Cardiovascular Research Assistant
hace 1 día
Sioux Falls
At Avera Heart Hospital, you're not just joining a workplace you're becoming part of a family. With more than 700 dedicated employees, we deliver care that truly makes a difference. Our commitment to excellence has earned us the distinction of being one of only a handful of hospitals nationwide out of more than 4,000 to achieve a double 5-star rating from the Centers for Medicare and Medicaid Services. Position Highlights Works under the general direction of cardiovascular research leadership and in collaboration with principal investigators, research nurses, coordinators, physicians, advanced practice providers, and operational teams. Supports high-quality clinical research involving cardiovascular devices, medications, heart failure, structural and interventional cardiology, electrophysiology, vascular care, prevention, and other heart and vascular conditions. Performs diverse administrative, data, participant-support, and study-operational duties in accordance with approved protocols, delegated responsibilities, institutional policy, and applicable regulations. Essential Responsibilities - Continued • Review electronic health records and approved source documents to identify protocol-required data; enter and maintain accurate information in electronic data capture systems, study databases, registries, and tracking tools., • Support study start-up and maintenance by organizing regulatory documents, delegation and training records, study logs, protocol materials, manuals, and essential-document files., • Assist research staff with pre-screening and screening activities by applying approved criteria, preparing screening materials, tracking potential participants, and escalating clinical or eligibility questions to qualified study personnel., • Coordinate protocol-related appointments, tests, procedures, and follow-up activities across clinic, hospital, imaging, catheterization laboratory, electrophysiology, heart failure, pharmacy, and other departments., • Prepare visit checklists, source worksheets, participant packets, laboratory kits, device-study materials, and other supplies using the current protocol and schedule of events., • Process, package, document, and ship research specimens according to protocol, laboratory requirements, safety procedures, and shipping regulations within the employee's training and authorization., • Maintain study calendars, screening and enrollment logs, visit trackers, follow-up schedules, and reminders to support protocol compliance and participant retention., • Support participant communications using approved scripts and workflows; promptly route clinical concerns, adverse-event information, and urgent questions to licensed or otherwise qualified study personnel., • Assist with investigational device accountability and documentation, including receipt, storage coordination, inventory logs, use or disposition records, and reconciliation, as delegated and permitted by protocol and policy., • Support investigational medication workflows by coordinating with pharmacy and research staff, maintaining assigned logs, collecting protocol-required information, and documenting participant-reported adherence as delegated; does not independently dispense or provide medication guidance., • Request, de-identify when authorized, track, and upload imaging, electrocardiograms, hemodynamic data, device reports, and other study records to approved sponsor or central-review systems., • Perform quality checks for completeness, consistency, and timeliness; assist with data queries, missing-document follow-up, and corrections while preserving an appropriate audit trail., • Prepare materials and respond to requests for sponsor, contract research organization, monitor, auditor, and regulatory visits in coordination with research leadership., • Track completed research procedures, participant status, study milestones, staff workload, and other operational measures needed for study management and reporting., • Perform literature reviews and evidence searches as directed; organize findings and references for investigators and research staff., • Provide general administrative support, including research-chart preparation, document scanning and filing, secure communications, meeting preparation, supply ordering, and distribution of study materials., • Participate in team meetings, study training, process-improvement work, and cross-coverage; perform other duties within role scope as assigned. Primary Research Areas Devices Structural heart, interventional, rhythm-management, hemodynamic-monitoring, mechanical-circulatory-support, vascular, and other cardiovascular technologies. Medications Investigational and approved therapies studied in cardiovascular populations, including protocol-directed treatment, adherence, safety, and outcomes data. Heart Failure Acute and chronic heart failure, cardiomyopathy, remote monitoring, transitions of care, quality of life, and clinical outcomes. Additional Areas Electrophysiology, coronary and peripheral interventions, imaging, prevention, registries, real-world evidence, and investigator-initiated research. Role Boundaries This role supports, but does not independently make, clinical decisions; determine final eligibility; obtain informed consent unless specifically trained, delegated, and permitted; diagnose; prescribe; dispense investigational products; or provide medical advice. Clinical findings and safety concerns are escalated promptly through the study's approved workflow. • High school diploma or GED equivalent., • Ability to complete required institutional, privacy, safety, human-subject protection, and study-specific training within assigned timeframes., • Associate's or bachelor's degree in a health, science, research, or related field., • One to three years of healthcare, clinical research, cardiology, medical-record, data-entry, or comparable experience., • Experience with electronic health records, clinical-trial databases or registries, research documentation, medical terminology, and cardiovascular care workflows., • Strong attention to detail, organization, follow-through, and ability to manage multiple protocols, priorities, and deadlines., • Clear and professional written, verbal, and interpersonal communication with participants, families, clinicians, sponsors, and team members., • Ability to handle protected health information and confidential research information with discretion and in compliance with policy., • Ability to learn protocol requirements, recognize discrepancies or safety information, and escalate questions appropriately., • Apply Avera's mission, vision, core values, and social principles in service to patients, families, colleagues, and the community., • Uphold Avera's standards of Communication, Attitude, Responsiveness, and Engagement (CARE)., • Follow approved protocols, Good Clinical Practice principles, IRB requirements, privacy standards, sponsor requirements, and institutional policies applicable to assigned duties., • Maintain complete, accurate, timely, and traceable documentation; never backdate, obscure, or improperly alter research records., • Work effectively in a multidisciplinary team and coordinate workflow to support a safe, respectful, productive, and audit-ready research environment. Work is performed in office and healthcare settings and may include clinic, hospital, procedural, laboratory, or research areas. The noise level is usually moderate. Depending on assignment, there may be potential exposure to communicable disease, blood or body fluids, sharps, chemicals, radiation-controlled areas, or moving equipment. Employees must follow applicable safety precautions and use required protective equipment. Physical requirements may include extended computer use, movement between departments, and handling study materials or supplies. HR and Employee Health should validate the final physical-demand classification for the position.
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