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Clinical Research Assistant A/B

3 months ago

Philadelphia, Pennsylvania, United States University of Pennsylvania Full time

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. As an employer Penn has been ranked nationally on many occasions with the most recent award from Forbes who named Penn one of America's Best Large Employers in 2023.

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 Assistant A/B (Department of Dermatology)

Job Profile Title

Clinical Research Assistant A

Job Description Summary

This full-time staff member will support the Clinical Studies Unit (CSU) research team for the Department of Dermatology. The CSU supports the department at large and the Clinical Research Assistant will have the opportunity to work with a variety of investigators and clinical studies including investigator-initiated studies and clinical trials phase II through IV. The CRA will take direction from the Coordinators that they work with to ensure necessary tasks are completed as expected. The CRA will be responsible for subject prescreening, recruitment, obtaining informed consent as appropriate for potential research subjects, and screening/enrolling subjects into various studies as specified per protocol. The CRA will be responsible for the collection, processing and shipping of clinical biospecimens to include those collected via phlebotomy and ensuring appropriate documentation. Support of the Research Nurse and Coordinators includes preparation of case report forms, labeling tubes from blood collection and scheduling of clinical research study participant appointments and completing various protocol-directed procedures: blood draws, ECG, blood pressure/vital signs and questionnaire administration. This individual will also need to maintain appropriate subject records, data, and database entry in a complete, careful and timely manner. This includes study specific databases, binders, REDCap and CRMS. S/he must demonstrate vigilance in subject protections, protocol compliance, and data quality. The CRA would need to coordinate with the Mohs Clinic contributing to the Dermatology biobank for the processing, handling and storing of collected human specimens and maintaining a detailed electronic specimen log. The CRA must be self-sufficient, detail-oriented and able to identify problems and solve them with support, including assessing the need for further intervention or care by licensed staff. S/he must be able to handle confidential information and meet objective in compliance with all legal, regulatory, and protocol guidelines. Excellent and effective communication, organizational and administrative skills are necessary including the ability to check and prepare study-related materials. The CRA must also work as a team member, showcasing the ability to effectively interact with multidisciplinary teams including patients, families, physicians, nurses, pharmacists, administrative and laboratory staff. S/he will adhere to all University of Pennsylvania, IRB, federal, and ICH-GCP guidelines, policies, and practices.

Job Description

Job Responsibilities

  • Subject prescreening, recruitment, obtaining informed consent as appropriate for potential research subjects, and screening/enrolling subjects into various studies as specified per protocol. While working with a variety of investigators and clinical studies including investigator-initiated studies and clinical trials phase II through IV. Must adhere to all University of Pennsylvania, IRB, federal, and ICH-GCP guidelines, policies, and practices.
  • Responsible for the collection and processing of clinical biosamples to include those collected via phlebotomy, and ensuring appropriate documentation, storage and/or shipping for clinical trials. Coordinating with the Mohs Clinic contributing to the Dermatology biobank for the processing, handling and storing of collected human specimens and maintaining a detailed electronic specimen log.
  • This individual will also need to maintain appropriate subject records, data, and database entry in a complete, careful and timely manner. S/he must demonstrate vigilance in subject protections, protocol compliance, and data quality. This will require learning various data systems include study/sponsor specific, REDCap and CRMS.
  • Work under the supervision of the Coordinators that they work with to ensure necessary tasks are completed as expected. Support of the Research Nurse and Coordinators includes preparation of case report forms, labeling tubes from blood collection and scheduling of clinical research study participant appointments and completing various protocol-directed procedures: blood draws, ECG, blood pressure/vital signs and questionnaire administration. Excellent and effective communication, organizational and administrative skills are necessary including the ability to check and prepare study-related materials.
  • Perform additional duties as assigned

Duties

We are looking for a highly motivated, dedicated and enthusiastic individual who will provide study assistance/coordination for patient-oriented clinical and translational research projects within the Department of Dermatology. This full-time staff member will support the Clinical Studies Unit research team. The CSU supports the department at large and the Clinical Research Assistant will have the opportunity to work with a variety of investigators and clinical studies including investigator-initiated studies and clinical trials phase II through IV. The primary duties will include, but are not limited to:

CRC A:

  • Responsible for prescreening, subject recruitment, obtaining informed consent as appropriate for potential research subjects, and screening/enrolling subjects into various studies as specified per protocol
  • Assist with preparing and performing study visits by labeling and creating visit packets and completing protocol-directed procedures: blood draws, ECG, blood pressure/vital signs and questionnaire administration
  • Scheduling participant visits and necessary testing
  • Responsible for the collection, processing and shipment/delivery of clinical biospecimens (tissue, blood, serum, etc.) and ensuring appropriate documentation
  • Escorting participants to other testing/procedure areas
  • Coordinate with the Mohs Clinic teams contributing to the Dermatology biobank by the handling, processing and storage of collected human specimens and maintaining a detailed electronic specimen log
  • Collect, review and maintain appropriate and accurate subject records and data
  • Conduct database entry in a complete, careful and timely manner in accordance with the study protocol
  • Assist in the coordination, creation, organization, maintenance and filing of all documentation, logs, spreadsheets and databases required by the sponsor or clinical research organization (CRO) – source documentation, case report forms, study and regulatory binders, participant binders
  • Demonstrate vigilance in subject protections, protocol compliance, and data quality.
  • Participate in study team meetings and ongoing protocol training and professional development
  • Perform general administrative duties to support the CSU and Department of Dermatology
  • Adhere to all University of Pennsylvania, IRB, federal, and ICH-GCP guidelines, policies, and practices.

CRA B

  • Perform all duties as listed above with less supervision from the study team (Director of Operations, Project Managers, Clinical Research Coordinators)
  • In addition to the above, the person will be expected to do more in-depth prescreening and review of medical records, data entry, and conduct delegated study visit tasks autonomously.

Qualifications

A High School Diploma or GED and 1 to 2 years of experience or equivalent combination of education and experience required for a CRA A or 3 to 5 years for a CRA B.

College degree or coursework a plus. Ability to perform phlebotomy is required. Teaching will be provided if there is no previous experience. Prior clinical research experience and familiarity with medical terminology is highly desirable. Experience with REDCap is a plus. Experience with Microsoft Office is required and experience with hospital databases (e.g., EPIC, etc.) is a plus. In addition, the CRA needs to be able to work independently as well as part of a team, demonstrate great attention to detail, have excellent communication and interpersonal skills, be highly organized, and be willing to seek guidance as necessary and accept critical feedback.

This position is contingent upon funding.

Job Location - City, State

Philadelphia, Pennsylvania

Department / School

Perelman School of Medicine

Pay Range

$ $19.37 Hourly 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. ​ To learn more, please visit: 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.