Job Description :
SUMMARY:
Performs data entry, creation and maintenance of files, spreadsheets, proposals, and reports. Assists with the
reviews and analyses of project specific data and management of study-related committees.
ESSENTIAL FUNCTIONS:
1. Performs data entry of medical monitor contact reports (MMCRs) into ProjecTrend and/or IMPACT, while
tracking and organizing MMCR data.
2. Assists Medical Affairs Scientists with review of medical data listings, Case Report Form (CRF) line and lab
listings, and medical coding; highlights areas for medical review
3. Supports study-related committees by attending meetings, preparing meeting minutes, and maintaining all
committee-related documents. May serve as a committee manager.
4. Uploads and manages documents collected for pre-enrollment review and endpoint adjudication into
TrialEASTM.
5. Supports the Medical Affairs and Medical Operations departments and staff with the following duties:
a. Performs file creation, retention, and maintenance (paper and electronic);
b. Maintains Medical Monitor and Medical Operations study assignment roster, including tracking the
assignment of back-up staff where appropriate;
c. Maintains request for proposals (RFPs) spreadsheet including tracking awarded and lost projects pertaining
to Medical Affairs;
d. Initiats and follows up with study sites as necessary;
e. Maintains the SharePoint web sites for Medical Affairs and Medical Operations by granting user access,
creating new document libraries, and updating out of office calendar for department members.
6. Ensures compliance with the Code of Federal Regulations (CFR), HIPAA, state regulations, International
Committee on Harmonization (ICH), and GCP guidelines, and sponsor Standard Operating Procedures (SOPs),
and Work Instructions (WIs), where appropriate.
Qualifications
OTHER RESPONSIBILITIES:
Performs other work related duties as assigned. Minimal travel may be required (up to 25%).
Note: If there are additional responsibilities that are specific to an individual employee, department, country, or
other grouping, please use the Job Description Addendum Template
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