Job details
Job type full-time
Full job description
Internal job description
Basic functions:
Participates in the preparation and execution of phase i-iv clinical trialsOversees the progress of clinical investigations by conducting site evaluation, initiation, interim and close out visits to sitesMonitors clinical trials in accordance with good clinical practices and procedures set forth by iqvia biotech and sponsorsWorks closely with the clinical trial manager (ctm) and/or lead cra to ensure all monitoring activities are conducted according to study requirements.
Essential job functions, duties and responsibilities:
Participates in the investigator recruitment processPerforms site evaluation visits of potential investigatorsMay collaborate with the integrated site services (iss) department to evaluate 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 studyObtains regulatory documentation for successful implementation, monitoring, and evaluation of clinical trialsWorks 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 ecrf completion and the use of the edc system, monitoring activities and study close-out activities.
Assists in resolving any issues to ensure compliance with site file audits in conjunction with the iss department.
Assures adherence to good clinical practices, investigator integrity, and compliance with all study procedures through on-site monitoring visits including an ongoing site file reviewPerforms validation of source documentation as required by sponsorPrepares monitoring reports, confirmation and follow-up 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 sponsorPerforms investigational product inventoryEnsures return of unused materials to designated location or verifies destruction as required.
Reviews the quality and integrity of the patient clinical data through (1) in house review of electronic crf data and (2) on-site source verificationWorks with sites to resolve data queries.
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.
Authorized to request site audits due to data integrity concerns.
Attends investigator and study-related meetings, as required.
Attends company, departmental, and external meetings, as required.
Conducts 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 database lock and resolution of outstanding action items.
Ensure internal and study-related trainings and any metrics are completed per iqvia biotech and/or study timelines; ctms should be current at all times with the pertinent site updates/contacts.
Knowledge, skills and abilities:
Knowledge of clinical research process and medical terminology.
Strong written and verbal communication skills to express complex ideas to study personnel at research and clinical institutions.
Good organizational and interpersonal skills.
Ability to reason independently and recommend specific solutions in clinical settings.
Ability to understand electronic data capture including basic data processing functions.
Knowledge of current gcp/ich guidelines applicable to the conduct of clinical research.
Ability to qualify for a major credit card, rent an automobile
Physical requirements:
Very limited physical effort required to perform normal job duties
Extensive use of telephone and face-to-face communication requiring accurate perception of speech
Extensive use of keyboard requiring repetitive motion of fingers
Regular sitting for extended periods of time
Minimum recruitment standards:
Bs/ba/bsc (or equivalent) in one of the life sciences with a minimum of 12 months of field monitoring experience
Twelve months experience in clinical research and coordinating clinical trials or successful completion of iqvia biotech cra training program required; experience in a clinical setting is a plus; monitoring experience is preferred.
Must possess at least 1 year of oncology experience.
Must be able to travel domestically approximately 65%-85%.
Valid driver’s license
Computer skills including proficiency in use of microsoft word, excel and powerpoint and use of a laptop computer
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At iqvia, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier worldThe advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 70,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the wayLearn more at jobs.iqvia.com.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law.
Iqvia, incProvides reasonable accommodations for applicants with disabilitiesApplicants who require reasonable accommodation to submit an application for employment or otherwise participate in the application process should contact iqvia’s talent acquisition team at workday_recruiting@iqvia.com to arrange for such an accommodation.
