Title: Site Trial Coordinator
Company Name: Toxicology Society of Bangladesh (TSB)
Job Location: Rajshahi
Employment Status: Full-time
∎ Masters degree in any discipline
∎ A basic degree in Health or Life Science related discipline OR a degree in any other (Arts/ Commerce/Business Administration/ Human resource management/ Public administration) discipline with at least one-year working experience in the health-related research projects, clinical trial projects OR Certificate/diploma in health-related or Science discipline with 5 years working experience in the project coordinating task.
∎ Having a Master's in Business Administration (MBA) or Advanced certificate course in Human Resource Management or Master in Public Health/Clinical Trials will be preferred
∎ At least 1 year(s)
∎ The applicants should have experience in the following area(s): Administration, Coordination, Finance, Project Management/ Co-ordinator, Research Support
∎ Freshers are also encouraged to apply.
∎ Reports To: Site Principal Investigator / Senior Trial Manager (UOE).
∎ Job purpose: Provide a vital link between Clinical sites and TSB/UoE main office to implement the project process and systems in the sites. Ensure the day to day smooth functioning of investigator sites in terms of Patients Recruitment, Database Audit, Clinical trial Logistics and study documentations etc.
∎ Position Summary: Oversees site operational aspects of all clinical studies in the site and lead the in-house project staff (Clinical Research Fellow - CRF and Research Assistant-RA) toward maximum productivity of the site.
∎ Key Relationships
∎ Team members directly interacting with this position
∎ RAs, CRFs, Senior Trial Manager, RALM, Data Manager
∎ Other stakeholders
∎ Principal Investigators / Co-Investigators
∎ Postgraduate fellows
∎ Local collaborators: Study Physicians/Ward & Hospital Staff
∎ Hospital Staffs
∎ This position is accountable for achieving the site functional goal of organizing high-quality participant recruitment to the clinical studies/other projects.
∎ Support the timely recruitment of trial participants with secure randomization processes and subsequent efficient and effective Cohort/RCT data management.
∎ Responsible for the site study database audit.
∎ Maintain a database that records details of clinical trial shipments, and in collaboration with the dedicated clinical trial logistics officials (i.e. Logistics Manager) ensure that there are adequate supplies of clinical trial materials & drugs to meet study needs (i.e. sampling tubes, syringes, reagents etc.). Plan, order and distribute drug & non-drug clinical trial supplies e.g. clinical supplies etc.
∎ Responsible for working roster of site research staff (CRF and RA).
∎ Responsible for the specimen collection and storage in the sites & shipment. Inspecting and logging in patient specimens.
∎ Ensure good documentation practice in the entire study
∎ Adequate compliance of study protocol & processes, report any deviations/ violations as per the process to Senior Trial Manager
∎ Support PI in AE/SAE reporting
∎ Responsible for managing the case report and consent forms and other audit documents (electronic and paper hard copy as appropriate) in terms of file arrangements, backups, accuracy and quality of the data contents.
∎ Responsible for Query management & data clarifications as when required
∎ Responsible for the preparation of monthly study recruitment progress report and maintaining a detail excel audit sheet as per respective principal study requirement.
∎ Key Performance Indicators (KPIs)
∎ patient recruitments according to SOP /study guidelines
∎ No. of case reports on required cases
∎ No of quality study database reports per specific time period. (Study Progress, SACTRC Wiki, Data pack)
∎ Data Record Collected = Data Record Possible - No. of Invalid Records.
∎ Experience in international clinical research projects will be preferred
∎ Critical thinking and problem-solving skills,
∎ Decision-making, planning and organizing skills
∎ Communication skills
∎ Good analytical skills for recruitment forecasts
∎ High level of work ethics
∎ Conflict management, adaptability and stress tolerance.
∎ Fluent in Microsoft (Excel, Word, Powerpoint, Outlook)
∎ Good coordinating and organizational skills.
∎ Fluency in both languages English and Bangla
∎ Good leadership skills
∎ Excellent documentation skills
∎ Knowledge of Clinical data management and Good Clinical Practice (GCP) would be an added advantage.
∎ Able to work independently with minimum supervision.
∎ A helpful and flexible attitude and ability to relate to colleagues of all levels.
∎ Willing to travel for field visits.
Job Source: Bdjobs.com Online Job Posting.
Application Deadline: 21 Oct 2021
∎ 2 Oct 2021
∎ Toxicology Society of Bangladesh (TSB)
: Only Shortlisted candidates will be asked for the interview.Mention Expected salary in email.