Clinical Research Associate Job Description
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We are seeking a highly skilled Clinical Research Associate to join our team. The successful candidate will be responsible for ensuring the rights and well-being of trial participants are protected, and reported trial data are accurate, complete, and verifiable from source documents.
The Clinical Research Associate will act as the primary contact between investigational sites, sponsors, and our organization, ensuring that clinical trials are conducted in accordance with ICH GCP guidelines, local and global regulatory requirements, and organizational SOPs.
* Key Responsibilities:
* Foster relationships with principal investigators, study coordinators, pharmacists, and other site trial personnel to ensure efficient, expedited, and smooth management of clinical trials.
* Maintain internal and external customer relationships to focus on timely and productive project delivery as per study requirements and timelines.
* Collaborate with in-house Clinical Research Associates and Regulatory Start-up Associates to prepare site essential documents, support ethics and regulatory submission and approval processes, and understand applicable local and international regulatory requirements.
* Ensure participant recruitment as per site targets, drive site recruitment and engagement initiatives, and prepare site-specific recruitment plans.
* Monitor investigational sites according to ICH GCP, including all monitoring visit types across phases of clinical trials, such as site selection, initiation, monitoring, and close-out visits.
Requirements and Qualifications:
* Graduate degree in a clinical or life sciences-related field, or relevant experience/qualifications in allied professions may also be considered.
* Excellent time management skills, attention to detail, ability to work well in a team, and computer literacy are essential.
* Relevant experience in the research, pharmaceutical industry, or related field, depending on job level (CRA II, CRA III, SCRA).
Benefits:
* We offer hybrid working arrangements and flexible working hours to achieve work-life balance.
* Paid parental leave for both parents and flexible leave entitlements.
* Ongoing development programs and wellness initiatives.
About Us:
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 individuals who are passionate about working in clinical research and biotech, including those who identify as LGBTIQ+, have a disability, or have caring responsibilities.