Clinical Research Coordinator C

Clinical Research Coordinator C

The clinical research coordinator 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 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 C will also manage clinical trials that involve hands-on, technologically advanced and special skill set involving investigational procedures with Radiology.

Job Description

Job Responsibilities

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

Position Contingent Upon Funding

Qualifications

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

Preferred:

• 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 is required with certain in-patient studies.

• Job Location - City, State

• Philadelphia, Pennsylvania

• Department / School

• Perelman School of Medicine

• Pay Range

• $63,085.00 - $63,085.00 Annual Rate

• Salary offers are made based on the candidate’s qualifications, experience, skills, and education as they directly relate to the requirements of the position, and in alignment with salary ranges based on external market data for the job’s level. Internal organization and peer data at Penn are also considered.

• Equal Opportunity Statement

• The University of Pennsylvania is an equal opportunity employer. Candidates are considered for employment without regard to race, color, sex, sexual orientation, religion, creed, national origin (including shared ancestry or ethnic characteristics), citizenship status, age, disability, veteran status or any class protected under applicable federal, state or local law.

• Special Requirements

• Background checks may be required after a conditional job offer. Consideration of the background check will be tailored to the requirements of the job.

• University Benefits

• Health, Life, and Flexible Spending Accounts: Penn offers comprehensive medical, prescription, behavioral health, dental, vision, and life insurance benefits to protect you and your family’s health and welfare. You can also use flexible spending accounts to pay for eligible health care and dependent care expenses with pre-tax dollars.

• Tuition: Take advantage of Penn's exceptional tuition benefits. You, your spouse, and your dependent children can get tuition assistance here at Penn. Your dependent children are also eligible for tuition assistance at other institutions.

• Retirement: Penn offers generous retirement plans to help you save for your future. Penn’s Basic, Matching, and Supplemental retirement plans allow you to save for retirement on a pre-tax or Roth basis. Choose from a wide variety of investment options through TIAA and Vanguard.

• Time Away from Work: Penn provides you with a substantial amount of time away from work during the course of the year. This allows you to relax, take vacations, attend to personal affairs, recover from illness