Quality Control Officer for Broad One Health Endectocide-based Malaria Intervention in Africa (BOHEMIA) At Barcelona Institute for Global Health

The Barcelona Institute for Global Health (ISGlobal) is a cutting-edge institute addressing global public health challenges through research, translation into policy and education. ISGlobal has a broad portfolio in communicable and non-communicable diseases including environmental and climate determinants, and applies a multidisciplinary scientific approach ranging from the molecular to the population level. Research is organized in the following main areas, Malaria and other Infectious Diseases, Maternal, Child and reproductive Health, Urban Health and Child and environmental health, Climate & Non-Communicable Diseases. ISGlobal is accredited with the Severo Ochoa distinction, a seal of excellence of the Spanish Science Ministry.

Venue

Barcelona

What We Are Looking for

ISGlobal is seeking a Quality Control Officer who is interested in taking over and managing activities of the project BOHEMIA.

The BOHEMIA project aims at contributing to the global public health impact for malaria developing a complementary vector control strategy. Based in Barcelona but with availability to travel overseas, the successful candidate will support the Chief Scientific Officer (CSO) and study compliance team in the tracking of the study´s multiple protocols and the overall quality control of the project according to GCP guidelines. The Quality Control Officer will be responsible for tracking submissions, maintaining an up-to-date Trial Master File, providing supports to the CRAs in study monitoring, study drug importation and repackaging, and other QC related duties. In summary, the successful candidate will help oversee study tracking, monitoring and compliance, and quality control.

Key Responsibilities

Support the Chief Scientific Officer (CSO) and study compliance team in the tracking of the study´s multiple protocols and the overall quality control of the project according to GCP guidelines.

Study Tracking:

• Track submissions to ethics review committees across all BOHEMIA protocols as well as queries and approvals
• Notify responsible persons within the BOHEMIA team of deadlines for submission of progress reports to ethics review committees across all BOHEMIA projects
• Work in conjunction with the study´s Clinical Trial Manager (CTM) to:

Maintain version control of protocols and supplementary documents

Maintain an up-to-date protocol submission tracking system

Track progress report submissions from start until submission

Study Monitoring/ Quality Control:

• Review database reports for the BOHEMIA Safety and Efficacy protocol and identify data anomalies

Report data anomalies in the required format to the Lead Clinical Research Associate (LCRA)

Identify trends in non-compliance

• Support review of electronic data to identify potential risks and trend critical data and processes
• Maintain the electronic Trial Master File on behalf the CTM, including filing and archiving of clinical trial documents, and the maintenance of study files.

Drug safety/Pharmacovigilance

• Conduct quality control of severe adverse (SAE) event and pregnancy follow up reports from site
• Provide unblinded SAE reports to the Outreach Coordinator for monthly reporting to ethics committees
• Submission and/or support of submissions of blinded CIOMS-I forms to ethics committees
  Other:
• Support CSO with the QC of the ethics submissions and reports.
• With support from the CSO, coordinate and oversee study drug supply from procurement to delivery on site, including the required documentation.
• Take on other clinical trial related tasks on an as needed basis throughout the duration of the study

Auxiliar task

• This job description reflects the present requirements of the post but may evolve at any time in the future as duties and responsibilities change and/or develop providing there is appropriate consultation with the post-holder.
• This job description is not a definitive or exhaustive list of responsibilities but identifies the key responsibilities and tasks of the post holder. The specific objectives of the post holder will be subject to review as part of the individual professional assessment process.

Requirements

Training and experience /Qualifications:

• Bachelor’s degree in relevant field (Masters preferred)
• At least 2 years’ clinical operations experience providing support to clinical trial management/operations teams, preferably in a global environment, (e.g., Lead CRA, Clinical Trial Assistant, Clinical Trial Manager)
• Knowledge of quality assurance processes and procedures
• Knowledge of good clinical practice (GCP) guidelines

Skills:

• Takes ownership and responsibility for tasks and demonstrates effective self-management and proactivity
• Strong follow through to ensure that quality and productivity standards of own work and that of the team are consistently and accurately maintained
• Critical thinker capable of supporting the project with creative solutions when needed in a fast paced environment
• Ability to leverage clinical research experience to adapt to a non-traditional research environment to ensure standards of ICH GCP are maintained
• Excellent organizational and time management skills
• Must be detail oriented, have the ability to prioritize and handle multiple tasks simultaneously
• Ability to communicate and interact competently and professionally at all levels within a diverse environment.
• Ability to work effectively both as a team member and independently
• Demonstrated adaptability and ability to manage a rapidly changing
• environment at times with ambiguity
• Proficiency with electronic communications and Microsoft office.
• Experience in working in international environments and interest in public health in developing countries are assets

Language level

• Excellent fluency in written and spoken English. Project written communications and daily work will be in English.
• Spanish, Portuguese and/or Swahili are an asset

Specific Requirements

• Availability to travel overseas as required no more than 25% of the time
• Current GCP certification (a course will be provided upon hiring)

Conditions

• Duration: Until June 2024
• Starting date: As soon as possible
• Contract: full time
• Salary Range: Technician 1

The post holder will adhere to ISGlobal principles contained in People management policy, including Equity, diversity and health safety. The post holder will respect, and accountable to ensure ISGlobal policies and procedures.

Selection Process

The selection process is designed in two phases:
1- Interview phase of a technical nature, with the team that requires the incorporation. To assess the person’s skills and CV.
2 – Meeting with HR with the finalist(s) to finish assessing the profile and discuss contractual and institutional issues.

If needed any technical test could be pass. A Psychological Competency Evaluation Test will be required for the structural or transversal positions.

In accordance with the OTM-R principles, a gender-balanced recruitment panel is formed for every vacancy at the beginning of the process. After reviewing the content of the applications, the panel will start the interviews, with at least one technical and one administrative interview. A profile questionnaire as well as a technical exercise may be required during the process.