Clinical Research Coordinator

We are looking for a dedicated and detail-oriented Clinical Research Coordinator to join our team. In this role, you will play a crucial part in the planning, implementation, and coordination of clinical trials to ensure their success. If you are passionate about contributing to medical research and making a difference in healthcare, this position is perfect for you.

Key Responsibilities:

Supporting the Principal Investigator and Subinvestigators’ team with clinical studies activities
Liaise with CRAs to ensure the performance of clinical studies; ensure quality standards; resolve logistic and practical issues clinical trial related and promote the team-working environmen
Participate in Site selection visits, initiation visits, training during the study, close-out visits
Coordinate and oversee all aspects of clinical trials from start to finish
Interact with staff regarding objectives and status of clinical projects
Work closely with the research team to ensure compliance with protocols and regulations, Ensure regulatory compliance with ICH/GCP guidelines, and company SOP's
Assists the PI in the development of materials and tools necessary to appropriately train individuals involved in the conduct of the study around issues related to (but not limited to) protocol requirements, schedule of visits, and execution of research plan. Establishes with the PI the specific training for each study for the entire study team, ensures that the team performs those specific training per study at the beginning of it, and then whenever another training for the team is requested by the Sponsor/CRO/CRA, and maintains documentation of training
Develops and implement study design templates and budget customization in eSource platforms, as well as update and customize procedures according to the new Amendments; extracts reports.
Enter data and related documents for all subjects and all visits into all the required eSource platforms, no matter if it’s the company’s or Sponsors/CROs; Organize, maintain, and update Investigator Site Files
Solve queries, close unfinished tasks in all eSource platforms
In charge of checking/printing/maintaining the temperature logs of medicine refrigerators/biological sample freezers/ambient medicine room
Calls patients and makes appointments for further procedures/investigations during the pre-screening/ screening visit/other visits (Xray/MRI/colonoscopy etc.); Ensures that the scheduled visits are made and makes follow-ups with him for rescheduling
Calls patients from the database and takes them through a telephone pre-selection questionnaire for pre-screening visits to the site
In charge of the follow-up of on-site/study equipment periodic calibration/verification to ensure the maintenance of the said equipment. Monitors the validity of the calibration/maintenance certificates on the equipment used in the studies.
Participate in monitoring visits (make available to CRAs study documents Investigator site files, patient documents, medication used, answer and solve problems during monitoring); Prepare/check documents/medication/logs for monitoring/audit visits or inspections
In charge of receiving the study medication at the site and following all the steps of the medication reception process at the Site; Distributing study medication at each study visit to patients; Completing the medication log per site & patient (if applicable)
In charge of controlled destruction of medication used and monitored by CRA or materials not used during the study, as well as of the archiving process of printed study documents after the close-out visit
Collaborates with the PI and management to prepare a categorized budget and justification. Confirms accuracy and completeness of budgeted costs.
Elaborates reports, analyzes, proposing solutions for patient recruitment efficiency and reaching recruitment targets
Request access to the Sponsor's electronic systems for the entire study team (IWRS, e CRF, the platform for medication allocation, imaging, EKG, for laboratory biological samples)
Collect and maintain accurate data and records
Monitor and report adverse events or any deviations from the protoco

Qualifications:

Healthcare professional (resident doctor, researcher, pharmacist, physicist, biologist, chemist, nurse, psychologist ) with a minimum of 2+ years of proven experience in clinical trials
ICH/GCP valid training with a very good knowledge of ICH/GCP guidelines and standards in the clinical research area
Proficiency in the English language, business level
Goal-oriented, with great attention to detail and a results-driven approach
Very good organizational and project management skills, able to understand the needs of the project (clinical trial) and organize the study team to achieve project goals, without errors or delays in the established timeframe
Able to handle multiple priorities within a matrix environment and to perform activities in a timely and accurate manner
Computer literacy with excellent technical skills in using & learning digital / eSource platforms / softs
Team player with outstanding communication skills
Reliable and trustworthy

As a Clinical Research Coordinator, you will have the opportunity to work on cutting-edge research projects that have the potential to improve patient outcomes and advance medical knowledge. You will collaborate with a multidisciplinary team of professionals and contribute to the development of new treatments and therapies.

If you are looking for a rewarding career that combines your passion for healthcare with your organizational skills, we encourage you to apply this position. Join us in our mission to make a difference in the lives of patients and contribute to the future of medicine.