Clinical Research Monitor 128 views0 applications

Medical Care Development International (MCDI), the international division of US-based not-for profit Medicare Care Development (MCD) uses practical, evidence‐based and high‐impact approaches to strengthen health systems in developing countries and to improve the health of vulnerable populations. MCDI has implemented public health programs in over 40 countries in collaboration with donors, national governments, the private sector, health agencies, communities and local stakeholders to improve health and save lives in the following areas: water, sanitation and hygiene; malaria control; maternal, neonatal and child health; tuberculosis; HIV/AIDS; and other communicable diseases.

Sanaria’s is a biotechnology company that aims to develop and commercialize whole-sporozoite vaccines that confer high-level, long-lasting protection against Plasmodium falciparum, the malaria parasite responsible for more than 95% of malaria associated severe illness and deaths. Sanaria works to develop vaccines to prevent all human malaria, including drug resistant stands worldwide.

Sanaria, in conjunction Medical Care Development International, are actively seeking a fulltime English/Spanish bilingual Clinical Research Monitor for a 2.5-year international assignment in Bioko Island, Equatorial Guinea. Study activity will begin on Bioko Island in September 2019 and the study is scheduled for initiation in January 2020 and conclusion in early 2022. The Clinical Research Monitor will live in Bioko Island for the duration of the study and will report to Sanaria’s lead Clinical Research Monitor and Clinical Research Manager, under the direction of the Deputy Chief Medical Officer and Chief Medical Officer.

The selected candidate will be an employee of Sanaria’s partner Medical Care Development International (MCDI) and under administrative supervision of the Director, Equatorial Guinea Malaria Vaccine Initiative, based in Malabo, EG

This is a new position and an exciting opportunity to be part of two growing international organizations.

Knowledge, Qualifications and Skills:

· BA/BS (Masters preferred) in a health / science concentration

· Required: 3-5 years of experience with clinical monitoring

· English and Spanish spoken and written fluency

· Expert knowledge of FDA Regulations, US Code of Federal Regulations, and ICH-GCP guidelines

· Knowledge of phase 3 clinical trials, preferably those conducted under a US IND

· Understanding of Sanaria and MCD’s mission, objectives and values

· Knowledge of the clinical protocol and associated monitoring, data management, and data analysis plans

· Knowledge of clinical databases

· GCP certification

· Preferred: previous experience working with international sites in Africa and monitoring malaria and or vaccine trial

· Ability to adapt to and thrive in a dynamic environment

· Excellent oral and written communication skills

· Self-motivated and mission focused

· Culturally competent to effectively interact within a diverse environment

· High professional standards for clinical trial execution, monitoring and reporting

· Solid judgment, reasoning and planning

· Good listening skills, patience, and composure

Essential Duties and Responsibilities:

Monitoring Duties and Responsibilities

· Assist with the development of project-specific training materials for the team.

· Conduct comprehensive training for the study team on good clinical practices (GCP), good documentation practices, investigator responsibilities, protocol and standard study procedures, deviation identification and reporting, adverse event reporting, drug accountability procedures, etc.

· Conduct a Study Initiation Visit (SIV) and assist with any additional trainings associated with the Investigator Meeting.

· Conduct continuous onsite study monitoring from study screening, through study activation, through study closeout (24-25 months).

· Complete initiation, interim and closeout monitoring reports.

· Conduct 100% consent / assent form verification.

· Ensure the integrity of all clinical data by review of source data, verification of electronic case report forms, review of data query documentation, and ensuring adverse events and medications are properly reported.

· Ensure adherence to the study protocol, International Council for Harmonization (ICH) good clinical practices (GCPs), the US Codes of Federal Regulations (CFRs), applicable SOPs, and applicable local and national regulations, report and document deviations.

· Verify that all study staff and facilities (clinical, laboratory and pharmacy) have adequate qualifications and resources, and these remain adequate throughout the study.

· Assist with the preparation and review of IRB/EC submissions.

· Maintain the Investigator Site File (ISF) to ensure it is current and that all required documents are in place; this may be expanded to include documents maintained by the quality assurance (QA) department as well.

· Assist with the maintenance of the Trial Master File (TMF); this includes reviewing, retrieving and uploading site documents into Sanaria’s electronic Trial Master File (eTMF) system, Veeva Vault eTMF®.

· Track and supervise collection of ongoing study data for the purpose of regular project status reporting as required.

· Review and monitor other clinical documents as necessary.

· Conduct ongoing assessments of the risk management strategy.

Other Essential Duties and Responsibilities

· Communicate weekly with the lead CRA on monitoring progress and critical findings.

· Support on-site clinical teams through regular meetings to provide feedback and promote compliance with respect to the protocol and applicable guidance and regulations as listed above, particularly those associated with data accuracy and data quality.

· Participate in regular Sponsor/Site teleconferences; communicate regularly and frequently with Sanaria clinical staff.

· As needed, aid in the support of the site quality assurance (QA) department; help to implement additional measures of QA and follow up on action items.

· Liaise with FHI360, the contracted database company for database related issues identified by the site. This includes becoming trained on FHI360’s data management system, OpenClinica, in order to conduct onsite source document verification (SDV).

· Prepare and implement ongoing, refresher, site-specific training as necessary.

· Support the maintenance of project timelines, budgets and deliverables.

Additional Duties and Responsibilities:

· Assist with the Site Feasibility and/or Site Qualification Visit as needed

· Participate in global conference calls and meetings to review progress of ongoing clinical trials.

· Review Spanish version documents for correct translation.

· Participate in review of progress reports and safety reports to ensure the accuracy, scientific excellence, and congruence of message between studies in a project.

Location: Malabo, Equatorial Guinea

Projected start date: September 1^st, 2019

We are an Equal Opportunity Employer.