The Data Specialist is responsible for clinical trial data integrity and timely submission. Responsible for assisting in the development and maintenance of clinical trials management system for the Office of Research. Responsible for working with contracted vendors to collect and upload data in a timely fashion. Responsible for assisting in the maintenance of physician and subject payments per the study contract. Assist in the conversions and transfer of data to federal regulatory agencies to satisfy reporting requirements. Assist in regulatory reporting of relevant to data collected. Assist in the development and use of templates, forms and reports on behalf of the Department. Assist in data needs and the development of cost and utilization reports required for the Department. Assists in the maintenance of subject files and EMR.
- Coordinate data management for trial sponsor and physician initiated clinical research studies.
- Perform a Variety of administrative tasks in the conduct of clinical research studies
- At all times monitor the conduct of the study relevant to patient safety and care.
- Assists the research coordinator with clinical trial administration including data review, collection, and entry in selected data bases, completion of case report forms, and setting up of and maintenance of files.
- Assist in study feasibility in relation to data collection time and evaluation of sponsor electronic data capture system.
- Responsible for assisting in the development and maintenance of clinical trials management system for the Office of Research.
- Responsible for creating a database and systems for reporting on the quality and outcomes of federally funded projects including data entry, management and analysis.
- Assists with communications with the Sponsor or its representatives and participates in study Monitor visits, and facilitates communication between Principal Investigator and Sponsor or Sponsor's representatives
- Accountable for deadlines and accuracy reporting.
- Assist in development of training materials and documentation manuals.
- Coordinates meetings and intra and inter department communications.
- Fulfills all compliance responsibilities related to the position.
- Assist with the preparation of biologic specimens for shipment to study reference laboratory.
- Assist with the upload or shipment of radiology subject imaging to study reference laboratory.
- Utilizes Good Clinical Practices in the conduct of clinical trials as per established protocol. Follows Stamford Hospital’s Standard Operating Procedures, AAHRPP, HIPPA, and FDA guidelines for clinical research, keeps updated with those procedures and/or guidelines, and complies with finance compliance policies and procedures.
- Assist with the training of less experienced team members
- Assists the Department Director and Manager in special projects
- Performs other duties as assigned.
- This position requires a minimum formal education of a Bachelors degree.
- Prior research or data management experience preferred
- Clinical research certification (such as CCRC, CCRP or other certification approved by Director) preferred. If not yet certified, expected certification within 18-24 months of hire date.
- Strong Computer Skills: MS excel, Clinical Trial Management System, Word and Power Point, Electronic Data Capture
- Desired (but not required) criteria include Knowledge of Data Management, General Medicine, Clinical Trials and Research.
- Strong written and verbal communication skills
- Ability to work independently; organize, plan and adjust work assignments while meeting deadlines
- Able to coordinate multiple projects of varying complexity simultaneously and work efficiently to meet department and Investigator timelines
- Demonstrated ability to establish and maintain effective working relationships
- Requires the ability to communicate effectively in English, both verbally and in writing, and to maintain confidentiality of sensitive information.
- Maintains knowledge of, and follows, relevant departmental and Stamford Hospital policies and procedures.
- Participates in mandated Stamford Hospital / Office of Research education / training initiatives
