Clinical Research Associate II / Sr CRA - Sponsor Dedicated - Oncology (Home-Based in Western US)
Company: Syneos Health/ inVentiv Health Commercial LLC
Location: Morrisville
Posted on: May 30, 2025
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Job Description:
Description Senior Clinical Research Associate I
Syneos Health is a leading fully integrated biopharmaceutical
solutions organization built to accelerate customer success. We
translate unique clinical, medical affairs and commercial insights
into outcomes to address modern market realities.
Our Clinical Development model brings the customer and the patient
to the center of everything that we do. We are continuously looking
for ways to simplify and streamline our work to not only make
Syneos Health easier to work with, but to make us easier to work
for.
Whether you join us in a Functional Service Provider partnership or
a Full-Service environment, you'll collaborate with passionate
problem solvers, innovating as a team to help our customers achieve
their goals. We are agile and driven to accelerate the delivery of
therapies, because we are passionate to change lives.
Discover what our 29,000 employees, across 110 countries already
know:
WORK HERE MATTERS EVERYWHERE
Why Syneos Health
Job responsibilities
Performs site qualification, site initiation, interim monitoring,
site management and close-out visits (performed on-site or
remotely) ensuring regulatory, ICH-GCP and/or Good
Pharmacoepidemiology Practice (GPP) and protocol compliance. Uses
judgment and experience to evaluate overall performance of site and
site staff and to provide recommendations regarding site-specific
actions; immediately communicates/escalates serious issues to the
project team and develops action plans. Maintains a working
knowledge of ICH/GCP Guidelines or other applicable guidance,
relevant regulations, and company SOPs/processes.
Verifies the process of obtaining informed consent has been
adequately performed and documented for each subject/patient as
required/appropriate. Demonstrates diligence in protecting the
confidentiality of each subject/patient. Assesses factors that
might affect subject/patient's safety and clinical data integrity
at an investigator/physician site such as protocol
deviation/violations and pharmacovigilance issues.
Per the Clinical Monitoring/Site Management Plan (CMP/SMP):
Assesses site processes
Conducts Source Document Review of appropriate site source
documents and medical records
Verifies required clinical data entered in the case report form
(CRF) is accurate and complete via review of site source documents
and medical records
Applies query resolution techniques remotely and on site, and
provides guidance to site staff as necessary, driving query
resolution to closure within agreed timelines
Utilizes available hardware and software to support the effective
conduct of the clinical study data review and capture
Verifies site compliance with electronic data capture
requirements
May perform investigational product (IP) inventory, reconciliation
and reviews storage and security. Verifies the IP has been
dispensed and administered to subjects/patients according to the
protocol. Verifies issues or risks associated with blinded or
randomized information related to IP. Applies knowledge of
GCP/local regulations and organizational procedures to ensure IP is
appropriately (re)labelled, imported and released/returned.
Routinely reviews the Investigator Site File (ISF) for accuracy,
timeliness and completeness. Reconciles contents of the ISF with
the Trial Master File (TMF). Ensures the investigator/physician
site is aware of the requirement of archiving essential documents
in accordance with local guidelines and regulations.
Documents activities via confirmation letters, follow-up letters,
trip reports, communication logs, and other required project
documents as per SOPs and Clinical Monitoring Plan/Site Management
Plan. Supports subject/patient recruitment, retention and awareness
strategies. Enters data into tracking systems as required to track
all observations, ongoing status and assigned action items to
resolution.
Understands project scope, budgets, and timelines for own and
others' activities in the clinical team; manages site-level
activities / communication to ensure project objectives,
deliverables and timelines are met. Must be able to quickly adapt
to changing priorities to achieve goals / targets.
May act as primary liaison with project site personnel, or in
collaboration with Central Monitoring Associate. Ensures all
assigned sites and project-specific site team members are trained
and compliant with applicable requirements.
Prepares for and attends Investigator Meetings and/or sponsor face
to face meetings. Participates, and may, with supervision, lead,
global clinical monitoring/project staff meetings (inclusive of
Sponsor representation, as applicable) and attends clinical
training sessions according to the project specific
requirements.
Provides guidance at the site and project level towards audit
readiness standards and supports preparation for audit and required
follow-up actions.
