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In-house CRA

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ICON plc

Jul 28

Applications are closed

  • Job
    Full-time
    Expert / Leadership (9+ years)
  • Reading
    Remote

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Requirements

  • Minimum Bachelor's degree in a life science
  • 12 months + of a Clinical Trial Assistant, Study Coordinator or similar role experience within the clinical/pharmaceutical industry
  • Understanding of ICH GCP Compliance
  • Excellent communication and organizational skills
  • A phenomenal teammate

Responsibilities

  • Serve as the primary in-house contact for sites and investigators participating in studies
  • Conduct and completes remote site management activities, with support as needed, according to applicable SOPS and the Study Monitoring Plan
  • To contact Clinical sites for specific requests (e.g. enrolment updates, missing documentation, data entry timeliness, data query follow-up, CDA finding follow-up, and action Item resolution or other sponsor specific CRA tasks)
  • Take responsibility for project tasks and sees these tasks through to successful completion, with support
  • Maintain a professional interpersonal relationship with study team, sites, and Sponsors
  • Become familiar with ICON’s SOPs/WPs, ICH GCP guidelines, appropriate regulations, ICON systems and the principles of and assist with investigator recruitment
  • Participate in QA Audits as needed
  • Regularly attend and gives to project specific and departmental meetings
  • Ability and willingness to travel as needed (drive and fly)
  • Maintain Sponsor and patient confidentiality
  • Other duties as assigned

FAQs

What is the primary role of an In-House CRA at ICON plc?

The primary role of an In-House CRA at ICON plc is to serve as the main contact for clinical sites and investigators participating in studies, conducting remote site management activities, and ensuring effective communication and resolution of study-related issues.

What qualifications are necessary for someone applying for the In-House CRA position?

Candidates are required to have a minimum Bachelor's degree in a life science and at least 12 months of experience in a Clinical Trial Assistant, Study Coordinator, or a similar role within the clinical or pharmaceutical industry.

Is experience in ICH GCP compliance required for this position?

Yes, an understanding of ICH GCP compliance is necessary for the In-House CRA role at ICON plc.

What specific tasks will I be responsible for in the In-House CRA role?

Responsibilities include contacting clinical sites for various requests, maintaining professional relationships with study teams and sponsors, participating in quality assurance audits, and completing remote site management activities according to applicable SOPs and the Study Monitoring Plan.

Are there opportunities for career development at ICON plc?

Yes, ICON plc fosters a culture that rewards high performance and nurtures talent, providing opportunities for career development and professional growth.

Will I be required to travel for this position?

Yes, the role requires the ability and willingness to travel, both by driving and flying, as needed.

What type of benefits does ICON plc offer to its employees?

ICON plc offers competitive salary packages, annual bonuses based on performance goals, a range of health-related benefits, competitive retirement plans, life assurance, and an inclusive workplace environment.

How does ICON plc ensure a diverse and inclusive workplace?

ICON plc is committed to being an equal opportunity employer, providing a workplace free of discrimination and harassment, and offering equal consideration for employment to all qualified applicants.

How should I inform ICON plc about needing accommodations during the application process?

If you require a reasonable accommodation due to a medical condition or disability, you can inform ICON plc through the form provided in the application process.

What is the significance of maintaining sponsor and patient confidentiality in this role?

Maintaining sponsor and patient confidentiality is crucial in the In-House CRA role to ensure ethical standards, compliance with regulations, and the trust and integrity of the clinical research process.

Science & Healthcare
Industry
10,001+
Employees

Mission & Purpose

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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