Clinical Research Coordinator A (Department of Endocrinology, Diabetes and Metabolism)
University of Pennsylvania

University OverviewThe 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 TitleClinical Research Coordinator A (Department of Endocrinology, Diabetes and Metabolism)Job Profile TitleClinical Research Coordinator AJob Description SummaryThis entry-level position will support the faculty and clinical research staff of the Department of Medicine in the preparation for, conduct of, and completion of any and all Human Subjects Research projects and sub-projects in which they are engaged, primarily for the rare disease Fibrodysplasia Ossificans Progressiva (FOP). This position requires significant dedication and resilience to acquire and apply regulatory knowledge with the duty to protect research patient safety and data integrity. This position will report administratively to the project manager in the Department of Medicine and will report, on a study-specific basis, to the respective principal investigators. The CRC-A will also work on department level research, education, and quality/process improvement initiatives as required.Job Description

Job Responsibilities

• Complete onboarding and demonstrate accountability for ongoing training and certificate maintenance assigned as required for the university, department, and as-needed specific to individual studies. Participate in ongoing institutional, departmental and global training requirements to ensure ongoing readiness to perform the job at the highest level of engagement possible at all times. Develop working knowledge of and apply relevant national and international principles of human subject protections and privacy throughout all clinical research activities. Employ self-engagement to learn of appropriate trainings and certifications applicable to the position. Demonstrate accountability for CRC role in maintaining participant safety and data integrity. At close of introductory period, be able to articulate the purpose of and describe the importance of each study and identify key elements of clinical study protocols. Learn and demonstrate understanding of roles and responsibilities of investigators, sponsors, CROs, and regulatory bodies including specific role of IRBs. After completing institutional CRC onboarding certification, be able to demonstrate understanding of principles of Belmont Report, and ICH and GCP guidelines.

• Understand individual role and responsibilities including the limitations of the role in performing clinical study activities. Understand reporting structure and who to contact for support. Collect and enter data with timeliness, accuracy, and low query rates. Identify and understand data points that are used for analysis of safety and effectiveness. Ensure source data are attributable, legible, contemporaneous, original and accurate and data in EDC systems are attributable, accurate, complete and verifiable. Demonstrate ability to work on electronic clinical and research platforms including use of mobile devices. Schedule & assist with conducting all tasks involved in remote and site study visits per protocol. Assist with performing clinical assessments as appropriate to training and licensure. Assist with collecting, processing and shipping biological samples per protocol, laboratory manual and IATA guidelines. Complete data entry in EDCs including CTMS and subsequent query resolution within specified timeframes. Electronically transfer or ship images or other required elements per protocol and resolve subsequent queries. Request and ship IP and other medications or medical supplies as needed, assist with calculating IP compliance and updating internal drug accountability and visit trackers. Understand and follow SOP for control, storage and dispensing of IP. Identify any deviations of handling investigational product, report and work with IDS if appropriate to solve the issue. Assist with ensuring subject understanding of IP dosing and potential side effects. Request remote nursing services and respond to remote clinician questions, and schedule local clinical services or testing if needed. Assist with maintaining organized and complete investigator site files and subject binders including training and signature logs. Complete necessary scheduling, documentation and respond to messages in PennChart including creating orders for procedures and medications as needed. Complete daily billing review in PennChart, assist with tracking study expenses, and review invoices for billable activity as needed.

• Interact with patients, their caregivers, and external vendors in the execution of clinical research and achievements of patient visit milestones. Document and report medical history, adverse events and conmeds. Recognize differences in types of adverse events and appropriately document and report information per GCP guidelines using study-specific timelines and reporting channels. Assist with collecting and appropriately share additional or supporting documentation including local laboratory or imaging reports and clinical encounter notes. Assist with reporting and record data following internationally accepted guidelines.

• Participate in monitoring and auditing visits and subsequent analysis of protocol deviations and implementation of corrective measures. Adjust individual conduct as needed to be in line with corrective action plans. Support site involvement in FDA auditing and submission of NDAs. Assist with writing, editing, and submitting study documents such as protocols, summaries and ICFs to the IRB and applicable ancillary regulatory committees. Communicate directly with IRB and ancillary regulatory committees when regulatory questions arise and respond to communications generated from regulatory submissions. Ensure that regulatory submissions meet reporting requirements and approvals do not lapse or expire.

• Understand the purpose of and assist in the organization and facilitation of site qualification, site initiation, and site close-out visits virtually or in person. Provide team members and stakeholders with timely study activity and status reports. Use appropriate communication channels between the site staff, regulators, sponsors, and CROs. Demonstrate interpersonal skills. Articulate information succinctly and appropriately verbally and in writing. Apply appropriate professional communication practices in written and verbal interactions to maintain legal, ethical, and productive relationships. Establish contacts and partnerships with other clinical departments and supportive services within the institution in addition to individuals from the sponsor or third-party vendors including any CROs. Establish and maintain productive professional relationships with all individuals involved in research study execution to sustain efficient and effective clinical trails currently and in the future.

• Demonstrate professionalism and contribute to the success of Division and Department through attire, attitude, work-ethic, self-motivation, and quality products. Show initiative and team cooperation. Locate, understand, and adhere to SOP guidelines in research department. When working on multiple projects, demonstrate effective time management and organizational skills. Seek guidance when questions arise. Demonstrate willingness to be challenged and initiative to overcome logistical and other study conduct obstacles as they arise. Adhere to all University of Pennsylvania policies, and department/divisional policies. Demonstrate accountability through attendance, participation and engagement. Assist and support research and management staff as requested. Participate in routine operational "side work" to ensure the smooth operation of the overall program.

• Understand trial eligibility criteria for study participants and participate in screening process. Understand what groups are considered vulnerable populations in research and the regulations that protect them. Recognize and demonstrate sensitivity to racial, ethnic and cultural diversity. Demonstrate sensitivity to patients with severe disability and their caregivers by acting as their advocate. Minimize participation burden by navigating logistical concerns including travel, financial hardship, and other barriers to participation or protecting patient safety. Build rapport with potential and existing participants to address questions and achieve participant understanding of study purpose and their responsibilities as a participant. Emphasize the rights of the participant and voluntary nature of research.

• Identify and use tools, strategies, and procedures for managing and tracking participant recruitment, retention, and compliance. Assist in development and editing of study SOPs, source documents, reports, and documents for regulatory submission. Demonstrate an understanding of the purpose and content of study legal materials including contracts, budgets, indemnification, confidentiality disclosure agreements, conflict of interest reporting, MTAs & DTAs, and IRB approvals.

• Train and educate others in the conduct of human subjects research as needed. Training responsibilities may include teaching clinical staff protocol specific activities and procedures and educating healthcare coworkers on the difference between standard of care and clinical study activities. Assist research staff with cross training others on the team on study-specific tasks and, where applicable, training students, temporary workers, and other staff on applicable topics including institutional processes and foundational clinical research and GCP information.

• Other duties and responsibilities as assigned

Qualifications

• Bachelor of Science and 1 to 2 years of experience or equivalent combination of education and experience is required.

Job Location - City, StatePhiladelphia, PennsylvaniaDepartment / SchoolPerelman School of MedicinePay Range$43,888.00 - $44,947.00 Annual 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: https://www.hr.upenn.edu/PennHR/benefits-pay

---