Physical Therapy at St. Luke's · 5 days ago
Clinical Trials and Research Administrative Assistant (Hybrid)
Allentown, PA
Full-time
Hybrid
Mid Level
3+ years expSt. Luke's is dedicated to providing excellent care and improving access to healthcare in the communities they serve. The Clinical Trials and Research Administrative Assistant will provide essential regulatory and administrative support to ensure studies comply with institutional, sponsor, and federal requirements.
Health CareHospitalRehabilitation
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
At least three years administrative assistant experience with proven project management abilities required
Must be proficient in MS Word, Excel, PowerPoint and Electronic Mail
Requires sitting for up to eight hours per day (four hours at a time), and walking to various locations/departments
Requires regular fingering, handling and twisting
Occasionally requires lifting, carrying, pushing and pulling objects weighing up to 25 pounds
Occasionally requires reaching above shoulder level
Must have the ability to hear as it relates to normal conversation, and to see as it relates to general vision
Preferred
Bachelor's degree highly preferred
A combination of education and adequate and appropriate experience is acceptable
Continued training in new versions of software or new computer systems expected
Company
Physical Therapy at St. Luke's
Physical Therapy at St. Luke's is a patient-oriented rehabilitation practice that emphasizes education, healing, and exceeds expectations.
201-500 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase