As a Registry Manager, you will serve as a key member of the team and will be responsible for the day-to-day operations at assigned participating sites.
A day in the Life: • Works on site problems of moderate scope where analysis of data requires evaluation of identifiable factors. Demonstrates good judgment in selecting methods and techniques for obtaining solutions. Networks with senior internal and external personnel in own area of expertise. • Interface with sites participating in assigned registry. • Communicate appropriately to Registry Mgt. of all site concerns or issues that may arise. • Implement and facilitate protocol execution and regulatory compliance during site initiation and throughout sites participation in the registry. • Identify and support site staff with data queries in a timely manner. • Conduct SIV and Remote Site Management and Metric Review visits. • Maintain registry Master File documentation and performance. • Identify and communicate poor performing sites in a timely yet appropriate manner. • Provide input to the development of registry timelines, procedures, forms, registry support materials, manuals, and tracking systems as requested by manager.
Keys to Success:
Education • Bachelor's degree, preferably in life sciences, public health, health services research or related area and or equivalent experience • Advanced degree, Research, and regulatory certifications, i.e.., RAPS or ACRP certificates preferred
Experience • 4 + years' experience in a clinical research setting. • Requires knowledge and utilization of MS Office, Salesforce, REDCap Cloud platforms. • Requires GCP and HSP training certificate per policies and procedures.
Knowledge, Skills, Abilities • Demonstrated ability to write clear and complete assignments with attention to detail and high degree of accuracy. Strong interpersonal skills. • Must be able to manage multiple study timelines, sites, and subscriber's commitments. • Experience analyzing and interpreting written material and quantitative data to draw conclusions and make recommendations based on that data preferred • Demonstrated proficiency in accessing information stored in large data systems.