Clinical Trials and Research Assistant

St. Luke’s University Health Network•Allentown, PA

About The Position

St. Luke's is proud of the skills, experience and compassion of its employees. The employees of St. Luke's are our most valuable asset! Individually and together, our employees are dedicated to satisfying the mission of our organization which is an unwavering commitment to excellence as we care for the sick and injured; educate physicians, nurses and other health care providers; and improve access to care in the communities we serve, regardless of a patient's ability to pay for health care. The Clinical Trials and Research Assistant provides essential regulatory and administrative support to the Clinical Trials Office management and staff helping to ensure studies are conducted in compliance with institutional, sponsor, and federal requirements. This role supports the day-to-day study operations by coordinating regulatory documentation, assisting with scheduling and visit logistics, and maintaining accurate records and systems for study monitors and staff.

Requirements

At least three years administrative assistant experience with proven project management abilities required.
Must be proficient in MS Word, Excel, PowerPoint and Electronic Mail.
Continued training in new versions of software or new computer systems expected.

Responsibilities

Coordinate the daily operation of the Clinical Trials Office (CTO) for department management and staff by providing regulatory and administrative support
Serve as a knowledgeable resource to management, staff, physicians, and the general public by maintaining a comprehensive understanding of CTO operations, clinical research activities, and departmental workflows throughout the network
Maintain department out of office calendar and timekeeping logs for biweekly timecard approvals in payroll system as timekeeper in UKG Dimensions
Responsible for the daily review of the central Clinical Trials Office email inbox and forwarding correspondence received to appropriate team member
Create and maintain research readiness profiles for all CTO staff, investigators, and key personnel including the collection, filing, and maintenance of initial and ongoing institutional research readiness documents (e.g., CITI GCP/HSP, FCOI, CV, ML, NCI) as well as ensuring ongoing compliance with requirements
Order and maintain office supplies (e.g., day-to-day supplies, business cards, equipment) and files associated with purchases; work with research finance regarding financial records for all costs generated by this role and support general office management related to these areas for each CTO location
Assist, as needed, with preparation, maintenance, tracking, and signature retrieval of essential regulatory documents in accordance with sponsor, regulatory, and institutional requirements and ensure documents are filed and audit ready; serve as SuperUser for department electronic regulatory binder system
Process IND Safety Reports (INDSR) in preparation for review by Principal Investigators, clinical teams, and for IRB submission
Facilitate scheduling of Pre-Study Visits (PSV), Site Initiation Visits (SIV), Interim Monitoring Visits (IMV), Closeout Visits (COV), and ad hoc meetings with study sponsors
Responsible for provisioning access to Epic CareLink and Florence eBinders and manage associated access agreements