Clinical Trials Coordinator in the Barcelonaβeta Brain Research Center
About the employer
The Barcelonaβeta Brain Research Center (BBRC) is a research center, constituted by the Pasqual Maragall Foundation. The goal of BBRC is to develop the understanding of age-related cognitive disability in order to provide practical solutions to the global challenges posed by the world’s aging population. This goal will be achieved by championing primary and secondary prevention programs for Alzheimer’s disease and other related neurodegenerative disorders, the study and promotion of healthy aging, and the research of mechanisms affected by healthy or pathological aging. The vision of BBRC is to provide the society with distinct and innovative solutions for age- related cognitive disability in order to attain a multidisciplinary comprehension of the aging process and the pathophysiology of neurodegeneration. At present BBRC deploys its research mission through the Alzheimer’s Prevention Program.
Pasqual Maragall Foundation, Pompeu Fabra University and “la Caixa” are permanent members of the BBRC Board. International competitive recruitment, state-of-the-art scientific facilities, effective management and continuous high-standard peer-review evaluation are the BBRC core proceedings to ensure achieving world-class research results. BBRC is affiliated and located in the Campus Ciutadella of the Barcelona Pompeu Fabra University, the building contains excellent technical facilities, including a research-dedicated 3T MR scanner and Clinical Trials facilities.
BBRC is also part of the Barcelona Biomedical Research Park (PRBB), a large research facility that hosts other seven different research institutions related to biomedical research, including the Center for Genomic Regulation (CRG), the Hospital del Mar Medical Research Institute (IMIM), the Department of Experimental and Health Sciences of the Pompeu Fabra University (CEXS- UPF), the Institute of Evolutionary Biology (IBE CSIC-UPF), the Barcelona Institute of Global Health (ISGlobal) and the Barcelona site of the European Molecular Biology Laboratory (EMBL), among others, in a multidisciplinary, collaborative and stimulating international environment in close contact with a clinical setting, thus conducive to translational research.
For more information see: www.barcelonabeta.org and www.fpmaragall.org
About the project
The ALFA (for Alzheimer and Families) parent cohort, established by the BarcelonaBeta Brain Research Center, is composed by 2743 cognitively normal participants aged between 45 and 75. This cohort was established as a research platform to characterize
preclinical Alzheimer’s disease (AD) in asymptomatic individuals and is being leveraged to perform different studies and trials to prevent AD.
participants (55-80 years), who are experiencing a decline in their memory or other cognitive abilities (people with Subjective Cognitive Decline)). Its main goal is the early detection of blood and digital biomarkers that represent the pathophysiological changes related to AD in people (either cognitively unimpaired or MCI) experiencing a subjective worsening of their cognitive performance. It is a longitudinal study with annual follow-up visits (MRI and lumbar puncture are performed only every 2 years).
Furthermore, BBRC is participating in clinical trials from the Pharma-industry in order to test the preventive effect of experimental drugs in a group of participants with positive AD biomarkers.
About the job
BBRC is looking for a candidate to Coordinate the start-up, execution and follow-up of clinical Trials from external Sponsor and assure the studies are developed with expected quality standards and within the expected timings. The CTC is responsible for overseeing the day to day operations of clinical trials assigned.
Responsibilities
● Assures the correct execution of clinical trials, developing all the project phases in accordance with guidelines and logistic needs, including material, essential documents, and activities planning (initiation, execution and closure) of clinical trials.
● Reviews and develops a familiarity with the protocol, e.g., study proceedings and timelines, inclusion and exclusion criteria, confidentiality, privacy protections, etc.
● Collects documents needed to initiate the study and submit to the sponsor (e.g., Sites Forms, CVs, etc.).
● Coordinates the communication of study requirements to all individuals involved in the study. Provides appropriate training and tools for study team members. Documents date of training and signatures of study personnel trained on study specific training log.
● Coordinates participant tests and procedures.
● Collects data as required by the protocol. Assures timely completion of Case Report Forms.
