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University of Pennsylvania Clinical Research Coordinator B in Philadelphia, Pennsylvania

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

Job Profile Title

Clinical Research Coordinator B

Job Description Summary

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.

Job Description

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. Independently manages different phases of complex clinical trials and mentors Coordinators and Research Assistants. Works with partnering institutions and creates multi-center budgets and manages expenses. Participates in study team meetings, disease site group meetings, and ongoing protocol training/compliance meetings. Supports in the monitoring of external sites and assists in the management of mult-isite trials. Adheres to all University and other regulatory guidelines.

Responsibilities/Duties

  • 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

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

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

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

Track and compile completed study visits for invoicing

Assist with review of invoices from sites

-Lead development of CRFs for new studies by reviewing and adapting previous study CRFs

Coordinate efforts and feedback between study team and database developers

Review data entry efforts by junior coordinators and external study sites for timelines and accuracy

Review data queries and identify and resolves discrepancies

Assist with data cleaning and data analysis preparation efforts

Work with sites to address data discrepancies and/or performance issues

-Conduct monitoring and closeout visits and compile reports

Support and interact with PIs and study staff

Prepare guidance documentation

Oversee inventory to ensure timely ordering and shipment of supplies

Attends meetings

Maintain trainings and certifications (CITI, GCP, PENN CRC certificate)

Adhere to all University, GCP, and FDA guidelines

Perform additional duties as assigned

QualificationsBachelor's Degree with 2-4 years of related experience in research and clinical study methodologies or equivalent combination of education and experience is required.Working ConditionsOffice, Library, Computer Room; Requires extensive safetyPhysical EffortTypically 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.

The University of Pennsylvania's special character is reflected in the diversity of the Penn community. We seek talented faculty and staff who will constitute a vibrant community that draws on the strength that comes with a substantive institutional commitment to diversity along dimensions of race, ethnicity, gender, sexual orientation, age, religion, disability, veteran status, interests, perspectives, and socioeconomic status. Grounded in equal opportunity, nondiscrimination, and affirmative action, Penn's robust commitment to diversity is fundamental to the University's mission of advancing knowledge, educating leaders for all sectors of society, and public service. The University of Pennsylvania prohibits unlawful discrimination based on 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.

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