Clinical Research Coordinator B
About The Position
The clinical research coordinator B will manage the coordination of Phase I-IV multi-center clinical trials, including coordination, organization and maintenance of all documentation required by Sponsor or CRO as well as working with partnering institutions on managing invoicing, and IRB paperwork under limited supervision and will need to use independent judgment; resolve data queries with Sponsor or CRO; recruit, screen and enroll potential study subjects; participate in the conduct of audits; process and ship blood and specimens; schedule patient visits and any necessary testing; obtain records required to complete case report forms; conduct initiation, monitoring and close out visits with Sponsor of CRO; adhere to all PENN, ICF, and FDA guidelines; prepare and process all IRB documentation. The clinical research coordinator B will also manage clinical trials that involve hands-on, technologically advanced and special skill set involving investigational procedures with Radiology.
Requirements
- Bachelor of Science and 2 to 3 years of experience or equivalent combination of education and experience is required.
Nice To Haves
- Practical experience coordinating the day-to-day activities of multiple research projects
- Effective verbal and written communication skills
- Ability to learn new methods quickly and multi-task
- Demonstrated ability to work as part of a team as well as independently
- Knowledge or experience in cancer preferred but not required
- Ability to work flexible hours
- Possess working knowledge of the Title 21 Code of Federal Regulations (CFR), International Conference of Harmonisation (ICH) and Good Clinical (Research) Practice (GCP) Guidelines.
- Experience within patient population is preferred and special skill set involving investigational procedures with certain in-patient studies.
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
- 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
Benefits
- Excellent healthcare and 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 for employees, spouses, and dependent children
- Retirement plans (Basic, Matching, and Supplemental)
- Time away from work (vacations, personal affairs, illness, family time)
- Long-Term Care Insurance
- Wellness and Work-life Resources
- Professional and Personal Development resources
- Access to University resources, cultural and recreational activities
- Discounts and Special Services (arts, entertainment, transportation, mortgages, new cars, cellular phone service, movie tickets, theme parks)
- Flexible Work Hours
- Penn Home Ownership Services (forgivable loan for eligible employees)
- Adoption Assistance
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
