Senior Clinical Research Associate
Senior Clinical Research Associate
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Salary Not Disclosed
1 Vacancy
Job Description
Were searching for a knowledgeable teamoriented Senior CRA to manage the clinical aspects of fullservice global projects in Malaysia. As a Senior CRA at PSI you will work on the frontline of communication with project stakeholders ensuring the successful conduct of clinical trials in a variety of therapeutic indications. You will maintain the highest quality standards in the industry while performing and supervising study startup clinical monitoring and site management activities on the country/regional level.
You will become one of our first team members in Malaysia and contribute to the development of PSI Operations.
You will:
- Supervise study activities timelines milestones and schedules on the country level.
- Conduct and report all types of onsite monitoring visits.
- Be involved in study setup including site contract and budget negotiations.
- Be responsible for site communication and management.
- Ensure consistency of all study processes and identify country differences.
- Oversee maintenance of studyspecific and corporate tracking systems.
- Contribute to the development and update of project planning documents essential documents and project instructions.
- Be a point of contact for inhouse support services contractors global crossfunctional teams and vendors.
- Responsible for execution and oversight of clinical trial country submissions and approvals for assigned protocols.
- Development of local language materials including local language Informed Consents and translations.
- Works in partnership with IRB/IEC and Regulatory Authority in submission and approvalrelated interactions for assigned protocols.
Qualifications :
The ideal candidate must possess the following qualifications:
- Bachelors degree in Life Sciences Pharmacy or Registered Nursing; or an equivalent combination of education training and experience. Registered pharmacists are strongly preferred.
- Minimum of 45 years of demonstrable independent onsite monitoring experience or equivalent expertise.
- Extensive experience in conducting all types of monitoring visits in Phase II and/or III clinical trials.
- Proficiency in feasibility assessment and study setup processes is highly desirable.
- Specialized experience in Oncology or Hematology therapeutic indications is a significant advantage.
- Demonstrated ability to plan effectively multitask efficiently and thrive in a dynamic team environment.
- Superior communication collaboration and problemsolving skills are essential.
- Willingness and ability to travel extensively within Malaysia is a prerequisite for this position.
Remote Work :
Yes
Employment Type :
Fulltime
Employment Type
Remote
