Clinical Research Associate II

Clinical Monitoring Sofia, Bulgaria


Description

Position at Premier Research

Premier Research helps highly innovative biotech and specialty pharma companies transform life-changing ideas into reality, targeting unmet needs in analgesia, neuroscience, oncology, pediatrics, and rare diseases. 

We’re looking for an exceptional Clinical Research Associate II to bring your passion to our team. You will be encouraged to grow professionally and personally while enjoying cross-functional partnerships with genuinely supportive colleagues, regardless of location or seniority. Most importantly, you will be using your skills to bring tangible hope to critically ill patients around the world.  

At Premier Research, we are science-minded and heart-centered. Join us.


What You’ll Be Doing:

Monitors progress of clinical studies at the site level to verify that the rights and well-being of subjects are protected, that the reported study data are accurate, complete, and verifiable from source documents, and that the study is conducted in accordance with protocol, standard operating procedures, International Organization of Standardization (ISO)/Good Clinical Practices (GCP) and other applicable regulatory requirements. Provides support in start- up, enrollment, follow- up and closure of clinical trial activities.

  • Conducts source verification by comparing data recorded on Case Report Forms against source documents, verifying Informed Consent Forms for accuracy and completeness, and reviewing regulatory documents and device accountability records Issues, investigates, and resolves any data discrepancies identified during source verification activities
  • Ensures clear written communication to clinical sites and project team members through monitoring reports, follow-up letters, study memos, and general correspondence.
  • Maintains thorough documentation and proper escalation of issues related to visit reports.
  • Ensures all site personnel are appropriately trained and prepared to conduct the clinical study in accordance with the protocol and applicable regulations.
  • Monitors and maintains site personnel list as well as qualification and training records.
  • Ensures any identified non-compliance issues are addressed, clearly communicated, documented and escalated as required through monitoring visits, analyzing study metrics, and general study data overview.
  • Supports regulatory inspection activities as required.
  • Ensures that all reportable events are identified, clearly documented and reported per protocol and as per applicable requirements and regulations.
  • Participates in study-specific meetings, teleconferences and trainings.
  • Collaborates with cross-functional team members and study sites throughout all study phases.
  • Manages study contracts, requests/collects relevant investigator/site documentation (i.e. regulatory documents, financial disclosure forms, curriculum vitae/medical license), and reviews and approves documents in applicable database.
  • Performs budget negotiations with clinical trial sites
  • Performs additional duties as assigned

You'll need:

  • Bachelor’s degree, or international equivalent from an accredited institution, preferably in a clinical, biological, scientific, or health-related field or equivalent combination of education, training and experience
  • 3 to 5 years of practical experience conducting continuous independent onsite monitoring of clinical research sites as well as site management activities. Alternately, must have proven experience in all primary job functions.
  • Demonstrates excellent English verbal and written communication skills
  • Proven ability to drive a successful customer experience through positive customer interactions, provision of quality and timely deliverables, and task ownership
  • Strong analytical and organization skills, able to work independently and manage multiple projects simultaneously in a fast-paced environment with changing priorities
  • Knowledge of International Conference on Harmonisation (ICH)/Good Clinical Practices (GCP) and/or ISO14155 requirements as well as detailed knowledge of the relevant country specific regulatory requirements for conducting clinical trials.
  • Performs additional duties as assigned
  • Travel: 70-85%