Clinical Research Associate (CRA) - 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 Clinical Research Associate to perform monitoring tasks for the INTEGRATE study at inclusion sites in Nigeria and other support tasks.
• He/she will work in direct link with the INTEGRATE international CRAs and the ALIMA coordination team. He/she will collaborate closely with the Infection Control Research Center (ICRC) team, the Federal Medical Center Owo (FMCO) team, the Irrua Specialist Teaching Hospital (ISTH) team and the ALIMA team in Owo.
• The post holders 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.

Tasks & Responsibilities

• The Clinical Research Assistant will be based with ALIMA’s team in the Abuja office.
• He/She will monitor the trial throughout its duration, which involves visiting the trial sites on a regular basis and dealing with and solving any issues.
• Travel will be required to the inclusion sites approximately once a month for each site.

The Clinical Research Associate will:

• Monitor compliance with good clinical practices and study procedures
• Ensure that events occurring during the trial are promptly communicated to the coordinating team and the relevant authorities.
• Ensure compliance with current regulations and ethical rules.
• Provide detailed monitoring reports to the INTEGRATE coordination team.
• Guarantee the quality of the data collected and check their concordance with source documents.
• Ensure that the study's folders at each site are kept up to date.
• Participate in regular meetings.
• Carry out end-of-study closure activities.

Professional conduct:
The Clinical Research Associate will be expected to:

• Comply with the Lassa ward infection and control procedures at all times
• Maintain patient confidentiality
• Comply with data integrity and security policies
• Follow the supervision and instructions of the INTEGRATE coordination team and supervisor
• 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 in relation to 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 meetings, and develops team spirit and solidarity

Requirements
Education:

• Medical or Paramedical Diploma
• Additional training in clinical research is desirable
• Good Clinical Practices Certificate

Experience:

• Previous experience in clinical trial management, preferably as a clinical research associate or in a similar position.

Skills:

• Master medical terminology and research vocabulary
• Knowledge of good clinical practice
• Advanced computer skills on MS Office
• Fluent in English is essential.

Qualities Required:

• Excellent communication skills
• Drafting quality
• Adaptability and organizational skills
• Ability to work independently and as part of a team
• Mobility
• Respect for confidentiality (medical and study related)
• Ability to follow procedures
• Effective management of priorities
• Ability to manage periods of high activity
• Full knowledge of good clinical practice
• Good time-management

Languages:

• Ability to communicate in English and the main Nigerian languages spoken in the location of assignment, Owo. Candidates from Ondo state are encouraged to apply.

Conditions:

• Contract term: contract under Nigerian law, 6 months, renewable. Level 7.