Oferta de trabajo: Clinical Site Monitor (External Consultant)

Descripción

The Barcelona Institute for Global Health, ISGlobal, is the fruit of an innovative alliance between academic, government, and philanthropic institutions to contribute to the efforts undertaken by the international community to address the challenges in global health. ISGlobal provides a hub of excellence dedicated to scientific research and the provision of health care. The institute, which originated in a joint initiative of the Hospital Clínic de Barcelona and the University of Barcelona, has amassed over 30 years of experience in the field of global health. The pivotal mechanism of its work model is the transfer of knowledge generated by scientific research to practice, a task undertaken by the Research, Training and Policy and Global Development departments. Its ultimate goal is to help close the gaps in health disparities between and within different regions of the world.

What We Are Looking for

In order to ensure the successful implementation and quality of the trials, ISGlobal is seeking an external consultant to work as Clinical Monitor. Contract will be implemented as an external consultant.

About the Project

Malaria infection during pregnancy is an important driver of maternal and neonatal health especially among HIV-infected women. In Africa, at least one million pregnancies are co-infected with malaria and HIV annually. The interaction between the two infections is particularly deleterious in pregnancy, leading to increased risk of malaria and HIV viral load, which may increase the frequency of mother to child transmission of HIV (MTCT-HIV). Intermittent preventive treatment in pregnancy (IPTp) with sulphadoxine-pyrimethamine (SP) is recommended for malaria prevention in HIV-uninfected women but it is contraindicated in those HIV-infected on cotrimoxazole prophylaxis (CTXp) due to potential adverse effects. A recent EDCTP-funded trial showed that an effective antimalarial added to CTXp and long-lasting insecticide treated nets (LLITNs) in HIV-infected pregnant women improves malaria prevention and maternal health. However, the antimalarial used (mefloquine) was not well tolerated and it was associated with an increase in HIV viral load at delivery and a two-fold increased risk of MTCT-HIV. These findings highlight the need to find alternative drugs with better tolerability and safety profile to prevent malaria in this vulnerable group and to further study the pharmacological interactions between antimalarials and antiretrovirals (ARVs).

Dihydroartemisinin-piperaquine (DHA-PPQ), because of its long half-life and good tolerability constitutes one of the best candidates for IPTp in HIV-infected pregnant women. However, there is limited information on the pharmacokinetics of DHA-PPQ with concomitant use of ARVs and CTX, particularly in pregnant women. A randomized double blind placebo-controlled trial to evaluate the safety and efficacy of DHA-PPQ for IPTp in HIVinfected pregnant women receiving CTXp and using LLITNs will be conducted in two sub-Saharan countries where malaria and HIV infection are moderately to highly prevalent. In addition, the possibility for a pharmacokinetic interaction between DHA-PPQ and ARVs will be assessed in a sub-sample of participants. Women will receive ARV therapy according to national guidelines and their infants will be followed until one year of age to evaluate the impact of DHA-PPQ on MTCT-HIV.

The findings of this project will be relevant for the control of two of the most important poverty- related diseases (PRDs), in one of the most vulnerable groups, HIV-infected pregnant women exposed to malaria.

KEY RESPONSIBILITIES

  • Ensure timely and quality monitoring of the clinical trial and achievement of the established objectives.
  • Ensure efficient coordination of the clinical monitoring procedures

SPECIFIC DUTIES

1. Trial Coordination

  • Ensure that all trial activities are implemented according to project objectives and timelines.
  • Work with Project Manager and Project Management Team to ensure definition of objectives and the setting of priorities

2. Trial Clinical Monitoring

  • Support to site’s regulatory authority applications and approvals in case of protocol amendments
  • Locating and assessing the suitability of facilities at the study centres
  • Monitoring the clinical trial throughout its duration
  • Closing down study centres on completion of the trials
  • Writing the monitoring reports
  • Carrying out the medical products accountability on site
  • Supporting sites to keep the clinical trial file updated
  • Answering the discrepancy report forms
  • Having an efficient relationship with the sites’ investigator’s team

REQUIRED QUALIFICATIONS

  • University degree in Sciences (Biology, Pharmacy, Biomedical science or related field)
  • At least 3 years of clinical monitoring experience in clinical trials
  • Excellent management, project planning, and organizational skills
  • Knowledge of written and spoken English is required; knowledge of Spanish, Catalan, French or Portuguese is a strong plus
  • Advanced knowledge of GCP and Legislation about Clinical Trials
  • Excellent computer skills: MS Word, Excel, Outlook software or equivalent
  • Demonstrated reporting skills
  • Ability to effectively work both as a team member and independently
  • Experience working international environments is preferred
  • Preferably, having a team leader spirit, team working, good communication skills and Project management skills
  • Ability to travel following a travel calendar but also at short notice (10-15 days) Compensation for this position will be based on the applicant’s experience and qualifications.

 

How to Apply

Applicants must fill in the request form including the following reference: CM_MAMAH_June19. The receipt of applications will be open until 30th June 2019.


Applications will be accepted until 17.00 CET of the closing date.
Only shortlisted candidates will be contacted.

In ISGlobal we are committed to maintaining and developing a work environment in which the values and principles of our organization are respected and equal opportunities between women and men be promoted in each of the areas in which we operate, not tolerating discrimination based on criteria such as age, sex, marital status, race, ethnicity, disabilities, political leanings, religion or sexual orientation.