious Disease

Immunology

Neuro-Psych

Endocrine

Strong overall Gen Med

#LI-TG2

#LI-REMOTE

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 maximize 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 site to read more about the benefits ICON offers.

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 or submit a request here.

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.

Are you a current ICON Employee? Please click here to apply

The Company
HQ: Dublin
34,685 Employees
On-site Workplace
Year Founded: 1990

What We Do

Since our foundation in Dublin, Ireland in 1990, our mission has been to help our clients to accelerate the development of drugs and devices that save lives and improve quality of life. We do this by delivering best in class information, solutions and performance, with an unyielding focus on quality at all times.

We offer a full range of consulting, development and commercialisation services from a global network of offices in 53 countries. We focus our innovation on the factors that are critical to our clients – reducing time to market, reducing cost, and increasing quality – and our global team of experts has extensive experience in a broad range of therapeutic areas.

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