Clinical trial Manager for ASA – SARS project At International Solutions Group

ISGlobal – Barcelona Institute for Global Health is a research centre in international health whose ultimate goal is to help close the gaps in health disparities between and within different regions of the world. For this, we leverage on knowledge generation (research), transmission (training) and application (policy and global development). ISGlobal is a WHO Collaborative Center for Malaria Elimination and Eradication.

Lugar

Barcelona

What We Are Lookinng for

• ISGlobal is looking for an experienced Clinical Trial Manager for the ASA SARS project.

The project

ASA SARS is a La Marató funded, 2-year project, a randomized, double-blinded, placebo-controlled multicentre trial in 398 SARS-CoV-2-infected pregnant women with the objective of evaluating the efficacy and safety in reducing the incidence of adverse maternal and perinatal outcomes of adding daily LDASA to the already recommended low molecular weight heparin (LMWH) from the first or second trimester up to 36 weeks’ gestation in SARS-CoV-2-infected pregnant women. Pregnant women undergoing routine first or second trimester blood tests will have a SARS-CoV-2 rapid antigen test done if they agree to participate. Women with a positive SARS-CoV-2 rapid antigen test will be further tested with a confirmatory SARS-CoV-2 PCR test. In case of being also positive for the SARS-CoV-2 PCR test, she will be randomised 1:1 to receive, additionally to LMWH for at least 10 days, daily LDASA (150 mg) or placebo, up to 36 weeks of pregnancy. Women will be followed-up for the duration of the intervention and the pregnancy outcome will be registered.

The findings of this study will contribute to reduce SARS-CoV-2- related complications in a highly vulnerable group to the infection.

The project will be conducted in 4 sites in Spain (Madrid and Barcelona) and one site in Mozambique (Maputo)

Background

SARS-CoV-2 infection in pregnancy is associated with poor maternal and perinatal outcomes. One explanation is the pregnancy-associated prothrombotic status, which may increase during infection, leading to placental and vascular complications. Administration of low-dose acetylsalicylic acid (LDASA) has been shown to improve maternal and perinatal outcomes in women at high-risk of endothelial and placental complications. However, there are no data on the effects of LDASA in preventing complications in SARS-CoV-2- infected pregnant women.

Main duties and responsibilities

• Ensure that all human subject research activities that will be done under the ASA SARS clinical trial are conducted under standards of Good Clinical Practices/ICH and as per clinical trial SOPs
• Support the clinical research team at the coordination office and project hospitals in the full spectrum of the trial including:
• Protocol development
• Obtaining ethical and regulatory approval for the trial prior to study site initiation
• Trial management activities from start up to close out
• Development of trial tools and templates
• Management of clinical trial monitors
• Review and approval of monitoring reports
• Review and approval of monitor timesheets and expenses
• Site management and closure
• Trial tracking
• Verify that all subject research activities undertaken in project hospitals are conducted according to the standards of – – ICH-Good Clinical Practice, international and local regulations.
• Receives and takes appropriate action following monitoring reports
• Oversees and coordinates study drug supply from procurement to delivery on site, including the required documentation
• Maintains responsibility for the Trial Master File and archiving of thereof, for the correct filing and archiving of clinical trial documents, and the maintenance of study files.
• Coordinates, manages and participates in clinical trial meetings
• Provides project status updates and reports to the PI as required
• Risk identification and escalation to the PI
• Issue identification and applicable escalation to the PI
• Participates in site selection and initiation visits and assists with HSR training of field staff.
• Attends consortium and other meetings as required. Presents data as required.
• Contributes to funder reports

Qualifications

• Required:
• At least 1 years of experience across all stages of the clinical trial lifecycle, i.e. from protocol development to final study report, and especially in managing clinical trials.
• Minimum of BSc or health/science degree equivalent
• Current ICH/GCP certification
• Excellent written and spoken English
• Willingness to travel to the project hospitals in Spain (Madrid and Barcelona)
• Excellent communications and collaboration skills.
• Preferred:
• Working experience in Portuguese/Spanish

Additional skills

• Results-oriented approach to problem solving
• High professional standards for clinical trial execution, monitoring and reporting
• Accustomed to team work and willingness to contribute to elements outside the clinical trial scope
• Ability to work under pressure
• Ability to work independently where necessary

Conditions

• This position is Barcelona-based but it will require support in the coordination of the Mozambican sites.
• Compensation for this position will be based on the applicant’s experience and qualifications. This position starts immediately.