Senior Clinical Operations Coordinator
Company: Randstad USA
Location: Cherry Hill
Posted on: June 23, 2022
Job Description:
Responsibilities:May include but not limited to the
following:
- As required, maintain local files as applicable (e.g.,
maintenance of the local regulatory files as required by the local
regulatory requirements and Standard Operating Procedures (SOPs),
resource training files).
- Serve as first point of contact for regionally-based Clinical
Research Associates (CRAs) and clinical study site personnel, as
required for project.
- As required, devise and/or employ established tracking
mechanisms to accurately and effectively track and report study
activities and deliverables.
- May work across multiple projects and must be able to work
effectively in a team setting and/or matrix environment.
- Assist the Country Clinical Monitoring Team (CCMT) as needed to
support assigned projects.Provide general study support including
but not limited to the following:
- Conduct administrative and logistical tasks related to clinical
study set-up, active conduct and closeout in support of the
CCMT.
- Organize and ensure timely shipment of documents and supplies
to CRAs, Study Start-up Vendor(s), investigational sites and
Headquarter (HQ) per CCMT requirements.
- Transmit, collate, track and file documents and data for the
CRA/CCMT and provide alerts relative to missing, inaccurate or
incomplete elements.
- Communicate and collaborate with local study coordinator and/or
regulatory coordinator to ensure timely and accurate completion of
all required documents for submission to IRB/REB and/or other local
committees, as applicable for study. For Central IRBs, collaborate
with the vendor to ensure timely submissions and procurement of
required approvals for study start-up. As necessary, track
submission progress and generate status update reports for
CCMT.
- Help ensure timely Investigational Materials/Study Drug release
to investigational sites via collection, quality review and
preparation of documents required for release approvals.
- Perform quality checks and upload documents to the electronic
Trial Master File (eTMF).
- Regularly input/update and maintain accuracy and currency of
data in the CTMS.
- May act as Super User of CTMS, lending technical system support
to a country / cluster of countries, if required.
- Prepare the Study Drug release, i.e., collect, quality check
and prepare documents for Study Drug approval and release in
collaboration with CRAs
- Assist in identifying and implementing best practices and
continuous process / systems improvement plans.
- May be requested to attend monitoring visits with CRAs to
collect critical documents, if needed.Position
Requirements:Education:
- Associate degree (or equivalent) required at a minimum; 4-year
degree in a scientific or health care discipline preferred
Experience:
- 3 - 4+ years' relevant work experience in clinical trials
operations and a working knowledge of ICH GCP, global standards,
local laws and regulations.Special Skills:
- Proficiency in Office WORD, EXCEL, POWERPOINT a must. Working
knowledge of electronic data capture (EDC) and Clinical Trial
Management Systems (CTMS) preferred.
- Demonstrated ability to multitask and focus on multiple
deliverables simultaneously.
- Must possess strong communication skills (both written and
verbal).
Keywords: Randstad USA, Cherry Hill , Senior Clinical Operations Coordinator, Healthcare , Cherry Hill, New Jersey
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