সিলেটের চাকরির খবর
Job title: Research Assistant (RA)
Job description: Job Context
- This position should provide clinical support to site principal investigator (PI) for proper conduction of CCBOC study at the site as per the study protocol, regulatory guidelines & ICH-GCP. He / She is responsible for the proper medical care of the study participants. He/ She will be conducting the study following the protocol with adequate compliance.
- The research assistant is also obligated to ensure the project is conducted in compliance with applicable as per the protocol and applicable laws and regulations to ensure well-being of the participants.
- Location: Sylhet(Sylhet MAG Osmani Medical College Hospital)
- Reporting to: Site Principal Investigator
- Reporting to
- Principle Investigator/ Co-investigator
- Key Stakeholders:
- Other critical stakeholders
- Site Trial coordinator, Senior Trial Manager, Research administrator logistics manager, Trial data manager
- Research assistant (RA) should be aware and comply with, Good Clinical Practice and the applicable regulatory requirements.
- RA should be thoroughly familiar with the appropriate use of the investigational product(s), as described in the protocol.
- Research assistant should ensure that all persons assisting with the trial are informed about the protocol, the investigational product(s) and he/ she might have to take the informed consent of the research participants
- Research Assistant might be responsible for all trial-related medical decisions after consultation with the principal or co- investigators
- The RA should conduct the trial in compliance with the protocol to avoid any protocol deviation or violation
- The RA should ensure appropriate use of investigational medicinal product (IMP) in accordance with the approved protocol, working process document/ SOPs.
- RA should screen and randomize the patients as per the study protocol.
- The RA is responsible for describing the details of patient information sheet & consent form to participants or legally acceptable representative about the benefits and risk involve in the trials and should adhere to GCP, study protocol and other applicable ethical principles.
- RA must ensure availability of informed consent narrative for study monitoring/ audit as when required.
- The RA should ensure the accuracy, completeness, legibility, and timeliness of the data entry into Case report forms (CRF) or in handheld device throughout the study. Data reported in the CRF, that are derived from source documents, should be consistent with the source documents or the discrepancies should be explained.
- RA must ensure adequate reporting of Adverse event and Serious Adverse Event in consultation with the principal investigator an in AE/SAE reporting, offline or electronically as per the requirement.
- RA must assist Site trial co-ordinator for Query management & data clarifications as when required
- RA must ensure adequate documentation as per the study requirement.
- RA must be responsible for blood sample collection from the research participants, processing and storage of it as per the study protocol
- Support Study monitoring or audit as when required
- Work at office
- Bachelor of Medicine and Bachelor of Surgery (MBBS). Having a Master’s (MPH, M. Epi, etc.) degree will be added advantages.
- 1 to 2 year(s)
- Minimum 1-2 years of Clinical trial experience is preferred
- Experience in international clinical research projects will be preferred
- Critical thinking and problem-solving skills,
- Decision-making, planning and organizing skills
- Excellent communication skills
- High level of work ethics, detail-oriented
- Excellent coordination and organizational skills.
- Fluency in both languages English and Bangla is compulsory
- Good leadership skills
- Must be a team player
- Knowledge of Good Clinical Practice (GCP).
Job date: Fri, 25 Dec 2020 05:58:17 GMT
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