Study Site Manager (M/F) at Alliance for International Medical Action (ALIMA)

Post Description

• The INTEGRATE trial is a multinational, multicentre, controlled, randomized, adaptative phase II-III platform superiority trial with open-label parallel arms. The primary objective of the trial is to compare the efficacy of interventional medical products (IMPs) to standard of care drug (SCD) on prevention of death or organ failure in hospitalized participants with confirmed LF.
• We are looking for a Study Site Coordinator who will ensure the proper conduct of the INTEGRATE study at the Owo site. This includes ensuring compliance with the study protocol, regulations, and guidelines; Coordinating study-related procedures, monitoring study drug inventory, ensuring data quality and participant safety and well-being during the study.
• S/he will work in close collaboration and under the supervision of the Project Coordinator, the INTEGRATE project team, the Infection Control Research Center (ICRC) team, the Viral Hemorrhagic Fever Laboratory team at the Federal Medical Center Owo (FMCO) and ALIMA’s team in Owo.
• This is an exciting opportunity to gain experience in clinical research, working alongside an international team of doctors, nurses and researchers. The post holder will receive regular training in clinical research methods, as well as the use of advanced clinical monitoring equipment.

Protection of beneficiaries and community members:

• Level 3: The incumbent is responsible for the application of HR processes and may be required to conduct field visits. He/She may therefore be in contact with children and/or vulnerable adults. Therefore, a criminal record check or the presentation of a certificate of good conduct will be required. In situations where the impossibility of providing a criminal record or a certificate of good conduct is established, a declaration on honor will be requested.

Responsibilities

• Oversee the day to day operations of the study; keep track of principal indicators of the study and report ongoing study progress to the international coordination team.
• Ensure that the study is compliant with local and federal laws and regulations at all steps, in all departments (laboratory, ward, data management)
• Acts as a point of reference for study participants by answering questions and keeping them informed on the study progress.
• Coordinate all activities related to study IMPs, assess and follow-up as necessary in accordance with the study protocol and the study schedule
• Support the Medref in the follow-up of study medical items, equipment and supplies, as necessary in accordance with the study protocol and the study schedule
• Oversee the completion of Case Reporting Forms (CRF) and use of electronic data capture systems.
• Participates in the monitoring of CRFs by responding to the queries, and facilitate the national CRA activities when S/he is on site
• Organize and participate in all study related trainings on site, and ensure all the staff expertise follow-up
• Ensure that all SAE and AESI are declare and follow-up
• Support the Medref in Supervising all study related tasks performed (i.e medical examinations, blood tests,…), maintains accurate patient study documentation.
• Work closely with the Medref to ensure timely mortality review of the cases.
• Support the Medref to organize, manage the research team.

Professional conduct:
The Study Site Managernwill be expected to:

• Comply with the Lassa ward infection and control procedures at all times
• Maintain patient confidentiality
• Follow the supervision and instructions of the study manager and Project Coordinator
• Maintain and improve their professional knowledge and competence
• Undertake any other duties commensurate with the post. The duties listed are not definitive and may be added to or changed according to the needs of the research study

Others:

• Knows and applies the infection prevention and control procedures and protocols in use on the Lassa fever ward
• Knows and applies the safety procedures about viral hemorrhagic fevers
• Maintains their knowledge of the ALIMA association, including its operation, structure, internal rules and procedures, and respects and applies ALIMA’s values
• Keeps up to date with the objectives and activities of the research study
• Maintains awareness of the activities of other departments within ALIMA
• Helps develop the local political and social understanding of Lassa fever
• Participates in departmental and all study-related meetings, and develops team spirit and solidarity

Requirements
Education:

• Medical Doctor
• Additional training in clinical research is suitable (GCP/HSP)

Experience:

• Experience in clinical research, including data collection, is essential
• Experience in a hospital medical service
• Knowledge of at least one data entry software
• Experience in an infectious diseases department would be appreciated
• Knowledge of Office Pack software is essential
• Fluent English is essential. Yoruba language skills are strongly desirable

Qualities required:

• Rigor and organization
• Adaptability and initiative
• Developed interpersonal skills and diplomacy, ability to influence and lead team.
• Commitment

Languages:
The preferred candidate should be able to speak;

• English Language fluently.
• Local language.

Contract Term:

• Contract under Nigerian law, 6 months, renewable. Level 9.