Job location: Perelman Center for Adv Medicine

Employment Type: Full-time
Posted data: 2021-08-31
Req: JR00036869
University Overview

The University of Pennsylvania, the largest private employer in Philadelphia, is a world-renowned leader in education, research, and innovation. This historic, Ivy League school consistently ranks among the top 10 universities in the annual U.S. News & World Report survey. Penn has 12 highly-regarded schools that provide opportunities for undergraduate, graduate and continuing education, all influenced by Penn’s distinctive interdisciplinary approach to scholarship and learning.

Penn offers a unique working environment within the city of Philadelphia. The University is situated on a beautiful urban campus, with easy access to a range of educational, cultural, and recreational activities. With its historical significance and landmarks, lively cultural offerings, and wide variety of atmospheres, Philadelphia is the perfect place to call home for work and play.

The University offers a competitive benefits package that includes 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, and much more.

Posted Job Title

Clinical Research Coordinator B (Dermatology)

Job Profile Title

Clinical Research Coordinator B

Job Description Summary

This position's primary function is to facilitate, promote, and ensure good clinical practice in the conduct of all research protocols in the Department/Center. Participates in study team meetings, and ongoing protocol training/compliance meetings. Supports in the monitoring of external sites and assists in the management of multisite trials. Adheres to all University and other regulatory guidelines.

Job Description

The primary responsibility of the Clinical Research Coordinator B position is to implement study protocols and data collection procedures with patients for Phase IV clinical trials and observational studies with guidance from senior clinical research staff. The ideal candidate for this position will have the ability to handle a variety of clinical trial related responsibilities in accordance with University of Pennsylvania, GCP, ICF, and FDA guidelines. In addition, this person should have excellent communication skills, experience interacting directly with patients in clinical settings, and demonstrate the ability to direct his/her own work with minimal to moderate supervision.

Responsibilities/Duties

-Recruitment:

• Identify and implement strategies to ensure successful patient recruitment and enrollment goals are met within specified timelines including but not limited to development of study brochures, outreach to clinics and private providers, print and radio advertisements and internet advertisement.
• Initiate and maintain communications with health care providers and staff at local health care clinics and private practices in an effort to obtain patient referrals
• Triage interest inquiries (via telephone, email, or in-person encounters) and prescreen potential participants

-Enrollment:

• Schedule and coordinate screening/enrollment visits
• Perform screening procedures per study protocol including approaching participants in clinic or by phone, requesting and reviewing medical records, and asking eligibility questions
• Complete informed consent procedures with patients during standard of care clinic visits as well as during scheduled research encounters
• Track recruitment and enrollment progress at Penn and external study sites and prepare weekly updates for the research team
• Coordinate components of training and monitoring activities for external study sites
• Coordinate communication with research staff at external study sites

-Visit implementation/data collection:

• Schedule and coordinate all study data collection visits with various Penn clinics/providers and departments for patient baseline, follow up, and end of study visits
• Serve as main point of contact for study participants
• Collect and record patient demographics, social histories, vitals, concomitant medications, and other relevant data
• Collect blood samples by performing venipuncture or coordinating visits to outpatient labs
• Collect saliva and urine samples
• Work with providers on the collection of skin biopsies and prepare samples for processing and storage
• Track and maintain records of biospecimens and PET/CT scans
• Work with providers and study participants on the completion of CRFs and source documentation for study assessments, questionnaires, and other data collection procedures
• Communicate with PennIDS to track study drug inventory, place orders, and ensure proper drug storage and timely shipping of study drug to external study sites
• Communicate with external sites to ensure proper packaging and delivery of lab specimens
• Initiate and complete the required financial procedures and documentation, including proper scheduling of research procedures, for the distribution of participant compensation

-Regulatory:

• Draft informed consent forms, data collection forms, protocol revisions and advertisements for regulatory submissions
• Prepare components of IRB submissions such as institutional forms, FDA forms, continuing review and modification submissions, deviation and exception memos, and adverse events reporting
• Prepare components of all external study site regulatory documentation including Investigator Agreements, FDA forms, CITI trainings, Investigators’ CVs and medical licenses.
• Assist senior clinical research staff in communications with study sponsors and to provide proper documentation and enrollment updates

-Data entry and monitoring:

• Coordinate efforts and feedback between study team and database developers
• Review data queries and identify and resolves discrepancies
• Assist with data cleaning and data analysis preparation efforts
• Assist with monitoring and close out procedures with sponsors and other study sites

- Other responsibilities:

• Support and interact with PIs, co-investigator, research managers, and other CRCs and staff
• Prepare components of MOPs, lab manual, and other guidance documentation for new studies
• Oversee inventory maintenance at Penn and at external sites to ensure timely ordering and shipment of supplies
• Attends study related meetings
• Maintain all relevant trainings and certifications (CITI, GCP, PENN CRC certificate and assigned Penn Profiler trainings)
• Adhere to all University of Pennsylvania, GCP, and FDA guidelines
• Position involves work-related responsibilities that may occur outside of usual office hours
• Perform additional duties as assigned.

Qualifications

• A BS/BA degree, and at least 2-3 years of experience in clinical research or the equivalent combination of education and experience required; Master’s degree preferred
• Knowledge of IRB and Human Research Protection Regulations
• Experience working directly with patients
• Ability to follow detailed clinical research protocols
• Excellent communication and interpersonal skills
• Excellent organization skills and demonstrated attention-to-detail
• Phlebotomy experienced preferred
• Ability to work independently with minimal to moderate supervision
• Ability to multi-task and be flexible in both task and schedule
• Proficient with Microsoft Office Suite and electronic study tracking systems

Working Conditions
Office, Library, Computer Room; Requires extensive safety

Physical Effort
Typically sitting at a desk or table; Occasional lifting 25 lb. or less

This position is contingent upon funding

Job Location - City, State

Philadelphia, Pennsylvania

Department / School

Perelman School of Medicine

Pay Range

$42,953.00 - $77,315.00

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.

To learn more, please visit: https://www.hr.upenn.edu/PennHR/benefits-pay