Clinical Research Assistant (CRA)
Job Description
Title: Clinical Research Assistant (CRA)
Company Name: Toxicology Society of Bangladesh (TSB)
Vacancy: Not specific
Job Location: Khulna
Employment Status: Full-time
Educational Requirements:
∎ Bachelor of Medicine and Bachelor of Surgery (MBBS). Having a Master's (MPH, M. Epi, etc.) degree will be added advantages.
Experience Requirements:
∎ 1 to 2 year(s)
∎ The applicants should have experience in the following area(s):
Research Assistance
∎ The applicants should have experience in the following business area(s):
Research Organization
∎ Freshers are also encouraged to apply.
Job Context:
∎ This position should provide clinical support to the 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 the well-being of the participants.
∎ Location: Khulna (Khulna Medical College Hospital)
∎ Reporting to: Site Principal Investigator
∎ Reporting to: Principal Investigator/ Co-investigator
∎ Key Stakeholders:
∎ Other critical stakeholders
∎ Site Trial coordinator, Senior Trial Manager, Research administrator logistics manager, Trial data Associate
Job Responsibilities:
∎ Research assistants (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.
∎ The 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
∎ The 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 the appropriate use of the 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 the patient information sheet & consent form to participants or legally acceptable representatives about the benefits and risks involved in the trials and should adhere to GCP, study protocol, and other applicable ethical principles.
∎ RA must ensure the availability of an informed consent narrative for study monitoring/ audit when required.
∎ The RA should ensure the accuracy, completeness, legibility, and timeliness of the data entry into Case report forms (CRF) or in handheld devices 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 Events and Serious Adverse Events in consultation with the principal investigator in AE/SAE reporting, offline or electronically as per the requirement.
∎ RA must assist the Site trial co-ordinator for Query management & data clarifications as to when required
∎ RA must ensure adequate documentation as per the study requirement.
∎ RA must be responsible for a 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
Additional Requirements:
∎ 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).
Salary:
∎ Negotiable
∎ Mention expected salary and current location in Email or online application.
Job Source: Bdjobs.com Online Job Posting.
Application Deadline: 12 Jul 2022
Company Information:
∎ 28 Jun 2022
∎ Toxicology Society of Bangladesh (TSB)
Category: Medical/Pharma
: Mention your expected salary and current location in the mail.
Deadline Expired on 12th Jul 2022
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