Clinical Research Associate II

The Clinical Research Associate II is responsible for the feasibility, initiation, monitoring, and close-out of investigative sites.

Major responsibilities include ensuring the safety and well-being of study participants at assigned sites, ensuring site compliance with Good Clinical Practice (GCPs), applicable regulations, the protocol and study plans; ensuring data integrity through source data verification and monitoring process, and ensuring site compliance with all Investigational Product (IP) storage, inventory, dispensing, dosing, and disposition requirements.

EU CRAs could have a shared role of Regulatory Affairs Officer and CRA. The Regulatory department will oversee the Regulatory role while the Clinical Operations Manager will oversee the CRA role.

Duties and Responsibilities

• Participates in the identification of potential investigative sites, conducts site qualification visits, collects, and reviews site regulatory documents, and prepares site qualification visit reports and associated documentation; participates in the final selection of investigative sites
• Conducts site initiation visits; trains site personnel on Client and regulatory requirements for study conduct; participates in and/or conducts site meetings and investigator meetings, and prepares site initiation visit reports and associated documentation
• Conducts site monitoring visits and follow-up to identify significant problems and issues, and to ensure that all clinical aspects of studies are being carried out in accordance with study plans, GCPs, and applicable regulations; prepares monitoring visit reports and associated documentation
• Reviews on-site files and records, Case Report Forms, and source documents for completeness, accuracy, consistency, and compliance; identifies deficiencies and discrepancies; initiates corrective action as required
• Assists in submissions to the Independent Ethics Committees (central and local) and to Competent / Regulatory Authorities
• Arranges site payments and facilitates site budgets and contracts as requested
• Ensures training is performed within a reasonable period and is current and appropriately documented
• Ensure protocol deviations are appropriately documented, and action items are followed through to completion
• Manages site monitoring visit schedule, and the follow-up of issues between visits, along with ongoing regular communication with the sites and the clinical study team
• Maintains close contact with the site staff, to be aware of patient enrolment, enrolled patients’ status, IP supply and any further site requests or issues
• Ensures essential documents are filed in the Trial Master File (TMF) according to the project guidelines
• Ensures appropriate and timely transmission of clinical data to data management; reviews data queries, and clarifies and/or obtains changes to data as appropriate
• Conducts site close-out visits to include final IP reconciliation and disposition, review of completeness and accuracy of files, and retrieval of documents for the TMF; prepares site close-out visit reports and associated documentation
• Attend team meetings as required
• Participates in systems User Acceptance Testing as required
• Senior CRA assists with the development and implementation of study-specific monitoring and reporting procedures, methods, guidelines, and tools; participates in development of participant tracking systems; conducts monitoring assessment visits for the purpose of rescuing a troubled site or performing audit preparation at the direction of the CTM
• Senior CRA oversees work for assigned CRAs on a designated project; reviews and approves monitoring visit reports; manages the visit schedule; provides feedback during the annual review process regarding performance of assigned CRAs
• Other duties as assigned

Required Skills and Abilities

• Require a minimum of four years’ clinical research experience.
• Life Science degree or equivalent experience combined with successful completion of a recognized CRA training program is essential.
• Requires a minimum of two years’ monitoring and site management experience as Clinical Research Associate
• Pulmonology and Oncology therapeutic expertise is preferrable
• Excellent understanding of the clinical research process, clinical trial-related systems and procedures, regulations and GCPs, and the scientific/clinical knowledge to be able to understand the nature of drugs being studied
• Excellent written and verbal communication skills, and time management, organizational and problem‑solving skills
• Fluent in German language (speaking, writing) and good comprehension of English language where English is not the local language
• Excellent people skills and ability to work successfully in a matrixed team environment
• Dedication to quality in all work tasks and deliverables
• Ability to prioritize and manage multiple tasks as necessary, including during travel and monitoring visits
• Working knowledge of computer systems, applications, and operating systems