Clinical Research Coordinator A/B-Regulatory (Department of Radiation Oncology)

Description

Job Responsibilities

CRC A

Assist the Regulatory Affairs Specialist in preparing, submitting, and processing approvals from the IRB and other Penn review entities for new research studies as well as for continuing reviews, modifications, reportable events, and study closures throughout the life of a study

Under supervision, prepare, submit, and process approvals of Confidential Disclosure Agreements, Data Use Agreements, and other agreements between Penn’s legal office and external entities

Participate in resolution of regulatory-related queries for Site Initiation Visits, audits and monitoring visits, Close-Out Visits, and as needed with Penn entities, industry sponsors, and external institution coordinating centers

Assist the Regulatory Affairs Specialist in managing sites for the department’s multi-site trials by tracking essential documents, personnel credentials, and institution credentials from the sites

Assist with registering and updating study records in Penn’s Clinical Research Management System (CRMS) and in departmental online portals such as SharePoint

Assist with setting up and maintaining regulatory files in the departmental Shared Drive, study e-regulatory binders in PennVault, and in physical binders

Attend CRU weekly team meetings and other meetings as required

Administrative duties will include but are not limited to : maintaining the CRU’s weekly team meeting training log and taking meeting minutes;

ordering and tracking office supplies; tracking the department’s personnel credentials (CVs, licenses, CITI trainings) and institution credentials (lab certificates, etc.

coordinate the CRU’s submissions to the department’s quarterly newsletter; assist the Regulatory Affair Specialists in creating and updating the CRU’s guidance and administrative documents;

and assist the Regulatory Affairs Specialist in planning regulatory trainings and events for the team.

Other duties and responsibilities as assigned

CRC B

In addition to the above, the Clinical Research Coordinator B (Regulatory Coordinator) will be expected to effectively and independently manage above multiple tasks while demonstrating leadership skills within the program.

The CRC B will also work directly with PIs and project managers to help prioritize challenges and problem-solve emergent issues following research protocol.

Qualifications

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

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

Preferred

Effective problem-solving abilities; effective communication and writing skills; strong organizational and time management skills;

flexible and able to multi-task; demonstrated ability to work as part of a team, as well as independently; knowledge of IRB and human research protection regulations.

This position is hybrid eligible after successful completion of intro period and 6 months of service.

Position is contingent upon funding.

Job Location - City, State

Philadelphia, Pennsylvania

Department / School

Perelman School of Medicine

Pay Range

$37,220.00 - $52,661.00 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, as well as internal and market factors and grade profile.

Affirmative Action Statement

Penn adheres to a policy that prohibits discrimination on the basis of race, color, sex, sexual orientation, gender identity, religion, creed, national or ethnic origin, citizenship status, age, disability, veteran status, or any other legally protected class.

Special Requirements

Background check required after a conditional job offer is made. 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 or injury, spend time with family whatever your personal needs may be.

Long-Term Care Insurance : In partnership with Genworth Financial, Penn offers faculty and staff (and your eligible family members) long-term care insurance to help you cover some of the costs of long-term care services received at home, in the community or in a nursing facility.

If you apply when you’re newly hired, you won’t have to provide proof of good health or be subject to underwriting requirements.

Eligible family members must always provide proof of good health and are subject to underwriting.

Wellness and Work-life Resources : Penn is committed to supporting our faculty and staff as they balance the competing demands of work and personal life.

That’s why we offer a wide variety of programs and resources to help you care for your health, your family, and your work-life balance.

Professional and Personal Development : Penn provides an array of resources to help you advance yourself personally and professionally.

University Resources : As a member of the Penn community, you have access to a wide range of University resources as well as cultural and recreational activities.

Take advantage of the University’s libraries and athletic facilities, or visit our arboretum and art galleries. There’s always something going on at Penn, whether it’s a new exhibit at the Penn Museum, the latest music or theater presentation at the Annenberg Center, or the Penn Relays at Franklin Field to name just a few examples.

As a member of the Penn community, you’re right in the middle of the excitement and you and your family can enjoy many of these activities for free.

Discounts and Special Services : From arts and entertainment to transportation and mortgages, you'll find great deals for University faculty and staff.

Not only do Penn arts and cultural centers and museums offer free and discounted admission and memberships to faculty and staff.

You can also enjoy substantial savings on other goods and services such as new cars from Ford and General Motors, cellular phone service plans, movie tickets, and admission to theme parks.

Flexible Work Hours : Flexible work options offer creative approaches for completing work while promoting balance between work and personal commitments.

These approaches involve use of non-traditional work hours, locations, and / or job structures.

Penn Home Ownership Services : Penn offers a forgivable loan for eligible employees interested in buying a home or currently residing in West Philadelphia, which can be used for closing costs or home improvements.

Adoption Assistance : Penn will reimburse eligible employees on qualified expenses in connection with the legal adoption of an eligible child, such as travel or court fees, for up to two adoptions in your household.