Senior Study Start Up Clinical Research Associate

ICON plc is a world-leading healthcare intelligence and clinical research organization. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organizations.

With our patients at the center 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.

As a Senior Study Start Up Clinical Research Associate, you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. You will be a part of ICON Strategic Solutions, embedded to a sponsor.

We believe our Clinical Operations team is second to none. You will receive the support you need to develop personally and professionally and work in an environment where you matter. Our team pushes forward together. United in solving problems, developing close site relationships, and reaching the end goal. Operating as a key part of a global study team, the CRA plays a fundamental role in our clients’ drug development processes.

Here at ICON, we want our employees to succeed and ensure that they are set up for this success through constant training, development and support.

The Study Start Up Clinical Research Associate is responsible for country study start up (SSU) activities and performing quality review of essential documents.  The SSU CRA is responsible for overseeing and leading SSU activities in collaboration with country team members (CLM and CRA) with the objective to improve site activation and maximize patient recruitment time.

Responsibilities

• Responsible for the selection of study sites by assessing the site’s eligibility for a specific study.
• Responsible for study specific start-up activities from country allocation to site greenlight.
• Site relationship management to ensure efficient and sustainable study start-up at site. 
• Proactive site preparation and early identification of real site needs and issues
• Interact with site and study personnel to collect country specific documents such as IRB/IEC approvals, financial disclosure, CVs/medical licenses, etc. and review for accuracy, completeness, and adherence to ICH/GCP.
• Perform quality review of country and site level essential documents following a risk-based approach, issue queries, and communicate outcome to identified users at key milestones and during the study.
• Preparation, tracking, and distribution of site start up documentation including Investigator Site File
• Obtain any required approvals for relevant site document (e.g., informed consent, financial disclosures) to ensure start up timelines are met.
• Manage oversight, in collaboration with CLM, of country and site start up activities and eTMF quality using Vault Clinical reports and dashboards.
• Support start up process improvement implementation.
• Assist with audits/inspections of relevant start up activities and/or eTMF
• Attend and actively participate in team meetings by providing site greenlight projections and timelines.
• Provide input on site activation strategy.
• Ensure awareness of related local regulations and support maintenance of country intelligence in Veeva

Deliverables:

• Site selection visits /SSV’s.
• Submission package – collection and preparation of site documents.
• Timely site greenlight milestones complete.

Skillsets:

• Strong site management capabilities
• Demonstrated negotiating and problem-solving skills
• Strong communication and risk identification skills
• Demonstrated ability to quality review documents and identify discrepancies/inconsistencies
• Ability to embrace Veeva Clinical Vault system and associated functionality
• Strong written and verbal English communication skills
• Demonstrated organization skills and attention to detail
• Strong service orientation
• Ability to work independently and manage multiple tasks and priorities

Requirements:

• The incumbent should have a Bachelor’s degree (or equivalent experience) and minimum of 2 years of experience in the capacity of Clinical Research Associate, involved in Start-Up activities in Kenya.
• A working knowledge of ICH-GCP guidelines and local and international regulatory requirements is essential.

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.

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