We are currently seeking a Clinical Research Associate, responsible for monitoring Phase I-IV clinical drug/device trials for industry and government clients according to Good Clinical Practice (GCP). Within the role, you will ensure the proper conduct of assigned clinical studies, including the correct implementation of the approved protocol, timely data entry at the sites, and appropriate enrolment goals. In addition, you will act as the liaison to clinical investigators and their coordinators to ensure the quality and integrity of the data collected and utilized for analyses. You will ensure the execution of clinical trials in a timely and efficient manner as well as being familiar with regulatory compliance requirements, and federal and international regulations relevant to the studies being monitored.
Essential duties within the role include:
- Assisting in the selection of investigators through the conduct of pre-study visits to evaluate the capability of the site in order to successfully conduct the clinical trial
- Ensuring all regulatory documentation has been obtained prior to initiating the clinical study
- May be asked to assist with the conduct of SIVs
- Conducting Interim Monitoring Visits (IMV) and Close-out Visits (COVs), as assigned, and work with the sites to have them audit-ready at all times
- Monitoring all aspects of a clinical trial from pre-study visits through to COVs to ensure study requirements are met and sites are compliant with the protocol, product, device requirements, and regulatory obligations in accordance with FDA, ICH GCPs, local regulatory requirements, and corporate SOPs
- Preparing monitoring visit reports
- Ensuring timely and efficient execution of clinical trials and that sites are audit-ready at all times.
- Assisting in team meetings with other CRAs and meeting with site staff
- Contributing to draft study materials, such as Manual of Operation (MOP), Case Report Forms (CRF) and guidelines, patient Informed Consent (IC) templates, and other study-specific documents as required
- Performing in-house CRF review and query resolution
- Reviewing and verifying the accuracy of the data on-site or remotely, and initiating action(s) to resolve issues identified.
- Participating in the in-house review of listings and generating queries after this remote monitoring
- Reviewing Adverse Event (AE) incidence, both serious and non-serious.
- Ensuring clinical supplies are properly stored and accounted for, and any necessary blinding is maintained.
- Confirming the IC process is completed and documented appropriately, and patient safety and confidentiality is maintained.
- Assisting the internal study Project Manager with communications to:
- Authorities and IRBs
- Institutions (e.g. hospitals, private practice)
- Investigational sites
- Participating in clinical staff meetings, project team meetings, clinical training sessions, etc.
- Maintaining awareness of overall development in the field of clinical research, as well as assigned areas, by reading related literature, attending professional meetings, maintaining required certifications
Desirable Skills and Experience
- 1-3 years of clinical monitoring experience as a CRA (training time included)
- Prior clinical trials experience monitoring clinical trials in a commercial setting
- Sound knowledge of medical terminology
- Excellent written and verbal communication skills
- Good analytical and problem-solving skills
- Detail-oriented and the ability to multi-task
- Ability to work both independently and within a matrix team environment
- Ability to travel (75-80%) – primarily in the US
- Knowledge of Microsoft Office including Word, Excel, and PowerPoint