Study Coordinator

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.

About the job

BBRC is looking for a candidate to coordinate the start-up, execution and follow-up of Clinical Research Studies sponsored by BBRC and ensure the studies are developed with expected quality standards and within the expected timings. The SC is responsible for overseeing the day to day operations of Clinical Studies assigned and for giving support to the BBRC CTA.

Study Coordinator Responsibilities

• Ensures the correct execution of clinical research studies, developing all the study phases in accordance with guidelines and logistic needs, including material, essential documents, and activities planning (initiation, execution and closure) of studies.
• Reviews and develops a familiarity with the protocols, e.g., study proceedings and timelines, inclusion and exclusion criteria, confidentiality, privacy protections, etc.
• Collects documents needed to initiate the study. (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.
• Supervises the collection of data as required by the protocol.
• 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.
• Completes study documentation and maintains study files in accordance with the local law.
• Retains all study records in accordance with the local law. Prepares and distributes studies status reports (recruitment, timing. etc.).
• 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.
• Verifies that source data are accurate, complete and maintained properly, and verify protocol compliance, including safety reporting.
• 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 studies in accordance with Standard Operating Procedures and/or current regulations, and GCP and ICH guidelines.
• Participate in BBRC meetings related to projects assigned.

Clinical Trial Assistant Back-Up Responsibilities

• Gives support to BBRC CTA submitting and managing agreements, contracts and documentation with CROs, laboratories, Sponsors, etc.
• Gives support to BBRC CTA preparing and collecting all regulatory documentation, monitoring and submitting protocols to the relevant Agencies, and send notifications and reports to the competent authorities.
• Gives support to BBRC CTA to reconcile study costs between the operations department and the economics department
• Guarantee the integrity of Trial Master File (TMF) of each clinical research assigned with the BBRC CTA.

Required qualifications, competences and technical skills

• Bachelor's or Master's Degree
• 3 years of experience working in a clinical environment or medical setting
• Perfect knowledge and training to GCP
• Excellent skills in Spanish and Catalan. Good skills in English.
• 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: Study Coordinator