Research Compliance Manager -Monitoring job at MRC/UVRI and LSHTM Uganda Research Unit
Job Purpose
The position holder will work in the Research Governance Department to ensure that clinical trials and other studies at the MRC/UVRI and LSHTM Uganda Research Unit (the “Unit”) and collaborating institutions are conducted in line with GCP and applicable ethical and regulatory requirements. This involves regular reporting on oversight and support activities to the Head of Research Governance.
The post-holder will support investigators and their teams to develop study specific procedures and provide input and advice on best practice at all stages of study conduct. The post-holder promotes high quality research and compliance by engaging with research teams in a positive manner through trainings, workshops and ad hoc meetings. The role is an essential link between activities in the field/trial site and the Sponsor. Where The Unit is delegated/acts as the clinical trial Sponsor, the Research Compliance Manager-Monitoring supports the delivering of appropriate Sponsor oversight. Where The Unit is not the Sponsor, the Research Compliance Manager-Monitoring supports the investigator in meeting local ethics, regulatory and The Unit’s/LSHTM’s requirements.
Roles & Responsibilities
Clinical trial monitoring;
• Support development of risk-based monitoring plan;
• Conduct pre study/site selection visits, site initiation visits including participating in the activation/green light process, interim visits and close-out visits;
• Provide on-site monitoring according to the clinical trial protocol, monitoring plan and Unit procedures;
• Review informed consent process and documentation at trial site;
• Review source data, Serious Adverse Events (SAE) and all trial related documentation for accuracy, contemporaneity and completeness;
• Positively and effectively communicate and discuss monitoring findings with investigator teams;
• Facilitate the development and implementation of corrective action plans;
• Prepare accurate and timely monitoring reports and follow-up letters;
• Follow-up issues and corrective actions consistently, effectively and timely;
• Proactively engage research teams to pre-emptively identify and address areas of concern;
• Deliver a range of remote monitoring activities, including review of trial data;
• Critically review monitoring reports for trials monitored by external parties, including acting as a point of contact for external monitors;
• Participate in internal and external audits/inspections;
• Participates in the maintenance of the Investigator Site File (ISF) and Trial Master File (TMF) where applicable;
• Check trial facilities are adequate, including storage areas (drugs, records), labs, spaces for treatment and informed consent storage and other areas;
• Confirm investigational products are handled, stored and used in line with the protocol, Investigational Product (IP) Manual and Unit Standard Operating Procedures (SOPs);
• Ensure samples and records are stored appropriately with adequate environment controls; and,
• Participate in reciprocal monitoring of studies conducted at the Unit and collaborating institutions.
Clinical trial support;
• Act as a focal point for communication with the trial team for Unit sponsored trials and contact site staff regularly;
• Register clinical trials on public databases and update entries, as required;
• Ensure that SAEs and other reportable events are well documented and appropriately reported and followed up;
• Review Data Safety Monitoring Board (DSMB) and Trial Steering Committee (TSC) charters for Unit Sponsored trials, as applicable;
• Oversee that Unit sponsored studies are well managed and delivered to expected timelines;
• Maintain appropriate Sponsor records for Unit sponsored trials;
• Ensure that trials are conducted in line with the principles of ICH Good Clinical Practice
• (GCP), regulatory requirements and ethical guidelines;
• Participate in ensuring compliance to GCLP and ISO 15189 including re-accreditation activities;
• Participates in preparing regular trial updates to oversee recruitment rate and compliance;
• Train staff on the ethical and regulatory requirements, GCP, HSP, study protocols, consenting procedures, study tools and SOPs among others in liaison with the training department whenever applicable;
• Participate in trainings conducted by the department;
• Pro-actively participate in guiding and supporting investigators in completing pre-trial activities required for Sponsor study-start approval; and,
• Support development and review of trial-specific risk assessments.
Others;
• Participate in the development and review of Department/Unit SOPs;
• Participate in meetings;
• Maintain department databases, trackers and resources;
• Support department administration;
• Drive and advocate for good research practice at the Unit;
• Collaborate and work closely with the study teams;
• Willing to undertake local and international travels to undertake monitoring activities; and,
• Undertake any other duty assigned by their line manager within the broader remit of the post.
Line Management Responsibilities;
• The Job holder provides support to the clinical trial monitors and the clinical trial assistants.
LSHTM Integration;
• Participate positively and proactively in the process of integrating and harmonizing procedures across all LSHTM sites; and,
• Participate in activities across the Unit in Uganda and Gambia, and the wider LSHTM.
Environment;
• Develop strategies to reduce adverse environmental impact of the Research Governance department;
• Participate in carbon emission reduction activities across the Unit and wider LSHTM; and,
• Act as an advocate for the responsible and efficient use of resources.
Person Specification
• Bachelor’s degree in Nursing or Clinical Medicine or a Diploma in Nursing or Clinical Medicine and a relevant degree;
• Masters in Clinical Trials, Public Health or a Post Graduate Diploma in a Research related field.
• Training in clinical trial monitoring and or certification;
• Should possess training in Human Subjects Protection;
• Training in Good Clinical Practice;
• At least 3 years of experience in conducting research;
• At least 3 years of experience in conducting clinical trial monitoring;
• Experience in conducting trainings including GCP, SIV trainings etc.;
• Experience in auditing or being audited by Sponsor and regulatory bodies;
• Should have comprehensive understanding of local and international research guidelines and regulations across multiple disciplines;
• Should demonstrate knowledge and experience with research methods;
• Self-driven;
• Hardworking;
• Team work;
• Enthusiastic about research; and,
• Excellent communication skills demonstrating both open and clear communication
Application Procedure
Follow the link below to fill a form and submit your application documentation:
https://redcap.link/Research_Compliance_Manager_Monitoring
Filling the form more than once will lead to automatic disqualification. High level of integrity while filling the form is required and will be considered during shortlisting.
Combine all your application documentation i.e. cover letter, CV & certified copies of academic documents into one PDF document. Deadline for application is 20th October 2023, 5:00pm. Only shortlisted candidates will be contacted for interview. This position is open to Ugandan nationals only. Strictly follow the application procedure as failure to do so will lead to automatic disqualification. Only online applications through the link provided will be accepted. You will receive a notification in your email if your application and documentation have been successfully received.
N.B: You will be required to present certified copies of your academic documentation before employment.
The applications should be addressed to:
The Head of Human Resources,
MRC/ UVRI and LSHTM Uganda Research Unit,
P.O. Box, 49, Entebbe, Uganda.
Consider your application unsuccessful if not contacted within eight (8) weeks after the closing date of the advert. Any form of lobbying at any stage will lead to automatic disqualification. By submitting your personal information, you consent to the MRC/ UVRI and LSHTM Uganda Research Unit holding and using it in accordance with its recruitment policy and procedure. The Unit reserves the right to verify documents attached with the relevant awarding institutions to authenticate their validity.
