Senior Clinical Research Associate, Oncology, East Coast, US, IQVIA Biotech
Company: IQVIA
Location: Raleigh
Posted on: May 26, 2023
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Job Description:
IQVIA Biotech is seeking Senior Clinical Research Associates to
join our growing team. Ideal candidates will have 5+ years of
experience in oncology monitoring with a preference in CAR-T.
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.
LEAD CRA ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:
The Lead Clinical Research Associate may perform any of the
following tasks:
Participate in the investigator recruitment process. Perform site
evaluation visits, as needed, of potential investigators. Evaluates
the capability of the site to successfully manage and conduct the
clinical study.
Collaborate 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
Perform 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.
Assists with, and attends, Investigator Meetings for assigned
studies.
Train site staff on the EDC system and verify site computer
system.
Assist in resolving any issues to ensure compliance with site file
audits in conjunction with ISS.
Assure 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.
Document 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.
Review the quality and integrity of the clinical data through (1)
in house review of electronic CRF data and (2) on-site source
verification. Work with sites to resolve data queries.
May review draft protocols, eCRFs, monitoring reports and follow-up
letters, study manuals and other prepare study-related documents
and templates, as requested by the CTM and/or PM.
May serve 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.
Assist CTM and/or PM in review of project budgets, monitoring
costs, potential overruns and propose/implement cost effective
solutions.
Assist the study management in identifying and generating changes
in scope
Perform 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.
Authorized to request site audits due to data integrity
concerns.
Attends study-related, company, departmental, and external
meetings, as required.
Ensure 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.
Ensure all study deliverables are completed per IQVIA Biotech and
study timelines
May conduct Field Evaluation Visits and field training of CRA Is,
IIs and Sr CRAs.
Serve as mentor for junior CRAs and those new to the company and/or
study.
Participate in the performance appraisal program by providing
timely and accurate feedback regarding the performance of a
perspective CRA.
Review and approve CRA travel expenses and time sheets.
Perform other duties, as requested.
TECHNICAL CTM ESSENTIAL JOB FUNCTIONS, DUTIES AND
RESPONSIBILITIES:
The Technical CTM may perform any of the following tasks for
oncology studies:
Create master tracker(s) to house information generated from
various reports such as:
and CM_Data_Cleaning_Report_By_Subject both Business Objects
reports
Reconcile patients that have come off treatment and off study
Generate and review various IL2 reports
Works closely with CDRC to ensure data is further reviewed and
discrepancies documented.
The Technical CTM may participate in CDRC review and aid in Patient
Profile review, as necessary.
There may be additional tracking required as a result of CDRC's
review.
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.
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 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
CLASSIFICATION (US):
This position is classified as exempt under the Fair Labor
Standards Act; employees are not eligible for overtime
compensation.
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
As the COVID-19 virus continues to evolve, IQVIA's ability to
operate and provide certain services to customers and partners
necessitates IQVIA and its employees meet specific requirements
regarding vaccination status.
https://jobs.iqvia.com/covid-19-vaccine-status
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 Q - Solutions, contributes to our
shared goal of improving human health. Thank you for your interest
in growing your career with us.
EEO Minorities/Females/Protected Veterans/Disabled
Keywords: IQVIA, Raleigh , Senior Clinical Research Associate, Oncology, East Coast, US, IQVIA Biotech, Healthcare , Raleigh, North Carolina
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