The Clinical Research Associate 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 (RAO) and CRA. The Regulatory department will oversee the RAO role while the Clinical Operations Manager (COM) 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 (e.g., Clinical Trial Associate, Study Coordinator) or equivalent.
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
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
Ability to travel up to 75%
Possess a valid driver’s license, as required