Clinical Research Coordinator

University of Pennsylvania Perelman School of Medicine•Institute, WI

1d•$47,313 - $47,313•Onsite

About The Position

Assists in the management of clinical trials under direct supervision by coordinating patient screening, enrollment, data collection, and sample handling. Supports IRB submissions and helps prepare manuscripts, grant proposals, and presentations. Works closely with the Principal Investigator, manager, and study team to address study needs, implement approved changes, and monitor outcomes. Contributes to investigator-initiated, multi-center, and patient-oriented clinical and translational research studies.

Requirements

Bachelor of Science and 1 to 2 years of experience or equivalent combination of education and experience is required.

Responsibilities

Adhere to an IRB approved protocol
Participate in the informed consent process of study subjects
Support the safety of clinical research patients/research participants
Coordinate protocol related research procedures, study visits, and follow-up care
Screen, recruit and enroll patients/research participants
Maintain study source documents
Report adverse events
Understand good clinical practice (GCP) and regulatory compliance
Educate subjects and their support members on protocol, study intervention, etc.
Comply with Institutional policies, standard operating procedures (SOPs) and guidelines
Manage essential regulatory documents
Register and keep study up to date on CRMS
Complete case report forms (paper & electronic data capture) and address queries
Submit documents to regulatory authorities (e.g. IRB, FDA, etc.) and/or review/monitoring boards (ie, DSMB, independent safety officer)
Facilitate pre-study, site qualification, study initiation, and monitoring visits
Facilitate study close out activities
Assist project manager(s) with study start-up
Attend and participate in team meetings
Collect, process and ship laboratory specimens
Schedule subject visits and procedures in EMR and keep track of visits
Complete subject visits per protocol in accordance to GCP
Retain records/archive documents after study close out
Develop Case Report Forms/Smartphrases in the EMR
Develop/edit informed consent document
Apply in depth knowledge of clinical research and independently coordinate the activities of 1 or more large-scale, complex multi-center / multi-institutional studies
Accountable for study oversight at one or more sites/institutions
Prepares study sites for internal/external regulatory audits (sponsor, FDA, NIH, etc)
Educates internal and external clinical staff, research teams and other coordinators; provides resources, and consulting on difficult protocols or projects
Assesses and critiques protocol feasibility and provides recommendations
May support 1 or more PI sponsored INDs or IDEs
Liaises between Research billing and the research team
Assist fellow research coordinators with studies as needed
Act as liaison for research subject, investigator, IRB, and sponsor.
Other duties and responsibilities as assigned

Benefits

excellent healthcare
tuition benefits for employees and their families
generous retirement benefits
a wide variety of professional development opportunities
supportive work and family benefits
a wealth of health and wellness programs and resources
comprehensive medical, prescription, behavioral health, dental, vision, and life insurance benefits
flexible spending accounts
tuition assistance here at Penn
tuition assistance at other institutions for dependent children
generous retirement plans
pre-tax or Roth basis retirement savings
wide variety of investment options through TIAA and Vanguard
substantial amount of time away from work
long-term care insurance
wellness and work-life resources
professional and personal development resources
access to a wide range of University resources
access to cultural and recreational activities
free admission and memberships to Penn arts and cultural centers and museums
discounts on other goods and services
flexible work options
forgivable loan for eligible employees interested in buying a home or currently residing in West Philadelphia
reimbursement for adoption expenses