"Clinical Research Coordinator A"

Job Description Summary

The purpose of this position is to provide research coordination and operational support for two ongoing research initiatives and related community engagement activities.

Job Description

The research coordinator will support two major initiatives:

• A Breast Cancer Research Foundation-funded pilot cluster randomized controlled study (RCT) evaluating ACCC-ASCO's "Just ASK^TM" training. The study aims to increase discussions about breast cancer clinical trials in clinical setting. The pilot will assess feasibility of a cluster RCT design, explore factors influencing the training completion and implementation, and conduct a qualitative analysis of physician-provider conversations about cancer clinical trials.
• Cervical Cancer prevention initiatives, including 1) the NCI-funded Self-collection for HPV testing to Improve Cervical Cancer Prevention (SHIP) Trial, which seeks to generate evidence to inform regulatory approvals for HPV-self-collection for cervical cancer screening in the U.S., and 2) Penn Medicine-led community-based HPV self-sampling programs aimed at improving screening access for women in underserved communities in West Philadelphia through partnerships with local community organizations.

The research coordinator will have the following specific responsibilities:

• Coordinate site-level study activities across multiple breast clinics within Abramson Cancer Center (ACC) hospitals, including screening and recruitment of participants, obtaining informed consent, facilitating study tasks (training completion, questionnaire administration and interviews), and managing participant remuneration and tracking.
• Collect and manage study data for the Just ASK^TM cluster RCT using REDCap; assist with qualitative analysis with N-Vivo to evaluate intervention effectiveness, identify barriers and facilitators to intervention implementation, and explore elements of the patient-provider communication about breast cancer clinical trials.
• Screen eligible patients referred for colposcopy or LEEP at Penn OBGyn clinics, consent and enroll participants in the SHIP trial and facilitate study activities including questionnaire administration and sample collection (self-collection and clinician collection).
• Ensure accurate and timely data entry and reporting in DFweb, REDCap and Velos; update and maintain study records in the Clinical Trials Management System (CRMS/Velos) including screening logs, adverse events and enrollment status; complete case report forms and resolve data queries.
• Maintain site-level regulatory and study documentation for research projects.
• Participate in weekly or bi-weekly meetings with PI, project manager and other team members to review study status. Contribute to agenda preparation and record minutes for circulation. Present regular study status updates to the research team.
• Support community engagement activities for HPV self-sampling programs, including planning and organizing outreach events with community partners and conducting post-event participant follow-up.
• Coordinate logistics for community-based HPV self-sampling programs.
• Adhere to the requirements of the University of Pennsylvania, Good Clinical Practice (GCP), FDA and all applicable regulatory bodies.
• Other responsibilities as reasonably assigned.

Position is contingent upon continued funding. Some work occurs outside of regular business hours as well as off-campus.

Qualifications

• Bachelor of Science and 1 to 2 years of experience or equivalent combination of education and experience is required.
• Must complete CITI training at the time of onboarding and maintain documentation of HIPAA training (required annually). Must demonstrate effective verbal and written communication skills. Must have the ability to learn new methods quickly and multitask. Demonstrated ability to work both independently and as part of a team. Ability to work flexible hours.
• Preferred but not required: Prior patient-oriented research experience. Experience or knowledge in oncology. Familiarity with IRB processes, human research protection regulations, Title 21 Code of Federal Regulations (CFR), International Conference of Harmonization (ICH), and Good Clinical Practice (GCP) Guidelines.

Job Location - City, State

Philadelphia, Pennsylvania

Department / School

Perelman School of Medicine

Pay Range

$46,500.00 - $46,500.00 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, and in alignment with salary ranges based on external market data for the job's level. Internal organization and peer data at Penn are also considered.