POSITION SUMMARY:

The Clinical Data Coordinator (CDC) will assist in the planning, implementation, conduct and reporting of the Data Management portion of clinical trials as a member of clinical trial study teams per Department SOPs, guidelines and GCP. The CDC will work with the Supervisor and Study Lead to develop/execute technical Data Management responsibilities.

DUTIES AND RESPONSIBILITIES (essential functions of position):

Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.

• Process and file incoming CRFs and/or radiographs.
  
• Assist in data entry and data processing into defined company database systems.
  
• Maintain all appropriate records and produce QC audit reports as needed.
  
• Provide assistance and/or manage the preparation and development of CRFs, diaries, and other study-related documents.
  
• Assist in preparation of study progress reports, status reports, and/or other ad hoc report listings as necessary.
  
• May participate in developing databases for specific project-related data acquisition.
  
• Perform other tasks required within Clinical Data Management as necessary to meet the needs of the business.
  
• May participate in the review of final data listings, tables, and graphs to facilitate validation of the clinical database, when required.
  
• May participate in the development and/or maintenance of SOPs and project management tools.

ESSENTIAL SKILLS, EXPERIENCE AND QUALIFICATIONS:

• Bachelor's degree in Nursing or a Health related field or a minimum of one to two years experience in clinical data management or working with clinical trials data. Candidate must be familiar with using a PC in the Windows environment and have an in-depth knowledge of MS Office.
  
• Candidate should be able to work independently and understand and carry out detailed instructions.
  
• Candidate should be able to interact with staff from multiple departments and be capable of working, interacting, and collaborating with people at all levels in the organization to complete project requirements.
  
• Candidate must have strong attention to detail, be flexible and open to suggestions and possess good communication skills.
  
• Candidate must be able to work concurrently on several projects, each with specific instructions that may differ from project to project.
  
• Analytical skills to analyze information, practices and procedures to formulate logical and objective conclusions and make recommendations for effective solutions required.
  
• Organizational skills in setting priorities, following through on assigned tasks, adhering to deadlines, working with competing deadlines necessary.
  
• Candidate must have ability to perform tasks accurately and in a timely manner with a minimum level of supervision and under frequent changes in priorities and deadlines.
  
  

NONESSENTIAL SKILLS, EXPERIENCE AND QUALIFICATIONS (not necessary but preferred):

• Experience with Oracle Clinical a plus.
  
• An understanding of GCP and ICH guidelines is necessary. Candidates with other backgrounds may be considered based on experience and education.
  
• Previous experience in Clinical Data Management responsibilities must include tracking CRFs, implementing edits, and tracking queries.
  
  

SUPERVISORY RESPONSIBILITIES:

N/A

PHYSICAL DEMANDS AND WORK CONDITIONS:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Regularly required to sit for extended periods of time; frequently required to stand, walk and use business equipment daily such as computer, printer, copier, fax, and telephone. Occasionally required to reach overhead, bend, and lift objects (up to 20 lbs.).
  
• Eyesight and hearing must be correctable to standard level.
  
• Some travel may be required.