Job Description

Title: Site Trial Coordinator

Company Name: Toxicology Society of Bangladesh (TSB)

Vacancy: 01

Age: 25 to 40 years

Location: Barishal (Barishal Sadar)

Salary: Negotiable

Experience:
∎ 2 to 3 years
∎ The applicants should have experience in the following business area(s):Hospital, Research Organization
∎ Freshers are also encouraged to apply.

Published: 15 Mar 2025

Education:
∎ Bachelor of Medicine and Bachelor of Surgery(MBBS), Bachelor/Honors, Bachelor of Science (BSc), Master of Science (MSc)

Requirements:

Additional Requirements:
∎ Age 25 to 40 years
∎ Experience in international clinical research projects will be preferred.
∎ Critical thinking and problem-solving skills.
∎ Excellent documentation skills.
∎ Quick learner & ability to assume responsibility.
∎ Technology Proficiency.
∎ Demonstrated ability to multi-task and prioritize in a fast-paced environment.
∎ Ability to exercise standards of professionalism, including appearance, presentation and demeanor.
∎ Effective communication and Interpersonal skills.
∎ Excellent coordination and organizational skills.
∎ Fluency in English (Verbal & written).Negotiation & leadership skills.
∎ Teamwork.
∎ Knowledge of Good Clinical Practice (GCP) & Clinical data management.
∎ Experience in international clinical research projects will be preferred.
∎ Critical thinking and problem-solving skills.
∎ Excellent documentation skills.
∎ Quick learner & ability to assume responsibility.
∎ Technology Proficiency.
∎ Demonstrated ability to multi-task and prioritize in a fast-paced environment.
∎ Ability to exercise standards of professionalism, including appearance, presentation and demeanor.
∎ Effective communication and Interpersonal skills.
∎ Excellent coordination and organizational skills.
∎ Fluency in English (Verbal & written).Negotiation & leadership skills.
∎ Teamwork.
∎ Knowledge of Good Clinical Practice (GCP) & Clinical data management.

Responsibilities & Context:
∎ Be aware of and comply with Good Clinical Practice guidelines and the applicable regulatory requirements.
∎ Be responsible for managing the poisoning and envenomation cases of this project effectively.
∎ Be 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.
∎ Oversee the collection, organization, and analysis of research data related to poisoning and envenomation cases.
∎ Responsible for duty roster of site research staff (CRA and CRN).
∎ Responsible for the specimen collection and storage in the sites & shipment, Inspecting and logging in patient specimens.
∎ Support PI in AE/SAE reporting.
∎ Ensure data quality and accuracy, adhering to ethical guidelines.
∎ 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 to meet study needs (i.e. sampling tubes, syringes, reagents etc.).
∎ Maintain regular communication with project team members, collaborators, and stakeholders.
∎ Ensure good documentation practice in entire study. Adequate compliance of study protocol & processes, report any deviations/ violations as per the process to Junior Trial Manager.
∎ 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 the monthly study recruitment progress report and maintaining a detailed excel audit sheet as per respective principal study requirements.
∎ Perform any other job-related duties as required.
∎ 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.
∎ Data entry
∎ Principal Investigator/ Co-Principal Investigator.
∎ Job Purpose
∎ Toxicology Society of Bangladesh (TSB) is the pre-eminent national professional organization dealing with poisoning and envenoming in Bangladesh. It was formally established in 2008 by a group of medical toxicologists with an aim to assemble interested people and actively involved in research on poisoning and envenoming over the preceding decades. Members are mostly clinicians and focused on toxicology. This position will provide clinical and administrative support to the site principal investigator (SPI) for proper conduction of the poisoning and envenomation project. He/ She will be conducting the study following the protocol with adequate compliance and 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 documentation etc.
∎
∎ Position Summary
∎ The Site Trial Coordinator will oversee and manage research project related to poisoning and envenomation, including data collection, analysis, reporting, and stakeholder collaboration. This role involves coordinating multidisciplinary research teams, ensuring ethical compliance, and contributing to advancements in prevention, diagnosis, and treatment of poisoning and envenomation cases. Oversee site operational aspects of all clinical studies in the site and lead the in-house project staff (Clinical Research Assistant (CRA) and Clinical Research Nurse (CRN) toward maximum productivity of the site.
∎
∎ Key Responsibilities
∎ Be aware of and comply with Good Clinical Practice guidelines and the applicable regulatory requirements.
∎ Be responsible for managing the poisoning and envenomation cases of this project effectively.
∎ Be 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.
∎ Oversee the collection, organization, and analysis of research data related to poisoning and envenomation cases.
∎ Responsible for duty roster of site research staff (CRA and CRN).
∎ Responsible for the specimen collection and storage in the sites & shipment, Inspecting and logging in patient specimens.
∎ Support PI in AE/SAE reporting.
∎ Ensure data quality and accuracy, adhering to ethical guidelines.
∎ 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 to meet study needs (i.e. sampling tubes, syringes, reagents etc.).
∎ Maintain regular communication with project team members, collaborators, and stakeholders.
∎ Ensure good documentation practice in entire study. Adequate compliance of study protocol & processes, report any deviations/ violations as per the process to Junior Trial Manager.
∎ 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 the monthly study recruitment progress report and maintaining a detailed excel audit sheet as per respective principal study requirements.
∎ Perform any other job-related duties as required.
∎
∎ Key Performance Indicators
∎ 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.
∎ Data entry
∎
∎ Key Stakeholders
∎ Principal Investigator/ Co-Principal Investigator.
∎
∎ Other critical stakeholders
∎ Senior Trial Manager (UOE), Junior Trial Manager, Research Administrator & Logistics manager, Finance Manager, Data Manager.

Skills & Expertise:

Workplace:
∎ Work at office

Employment Status: Contractual

Job Location: Barishal (Barishal Sadar)

Company Information:
∎ Toxicology Society of Bangladesh (TSB)
∎ 14/14, Block:A, Road No.:1, Shugandha R/A, Panchlaish-4203

Address::
∎ 14/14, Block:A, Road No.:1, Shugandha R/A, Panchlaish-4203

Read Before Apply: Please apply only who are fulfilling all the requirements of this job

Application Deadline: 19 Mar 2025

Category: Research/Consultancy