Clinical Research Coordinator B (Department of Gastroenterology)

University of Pennsylvania; Philadelphia (Philadelphia County); On-site; USD 43,000 - 56,000; Full time

Job summary

Join a prestigious institution as a Clinical Research Coordinator, where you'll play a vital role in pioneering clinical trials that advance medical knowledge. This position offers the chance to work closely with leading researchers and physicians, ensuring compliance with regulatory standards while managing all aspects of clinical trial coordination. In this dynamic role, you'll recruit participants, oversee data management, and contribute to groundbreaking studies that can change lives. If you're passionate about clinical research and eager to make a difference in the healthcare field, this is the opportunity for you!

Benefits

Comprehensive healthcare benefits

Tuition assistance

Generous retirement plans

Flexible work hours

Professional development opportunities

Wellness programs

Long-term care insurance

Adoption assistance

Discounts and special services

Access to university resources

Qualifications

• Bachelor's degree with 2-3 years of clinical research experience required.
• Strong skills in trial coordination and regulatory documentation.

Responsibilities

• Coordinate and implement clinical trials from start to finish.
• Maintain regulatory documentation and resolve data queries.
• Recruit and enroll study participants as per protocol.

Skills

Clinical trial coordination

Data entry

Patient recruitment

Regulatory compliance

Communication skills

Education

Bachelor of Science

Tools

EMR systems

Job description

Clinical Research Coordinator B (Department of Gastroenterology)

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.

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 (Department of Gastroenterology)

Job Profile Title
Clinical Research Coordinator B

Job Description Summary
The Division of Gastroenterology Research Team seeks a full-time Clinical Research Coordinator to organize, coordinate and implement different phases of investigator-initiated and industry-sponsored clinical trials of novel therapies or currently available therapies, as well as prospective and retrospective observational studies. This position will report directly to the Research Nurse Manager and work directly with Physician Investigators on clinical research performed. He/she will be responsible for all aspects of clinical trial coordination including subject recruitment, detailed data entry, subject visits, and follow-up and regulatory documentation. The successful candidate will comply with all policies relating to the University of Pennsylvania, Penn Medicine, FDA, GCP and other regulatory standards.

The Clinical Research Coordinator (CRC) is an integral and essential member of the Research Team. We are looking for an enthusiastic, professional and committed team member who will help accelerate our program through the conduct of cutting-edge clinical trials.

Job 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.
• 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.
• Other duties and responsibilities as assigned.

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.

Qualifications

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

This position is contingent upon grant funding.

Job Location - City, State
Philadelphia, Pennsylvania

Department / School
Perelman School of Medicine

Pay Range
$43,919.00 - $56,000.00 Annual Rate

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 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.
• Tuition: Take advantage of Penn's exceptional tuition benefits. You, your spouse, and your dependent children can get tuition assistance here at Penn.
• Retirement: Penn offers generous retirement plans to help you save for your future.
• Time Away from Work: Penn provides you with a substantial amount of time away from work during the course of the year.
• Long-Term Care Insurance: In partnership with Genworth Financial, Penn offers faculty and staff (and your eligible family members) long-term care insurance.
• 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.
• 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.
• Discounts and Special Services: From arts and entertainment to transportation and mortgages, you'll find great deals for University faculty and staff.
• Flexible Work Hours: Flexible work options offer creative approaches for completing work while promoting balance between work and personal commitments.
• Penn Home Ownership Services: Penn offers a forgivable loan for eligible employees interested in buying a home or currently residing in West Philadelphia.
• Adoption Assistance: Penn will reimburse eligible employees on qualified expenses in connection with the legal adoption of an eligible child.

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

To apply, visit https://wd1.myworkdaysite.com/en-US/recruiting/upenn/careers-at-penn/job/Perelman-Center-for-Adv-Medicine/Clinical-Research-Coordinator-B--Department-of-Gastroenterology-_JR00103358-1