Clinical Research Associate
Monitor assigned study sites (currently in Germany, Austria and Switzerland) to ensure subjects’ safety, and timely, high-quality data in compliance with study, protocol, ICH GCP and local regulations.
- Conduct all type of site visits (e.g. Feasibility assessment, Site Selection Visit, Site Initiation Visit, Monitoring Visits and Close-Out visit) and write reports and follow-up letters within the timeframe agreed at study start
- Attend CRA and Investigator meetings; if required, assist with training of investigative site personnel in GCP and local regulations and ensure sites are conducting clinical research according to the protocol, local regulatory requirements and other appropriate regulations
- Attend and participate in study team meetings/teleconferences as well as country meetings/teleconferences; ensure information in the Clinical Trial Management System (CTMS) is up to date
- Evaluate data query trends and interact with trial team in order to improve data quality.
- Ensure issues relating to data quality are escalated and resolved with the study team.
- Identify/evaluate potential Investigators for future studies; build effective and positive relationships with Investigators
- Assist in the preparation for site audits and inspections and in responding to any issues identified within the timeframe specified
- Keep medical and clinical knowledge for assigned therapeutic areas up to date; mentor/coach new CRA’s, and maintain annual training records
- Audits/Inspections: Support in responding to company, client and federal regulatory requirements/audits, Respond to audit findings
- Support the Clinical Monitoring Manager in all aspect of his/her responsibilities, as required
- When monitoring outsourced to a Clinical Research Organization (CRO):
- Support the Clinical Monitoring Manager in the management and oversight of the CRO
- Perform site visits with the CRO-CRA (in Europe, if necessary also in specific countries outside of Europe) to ensure protocol and procedures are correctly understood
- Perform Site Quality Visits (in Europe, if necessary also in specific countries outside of Europe) as outlined by the Clinical Monitoring Manager
- Support the study team in resolving quality issues linked to monitoring deliverables
- Perform spot checks of monitoring visit reports, TMF documentation or any other document/activity as defined in the oversight plan, if requested by the Clinical Monitoring Manager
- Perform safety reviews/SAE reconciliation and ensure appropriate action is taken at the investigative site in accordance with the appropriate policies and Standard Operating procedures (SOPs), as well as ICH-GCP guidelines and local regulations.
Qualifications and Experience:
- University degree in Biological Science/Pharmacy/Nursing or qualification in Nursing
- Minimum of 3 years' CRA experience or combination of CRA and other clinical research relevant experience
- Position requires international travel (50 – 60% travel time)
- Knowledge of the Clinical Development process
- Proficient knowledge of regional healthcare environment.
- Excellent knowledge of International Conference on Harmonization-Good Clinical Practice (ICH-GCP) guidelines and applicable local regulations
- Experience in working with electronic data capture, electronic Trial Master File (eTMF), and Clinical Trial Management Systems
- Experience in participating in internal audits, external audits, and/or investigator site audits
- Excellent verbal and written communication skills in English and German
- Highly self-motivated and proactive, with a keen attention to detail
- Goal oriented, able to effectively prioritize and execute tasks in a high-pressure environment
- Ability to work in a cross-functional team environment
- Strong interpersonal skills, excellent relationship-building and negotiation skills
- Strong problem-solving skills and ability to manage multiple clinical project activities
- Excellent organizational and time management skills as well as working flexibility