Accountabilities:
This role facilitates the preparation and submission of clinical data as per protocol, sponsor, and contractual requirements. Creates databases and data collection tools as needed for sponsored clinical research studies/projects. Oversees all data compliance in accordance with sponsor, contract and regulatory agencies regulations and requirements.
Maintains patient charts in an audit preparedness manner to ensure accordance with all regulatory agencies(e.g., FDA). Assists team leaders in the preparation of all audits performed by various governing agencies, study monitors, and internal affairs.
Assures timely and accurate submissions of research data and query resolution as per contract requirements.
Communicates to all sponsors, CROs and statistical centers as need related to data.
Works daily in collaboration with other core lab team members
Organizes and prepares for all study related sponsor visits up including, but not limited to Pre-Site Initiation Visits, Site Initiation Visits, Routine Monitor Visits, Close-Out Visits, Internal Audits, and Sponsor Audits.
Compares schedule of events to Case Report Form (CRF) in order to correctly capture study specific data points on the CRFs.
Collects and records study data from various source documents by into different case report systems.
Resolves data queries accurately and within contract and study specific timeframes.
Prepares reports, including but not limited enrollment logs which assists with institutional statistical analysis.
May create databases for Investigator all studies or projects
Oversees and facilitates the creation of data collection tools within the platform Exports data and reviews with principal investigator as appropriate
Collates data and assists in abstract preparation as needed
Covers and assists regulatory staff as needed, including but not limited to maintaining regulatory documentation and binders; processing internal and external SAE reports; obtaining signatures; facilitating addition of study personnel; and processing IRB submissions
follows SOPs
Supports physicians administratively including calendar and scheduling of clinical procedures
Assists with billing
Required:
High School Diploma
Preferred:
Bachelors Degree in health related discipline preferred
CCRC or CCRP preferred
2+ years in Healthcre Setting
