Clinical Research Coordinator Job at US Digestive Health

US Digestive Health Wyomissing, PA 19610

POSITION SUMMARY:

Under general supervision, the Clinical Research Coordinator provides assistance to the Research Department, including recruitment, managing data, and collecting, processing, and coordinating samples, specimens, and information.

DUTIES AND RESPONSIBILITIES:

  • Provide assistance to Research staff by organizing files, projects, information and data.
  • Collect, process, and assist in the compilation and verification of research data, samples, and/or specimens (following strict protocol and detailed instructions)
  • Enter data from forms and documents into databases and other documents
  • Assist with routine data verification and quality control, ensuring data integrity and consistency with prescribed study protocol
  • Become familiar with Research SOPs and study protocols
  • Ensure patient’s referring physician receives notification of patient’s participation in studies as requested by the patient
  • Collect, process, and ship blood/urine/stool specimens at patient visits
  • Complete and maintain case report forms per FDA guidelines, and review them against the patient’s medical record for completeness and accuracy
  • Submit patient stipends/reimbursement requests at the conclusion of study visits
  • Ensure the filing and maintenance of all regulatory documents
  • Maintain temperature logs
  • Order and distribute dry ice as needed
  • Periodically check expiration dates on clinical supplies and re-order as needed
  • Assist coordinators with preparation of source documents
  • Assist with subject recruitment by performing chart reviews, cold calling, etc.
  • Schedule patient visits
  • Process Lab specimens
  • Assist with vital signs
  • Perform Fibroscans once trained
  • Phlebotomy
  • Provide general office support to keep operations running smoothly
  • Other duties as assigned

EDUCATION & EXPERIENCE:

  • Completion of bachelor’s degree (in lieu of degree four years of relevant clinical research experience may be accepted)
  • Minimum two years of experience in a related healthcare position
  • Previous experience with clinical trials a must
  • Experience with pharmaceutical trials preferred

QUALIFICATIONS & REQUIREMENTS:

  • Able to effectively present information and respond to questions from physicians, staff and patients
  • Proficiency in Microsoft Office software preferred, knowledge of EMR systems required
  • Able to function effectively in a team setting
  • Must have critical thinking skills
  • Must possess excellent verbal and written communication skills as well as excellent interpersonal skills with patients, staff, and other health care professionals
  • Able to demonstrate consistent professional conduct and meticulous attention to detail
  • Completion of Good Clinical Practice and IATA training required
  • Must be able to work flexible hours as necessary
  • Previous phlebotomy experience preferred
  • Must be a self-starter and demonstrate initiative
  • Willingness to learn is a must

Job Type: Full-time

Benefits:

  • 401(k)
  • 401(k) matching
  • Dental insurance
  • Employee assistance program
  • Flexible spending account
  • Health insurance
  • Health savings account
  • Life insurance
  • Paid time off
  • Referral program
  • Vision insurance

Schedule:

  • 8 hour shift
  • Day shift
  • Monday to Friday

Ability to commute/relocate:

  • Wyomissing, PA 19610: Reliably commute or planning to relocate before starting work (Preferred)

Work Location: One location




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