CRA II Job at ICON, Remote

QS9yNUxFNlROMTdHTDg4ZGZhOHdqRUpQdWc9PQ==
  • ICON
  • Remote

Job Description

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

What you will be doing:

  • Completes onsite and remote monitoring activities in accordance with all ICH-GCP guidelines, applicable regulations, SOPs, and study processes. Activities include qualifying potential investigative sites, initiating clinical trials, maintaining study files, and providing instructions to site personnel and study close out.
  • Verifies the protection of study participants by confirming informed consent procedures and protocol have been performed in accordance to applicable regulations.
  • Ensures the integrity of clinical data and that the study is conducted in compliance with the approved protocol, GCP, applicable regulations, and SOPs.
  • Manages the investigative site staff to facilitate trial deliverables, e.g., subject enrollment, data deliverables.
  • Verifies proper management and accountability of Investigational Product (IP).
  • Writes and submits reports of investigational site findings and updates applicable tracking systems. Escalates observed deficiencies, issues, and corrective and preventative action plans as appropriate.
  • Manages essential documents as required by local regulations and ICH-GCP guidelines before, during, and after a clinical study; assists with resolution of investigational site/data queries.
  • Performs key risk assessment and management responsibilities throughout the project, including key risk indicator and site health analysis, site process evaluation, and project escalation.
  • Participates in audit preparation and follow-up activities as needed.
  • Independently performs a variety of onsite and offsite monitoring visit types.
  • Gathers and reviews information for assigned sites and identifies inconsistencies. With limited guidance from project and functional management, assesses risk and escalates as appropriate.
  • Assists with non-complex ad hoc, short-term assignments in support of additional studies or departmental initiatives.
  • May serve as preceptor, providing training to less experienced clinical team members

 

You are:

  • 2 years of experience supporting clinical trials including 2 year of on-site monitoring experience
  • In-depth knowledge of the drug development process
  • In-depth knowledge and practical utilization of ICH- GCP and applicable regulatory requirements
  • Sound knowledge of applicable policies and procedures, SOPs, work instructions and other guidance documents
  • Good spoken and written communication skills; good presentation skills
  • Strong interpersonal, collaboration and time management skills
  • High proficiency with Microsoft Office and company collaboration applications
  • Excellent skill in the utilization of applicable clinical systems
  • Excellent critical thinking skills
  • Excellent organizational skills
  • Ability to focus on detail for extended periods of time; high attention to accuracy
  • Ability to travel extensively
  • Ability to establish and maintain effective working relationships with investigative site staff
  • Undergraduate degree or international equivalent in clinical, science, or health-related field from an accredited institution; health care professional licensure, i.e., registered nurse
    • Equivalent combination of education, training and relevant experience may be considered in place of the education and experience stated above. All employees must read, write and speak fluent English and host country language.

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.

Job Tags

Remote job, Permanent employment, Temporary work, Local area,

Similar Jobs

Hilton Garden Inn Overland Park

Hotel Front Desk Associate - Receptionist Job at Hilton Garden Inn Overland Park

 ...Hilton Garden Inn of Overland Park is currently hiring for a full-time Hotel Front Desk Associate - Receptionist in the Overland Park, KS area. This hospitality position earns a competitive wage of $15/hour. In addition to competitive pay and our fantastic... 

International Window Cleaning Association

High Rise Window Cleaners Needed Job at International Window Cleaning Association

 ...this could be for you. We are a leader in the commercial window cleaning market in the Central Florida area. Our team members take great...  ...competition. More than 50 franchise brands offer office cleaning, home cleaning or carpet cleaning. About the only segment of the... 

Total Aviation Staffing, LLC

Helicopter VFR Pilot Job at Total Aviation Staffing, LLC

 ...safety record and a team of the industry's best aviation and medical professionals. Overview of the Role: As a Helicopter VFR Pilot, you will play a pivotal role in life-saving missions, swiftly transporting critical care to those in need in various challenging environments... 

Allbound Carrier

Class A Owner Operator Truck Driver Job Job at Allbound Carrier

Class A Owner Operator Truck Driver JobAllbound Carrier is currently seeking Owner Operators in your area! 88% paid to you!!Driver MUST HAVE at least 24 months OTR within the last 2 years and Class A CDL. We are looking to partner with professional, qualified drivers... 

Nehers

HERS Rater - Boston (with New Ecology) Job at Nehers

 ...New Ecology, Inc. seeks candidates for the position of HERS Rater. This position is part of an organization-wide technical services team with expertise in HERS and other rating systems, energy auditing, construction inspections, site verifications, and energy modeling....