Sr. CRA, Cardio, Renal, Metabolic (Central US) - IQVIA Biotech
Company: IQVIA Holdings Inc
Posted on: June 3, 2021
Join us at IQVIA Biotech and be a part of exciting biopharma
clinical research advancements. Immediate positions available for
qualified Sr./ Clinical Research Associates interested in
#Cardiology, #Renal and #Metabolic clinical research. Additional
expereince in Ophthalmology, Endocrinology, CNS/Neuro,
musculoskeletal clinical research studies is a plus.
For additional information contact me at
IQVIA Biotech Clinical Research Associates: Participate 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 to
ensure all monitoring activities are conducted according to study
requirements. The Senior CRA may also serve in the Lead CRA
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
- 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
- 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
- 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
- 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
- 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
- Authorized to request site audits due to data integrity
- 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
- 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
- Four+ years of oncology experience and/or medical device.
- Experience in monitoring and/or coordinating clinical trials
- Excellent written and verbal communication skills to express
complex ideas to study personnel at research and clinical
- Demonstrated ability to form strong functional
- Excellent, presentation, organizational and interpersonal
- Ability to interact with all levels of staff to
coordinate/execute study activities.
- Ability to handle several priorities within multiple, complex
- 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
- Knowledge of current GCP/ICH guidelines applicable to the
conduct of clinical research.
- Able to qualify for a major credit card, rent an
- For the Technical CTM role, the CRA must have a deep
understanding of IQVIA Biotech systems with the ability to learn
- Very limited physical effort required to perform normal job
- Extensive use of telephone and face-to-face communication
requiring accurate perception of speech
- Extensive use of keyboard requiring repetitive motion of
- Regular sitting for extended periods of time
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
- Prior project team leadership experience preferred.
- Working knowledge of budget management preferred.
- Must be able to travel domestically and internationally
- Valid driver's license
- Computer skills including proficiency in use of Microsoft Word,
Excel and PowerPoint and use of a laptop computer
This position is classified as exempt under the Fair Labor
Standards Act; employees are not eligible for overtime
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
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
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
Keywords: IQVIA Holdings Inc, Covington , Sr. CRA, Cardio, Renal, Metabolic (Central US) - IQVIA Biotech, Other , Covington, Kentucky
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