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Clinical Trial Coordinator

  • Location:

    Barcelona, Spain

  • Contact:

    Pablo Reina

  • Job type:

    Permanent

  • Contact phone:

    +34 93 522 23 38

  • Industry:

    Clinical Research

  • Contact email:

    pablo_reina@oxfordcorp.com

Job Description:

The CTC has 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 time-lines, 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.
  • 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.

Requirements:

  • Bachelor's or Master's Degree in life science or health-care.
  • 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.
  • 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.

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