Clinical Research Associate
An established research-based biotechnology company is advertising a vacancy for a Clinical Research Associate, based in their office in Beijing. The organisation focuses on molecularly targeted and immuno-oncology cancer therapeutics, and prides itself on its pipeline that consists of small molecules and monoclonal antibodies. This is an exciting opportunity to work with a leading company that creates solutions with a meaningful and lasting impact on cancer patients.
- Conducting co monitoring visits, if required.
- Ensuring that study milestones for sites responsible are met as planned (i.e., study start-up, recruitment, database analyses, closeout, etc.).
- Attending onboarding, disease indication and project specific training, and general CRA training as required.
- Documenting monitoring activities appropriately following ICH, GCP, and company standards.
- Conducting Quality Oversight Visits (QOV), as requested.
- Completing monitoring visit/ QOV reports timely.
- Assisting with investigator/site identification.
- Assisting site to prepare Ethics Committee submissions.
- Facilitating clinical trial site contract and budget negotiation.
- Managing site queries and communications.
- Assisting in managing clinical trials, if required.
- Establishing regular lines of communication with sites and COMs.
- Providing protocol and related study training to assigned sites.
- Evaluating the quality and integrity of site practices escalating quality issues as appropriate.
- Managing site performance by tracking regulatory submissions, recruitment, case report form (CRF) completion, and data query resolution.
- Collaborating with CRA Group/CRM to ensure recruitment plans and execute contingency plans, as needed.
- Performing additional task as assigned.
Skills and Requirements:
- Bachelor's level degree or above in life sciences, pharmacy, nursing, or medical.
- Understanding clinical trial processes with a thorough knowledge of ICH and associated regulatory guidelines.
- 1-3 years or more (SCRA) monitoring experience in the pharmaceutical or CRO industry.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Ada Li at firstname.lastname@example.org or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical Staffing is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.