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IQVIA Biotech is seeking an experienced Senior Clinical Research Associate to join our team.

• At least 4 years of onsite monitoring experience

• Minimum of 6 months of experience in Ophthalmology

• Experience with Cardiovascular/Renal/Metabolic (CVRM) studies is a plus.

• Location:Central or East Coast Region

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.

• Four+ years of oncology experience and/or medical device.

• 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.

• Able to qualify for a major credit card, rent an automobile

• For the Technical CTM role, the CRA must have a deep understanding of IQVIA Biotech systems with the ability to learn even more.

MINIMUM RECRUITMENT STANDARDS:

• BS/BA/BSc (or equivalent) in one of the life sciences or health care background (RPh, RN, etc) and a minimum of four (4) years of monitoring/site management experience is required; or equivalent combination of education, training and experience.

• Prior Clinical Research Organization (CRO) experience preferred.

• Prior project team leadership experience preferred.

• Working knowledge of budget management preferred.

• Must be able to travel domestically and internationally 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

IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. 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 world. Learn more at https://jobs.iqvia.com

We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities. https://jobs.iqvia.com/eoe

IQVIA’s ability to operate and provide certain services to customers and partners necessitates IQVIA and its employees meet specific requirements regarding COVID-19 vaccination status. https://jobs.iqvia.com/covid-19-vaccine-status

The potential base pay range for this role, when annualized, is $101,600.00 - $169,300.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.

IQVIA is a world leader in using data, technology, advanced analytics, and expertise to help customers drive healthcare – and human health – forward. Together with the companies we serve, we are enabling a more modern, more effective and more efficient healthcare system, and creating breakthrough solutions that transform business and patient outcomes.

To get there, it takes diverse skills and a curiosity to explore new possibilities. No matter your role, everyone at IQVIA, including our colleagues at Q² Solutions, contributes to our shared goal of improving human health. Thank you for your interest in growing your career with us.

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