Clinical Research Responsibilities
Coordinate Phase I – IV clinical trials.
Coordinate, organize and maintain all documentation required by sponsor or Clinical Research Organizations (CROs) (i.e., source documentation, case report forms, study and regulatory binders, and patient binders).
Resolve data queries with sponsor and CROs
Recruit, screen and enroll potential study patients as specified per protocol.
Participate in the conduct of audits by study sponsors, CROs, the FDA, and other entities as required.
Process and ship blood, urine, and serum specimens for each trial.
Schedule patient visits and any necessary testing; within the EMR or other tools
Attend Investigator Initiation meetings
Obtain slides from pathology and ship to sponsor/independent review per protocol guidelines.
Obtain records required to complete case report forms
Maintain source documentation
Participant/ subject appreciation and recognition
Ability to communicate and build a rapport with subjects
Conduct initiation, monitoring, and closeout visits with sponsors and/or CROs
Show vigilance in patient safety, protocol compliance, and data quality
Adhere to all University of Pennsylvania, ICF, and FDA guidelines
Coordination and oversight on time to study start up
Provide feedback and critical analysis of clinical research protocols
Participate in CRF testing and potentially design
Develop complex documents such as protocols and consents
May be responsible for orientation/mentoring of new staff and act as resource to current staff members with study related issues
Act in lead capacity in coordination of research team projects and assist Associate Director in overseeing execution of project timelines as well as completion of study related activities delegated to research coordinator who provides study related support (e.g., regulatory submissions and data entry)
Act in a lead for study communication with internal and external groups
Work directly with investigators to design, set-up and execute studies
Accountable for ensuring study timelines and goals are met.
May participate in and support budget preparation for trials as needed. May support a clinical trial budget through each phase of development, resolving issues and queries with input from the Research Team’s PM/PI as required
Independently move a clinical trial through each phase of development, resolving issues and queries with input from a supervisor as required
Management of clinical trials and will need to use more independent judgment
Regulatory Responsibilities
Prepare and process all Institutional Review Board (IRB) documentation through the IRB, including submissions, continuing reviews, amendments, and adverse event reporting.
Prepare and process all regulatory documentation with pharmaceutical companies and CROs
Obtain the appropriate signatures for regulatory forms.
Organize and maintain all documentation required by sponsor or CRO (institutional forms, FDA Form 1572, deviation memos, physicians and coordinators’ CVs and medical licenses, record of IRB certification and compliance).
Resolve regulatory related queries with IRB, study sponsors and CROs