"Clinical Research Coordinator B/C"

Clinical Research Coordinator B/C

Job Description Summary

The clinical research coordinator B/C 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 creating multi-center budgets, 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.

Job Responsibilities

Clinical Research Coordinator B

• 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

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

Clinical Research Coordinator C will have the same duties as B but will include the following

• 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

Position Contingent Upon Funding

Qualifications

Clinical Research Coordinator B

Bachelor of Science and 2 to 3 years of experience or equivalent combination of education and experience is required.

Clinical Research Coordinator C

Bachelor of Science and 4 to 6 years of experience or equivalent combination of education and experience is required.

Preferred

CRC-B
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.

CRC-C
practical experience coordinating the day-to-day activities of multiple therapeutic research protocols; 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

Job Location

Philadelphia, Pennsylvania

Department / School

Perelman School of Medicine

Pay Range

$52,500.00 - $62,000.00 Annual Rate

To apply, visit https://wd1.myworkdaysite.com/en-US/recruiting/upenn/careers-at-penn/job/Perelman-Center-for-Adv-Medicine/Clinical-Research-Coordinator-B-C_JR00116704-1