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Project Start-Up Specialist at RTI Research Triangle Institute in parsippany, New Jersey

Posted in Other 12 days ago.

Type: Full Time





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 Project Start-Up Specialist to join our dynamic team in Parsippany, New
Jersey.

In this exciting role, while serving as primary point of
contact for physician/site during recruitment phase of study, you will lead the
development of and own the physician/site recruitment plan for medical record
abstraction and primary data collection studies. Additionally, you will gather background data
and information to support proposal efforts, develop study specifications for
external recruitment partners, and participate in the review contractor and vendor proposals.

Additional responsibilities will include but not be limited
to:

- Lead and assist in conducting exploratory research and pilot
research during proposal development
- Assist members of research engagement and project management
teams identify protocol requirements to create a viable database of potential
physicians/sites for the study; maintain database and tracker for study
recruitment
- Lead the development of a screener that is used to assess
physician/site feasibility and interest; programs screener questionnaire in a
tool such a Qualtrics
- Assist in the preparation and review of essential study
documents, manuals, training materials
- Manage the collection of confidential disclosure agreements
from interested physicians/sites
- Manage all study start-up activities during recruitment
through study initiation meeting, where site management is transitioned to the
study site manager or project manager
- Assist with the preparation and review of IRB and ethics
submission materials
- Conduct training
- Participate in project team meetings and prepare
weekly/biweekly progress reports
- Manage correspondence and project communications as it
relates to recruitment and study start-up

Qualifications:

- Bachelor's level degree plus 1 year of directly related experience, or equivalent combination of education and experience (Note: A Bachelor's level degree is equivalent to 6 years of directly related experience)
- Demonstrated understanding of ICH, GCP guidelines and HIPAA regulations
- Demonstrated understanding of the clinical trial process across non-interventional (exploratory research, HEOR and Real World Evidence) and/or interventional trials.
- Ability to manage large Excel databases
- Excellent knowledge of MS Word, Outlook, PowerPoint, Excel.
- Demonstrated communications skills, both written and verbal


Preferred:

-
Master's level degree
-
Ability to program in Qualtrics
-
Demonstrated understanding of late-phase trials

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

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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