Overview
We are seeking motivated individuals with good interpersonal skills and desire for a challenging career in a university health system to join us on a rewarding career journey, as we grow our team of clinical research specialists. We will provide the training for exceptional candidates who have no prior clinical research experience.
Roles and Responsibilities:
- Assist investigators in screening, determining eligibility, recruitment, and follow-up visits of enrolled subjects
- Assist investigators in obtaining informed consent and documenting of informed consent process
- Assist investigators in collection of clinical data and biological samples, trace lab reports and maintenance of research database.
- Assist investigators in safety reporting to DSRB and HSA within stipulated timelines
- Assist in drafting DSRB ethics application, HSA clinical trial authorization application, amendments, and status reports
- Communicate with site study team members regarding any trial updates (protocol amendments, safety reports)
- Maintain Investigator Site File and ensure that all documents are complete and up to date
- Compliance with the ICH GCP, HBRA, HSA, IRB, and other applicable regulatory and ethical requirements as well as hospital policies
- Develop and maintain records of research activities, and prepare periodic and ad hoc reports, as required by investigators, administrators, funding agencies, and/or regulatory bodies
- Perform sample processing in the laboratory for further research analysis & storage of the samples.
- Perform administrative duties and ad-hoc projects as assigned by the supervisor.
Requirements:
Skills and Knowledge
- Analytical, quantitative and good communication skills (written & verbal).
- Be computer literate in Microsoft Word / Excel
Personal Traits
- Able to work well with different groups of staff, demonstrate team spirit.
- Positive, motivated, able to manage pressure, takes initiative.
- Able to work meticulously and independently
Educational Qualifications
- Diploma/ bachelor's degree in nursing / life science / healthcare related courses
- Previous work experience in clinical research/nursing will be an added advantage