Sr. Clinical Research Associate - Southeast

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, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life. Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

ICON ISS is searching for CRAs with dermatology experience to be dedicated to one sponsor on an FSP program. Travel is regional on West Coast, USA. 

Job Responsibilities:

Meetings

• Attend PSSV training as arranged by CPM
• Attend investigator meeting
• Support planning of investigator meeting
• Attend CRA training meeting
• Present at investigator meetings (e.g. host break out rooms, study-specific guidelines and procedures)
• Participate in project team meetings
• Attend other internal meetings

Site Selection

• Conduct site feasibility (PSSVs) - enter planned dates in Veeva

Clinical Monitoring

• Manage site performance
• Complete SDV and SDR
• Perform pre-study visits
• Perform study initiation visits
• Perform interim monitoring visits
• Perform close-out visits
• Write monitoring reports
• Write follow-up letters

Patient Recruitment

• Discuss Controlled Competitive Recruitment strategy with site at PSSV and SIV
• Present patient recruitment core story to site staff (SC and PI)
• Conduct motivational visits if time from last enrollment activity or site ready to screen is longer than planned

Requirements:

• Bachelor’s Degree in science or equivalent
• Thorough knowledge of ICH-GCP
• Excellent written and verbal communications skills
• Ability and willingness to travel up to 60% with 75% at peak times (regional travel)
• Valid driver’s license and valid passport (or willingness to obtain a passport)
• Excellent organizational skills and ability to manage time and work independently and as a team.
• Dermatology experience preferred but not required
• Must be bilingual - French and English

Experience per Level:

• Sr. CRA – Four (4) – Five+ (5+) years’ work experience as a Clinical Research Associate
• CRA II – Two (2) – Four (4) years’ work experience as a Clinical Research Associate
• CRA I – One (1) – Two (2) years’ work experience as a Clinical Research Associate

Benefits of Working in ICON:

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.

At 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.

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, color, 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.