Clinical Data Specialist

General Summary of Position
Works with the designated program to collect activity data, provide numeric reports and maintain the database of the program. Provide confidential donor and patient clinical reports to the appropriate regulatory bodies. Maintain and circulate the program activity calendar for effective communication with the referral network. Sample product labeling, coordination of and hand out of products to couriers. Control of all internal documents (SOPs and Forms). Coordinator for research studies. These functions are performed in accordance with all applicable laws and regulations and MedStar Georgetown University Hospital's philosophy, policies, procedures and standards.
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Primary Duties and Responsibilities

Collects data and provides reports to the regulatory bodies.

Monitors, audits and maintains regulatory compliance for all medical and stem cell product records.

Maintains the patient database. Performs regular tracking and generates paperwork and computerized reports describing clinical indicators, the status of current patients, diagnoses, etc.

Provides database management support for research studies conducted.

Communicates with the Regulatory bodies and is responsible for submitting protocol deviations and adverse event reports accordingly, as applicable in collaboration with relevant Medical Directors.

Obtains institutional consents, beneficiary information and the release and authorization for use or disclosure of medical records from peripheral stem cell and bone marrow donors.

Acts as a project lead for different studies implementation with NMDP. Identifies training needs and provides staff education and training for specific procedures and associated equipment and materials.

Responsible for stem cell product labeling, coordination of and hand out to couriers.

Maintains all Standard Operating Procedures (SOP's) and forms current and proceeds with modifications as dictated by the quality assurance committee. Ensures that all pertinent personnel has been informed about changes to existing SOPs and does so across services and institution departments, as applicable.

Maintains and circulates the program activity calendar for effective communication with the referral network on a twice weekly basis

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Minimum Qualifications
Education

• Bachelor's degree in relevant industry required
• Three years of progressive clinical research experience required

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Experience

• 1-2 years of experience in a research setting, or other relevant experience
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  Licenses and Certifications
  • CCRP - Certified Clinical Research Professional Clinical Research Professional Certification preferred
  
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  Knowledge, Skills, and Abilities
  • Experience in Medical Records;
  • Computer Science;
  • Health Information Systems;
  • Data Collection;
  • Experience with multiple types of data collection such as telephone interviewing and pen-and-paper surveys is required;
  • Experience entering time-sensitive data;
  • Experience developing queries and reports;
  • Capacity to trouble-shoot and identify and resolve problems independently;
  • Must be familiar with the PC-environment;
  • Familiarity with medical terminology a plus;
  • Good organizational and communication skills and ability to work with multiple health care professionals are essential.
  
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  This position has a hiring range of $63,793 - $107,411
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