Clinical Research Coordinator - Neonatology at Children’s Hospital of Philadelphia

Philadelphia, Pennsylvania, United States -

Full Time

Start Date

Immediate

Expiry Date

02 May, 26

Salary

71110.0

Posted On

01 Feb, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Clinical Research, Data Management, Patient Recruitment, Informed Consent, Regulatory Compliance, Good Clinical Practice, Biospecimen Collection, Adverse Event Reporting, Communication Skills, Time Management, Collaboration, Training, Documentation, Study Coordination, Financial Management, Protocol Development

Industry

research

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 does not discriminate on the basis of race, color, sex, national origin, religion, or any other legally protected categories in any employment, training, or vendor decisions or programs. CHOP recognizes the critical importance of a workforce rich in varied backgrounds and experiences and engages in ongoing efforts to achieve that through equally varied and non-discriminatory means. A Brief Overview Seeking CRC II to join established and active neonatal clinical research team at CHOP Newborn Care at Pennsylvania Hospital. Pennsylvania Hospital is the nation’s oldest hospital, a teaching facility of the University of Pennsylvania, and the busiest labor and delivery service in Philadelphia (with approximately 5000 annual births). The CRC’s primary role will be to manage an NIH-funded, prospective cohort study to understand antimicrobial pharmacology in mothers and infants in the immediate perinatal period. In close collaboration with the PI, responsibilities will include screening, time-sensitive consents, coordination of biospecimen collection and processing, and maintenance of study data and records. Under minimal supervision, this role substantially coordinates all clinical research activities within the scope of clinical research protocols. 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. As a condition of employment, CHOP employees who work in patient care buildings or who have patient facing responsibilities must receive an annual influenza vaccine. Learn more. 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.

Responsibilities

The Clinical Research Coordinator will manage an NIH-funded study focused on antimicrobial pharmacology in mothers and infants. Responsibilities include coordinating research activities, maintaining study data, and ensuring compliance with protocols.