Department Overview:
The Knight Cardiovascular Institute Clinical Research Assistant II (Assistant Coordinator) is responsible for various duties related to clinical trials. They will assist the study coordinators in supporting patient visits, assists in data collection and entry for the sponsor, and coordinates patient travel to ensure study subjects are able to meet their visits. This position will primarily support our Cardiomyopathy research team within the division of Cardiology, they may be reassigned secondary duties to support other sections within the Cardiovascular Medicine Clinical Trials Unit and Knight Cardiovascular Institute. This is an onsite role with limited hybrid opportunities.

Function/Duties of Position:

• Always promotes the mission of the Knight Cardiovascular Institute through our Professional Standards of timely Customer Service, Reliability, Productivity, Professionalism, Accuracy, Timeliness, Integrity, and Problem-Solving. Always Yes
• Responsible for many aspects of clinical trial operations from site initiation visit to closeout and assuring appropriate conduct of protocols to meet FDA guidelines. This includes but is not limited to:
• Works in collaboration with study coordinator to maintain and file regulatory and study documents of active trials to meet study requirements
• Create a weekly task list of outstanding items for review to ensure data entry to EDC is captured within obligatory time frames
• Collection and transcription of all laboratory and imaging data with guidance from the coordinator as needed.
• Data entry of visit data into central data repositories (eCRIS, internal subject trackers, etc.)
• Addressing all imaging and laboratory queries in sponsor ERT
• Maintaining laboratory reporting and signature requests from the PI
• Responsible for elements of patient visits including but not limited to:
• Work with coordinator in planning visit activities and scheduling participant appointments
• Take point on patient scheduling
• Coordination of patient travel
• Prepping any necessary documents prior to the visit
• Responsible for communicating with patients regarding scheduled appointments
• Work with coordinator in collaborating with ancillary departments to make sure all patients receive timely ECHO’s, Imaging, vitals (blood pressure, temp, respirations, height, weight) or other study related tasks as needed.
• Independently provide follow up for subjects who are no longer receiving treatment in the form of phone calls or clinic visits.
• Work with monitoring groups to ensure all data is captured as per protocol
• Assist the Clinical Trial Leadership, coordinators, or Principal Investigator with other research related projects and administrative/office related duties as needed
• Assist manager and coordinator as needed in supporting sponsor visits (i.e. proctoring visits, monitoring, site initiation, etc.)

Required Qualifications:

• Bachelor’s in relevant field OR
• Associate’s AND 2 years of relevant experience OR
• 3 years of relevant experience Bachelor’s degree with coursework in Science
• Ability to prioritize multiple tasks at one time
• Must have excellent communication, analytical and organizational skills: both written and verbal.
• Ability to work independently and as part of a team while being collaborative in resolving problems.
• Must be proficient with computers running Windows and PC applications e.g. MS Excel, Oracle, Access, Word and PowerPoint).
• Must have demonstrated excellent customer service skills both on the phone and in person.
• Demonstrated ability to work with a variety of diverse individuals and personalities.
• Must possess energy and drive to coordinate multiple projects simultaneously.
• Ability to use tact and diplomacy to maintain effective working relationships.

Preferred Qualifications:

• Bachelor’s degree with coursework in Science
• At least one year general office experience
• Knowledge of cardiology. Managing Access database or similardatabase.
• Microsoft office, medical terminology, analytical skills, trouble shooting skills.
• Ability to work independently as well as within a team environment.

• Always promotes the mission of the Knight Cardiovascular Institute through our Professional Standards of timely Customer Service, Reliability, Productivity, Professionalism, Accuracy, Timeliness, Integrity, and Problem-Solving. Always Yes
• Responsible for many aspects of clinical trial operations from site initiation visit to closeout and assuring appropriate conduct of protocols to meet FDA guidelines. This includes but is not limited to:
• Works in collaboration with study coordinator to maintain and file regulatory and study documents of active trials to meet study requirements
• Create a weekly task list of outstanding items for review to ensure data entry to EDC is captured within obligatory time frames
• Collection and transcription of all laboratory and imaging data with guidance from the coordinator as needed.
• Data entry of visit data into central data repositories (eCRIS, internal subject trackers, etc.)
• Addressing all imaging and laboratory queries in sponsor ERT
• Maintaining laboratory reporting and signature requests from the PI
• Responsible for elements of patient visits including but not limited to:
• Work with coordinator in planning visit activities and scheduling participant appointments
• Take point on patient scheduling
• Coordination of patient travel
• Prepping any necessary documents prior to the visit
• Responsible for communicating with patients regarding scheduled appointments
• Work with coordinator in collaborating with ancillary departments to make sure all patients receive timely ECHO’s, Imaging, vitals (blood pressure, temp, respirations, height, weight) or other study related tasks as needed.
• Independently provide follow up for subjects who are no longer receiving treatment in the form of phone calls or clinic visits.
• Work with monitoring groups to ensure all data is captured as per protocol
• Assist the Clinical Trial Leadership, coordinators, or Principal Investigator with other research related projects and administrative/office related duties as needed
• Assist manager and coordinator as needed in supporting sponsor visits (i.e. proctoring visits, monitoring, site initiation, etc.