Internal Monitor - Clinical Trials

Job Description

Title: Internal Monitor - Clinical Trials

Company Name: Projahnmo Research Foundation

Vacancy: --

Age: At least 24 years

Job Location: Dhaka, Sylhet

Salary: --

Experience:

• At least 1 year
• The applicants should have experience in the following business area(s): NGO

• MBBS, Master of Pharmacy, Master's degree in a relevant discipline such as Clinical Pharmacy, Public Health, Biomedical Sciences, Life Sciences, or another related field from a recognized university.

• At least 1 year
• The applicants should have experience in the following business area(s): NGO

• Age At least 24 years

Experience

• Minimum one (1) year of relevant professional experience in clinical trial monitoring, clinical research, quality assurance, or a related area.

• Practical experience working with clinical trials or health research projects is strongly preferred.

• Experience reviewing source documents, CRFs/eCRFs, informed consent documentation, and essential trial documents will be an advantage.

Required Knowledge and Skills

• Good understanding of ICH-GCP principles and clinical trial requirements.

• Knowledge of clinical trial protocols, informed consent procedures, protocol deviations, adverse-event reporting, and trial documentation.

• Ability to review study documents systematically and identify discrepancies and compliance issues.

• Strong attention to detail and commitment to research quality and participant safety.

• Good analytical, problem-solving, and report-writing skills.

• Good communication and interpersonal skills.

• Ability to work independently and collaboratively with multidisciplinary research teams.

• Proficiency in Microsoft Office applications and familiarity with electronic data-capture systems will be an advantage.

• Willingness to travel to trial sites as required.

Preferred Competencies

• GCP training/certification will be an advantage.

• Strong organizational and time-management skills.

• High level of integrity, confidentiality, and professional accountability.

• Ability to provide constructive feedback and work effectively with study teams to resolve monitoring findings.

• Commitment to high-quality clinical research and protection of trial participants.

Projahnmo Research Foundation (PRF), in association with Johns Hopkins University, USA has a long and illustrious history of conducting research in Bangladesh. PRF’s research has contributed to improvement of health of Bangladeshi citizens and has supported the career development of numerous Bangladeshi public health professionals. PRF is seeking qualified and motivated applicants from Bangladeshi nationals for the position of Internal Monitor for Clinical Trials.

Duty Station: Sylhet/Dhaka

Job Nature: Fixed term.

Job Summary

We are seeking a qualified and motivated Internal Monitor to support the implementation and quality oversight of clinical trials. The Internal Monitor will monitor trial activities to ensure compliance with Good Clinical Practice (GCP), approved trial protocols, Standard Operating Procedures (SOPs), regulatory requirements, and study-specific procedures.

The position will work closely with investigators, study managers, clinical and laboratory teams, data-management staff, and other relevant personnel to identify compliance issues, ensure timely corrective actions, and maintain high standards of trial conduct and documentation.

Key Responsibilities

• Conduct routine internal monitoring of clinical trial activities according to approved monitoring plans, study protocols, GCP, and applicable regulatory requirements.

• Verify that trial activities are conducted in accordance with the approved study protocol, informed consent procedures, SOPs, and GCP requirements.

• Review source documents, Case Report Forms (CRFs/eCRFs), study registers, participant files, and other essential trial documents for completeness, accuracy, consistency, and timeliness.

• Perform Source Data Verification (SDV) and ensure consistency between source documents and data entered into study databases or CRFs.

• Review the informed consent process and documentation to ensure that informed consent is obtained and documented appropriately.

• Monitor participant eligibility, enrollment, randomization, intervention administration, follow-up, and outcome assessment according to the study protocol.

• Review documentation and reporting of Adverse Events (AEs), Serious Adverse Events (SAEs), protocol deviations, and protocol violations.

• Ensure appropriate documentation, accountability, storage, dispensing, and reconciliation of investigational products, where applicable.

• Review Investigator Site Files, Trial Master Files, and other essential documents to ensure they are complete, current, and properly maintained.

• Identify protocol deviations, GCP non-compliance, documentation errors, and other quality issues and promptly communicate findings to the relevant study team.

• Prepare clear and timely monitoring reports, including findings, recommendations, and required corrective actions.

• Follow up on monitoring findings and ensure timely completion of Corrective and Preventive Actions (CAPA).

• Support trial sites in preparing for sponsor monitoring visits, audits, ethics committee reviews, and regulatory inspections.

• Assist in maintaining trial readiness for internal and external audits.

• Provide guidance and support to study staff on GCP, protocol compliance, documentation, and quality requirements.

• Participate in study initiation meetings, training sessions, monitoring meetings, and other trial-related activities.

• Maintain confidentiality of participant information and study data.

• Perform any other trial monitoring or quality-assurance responsibilities assigned by the supervisor.

• Salary: Competitive. (Salary can be negotiable based on qualifications and experience)

• Benefit: 12% retirement fund contribution by PRF will be given as per organizational policy.