Clinical Study Associate II
Location: Basking Ridge
Posted on: April 9, 2021
This Opportunity is with a company whoseresearch and development
is primarily focused on bringing forth novel therapies in oncology,
including immuno-oncology, with additional focus on new horizon
areas, such as pain management, neurodegenerative diseases, heart
and kidney diseases, and other rare diseases.Description:
- Assist in planning and execution of clinical studies, under the
supervision of the Study Manager role the Study Associate Manager
within Clinical Operations, in adherence to the protocol, Good
Clinical Practices (GCPs), appropriate Standard Operating
Procedures (SOPs), Food and Drug Administration (FDA)
regulations/EU Directive, and International Conference on
Harmonization (ICH) guidelines.
- Key focus is on providing clinical trial management support to
study teams and tracking CRO and other vendor performance against
project goals and milestones to monitor and ensure compliance with
Clinical Study Oversight Plan (CSOP).
- Reconcile the TMF document trackers generated by the CRO with
the document archive. Bring issues with the reconciliation to the
attention of the Study Manager and propose remediation plan.
- Distribute key study documents to the CRO and vendors as
- Provide clinical administrative support to the study teams.
This may include preparing meeting logistics, distributing agendas,
and minutes for study team meeting, meetings with Academic Research
Organizations (AROs), and meetings with CRO and Investigator
- Collect information and coordinate with Regulatory Operations
to post trial information on required public forums ().
- Support Fair Market Value process in evaluating study
- Under supervision, review and document CRO-generated reports,
such as site monitoring trip reports and protocol deviation reports
and elevate issues to the attention of the supervisor.
- Compile and maintain a monitoring review spreadsheet.
- Compile and maintain CRO Oversight Monitoring (CROOM) visit
output Track study metrics such as site start-up, Investigator/site
performance, recruitment, regulatory documents, TMF filing and QC
activities and elevate areas of concern to your supervisor.
- Create/maintain spreadsheets to track other items as needed,
(e.g. Vendor invoices).
- Analyze study site metrics reports to identify potential areas
of concern and bring to supervisor's attention.Additional Skills &
- Experience considered relevant includes 2-3 years of clinical
or basic research in a Pharmaceutical company, a Medical
device/Diagnostic company, Academic Research Organization (ARO) or
Contract Research Organization (CRO). CRA experience is
- A Bachelor's degree (preferred in Life Sciences) with relevant
clinical development experience is acceptable.
- Time spent directly in a medical environment (e.g. as a Study
Site Coordinator) is also considered relevant. About Aerotek:We
know that a company's success starts with its employees. We also
know that an individual's success starts with the right career
opportunity. As a Best of Staffing Client and Talent leader,
Aerotek's people-focused approach yields competitive advantage for
our clients and rewarding careers for our contract employees. Since
1983, Aerotek has grown to become a leader in recruiting and
staffing services. With more than 250 non-franchised offices,
Aerotek's 8,000 internal employees serve more than 300,000 contract
employees and 18,000 clients every year. Aerotek is an Allegis
Group company, the global leader in talent solutions. Learn more at
Aerotek.com.The company is an equal opportunity employer and will
consider all applications without regards to race, sex, age, color,
religion, national origin, veteran status, disability, sexual
orientation, gender identity, genetic information or any
characteristic protected by law.
Keywords: Aerotek, Newark , Clinical Study Associate II, Healthcare , Basking Ridge, New Jersey
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