Senior Research Associate

Position Summary

The Senior Clinical Research Data Associate is responsible for mentorship and day-to-day support of Research Data Associates across multiple therapeutic areas in the department, in addition to conducting data management activities in an efficient manner in accordance with regulations. The person in this position is responsible for collecting, storing, and reporting all study documentation accurately and within specific deadlines.

Duties include but are not limited to:

• Dedicated data management and specimen handling for research coordinator team in designated therapeutic areas
• Extracting medical information from patients’ medical records and data input into Electronic Data Capture systems (EDC)
• Preceptorship, mentoring, and training of new Clinical Research Data Associates
• Laboratory coordination for supply ordering, specimen processing, and outgoing lab shipments; additionally, interdepartmental coordination of pathology and imaging
• Future central scheduling for the research department, as needed
• Assisting Clinical Research Management with department initiatives and long-term projects, including NCI grant activities, Clinical Trial Management System planning and training (as relates to Clinical Research Data Associates), patient chart requests via fax or Epic Care Everywhere, and laboratory procedures.
• Prior experience in clinical research professional is needed to understand the clinical research process.
• Experience in data management with working knowledge of EDC studies and medication, clinical, or research related study or instruction is required.
• Must have experience working effectively and efficiently to handle multiple tasks simultaneously with high attention to detail and ability to exercise strong judgement within defined procedure and practices to determine appropriate action independently.
• Must display strong interpersonal, communication, organization, conflict resolution, team collaboration, and leadership skills and be technologically proficient with strong computer skills, including Microsoft Office, Data Management Systems and study documentation, data processing, and data review.

Minimum Requirements

Education           

• Associates Degree, suitable work experience may be substituted

Experience        

• Prior clinical research experience
• Medical terminology
• Computer experience
• Knowledge of GCP/ICH

License/Registration/Certifications       

• N/A

Preferred Requirements

Preferred Education      

• BS, BA

Preferred Experience   

• Experience as an end user working in: Epic EMR, Clinical Trial Management System (CTMS), and Electronic Data Capture (EDC)
• Laboratory or scheduling experience
• Team leadership or mentorship experience

Preferred License/Registration/Certifications   

• CCRP, CCRA, CCRC, RAPS, or other recognized research certification

Core Job Responsibilities

The Senior Clinical Research Data Associate must be comfortable working closely with:

• Investigators
• Sponsors (via email correspondence and monitoring, site initiation and close out visits)
• Hospital and research personnel participating in study patient visits
• Patients (via phone and in person: from recruiting to scheduling their study visits)
• Must be able to travel to conferences, or to off-site locations to provide education if needed.
• Ability to speak and write English fluently.                  
• Ability to work effectively as a team member.
• Ability to work without direct supervision.                   
• Ability to manage projects with sensitive timelines.
• Possession of excellent communication and organizational skills.