Responsible for elements of patient visits including but not limited to:

• Independently schedule and facilitate subject assessments with support from assistant coordinators.
• Independently performs subject pre-screening and screening.
• Responsible for working with the clinical research assistants to schedule visits.
• Communicating assessments and appointments with study subjects utilizing the electronic medical record system to document all communications and instructions regarding research visits
• Active involvement in obtaining and documenting informed consent
• Independent direct research subject contact to obtain or verify information while working with PI to triage clinical information and patient questions.
• Direct Collaboration with ancillary departments to ensure research subjects receive timely blood draws (PKs), ECGs, vitals (blood pressure, temp, respirations, height, weight), ECHO, imaging, or other study related tasks as needed. Delegation to research assistant as deemed necessary.
• Provide follow up for subjects who are no longer receiving treatment in the form of phone calls or clinic visits.
• Ensure all documentation post-visit is entered into EPIC and EDC
• Independently write clear, concise, and professional documentation into EPIC for source document creation
• Responsible for direct sponsor correspondence regarding patient safety, responding to queries, reporting adverse events, conduction of visits, etc.
• Assist with coordination of patient travel
• Assist with prepping any necessary documents prior to the visit
• Responsible for communicating with patients regarding scheduled appointments
• Assist with processing and shipping lab specimens
• Assist with retrieval of study drug for visits
• Independently work with monitoring groups to ensure all data is captured as per protocol
• Consent patients for procedures while they are in-patient
• Observe, document, and facilitate all research aspects of procedural days involving study subjects – including device accountability, scrub procurement, and coordinating with external partners and providing access to OHSU.

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:

• Collaborating with the clinical trials leadership regarding regulatory requirements of the study and creation of necessary sponsor, KCVI, OHSU and internal clinical trial documents and tools that facilitate study efficiency and team communication.
• Coordinating with the assistants in the collection and transcription of all source data with guidance as needed.
• Reviewing a weekly task list of outstanding items prepared by the team to ensure data entry to EDC is captured within obligatory time frames
• Collaborate with study team to identify and develop new study-specific processes; ensuring everything is in place for first subject
• Responsible for direct sponsor correspondence in regards to enrollment numbers and general study maintenance issues
• Data entry of visit data into central data repositories (CTMS systems, internal subject trackers, ClinCard, PI documents, etc.)
• Addressing all imaging and laboratory queries in sponsor EDC
• Maintaining laboratory reporting and signature requests from the PI
• Timely and complete adverse event reporting, including SAE

Other Duties as Applied

Job Related Knowledge, Skills and Abilities (Competencies):

• Very Strong understanding of Research Regulations and best practices
• Strong data abstraction and project management skills
• Ability to prioritize multiple tasks at one time
• Strong teaching skills with the ability to mentor junior staff
• 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
• Ability to perform the job duties with or without accommodation.

• Bachelor's degree with coursework in Science
• At least one year general office experience

Job Related Knowledge, Skills and Abilities (Competencies):

• Knowledge of cardiology.
• Managing Access database or similar database.
• Microsoft office, medical terminology, analytical skills, trouble shooting skills.
• Ability to work independently as well as within a team enviroSnment.