Clinical Research Coordinator B (Hybrid Eligible)

Description

Job Responsibilities

1. Recruitment Responsibilities

• Identify and implement strategies to ensure successful patient recruitment within specified timelines including but not limited to development of study brochures, outreach to the surrounding community, 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.

2. Enrollment Responsibilities

• Schedule and coordinate screening / enrollment visits.
• Perform screening procedures per study protocol including approaching participants in person or by phone, requesting and reviewing medical records, and asking eligibility questions.
• Complete informed consent procedures with patients during standard of care clinic visits, scheduled research encounters, or other unscheduled interactions with potential study participants.
• Track enrollment progress at Penn and external study sites and prepare weekly updates for the research team..

3. Visit Implementation / Data Collection Responsibilities :

• Schedule and coordinate all study data collection visits with various Penn. clinics / departments / providers for 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 per study protocols.
• Work with providers and study participants on the completion of CRFs and source documentation for patient assessments and patient-reported outcome questionnaires.
• Initiate and complete the required financial procedures and documentation for the distribution of participant compensation.

4. Data Systems and Monitoring Responsibilities :

• Create basic database (e.g. REDCap).
• Lead development of CRFs by reviewing study protocols and adapting previous study CRFs.
• Coordinate efforts and feedback between study team for complex database development.
• Conduct systematic data monitoring for Penn and external sites.
• Review data queries and identify and resolves discrepancies at Penn and external sites.
• Prepare, maintain, and present study progress reports (e.g. enrollment, data collection, discrepancies status, etc.).
• Assist with quantitative and qualitative data cleaning and data analysis preparation.
• Track research billing charges and participant payments and resolve discrepancies.
• Coordinate study close out procedures.

5. Regulatory Compliance Responsibilities :

• Draft components of IRB submissions such as consent forms, institutional forms, FDA forms, continuing review and modification forms, deviation and exception memos, and adverse event reporting forms for regulatory submissions.
• Prepare and track submissions to IRB electronic systems ensuring compliance with institutional requirements and guidelines.
• As needed, prepare components of regulatory submissions for external sites including Investigator Agreements, FDA forms, CITI trainings, and investigators qualification documents.
• Assist PI and / or senior clinical research staff with communications with study sponsors.

6. Other Responsibilities :

• Support and interact with PIs, co-investigators, research managers, and other research staff
• Assist with preparation of procedure and / or lab manuals and other guidance documents for new studies
• Attend study-related meetings
• Maintain all relevant trainings and certifications (CITI, GCP, PENN CRC certification and assigned Penn Profiler trainings)
• Adhere to all University of Pennsylvania, GCP, and FDA guidelines
• Perform other duties as assigned which may include assisting with the collection, processing, and shipping of human specimens.
• Position involves work-related responsibilities that may occur outside of the usual workday times (before 8am or after 5pm).

Qualifications

Bachelor’s degree and 2 to 3 years of research or public health-related experience or equivalent combination of education and experience is required.

Experience with community-based or clinic-based recruitment, enrollment, and data collection is preferred.

Candidates should demonstrate :

• Excellent interpersonal skills
• Meticulous attention to detail
• Ability to effectively communicate verbally and in writing with individuals of varied backgrounds and qualifications
• Strong organizational skills with ability to multi-task and meet deadlines under minimal to moderate supervision
• Experience working on a collaborative team and interacting directly with patients in clinical and / or community settings.
• High proficiency using computer programs for business and research operations (MS Office suite, Google Suite, email programs and database programs)

This position is contingent upon funding.

Job Location - City, State

Philadelphia, Pennsylvania

Hybrid Eligible This position is eligible for a hybrid work schedule with a workweek that is divided between working onsite and working remotely

Department / School

Perelman School of Medicine

Pay Range

$43,919.00 - $58,059.00 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.