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Title: Data Entry Coordinator/Clerk

Location:

About Company:

Who is ERG?

ERG is a leading U.S. based, privately held, independent clinical research site company, and provider of clinical development services with an expertise in early and late-stage neuroscience drug development. With 19 wholly owned clinical sites and 5 affiliated sites, we conduct in-patient and out-patient phase I-IV clinical research studies. ERG has 340+ in-patient beds, a large and growing database of patients suffering from mental illness, neurological disorders, sleep disorders, addictions, Acute and Chronic Pain, diabetes and other illnesses as well as normal healthy volunteers who participate in trials for the advancement of medicine. With access to over 32 million patients/subjects and 5000 + completed trials, ERG continues to grow its capabilities and expand into indications where there are tremendous unmet medical needs in the United States and globally.

Job Description:

The Data Entry Clerk is responsible for the overall coordination, organization, and efficient implementation of clinical data. Complete all study related data entry procedures under the direction of the Site Director. Maintain accurate, confidential files and documentation of study participants. In executing these position responsibilities, the Clinical Data Entry Clerk is guided by Good Clinical Practices (GCP), International Conference on Harmonization (ICH) guidelines, and company standard operating procedures and policies.

Responsibilities:

• Responsible for clinical data processing as directed by Site Director or another assigned manager.
• 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.
• Study, learn, and comply with ERG standard operating procedures and other policies, practices, and regulations where applicable.
• Additionally, this role may encompass responsibilities beyond those outlined above, as required by the evolving needs of the organization. This job description is intended as a foundation and may be subject to expansion or modification to best suit ERG’s objectives.

Skills and Qualifications:

• Education and experience
  • 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.
• Requirements
  • 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)