Fresher Research Compliance Officer NGO Jobs – Medical Research Council (MRC) UK / UVRI
Job Title: Research Compliance Officer
Organization: Medical Research Council (MRC) UK / UVRI
Duty Station: Entebbe, Uganda
Reports to: Head of Research Compliance and Quality Assurance
Position Code: RCO619
About US:
The MRC/UVRI Uganda Virus Research Unit on AIDS was established following a request in 1988 from the Uganda Government to the British Government for collaboration on the research of HIV (Human Immunodeficiency Virus) infection and AIDS (Acquired Immunodeficiency. The Unit is a center of excellence in HIV/AIDS related research. It conducts large-scale epidemiological and intervention studies, clinical trials, virological and immunological research and behavioural studies, and has generated a wealth of research results that have been used to inform policy and practice that have led to a large number of scientific publications in peer reviewed journals over time.
Job Summary: The Research Compliance Officer will support the Unit research program with a focus on ensuring that applicable local and international requirements are met while executing research studies at the Unit. S/He will liaise with the investigators and other research staff to ensure compliance with local and international regulatory and ethical guidelines/regulations. S/he will independently monitor research studies conducted at the Unit to ensure the integrity of study related procedures and processes.
Key Duties and Responsibilities:
- Responsible for ensuring that all documentation required to file submissions to the Ethics committees and regulatory bodies are properly prepared, complete and consistent with applicable guidelines
- Responsible for safely keeping regulatory submissions both paper and electronic in clearly labelled files
- Participate in the development and review of standard operating procedures, case report forms, informed consent forms, screening/enrolment logs, roles and responsibility logs among others.
- Should ensure that local and international Ethics and Regulatory approvals are obtained in a timely manner
- S/he should conduct or participate in the conduct of site initiation visit, interim study monitoring visits and close out visits.
- In charge of tracking expiration of various protocol approvals at multiple ethical and regulatory bodies and ensuring that all ongoing studies have valid approvals
- Coordinate correspondences with the Sponsors, PI/Designee, ECs & Regulatory bodies
- Should keep track of all submissions and update PIs of their statuses from time to time
- Should participate in the preparation and maintenance of the investigator site file and trial master file
- Should liaise with the PIs/Designee to develop and track studies for expiry and work with the study team to ensure that continuous approval is sought prior to study expiry
- Seek clearance from Uganda National Health Research Organization (UNHRO) for manuscripts resulting from the Unit research work prior to publications
- Manage translation of Informed consent forms, survey tools and other applicable documents into local languages
- Should ensure that adverse events and protocol deviation are appropriately documented and submitted within the timelines set by the ethics and regulatory bodies.
- Ensure GCP/GCLP compliance of Unit studies
- Ensure that all study staff are appropriately educated, trained and experienced to undertake their duties.
- Responsible for updating and maintaining regulatory records of Unit studies
- Develop and conduct employee regulatory training in liaison with the Unit Training department
- Monitor investigator initiated studies to ensure absolute adherence to Good Clinical Practice in accordance with ICH-GCP standards, Declaration of Helsinki, Good Clinical Laboratory Practice, Local and International Regulatory requirements
- S/he is to work closely with the PIs/Designee to ensure proper adherence to approved protocol, source data and CRF entry verification, review of the investigator Site File etc.
- Act as a point of contact for external monitors. S/he will notify and prepare site research teams on upcoming external monitoring visits/audits
- S/he will be responsible for timely writing and dissemination of internal monitoring reports and following up on action items for both internal and external monitoring reports/audits
- Review internal and external monitoring reports to identify any trends for training needs and liaise with the training department to have the requisite trainings undertaken
- S/he will establish and document internal quality assurance and quality control processes/procedures.
- Oversee the maintenance and tracking of research-staff CVs, GCP, HSP, SOP and protocol- specific trainings; and applicable practicing licenses as per local, international and sponsor requirements/ regulation.
- Ensuring that the operating licenses for the Unit Labs, Pharmacy and Clinics are up-to- date Maintain an inventory of all regulatory documents
- To generate applicable financial related requisitions
Qualifications, Skills and Experience:
- The ideal candidate for the Medical Research Council (MRC) UK / UVRI) Research Compliance Officer job must hold a diploma in a health related field such as Clinical Medicine, Nursing, Pharmacy or Public Health
- Bachelor’s Degree in Clinical Medicine, Nursing, Medicine and Surgery, Public Health or Health Services Management is desired.
- A Masters Degree is an added advantage
- Two years of work experience in a research setting.
- Should have training in GCP and or GCLP.
- Should have an understanding of local and international research guidelines.
- Knowledge of health research or should be interested in research.
- Excellent communication skills
- Should be knowledgeable in use of Microsoft Office packages
- Excellent organisation and management skills
- Ability to work independently and meeting tight deadlines
- Should be highly organised and demonstrate ability to organise, plan and prioritise work.
Competencies:
Core:
- Personal Integrity
- Emotional Resourcefulness
- Ability to Learn
- Forward Thinking
- Reliability
- Team Player
- Openness to Others
- Independence
- Proactivity
- Results Orientation
- Thoroughness
- Concern for Excellence
- Flexibility Towards Work
- Development Oriented
How to Apply:
The candidates should send their application letters, curriculum vitae including names, email addresses and telephone contact details of three (3) referees, plus copies of academic qualifications should be e-mailed to recruitment@mrcuganda.org. NB: Please quote the following position code in the subject line of the email: RCO619. Please also fill the following online form accordingly after submitting the application documents on the e-mail above. Click Here
Address to:
The Human Resource and Administration Manager
MRC/ UVRI and LSHTM Uganda Research Unit
P.O. Box, 49 Entebbe.
Uganda
NB: Only shortlisted candidates will be contacted for interviews. Note that academic qualifications will be subjected to verification by the issuing institutions. Please note that the Unit became part of the London School of Hygiene and Tropical Medicine effective 1st February 2018.
Deadline: 12th July 2019 by 5:00om
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