As a Study Start up CRA based in Ghana, you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.The Study Start Up Clinical Research Associate(Ghana) 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 in Ghana, 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.
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 Ghana.
- Must be a resident of Ghana/Based in Ghana.
- A working knowledge of ICH-GCP guidelines and local and international regulatory requirements is essential.
What ICON Can Offer YouOur 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 maximise 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 website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefitsAt ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we’ve done to become a more inclusive organisation. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON 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 through the form below.https://careers.iconplc.com/reasonable-accommodationsInterested 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.
