Clinical Research Assistant II - The Lurie Family Foundations Imaging Center | Philadelphia, PA

Detailed Information

  • Location: Philadelphia, PA

  • Company: Children's Hospital Of Philadelphia

affect their everyday life. Among patients with HIV, tobacco smoking is prevalent (40-70%). Smoking adversely affects the viral load suppression achievable by treatment (c ART), substantially impacting long-term survival and brain health. HIV smokers demonstrate excessive brain inflammation and elevated production of harmful radicals in the brain.

Both may contribute to brain injury and functional impairments. This study will use neuroimaging methods to study brain structure and function in individuals with HIV and tobacco smokers. This study is overseen by Dr. Muhammad Saleh (principal investigator) and study members Dr. Timothy Roberts and Dr. Lisa Blaskey (Neuropsychologist). We seek

a full-time Clinical Research Assistant (CRA) to assist across the project. The CRA will assist in recruiting, screening, and scheduling study participants for in-person and online study procedures.

The CRA will consent subjects for entry into the required protocol and report to the psychologist and Principal Investigator on the conduct of the assigned protocol. This individual will work closely with our team psychologist on acquiring clinical research data from research participants and will also support the imaging visits for the neuroimaging aspect of the project. Across research studies, the CRA will have regular contact with clinical and healthy populations. Finally, the CRA will

enter data into study databases, manage data flow, and maintain databases and paperwork.

Prior experience with some or all of these duties is a plus but is not necessary; many of the CRA's duties can be learned on the job. Successful applicants will be highly self-motivated, detail-focused, flexible, and fast learners who enjoy working in bustling research and clinical environments. This position offers valuable clinical research experience in preparation for applying to graduate school. As a member of Lurie Family Foundations Imaging Center, the individual can participate in outreach events and attend lectures and seminars on HIV, tobacco smoking, autism research, and mitochondrial diseases, allowing exposure to scientific and clinical leaders in the field.

Job Responsibilities Discuss the research study and screen potential research participants for enrollment in study Schedule follow-up visits for research participants (possible 2-day visits) Schedule and participate in visits with research participants Consent participants for enrollment in studies Work with participants to complete required study procedures (e. g. questionnaires) and ensure that all data collection instruments are administered and complete Collect and maintain study data (primarily in REDcap) as required for specific clinical research protocols Assist with IRB protocol amendments, poster presentations, and publication preparation as needed (including conducting literature reviews, creating figures, etc.

) Utilize appropriate resources, including other Clinical Research Assistants, team psychologists, and PIs to collect data accurately and completely Enter information in computer databases for the study in a timely manner (as soon as the data collection is complete after every visit) Provide timely information to the Principal Investigator on the progress of data collection for the study.

Communicate any difficulties or problems in collecting data as prescribed immediately to the team leaders and/or PI Perform chart and data reviews to backss compliance of data with IRB and other regulatory agencies Help maintain lab facility and equipment. Perform quality assurance procedures on all equipment daily or as needed. Monitor use of supplies and order new supplies as needed. Maintain day-to-day operations of the lab and keep the facility neat, organized, and safe. For this position, we'll need the person to be somewhat flexible with regard to their time. For example, some weeks we'll need this person to work later in the evening, but other weeks work regular 9 to 5 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 diverse talent who can help us deliver on our mission to be a world leader in the advancement of healthcare for children. We strongly encourage all candidates of diverse backgrounds and lived experiences to apply. A Brief Overview 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 Clinical Trial. 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.

(Required proficiency) Excellent verbal and written communications skills (Required proficiency) Strong time management skills (Required proficiency) Ability to collaborate with stakeholders at all levels (Required proficiency) 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 be fully vaccinated against COVID-19 and receive an annual influenza vaccine. Learn more. Employees may request exemptions for valid religious and medical reasons. Start dates may be delayed until candidates are immunized or exemption requests are reviewed. EEO / VEVRAA Federal Contractor Tobacco Statement

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