Clinical Research Coordinator A/B (Department of Otorhinolaryngology)

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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.

Posted Job Title

Clinical Research Coordinator A/B (Department of Otorhinolaryngology)

Job Profile Title

Clinical Research Coordinator A

Job Description Summary

We are looking for a highly motivated, dedicated, and enthusiastic individual who is excited about doing clinical-translational research on head and neck cancer. This individual should be interested in a career in science or medicine and can commit for a minimum of 2 years. The position would have the following three initial areas of emphasis:

The primary role would be to support all aspects of human biospecimen collection for research from head and neck mucosal and salivary cancer patients undergoing procedures as part of clinical care at the Pavilion or Pennsylvania Hospital. A second role would be to create and continuously update a list of clinical trials relevant to the head and neck mucosal and salivary malignancy that are open to enrollment anywhere within the Penn system. This list would be made easily accessible in digital format throughout the Penn system to facilitate patient enrollment. A third role would be to serve other discrete projects and infrastructure needs at the interface of clinical practice with head and neck mucosal and salivary cancer research on an ad hoc basis.

The successful applicant will manage study activities including subject recruitment, data entry, subject visits and follow-up, and regulatory documentation. He/she will interact directly with Principal Investigators, other lab members, research staff, and patients. It is expected that the clinical research coordinator (CRC) will develop a high level of independence, be able to problem solve, and take the lead on projects. The CRC will work in a supportive environment that is team-oriented, where creativity, enthusiasm, and dedicated effort are highly rewarded. Excellent organizational skills and attention to detail are necessary.

POSITION CONTINGENT ON FUNDING

Job Description

Job Responsibilities

Clinical Research Coordinator AAdhere to all University of Pennsylvania, GCP/ICH, and FDA guidelines.Weekly coordination of multiple investigator-initiated research and clinical trial focused in Head and Neck Cancer. Screen, recruit, and consent potential study participants as specified per protocol.Collect blood and other specimens and coordinate specimen storage and processing with various labs.Manage scheduling and coordination of subject study specified treatment, follow-up visits and procedures per study protocols.Complete CRFs and data entry to study databases, sample process and shipping, patient reimbursement, research billing review, etc.Coordinate the administration of the investigational product and study related medications including obtaining orders, collection of data from source documents pertaining to study visits and transcribe to case report form, including concomitant medications and adverse events.Maintain all study-related documents, i. Including DOA log, source documents, CRFs, AE forms, enrollment log, training log, correspondence, etc.Proper reporting of serios and non-serious adverse events to the study team.Prepare and participate in the conduct of audits by the study sponsors, CROs, the FDA, and other entities as required.Conduct initiation, monitoring, and close-out visits with sponsors and/or CROs.Maintain records of monthly/yearly progress reports, generate meeting agenda, record and distribution of meeting minutes, assist with IRB, CTSRMC, or other regulatory submissions.Other duties and responsibilities as assigned.

Clinical Research Coordinator B

The Clinical Research Coordinator B will have the same duties as A but will include the following:

Act in independent capacity in coordination of unit projects and assist unit managers in overseeing execution of project timelines as well as completion of study related activities delegated to research coordinators who provide study related support (e.g., regulatory submissions and data entry).Proper reporting of serious and non-serious adverse events to the Sponsor and all applicable institutional or study related committees and personnel (e.g., IRB, DSMC, DSMB/Medical Monitor) according to applicable regulations and policies.

Qualifications

CRC A: Bachelor of Science and 1 to 2 years of experience or equivalent combination of education and experience is required. Experience in clinical research compliance or auditing. Excellent interpersonal, writing, and analytical skills. Must be detail-oriented with excellent organizational and multitasking skills. The candidate should be able to work independently and as part of a team. Experience in oncology, REDCAP databases, specimen collection, and EPIC EMRs is desirable.

Oncology, REDCAP, Specimen Collection, and EPIC experience is Preferred.

CRC B: Bachelor's Degree and 2-4 years of experience or equivalent combination of education and experience is required. Experience in clinical research compliance or auditing. Excellent interpersonal, writing, and analytical skills. Must be detail-oriented with excellent organizational and multitasking skills. The candidate should be able to work independently and as part of a team. Experience in oncology, REDCAP databases, specimen collection, and EPIC EMRs is desirable.

Qualifications

Oncology, REDCAP, EPIC, and Specimen collection experience is preferred.

WORKING CONDITIONS

Office, Library, Computer Room: operating room, pathology suite, laboratory, exposure to biological or chemical substances Exposure to Chemicals, Requires extensive safety.

Physical Effort

Typically walking between research sites or sitting at a desk or table;; Travel between multiple research sites. Occasional lifting 25 lb. or less.

Job Location - City, State

Philadelphia, Pennsylvania

Department / School

Perelman School of Medicine

Pay Range

$37,220.00 - $58,000.00 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