IQVIA™ is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients.
Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to drive healthcare forward.
IQVIA Biotech has an exciting position within its EU Clinical Monitoring team. The Clinical Monitoring department is the largest team within IQVIA Biotech, providing CRA, Clinical Leads, Management and oversight to global clinical studies.
We're looking for a lively, enthusiastic and independent professionals who are willing to work from home with an international EU team.
Becoming a CRA at IQVIA Biotech doesn't stop with monitoring clinical sites, we provide our teams with opportunity and environments to grow and explore their skills.
We have a culture of developing top talent and taking them to where they want to be; be it Project Management, Safety, Management.
IQVIA Biotech specialises in working with smaller biotech and emerging biopharma clients and as such we have a vibrant, fast-paced work environment.
You’ll be working with a lot of the new innovative and upcoming research groups across a variety of therapy areas.
BASIC FUNCTIONS :
Participates in the preparation and execution of Phase I-IV clinical trials. Oversees the progress of clinical investigations by conducting site evaluation, initiation, and interim close out visits to sites.
Monitors clinical trials in accordance with Good Clinical Practices and procedures set forth by IQVIA Biotech and sponsors.
Works closely with the Clinical Trial Manager (CTM) and / or Lead CRA t0 ensure all monitoring activities are conducted according to study requirements.
The Senior CRA may also serve in the Lead CRA role.
ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES :
Participates in the investigator recruitment process. Performs site evaluation visits of potential investigators. Evaluates the capability of the site to successfully manage and conduct the clinical study.
Collaborates with the ISS department to coordinate activities with the site in preparation for the initiation of the study.
Obtains regulatory documentation for successful implementation, monitoring, and evaluation of clinical trials. Works with ISS and site staff to obtain regulatory (IRB / IEC) approval of study specific documents
Performs study initiation activities, reviewing with the site personnel the protocol, regulatory issues, study procedures, and provides training on completion of the eCRF;
monitoring activities and study close-out activities.
Trains site staff on the EDC system and verifies site computer system.
Assists in resolving any issues to ensure compliance with site file audits in conjunction with ISS.
Assures adherence to Good Clinical Practices, investigator integrity, and compliance with all study procedures through on-site monitoring visits.
Performs validation of source documentation as required by sponsor. Prepares monitoring reports and letters per the timelines defined in IQVIA Biotech SOPs by using approved IQVIA Biotech / sponsor templates and reports.
Documents accountability, stability and storage conditions of clinical trial materials as required by sponsor. Performs investigational product inventory.
Ensures return of unused materials to designated location or verifies destruction as required.
Reviews the quality and integrity of the clinical data through (1) in house review of electronic CRF data and (2) on-site source verification.
Works with sites to resolve data queries.
May review protocols, eCRFs, study manuals and other related documents, as requested by the Clinical Trial Manager and / or Lead CRA.
Serves as primary contact between IQVIA Biotech and investigator; coordinates all correspondence; ensures timely transmission of clinical data with the study site and technical reporting, as requested.
Performs study close-out visits per the study specific Clinical Monitoring Plan including final investigational product reconciliation and disposition, site study file reconciliation, data query resolution through to database lock and resolution of outstanding action items.
Assists with, and attends, Investigator Meetings for assigned studies.
Authorized to request site audits due to data integrity concerns.
Attends study-related, company, departmental, and external meetings, as required.
Ensures internal and study-related trainings are completed per IQVIA Biotech and / or study timelines; CTMS should always be current with the pertinent site updates / contacts.
Ensures all study deliverables are completed per IQVIA Biotech and study timelines
Conducts Field Evaluation Visits and field training of CRA Is, IIs and other Sr. CRAs.
Serves as mentor for junior CRAs and those new to the company and / or study.
Performs other duties, as requested.
KNOWLEDGE, SKILLS AND ABILITIES :
Strong knowledge of clinical research process, including working knowledge of all functional areas of clinical trials and medical terminology.
Experience in monitoring and / or coordinating clinical trials required.
Excellent written and verbal communication skills to express complex ideas to study personnel at research and clinical institutions.
Demonstrated ability to form strong functional relationships.
Excellent, presentation, organizational and interpersonal skills.
Ability to interact with all levels of staff to coordinate / execute study activities.
Ability to handle several priorities within multiple, complex trials.
Ability to reason independently and recommend specific solutions in clinical settings.
Ability to work independently, prioritize, and work within a matrix team environment.
Ability to mentor other CRAs and co-monitor, as required.
Knowledge of electronic data capture including basic data processing functions.
Knowledge of current GCP / ICH guidelines applicable to the conduct of clinical research.
For the Technical CTM role, the CRA must have a deep understanding of IQVIA Biotech systems with the ability to learn even more.