Clinical Research Associate II, Oncology (East Coast, US) IQVIA Biotech
Location: Morrisville, North Carolina; Alexandria, Virginia; Allentown, Pennsylvania; Alpharetta, Georgia; Bedford, New Hampshire; Bethlehem, Pennsylvania; Bridgewater, New Jersey; Cambridge, Massachusetts; Chesapeake, Virginia; Cleveland, Ohio; Columbia, Maryland; Danbury, Connecticut; Deerfield Beach, Florida; Deerfield, Illinois; Duluth, Georgia; Durham, North Carolina; East Norriton, Pennsylvania; Falls Church, Virginia; Frederick, Maryland; Marietta, Georgia; Raleigh, North Carolina; Roselle Park, New Jersey; Rockville, Maryland; Wilmington, North Carolina
At IQVIA Biotech, we offer a unique approach to serving biotech customers. A flexible model, therapeutically-aligned teams and dedicated resources in a transparent partnership. As a Senior Clinical Research Associate, you’ll have the opportunity to work directly with customers in a collaborative environment where you'll be part of a team bringing important treatments to patients.
In this highly specialized and dynamic role, you’ll utilize your extensive therapeutic knowledge to oversee uniquely-focused clinical studies. Working at the core of clinical research, you’ll be exposed to cutting-edge protocols and experience a dedicated partnership with your team like never before.
Join us and help reimagine the future of biotech.
- Full Time
- Level: Senior
- Travel: Yes
What makes a Senior Clinical Research Associate at IQVIA Biotech successful? Check out the top traits we’re looking for and see if you have the right mix.
As you grow your CRA career at IQVIA Biotech, you’ll play an important role in helping our customers drive healthcare forward and impact the lives of patients around the world.
What makes IQVIA Biotech different from my past companies is that I partner directly with smaller pharmaceutical companies and am able to become a true ‘expert’ by being aligned with a smaller amount of projects with a larger site load. IQVIA Biotech promotes a strong culture of communication and mentorship and I’ve thoroughly enjoyed my time since joining last year.Leah, Clinical Research Associate 2
Resources that promote your career growth
Leaders that support flexible work schedules
Roles that require specialty knowledge and training
Protocols aligned to your specific expertise
Dynamic work environments that expose you to new experiences
Programs to help you build your therapeutic-knowledge
Clinical Research Associate II, Oncology (East Coast, US) IQVIA Biotech
Participates in the preparation and execution of Phase I-IV clinical trials. Oversees the progress of clinical investigations by conducting site evaluation, initiation, interim and 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 to ensure all monitoring activities are conducted according to study requirements.
This position requires a minimum of 12 months of field monitoring experience.
ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:
- Participates in the investigator recruitment process. Performs site evaluation visits of potential investigators. May 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 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 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 review. Performs validation of source documentation as required by sponsor. Prepares 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 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 patient clinical data through (1) in house review of electronic CRF data and (2) on-site source verification. Works 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
- 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
- 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
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 world. The 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 way. Learn 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, Inc. provides reasonable accommodations for applicants with disabilities. Applicants 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 email@example.com to arrange for such an accommodation.
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