Site Manager-Clinical Research at RTI Research Triangle Institute

Posted in Other 3 days ago.

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Type: Full Time
Location: parsippany, New Jersey





Job Description:

RTI-Health
Solutions(RTI-HS) provides scientifically rigorous research and consulting
services to pharmaceutical, biotech and medical device companies. Grounded in
science and supported by state-of-the-art technology, our Surveys and
Observational Studies team can help you
develop real-world evidence through a variety of study types-surveys,
cross-sectional or longitudinal non-interventional studies, registries, and
chart abstractions.

At
RTI-HS, you will be provided the opportunity to conduct meaningful work in a
collaborative, cross functional environment.
We are focused on your career development and provide a generous
benefits packages that includes tuition reimbursement, parental leave, paid
time off, medical/dental, and 401K.

As
a result of our continued business growth, we are seeking a Site Manger to join
our growing team in Parsippany, New Jersey, to serve as the primary liaison for
study related site management issues, escalating to the study team as
needed. As the primary point of contact
for the site and wider study team, you will Interact with clients, vendors and
other functional areas as primary project contact for site issues and
questions. You will also prepare reports
and communicate any pending data queries to the sites in preparation for
interim analysis or final data base lock.

Additional
responsibilities will include but not be limited to:

- Collaborate
with internal and external stakeholders to meet project specific goals
- Send
notification to the sites when needed, for example, office closures or safety
notifications, if applicable.
- Once
the site has had its study initiation meeting; follow up with the site on
patient enrollment or conducting data abstraction for chart review
studies; follow up on patient
recruitment as agreed per contract.
- Track
protocol deviations
- Prepare
and submit document packages to central IRB/EC, if a protocol amendment takes
place during the conduct phase of the study,
- Draft
materials including informed consent documents, data collection forms, training
manuals
- Assist
in development of study protocol
- Collaborate
with Data Management Team to collect data according to study timeline by
following with the site on CRF completion, query resolution and will
address/escalate accordingly any questions from the site staff/Physician.
- Perform
essential document collection and review, maintenance and close out, ensuring
that sponsor and investigator obligations are being met and are in compliance
with applicable local regulatory requirements and ICH/GCP guidelines
- Assists
with the drafting or review of organizational process tools and templates,
study specific documents
- Responsible
for preparing and maintaining study documentation and tools while ensuring that
project-specific administrative documents (e.g., contact lists, study team
roster, metric trackers etc.) are maintained

Qualifications:

- Bachelors
level degree plus 4 years of experience
- Masters
level degree plus 2 years of experience
- Demonstrated
experience in one at least one of the following areas:
- Site
Management in a clinical or contract
research setting
- Clinical
Research Associate/Monitor
- Observational
study management
- Excellent
oral and written communication skills
- Ability
to manage large Excel databases
- Ability
to program in Qualtrics is a plus

RTI
is committed to Lead Forward. We innovate, develop talent, collaborate,
communicate, think globally, act strategically, and engage inclusively.

If
that aligns with your values, we would like to hear from you. Join us and experience the RTI Difference

#LI-BM1

.

We are proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, protected veteran status, or any other characteristic protected by law. Further information is available- https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf


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