Senior Clinical Research Associate Role Overview
We are seeking a skilled and experienced Senior Clinical Research Associate to join our team. The successful candidate will be responsible for monitoring clinical trials, ensuring that projects are conducted in accordance with applicable SOPs, regulations, and ICH guidelines.
Job Description
The Senior CRA will take responsibility for all aspects of the study at sites, including site qualification visits, feasibility, site selection, and start-up activities. This will involve leading the preparation of Human Research Ethics Committee submissions with sites, negotiating site budgets, and assisting with the execution of site contracts.
The successful candidate will also perform site initiation visits, interim monitoring visits, and site close-out visits. They will oversee all aspects of study site management to ensure high-quality data and maintain eTMF filing and study tracking in Clinical Trial Management System (CTMS).
Key Responsibilities:
* Monitor clinical trials and ensure compliance with SOPs, regulations, and ICH guidelines
* Perform site qualification visits and lead the preparation of Human Research Ethics Committee submissions
* Negotiate site budgets and assist with contract execution
* Perform site initiation, interim monitoring, and close-out visits
* Oversight of study site management to ensure high-quality data
* Maintenance of eTMF filing and CTMS study tracking
Required Skills and Qualifications
To be successful in this role, you will need:
Requirements:
* An Undergraduate degree in Life Sciences
* At least 3-4 years' experience in monitoring clinical trials in CRO, Pharmaceutical, and/or Biotechnology industry as a SCRA/CRA
* Experience in managing early phase oncology trials is highly preferred
* Experience in EDC & CTMS
* Experience in site management from feasibility, start-up, to site close-out
* Contract negotiation and HREC submission preparation skills desirable
* Understanding of ICH-GCP requirements, particularly for site management
Benefits
We offer a range of benefits to support your career and wellbeing, including:
Employee Benefits:
* Opportunities for professional growth and development
* A supportive and collaborative work environment
* Competitive salary and benefits package
* Flexible working arrangements
About Us
By joining our team, you will be part of a dynamic and progressive organization dedicated to delivering high-quality cancer care.
Covid 19 Vaccination Requirement
All employees are required to be fully vaccinated for COVID-19.