Raquel Marques Email and Phone Number

Project management and oversight of clinical studies sponsored by SPC and pharmaceutical industry:- Contributed to planning, adjusting and controlling clinical project activities, milestones, budget and timelines;- Be the contact point for industry, stakeholders and contracted vendors;- Communicate with relevant internal departments;- Review and contribute to study documents necessary for clinical study application and execution, including clinical study protocol (CSP) and informed consentform (ICF);- Collaborate in the development of the electronic case report form (eCRF);- Study submission to independent ethics committees (IEC);- Oversight of activities performed by contracted vendors/stakeholders, with main focus on approved CSP and ICH-GCP compliance, protection of studyparticipants and integrity of data collected;- eTMF management;- Select, qualify and contract vendors;- Contract preparation/revision;- Prepare and provide delivery of initial and ongoing training to the study team regarding protocol specifics, eCRF completion, Standard Operating Procedures(SOPs) and timelines for the project;- Monitoring of clinical studies sponsored by SPC (CRA Role), including preparation of Clinical Monitoring Plan.

Parkinson's disease is the 2nd most common neurodegenerative disease worldwide. The available therapeutic strategies rely only on the amelioration of the symptomatology of the disease. Therefore, the development of disease modifying strategies is extremely important for the management of PD in the long term. Throughout my Ph.D. journey, I explored the neuroprotective effects of secretome from mesenchymal stem cells in genetic animal models of the disease and the advantages of bioreactors as an important tool for the modulation and large-scale production of secretome under GMP conditions.

Project management and oversight of clinical studies:- Assess together with the team the feasibility of the clinical projects;- Contribute to definition of study design;- Review and contribute to study documents necessary for clinical study application and execution, including clinical study protocol (CSP) and informed consentform (ICF);- Contribute to planning, adjusting and controlling clinical project activities, milestones and timelines;- Communicate with relevant internal departments;- Study submission to IRB/IEC;- Collaborate in the revision of contracts;- Management of several funded projects involving clinical validation and usability evaluation of medical devices.

Project title: ‘Vitamin C and chemotherapy: a potential synergy against colorectal cancer’.