Job Description
SHIFT:
Day (United States of America)
Clinical Research Coordinator II Seeking Breakthrough Makers Children's Hospital of Philadelphia (CHOP) offers countless ways to change lives. Our diverse community of more than 20,000 Breakthrough Makers will inspire you to pursue passions, develop expertise, and drive innovation.
At CHOP, your experience is valued; your voice is heard; and your contributions make a difference for patients and families. Join us as we build on our promise to advance pediatric care-and your career.
CHOP's Commitment to Diversity, Equity, and Inclusion CHOP is committed to building an inclusive culture where employees feel a sense of belonging, connection, and community within their workplace. We are a team dedicated to fostering an environment that allows for all to be their authentic selves. We are focused on attracting, cultivating, and retaining talent who can help us deliver on our mission to be a world leader in the advancement of healthcare for children. We strongly encourage candidates of all races, colors, ethnicities, religions, perspectives, sexes, backgrounds, and lived experiences to apply.
A Brief Overview We are seeking a full-time Research Coordinator to join our team as soon as possible for at least one year. The position provides an exciting opportunity and experience for individuals interested in pursuing advanced graduate degrees in school psychology, clinical psychology, health psychology, or related fields.
Funded grant to CHOP by the Department of Education's Institute of Education Sciences, this research project is a real-world replication study of a school-based Homework, Organization, and Planning Skills (HOPS) program for students with deficits in organizational, time management, and planning skills. The study includes 6th through 8th grade students across cultural, racial, and socioeconomic backgrounds enrolled in a diverse set of about 30 schools across Pennsylvania and New Jersey. All schools are located within approximately 15-75 minutes of CHOP's Roberts Center for Pediatric Research.
Location of work will include both on-site at the Roberts Center for Pediatric Research and off-site at schools. Most schools are located within 15-75 minutes of CHOP's Roberts Center for Pediatric Research. Travel throughout the greater Philadelphia area is required. Mileage reimbursement for travel to schools is available. Flexible schedule is required including some early school meetings/session recordings and some evenings/weekends for consents.
Under supervision, this role substantially coordinates all clinical research activities within the scope of clinical research protocols, including data collection from caregivers, teachers, and school intervention providers; engaging and onboarding schools into the study; oversee payment of stipends to study participants; prepares amendments to IRB; contributes to supervision of a staff RA; prepares data for analyses; collaborates with statisticians on data management. Duties involve managing the day-to-day activities of the research study under the guidance of PI or managing study staff.
What you will do - Core responsibilities
- Adhere to an IRB approved protocol
- Participate in the informed consent process of study subjects
- Support the safety of clinical research patients/research participants
- Coordinate protocol related research procedures, study visits, and follow-up care
- Screen, recruit and enroll patients/research participants
- Maintain study source documents
- Report adverse events
- Understand good clinical practice (GCP) and regulatory compliance
- Educate subjects and family on protocol, study intervention, etc.
- Comply with Institutional policies, standard operating procedures (SOPs) and guidelines
- Must comply with federal, state, and sponsor policies
- Related responsibilities
- Prepare, manage, submit, and maintain essential regulatory documents (e.g. IRB, FDA, etc.) and remain aware of the regulatory status for projects within scope of role
- Register study on ClinicalTrial.gov as appropriate
- Complete case report forms (paper & electronic data capture) and address queries
- Facilitate pre-study, site qualification, study initiation, and monitoring visit as appropriate
- Facilitate study close out activities as appropriate
- Coordinate research/project team meetings
- Collect, process and ship laboratory specimens
- Schedule subject visits and procedures
- Retain records/archive documents after study close out
- Additional Responsibilities may include
- Manage study finances including sponsor invoicing & resolving study subject billing issues
- Develop advertisement materials
- Act as liaison for research subject, investigator, IRB, sponsor, and healthcare professionals
- Organize and/or run study-related meetings locally or across teams (for multi-site projects)
- Support study team communications and outreach
- Provide training to junior staff on conduct of research studies
- Document investigational product (drug/device) accountability
- Self-monitor and self-audit responsibilities
- Develop informed consent document and/or draft or edit IRB protocols or related documents such as study administration manuals
- Maintain Clinical Trial.gov
- Develop Case Report Forms
- Assignments to include more complex studies
Education Qualifications - Bachelor's Degree - Required
- Master's Degree in a related field - Preferred
Experience Qualifications - At least two (2) years of clinical/research coordination experience - Required
- At least three (3) years of clinical/research coordination experience - Preferred
Skills and Abilities - Basic knowledge of IRB and human subject protection
- Excellent verbal and written communications skills
- Strong time management skills
- Ability to collaborate with stakeholders at all levels
To carry out its mission, CHOP is committed to supporting the health of our patients, families, workforce, and global community. EEO / VEVRAA Federal Contractor | Tobacco Statement SALARY RANGE: $56,890.00 - $71,110.00 Annually
Salary ranges are shown for full-time jobs. If you're working part-time, your pay will be adjusted accordingly.
At CHOP, we are committed to fair and transparent pay practices. Factors such as skills and experience could result in an offer above the salary range noted in this job posting. Click here for more information regarding CHOP's Compensation and Benefits.
Job Tags
Full time, Part time, For contractors, Immediate start, Flexible hours, Shift work, Weekend work, Afternoon shift,