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About the Role

The Clinical Research Associate (CRA) ensures the rights and wellbeing of trial participants are protected and that trial data is accurate, complete, and verifiable. The CRA serves as the primary contact between investigational sites, Novotech, and the Sponsor, managing site relationships to ensure clinical trials comply with ICH GCP guidelines, regulatory requirements, and company SOPs.

Responsibilities

Build relationships with Principal Investigators, study co-ordinators, pharmacists, and relevant site trial personnel for efficient clinical trial management.
Foster internal and external customer relationships to ensure efficient, timely, and productive project delivery.
Prepare site essential documents and support ethics and regulatory submission processes in collaboration with IHCRA and RSA.
Understand local and international regulatory requirements relevant to specific clinical trials in collaboration with the RSU Team.
Ensure participant recruitment meets site targets and drive recruitment initiatives with site-specific plans.
Monitor investigational sites according to ICH GCP and the Clinical Monitoring Plan (CMP), including all visit types (selection, initiation, monitoring, close out, pharmacy, co-monitoring) either onsite or remotely.
Ensure participant rights and wellbeing, including consent form checks, eligibility confirmation, protocol compliance, investigational drug compliance, and review of Adverse Events/SAEs, reporting safety issues promptly.
Verify trial data accuracy and completeness, ensuring CRF data and queries are completed and resolved per study timelines.
Ensure study drug is appropriately stored, dispensed, accounted for, and reconciled per the CMP and Protocol.
Ensure the project Trial Master File (TMF) is up-to-date, current, and complete throughout the study duration.
Support sites in being audit and inspection ready.
Ensure all clinical trial management systems are current and up-to-date with relevant trial data.
Provide written and verbal site updates, including monitoring visit reports, to the PM/LCRA according to study requirements and SOPs, escalating key issues as per SOP.
Collaborate with IHCRA or DMA team on site payments, ensuring execution as per the Clinical Trial Agreement.
Assist the PM with the development of study-related project plans and templates and support study execution tasks.

Requirements

Graduate in a clinical or life sciences-related field.
Relevant experience/qualifications in allied professions may be considered.
Good time management skills.
Attention to detail.
Ability to work well in a team.
Computer literate.
Experience of working in the research, pharmaceutical industry or a related field is preferred, per job level.
CRA II: Approximately 1-2 years of Clinical Research Associate experience or equivalent experience (CRA II fast track) in other roles in the Clinical industry.
CRA III: At least 2-3 years of Clinical Research Associate experience in the Clinical industry.
Sr. CRA: At least 3-5 years of Clinical Research Associate experience in the Clinical industry.

Experience Level

CRA II: Approximately 1-2 years of Clinical Research Associate experience or equivalent experience (CRA II fast track) in other roles in the Clinical industry.
CRA III: At least 2-3 years of Clinical Research Associate experience in the Clinical industry.
Sr. CRA: At least 3-5 years of Clinical Research Associate experience in the Clinical industry.

Education Level

Graduate in a clinical or life sciences-related field.

Salary/Compensations

$70,000 – 140,000 Salary offered will be based on candidates experience level.

Benefits

Flexible working options
Paid parental leave for both parents
Flexible leave entitlements
Wellness programs
Ongoing development programs
NovoLife, our flexible benefits framework

About the Company

Novotech is a global full-service clinical Contract Research Organization (CRO).
At Novotech, ambition meets opportunity.
As a globally recognized leader in clinical research and scientific advisory services, we are proud to combine our position at the forefront of the industry with an award-winning workplace culture that values ambition, innovation, and growth.
Named Employer of Choice, Great Place to Work and Employer of Choice for Gender Equality (EOCGE), we are committed to fostering an environment that reflects the life-changing work we do.
Since 1997, we have expanded our global footprint, now with 30+ offices across Asia-Pacific, the United States, and Europe.
This growing network unites professionals from diverse backgrounds and disciplines to advance therapies that improve patient outcomes worldwide.
At Novotech, our employees are at the heart of our success.
By offering trust, flexibility, and autonomy through programs like NovoLife, our flexible benefits framework, we empower team members to create an effective work-life balance that delivers professional satisfaction and maximum results for clients.
With access to mentorship opportunities, professional development programs, and a dynamic community, Novotech offers a platform for driven individuals to achieve personal growth while shaping the future of healthcare.
Join us to be a part of a team that values your contributions and supports your ambition to make a global impact.
At Novotech we have advanced therapeutic and regulatory expertise, the ability to execute across markets and a client-centric service model, so that our clients get a trusted, long-term partner and an accelerated path to bring their life-changing advances to market.
This gives our employees the opportunity to develop their careers by joining a diverse and supportive global organization with a collaborative culture, whilst working with clients on the cutting-edge of life sciences.
At Novotech you will work alongside empowered teams with a shared commitment to success.
Strategic vs transactional mindset.
Ability to gain insights and make proactive decisions quickly.
Culture that fosters partnership and collaboration, where every voice is heard and valued.
Ongoing support from senior stakeholders and leadership team.

Equal Opportunity

We are committed to being an employer of choice for gender equality and providing an inclusive work environment where everyone is treated fairly and with respect.
We are looking for people who are passionate about working clinical research and biotech, including people who identify as LGBTIQ+, have a disability or have caring responsibilities.
We are a Circle Back Initiative Employer and commit to respond to every application.