St. Luke's University Health Network · 2 days ago
Clinical Trials and Research Assistant
Allentown, PA - 451 Chew St
Full-time
Onsite
Mid Level
3+ years expSt. Luke's University Health Network is dedicated to providing excellent care and improving access to healthcare. The Clinical Trials and Research Assistant supports the Clinical Trials Office by ensuring compliance with regulations and assisting with the day-to-day operations of clinical studies.
Emergency MedicineFitnessHealth CareHospitalNon ProfitPersonal Health
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
Qualification
Required
Bachelor's degree highly preferred. A combination of education and adequate and appropriate experience is acceptable
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
Company
St. Luke's University Health Network
St. Luke's University Health Network is a nonprofit, regional health network that provides care primarily in Pennsylvania and New Jersey It is a sub-organization of St. Luke’s College of Health Sciences.
10001+ employees
Funding
Current Stage
Late StageLeadership Team
Scott R. Wolfe
Sr. Vice President & Chief Financial Officer
Jared King
Chief Operating Officer, SLPG
Recent News
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