Note: The job is a remote job and is open to candidates in USA. Kelly Science and Clinical FSP, a managed solution provider and business unit of Kelly Services, supports a global MedTech client through its Clinical Operations division. The Clinical Study Administrator provides routine and technical administrative support for clinical trials, including study data tracking, site documentation, reporting, compliance support, vendor coordination, meeting organization, and study supply management.
Responsibilities
- As directed, provides support to the project teams which may include tracking study data, following-up with clinical sites on essential documents; assist in drafting and distributing study mailings, including study newsletters; assist in drafting of agenda/meeting minutes and scheduling of meetings
- Assist in payments/tracking for patient reimbursements
- Performs data entry in systems
- Run reports including training matrix reports, metrics for management reviews
- Support management of IRB/IEC renewal compliance
- Coordinate process for the review of study data, such as MRIs, by third-party vendors
- Assist in ordering, shipping, tracking of, study supplies including, but not limited to, investigational devices and site binders. Maintain master device accountability log as requested
- Assist with scheduling and organizing investigators and expert panel meetings
- Assist with file reviews and Audit preparation
- Is responsible for ensuring appropriate level of communication with managers, project leaders, and team members
- Work with management group to help achieve department goals
- Participate in process improvement activities within the department
- May be involved in other tasks to support Clinical Operations and Operating Company as needed
- Know, understand, incorporate, and comply with all applicable laws and regulations relating to business activities and Policies and Procedures of the Health Care Compliance Program and Code of Conduct
- May be asked to provide additional support to Clinical Operations staff, as needed
Skills
- Minimum of a Bachelor's Degree is required
- Previous clinical research experience
- Requires previous administrative support experience or equivalent for at least 1 year
- Clinical/medical background
- Requires experience and knowledge working with computer systems (Microsoft office - Excel, Word and Power Point)
- Tracking
- Written and verbal communications
- Attention to details
- Organizational skills
Benefits
- Full benefit options
- Medical, Dental, Vision, 401K and a variety of other benefits to choose from
- Paid time off, including holiday, vacation, and sick/personal time
- Remote work arrangement
Company Overview