● Register each participant in all BBRC’s trackers to ensure the protocol compliance, the updated study status and allow the billing of study procedures by the BBRC CTA.
● Maintains adequate inventory of study supplies. If handling investigational drugs/devices/kits, follows the sponsor protocol and guidelines.
● Completes study documentation and maintains study files in accordance with sponsor requirements including, but not limited to, consent forms, source documentation, narrative notes if applicable, case report forms, and investigational material accountability forms.
● Retains all study records in accordance with sponsor requirements. Guarantee the integrity of Trial Master File (TMF) of each clinical research assigned with the BBRC CTA.
Manages the progress of assigned studies.
● Tracks regulatory submissions and approvals, recruitment and enrolment, case report form (CRF) completion and submission, and data query generation and resolution.
● Prepares and distributes studies status reports (recruitment, timing. etc.).
● Ensures the inclusion of the participants agreed for the Clinical Trials assigned with BBRC Clinical Operation Office Coordinator, Pharma’s o CROS and controls the specific selection strategy needed for each study.
● Works with the BBRC scientific team to develop and implement recruitment strategies in accordance with CEIC requirements and approvals.
● Ensures the team conducts the correct informed consent process. Obtains appropriate signatures and dates on forms in appropriate places. Assures that amended consent forms are appropriately implemented and signed.
● Verify that source data and study database are accurate, complete and maintained properly, and verify protocol compliance, including safety reporting.
● Screens subjects for eligibility using protocol specific inclusion and exclusion criteria, documenting each potential participant’s eligibility or exclusion.
● Works with the PI and Clinical Operation Office Coordinator to manage the day to day activities of the study including problem solving, communication and protocol management.
● Monitor clinical trials in accordance with Sponsor Audits, Standard Operating Procedures and/or current regulations, and GCP and ICH guidelines.
● Act as the contact person with sponsors, Regulatory Authorities, CROS, pharmaceutical companies, suppliers, providers, subcontracted institutions and others stakeholders implicated in the projects assigned. Maintains effective and ongoing communication with sponsor, CROs, suppliers, research participants and PI during the course of the study.
● Participate in Sponsor's, CROs, BBRC meetings related to projects assigned.
Required qualifications, competences and technical skills
● Bachelor's or Master's Degree in life science or healthcare.
● 3 years’ of experience working in a clinical environment or medical setting, as a Clinical Trial coordinator from either hospital departments, a pharma/med company, a CRO environment.
● Perfect knowledge and training to GCP and Clinical trial regulations.
● Experience in undergoing audits and regulatory procedures
● Excellent skills in English and Spanish, Catalan would be positively considered.
● Team player attitude and Ability to work across multiple projects.
● Administrative excellence with attention to detail and accuracy.
● Interest in joining a non-profit organization with a mission of high social impact.
Benefits
● Starting date: ASAP
● Permanent contract
● Full time position 38 hours/week
● Salary will depend on experience and will be in accordance to BBRC’s salary scales
● Possibility of benefit from flexible working hours.
● Hybrid work model (on-site + teleworking) subject to the foundation’s regulations.
We offer a unique research opportunity in a highly innovative project in a multidisciplinary institution, promoting a diverse and inclusive environment and welcomes applicants regardless of age, disability, gender, nationality, ethnicity, religion, sexual orientation or gender identity.
In the foundation we also care about developing your professional career.
Application process
To apply, please submit a single PDF file containing the following:
1) Cover letter addressed describing research interests and relevant background
2) CV
3) The names of up to three individuals who could provide reference letters. All files or inquiries should be submitted electronically to: talent@barcelonabeta.org
Subject: Clinical Trials Coordinator (CTC)
In compliance with the data protection regulation, we inform you that your personal data will be processed by the Pasqual Maragall Foundation to manage the selection process for the job offer you have applied for.
You can exercise your rights of access, rectification, suppression, opposition and other rights present in the normative, sending an email to gdpr@barcelonabeta.org. For further information and how to use your rights, please see our privacy policy.
