Clinical Research Coordinator A/B

Clinical Research Coordinator A/B

University Overview

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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.

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Posted Job Title
Clinical Research Coordinator A/B

Job Profile Title
Clinical Research Coordinator A

Job Description Summary
The clinical research coordinator will assist in the coordination of clinical trials for the Pulmonary Vascular Disease Program. This position will conduct multiple research-related tasks such as: screen, recruit, consent and enroll eligible subjects using GCP guidelines; Implement various research protocols and guidelines; Provide education to the patient and/or families participating in the research studies. Manage patient treatment per protocol, schedule research visits and testing.

Job Description

The Clinical Research Coordinator A will be responsible for management and oversight of research medication administration, monitoring of patient care, monitoring of side effects/adverse events, and maintaining general oversight of patient status throughout study period. Responsible for drawing labs (phlebotomy training preferred), specimen processing and shipping. Responsible for performing vital signs and EKGs for study visits. Will record and report adverse events and serious adverse events per protocols. Responsible for the preparation and processing of Institutional Review Board (IRB) documentation through the IRB and defined regulatory authorities, including initial submissions, continuing reviews, amendments, deviation and adverse event reporting. Responsible for accurate data collection and data entry. Work closely with study sponsors and physicians. Communicate any research issues to PI and primary MD, communication with research team, including Investigators, project managers, clinical research coordinators and regulatory team, to ensure patient safety and proper study conduct. Demonstrate vigilance in patient safety, protocol compliance, and data quality.

With minimal supervision: the Clinical Research Coordinator B will coordinate Phase I-IV clinical trials and registries for the Pulmonary Vascular Disease Program. Screen, recruit, consent and enroll eligible subjects per protocol using GCP guidelines. Implement various research protocols and guidelines. Provide education to the patient and/or families. Responsible for management and oversight of research medication administration, monitoring of patient care, monitoring of side effects/adverse events, and maintaining general oversight of patient status throughout study period. Will record and report adverse events and serious adverse events per protocols. Manage patient treatment per protocol, schedule clinical and research office visits, interact with cardiology and pulmonary staff to schedule and oversee research testing. Responsible for drawing labs (phlebotomy training preferred), sample processing and shipping. Responsible for performing vital signs and EKGs for study visits. Organize and maintain all documentation required by the sponsor or CRO- includes source documentation, case report forms, and research charts. Responsible for accurate data collection and data entry. Responsible for the preparation and processing of all Institutional Review Board (IRB) documentation through the IRB and defined regulatory authorities, including submissions, continuing reviews, amendments, deviation and adverse event reporting. Work closely with study sponsors and physicians. Communicate any research issues to PI and primary MD, communication with research team, including Investigators, project managers, CRC and regulatory team, to ensure patient safety and proper study conduct. Participate in initiation, monitoring, audit and close-out visits. Participate in study team meetings and ongoing protocol training/compliance meetings. Demonstrate vigilance in patient safety, protocol compliance, and data quality. Adhere to all University of Pennsylvania, FDA and GCP guidelines. May act as a mentor to coordinators who have joined the program with less research experience.

Duties:

CRC-A

- Screen for eligible subjects, recruit in clinic and/or remotely and complete informed consent process for all trials conducted in the PVD Research program.

- Coordinate the conduct of multiple trials, as assigned. Trial types may be Phase I-IV clinical trials, data registries, and cohort studies. Tasks to complete include, but are not limited to, scheduling visits and testing, study assessments (vital signs), testing (EKG, six minute walk test), phlebotomy, specimen processing and shipping per protocol, and administration of questionnaires.

- Complete documentation and data entry of patient visits and patient care for assigned trials and database projects.

- Record/report adverse events and serious adverse events to the study PI, sponsor and all applicable institutional or study related committees and personnel (e.g. IRB, DSMB, DCC) within prescribed timelines.

- Coordinate the administration of study medication, including monitoring subject for post-administration adverse events or reaction

- Manage regulatory aspects for multiple trials, including submissions, continuing reviews, amendments deviation and adverse event reporting.

- Monitor, summarize, and report research progress to Investigators, sponsors and teams members; work directly with principal investigators and other coordinators as needed for the successful execution of clinical trials.

- Perform additional duties as assigned

CRC-B

- Coordinate conduct of multiple Phase I-IV clinical trials and registries - Screen, recruit, enroll eligible subjects

- Coordinate and complete visits for subjects in multiple trials. Complete study assessments (vital signs), testing (EKG, six-minute walk test), phlebotomy, administer questionnaires and lab processing and shipping per protocol. Coordinate the administration of study medication, including monitoring subject for post-administration adverse events or reaction.

- Complete documentation and data entry of patient visits and patient care for multiple trials and database projects.

- Manage regulatory aspects for multiple trials, including submissions, continuing reviews, amendments deviation and adverse event reporting.

- Record/report adverse events and serious adverse events to the study PI, sponsor and all applicable institutional or study related committees and personnel (e.g. IRB, DSMB, DCC) within prescribed timelines.

- Report research progress to Investigators, sponsors and teams members; work directly with principal investigators and other coordinators as needed for the successful execution of clinical trials - Participate in initiation, monitoring, audit and close-out visits. Participate in study team meetings and ongoing protocol training/compliance meetings.

- Perform additional duties as assigned

***Position contingent upon funding.***

Qualifications
CRC-A

Bachelor's Degree with 1-2 years of related experience in research and clinical study methodologies or equivalent combination of education and experience is required. Phlebotomy experience preferred.

Effective communication and writing skills; ability to multi-task and problem solve; Energetic, interactive and demonstrated ability to work as part of a team as well as independently; knowledge of IRB and human research protection regulations. Must possess strong computer skills and be able to independently and proficiently work in MS office suite. Position contingent upon funding.

CRC B

Bachelor's degree and 2-4 years of related experience or equivalent combination of education and experience required. Phlebotomy expertise 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.

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

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

Job Location - City, State
Philadelphia, Pennsylvania

Department / School
Perelman School of Medicine

Pay Range
$36,401.00 - $55,814.33

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

To apply, visit https://wd1.myworkdaysite.com/en-US/recruiting/upenn/careers-at-penn/job/Perelman-Center-for-Adv-Medicine/Clinical-Research-Coordinator-A-B_JR00044349-1

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