LOCATION: Royal Oaks, MI
Job Overview:
Perform a variety of administrative tasks in support of clinical trials and assist in the performance of clinical procedures to collect data on patients enrolled and/or seeking enrollment in clinical studies.
Responsibilities & Essential functions:
Provide clinical research support to investigators and site staff including:
- Verify and/or correct research study information on source documents. Research queries and variances, and provide feedback to the site data collector;
- Input research study data into trial Electronic Data Capture (EDC) system, maintaining quality control for content, accuracy, and completeness;
- Prepare and maintain research study files. Compile, collate and submit study information within established deadlines;
- Assist in the maintenance of regulatory documentation;
- Schedule subject visits and generate appropriate reports and documents for research subjects prior to visits;
- Input visit data into clinical trial management system (CTMS) to track patient visits and procedures completed against the study budget;
- Processing of required lab specimens, labeling of vials, and accurately filling out requisitions for storage and/or shipment per the study protocol and packaging and shipment regulations; Perform various administrative support functions such as reception, office organization, and office supply management
Qualifications:
Bachelor's degree preferred
Work Experience:
- Equivalent education and experience - High School Diploma and 3 years' relevant work experience in a clinical environment or medical setting, e.g. medical assistant, laboratory technician
- Basic knowledge of clinical trials;
- In-depth knowledge of departmental, protocol and study-specific operating procedures, consent forms, and study schedules;
- Basic knowledge of medical terminology;
- Knowledge in using MS Windows and Office applications such as Access, Outlook, Excel, and Word;
- Excellent interpersonal skills