Data Entry Clerk

Responsibilities

• Complete all study related data entry procedures under the direction of the Site Director.
• Maintain accurate, confidential files and documentation of study participants.
• Quality control the clinical data to ensure the data quality and report discrepancies to the coordinator.
• Complete any training as required by sponsor for access and approval to complete data entry.
• Enter data as appropriate for protocol into paper or electronic case report forms.
• Track to ensure that data entry is complete for subjects including completed study visits and related forms.
• With CRC and/or manager oversight assist Sponsor or CRO data manager with resolution of queries to ensure clinical data quality.

Qualifications

• High School Diploma or equivalent.
• Understand regulatory requirements, as well as Good Clinical Practices (GCP) and International Conference on Harmonization (ICH) guidelines.
• Able to communicate with providers, co-workers, sponsors, and others in a collaborative and courteous manner.
• Knowledgeable in medical terminology so as to communicate with physician office and staff.
• Able to initiate or modify behavior to achieve desired outcomes in spite of environmental factors, priorities, or problems that might not be well defined or that are subject to change.
• Excellent communication skills (interpersonal, written, verbal).
• Must be able to identify and communicate about research problems and processes across various levels of the organization.
• Good organizational and interpersonal skills.
• Attention to detail.
• Basic computer skills to include Word, Excel, as well as proprietary applications unique to the clinical research industry (such as Study Manager).