May provide training or mentorship to more junior level CRAs. May
perform training and sign off visits for junior CRA staff, as
assigned.
May be mentored and assigned clinical operations lead tasks under
supervision of an experienced Clinical Operations Lead (COL), or
operational line manager.
For Real World Late Phase (RWLP), the Sr. CRA I will use the
business card title of Sr. Site Management Associate I.
Additional responsibilities include:
Site support throughout the study lifecycle from site
identification through close out
Knowledge of local requirements for real world late phase study
designs
Chart abstraction activities and data collection
As required, collaborate and build relationships with Sponsor and
other affiliates, medical science liaisons and local country
staff
Identify and communicate out of scope activities to Lead
CRA/Project Manager
Proactively suggest potential sites based on local knowledge of
treatment patterns, patient advocacy and Health Care Provider (HCP)
associations
Identify operational efficiencies and process improvements
Develop country level informed consent forms
Collaborate with RWLP Regulatory team to ensure updated regulatory
information is applied and shared
Participate in bid defense meetings
Qualifications What we're looking for
Bachelor's degree or RN in a related field or equivalent
combination of education, training and experience
Knowledge of Good Clinical Practice/ICH Guidelines and other
applicable regulatory requirements
Must demonstrate good computer skills and be able to embrace new
technologies
Excellent communication, presentation and interpersonal skills.
Basic level of critical thinking skills expected.
Ability to manage required travel of up to 75% on a regular
basis
Get to know Syneos Health
Over the past 5 years, we have worked with 94% of all Novel FDA
Approved Drugs, 95% of EMA Authorized Products and over 200 Studies
across 73,000 Sites and 675,000+ Trial patients.
No matter what your role is, you'll take the initiative and
challenge the status quo with us in a highly competitive and
ever-changing environment. Learn more about .
Additional Information:
Tasks, duties, and responsibilities as listed in this job
description are not exhaustive. The Company, at its sole discretion
and with no prior notice, may assign other tasks, duties, and job
responsibilities. Equivalent experience, skills, and/or education
will also be considered so qualifications of incumbents may differ
from those listed in the Job Description. The Company, at its sole
discretion, will determine what constitutes as equivalent to the
qualifications described above. Further, nothing contained herein
should be construed to create an employment contract. Occasionally,
required skills/experiences for jobs are expressed in brief terms.
Any language contained herein is intended to fully comply with all
obligations imposed by the legislation of each country in which it
operates, including the implementation of the EU Equality
Directive, in relation to the recruitment and employment of its
employees. The Company is committed to compliance with the
Americans with Disabilities Act, including the provision of
reasonable accommodations, when appropriate, to assist employees or
applicants to perform the essential functions of the job.
AtSyneos Health, we believe in providing an environment and culture
in which Our People can thrive, develop and advance. We reward and
recognize our people by providing valuable benefits and a
quality-of-life balance. The benefits for this position may include
a company car or car allowance, Health benefits to include Medical,
Dental and Vision, Company match 401k, eligibility to participate
in Employee Stock Purchase Plan, Eligibility to earn
commissions/bonus based on company and individual performance, and
flexible paid time off (PTO) and sick time. Because certain states
and municipalities have regulated paid sick time requirements,
eligibility for paid sick time may vary depending on where you
work. Syneos complies with all applicable federal, state, and
municipal paid sick time requirements. The annual base salary for
this position ranges from $63,090 to $145,000. The base salary
range represents the anticipated low and high of the Syneos Health
range for this position. Actual salary will vary based on various
factors such as the candidate's qualifications, skills,
competencies, and proficiency for the role. Syneos Health has a
voluntary COVID-19 vaccination policy. We strongly encourage all
employees to be fully vaccinated. Additionally, certain local
governments or Syneos Health customers may have vaccine
requirements that apply to some of our employees. These employees
are required to submit proof of vaccination to Syneos Health and
maintain compliance with these requirements.
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#LI-Remote
Keywords: Syneos Health/ inVentiv Health Commercial LLC, Chapel Hill , Clinical Research Associate II / Sr CRA - Sponsor Dedicated - Oncology (Home-Based in Western US), Healthcare , Morrisville, North Carolina
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