Requisition Number: 11-25208
Job Titile: Senior Clinical Research Assistant
• 2 years relevant experience in clinical research or clinical coordination
• Knowledge of good clinical practices (GCP) as well as federal regulations pertaining to clinical research (IRB, FDA) - preferred.
• Knowledge of cancer-related clinical research preferred
• High degree of initiative and organization
• Ability to work independently and take initiative when necessary.
• Ability to work under stress and meet deadlines.
• Excellent communication skills
• Must be able to prioritize workload effectively
• Prefer good typing skills, good computer skills in a Windows environment, including Microsoft Word, very good editing and proofing skills.
• Excellent interpersonal and creative problem solving skills.
Willingness and ability to travel very intermittently.
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Job Description: The Children’s Hospital of Philadelphia Research Institute is an interdisciplinary institution dedicated to conducting basic, clinical and translational research on conditions and diseases that affect children, and is part of The Children's Hospital of Philadelphia and University of Pennsylvania research community.
The Senior Clinical Research Assistant position is in the laboratory of Dr. Stephen Grubb a Principal Investigator in the Oncology Research Division.
The SCRA will oversee a research project which may include multiple clinical trials. Providing leadership and direct responsibility for the implementation of study related activities for the project at CHOP. Responsible for overall management of the trial(s) to ensure compliance with study protocol, Sponsor, FDA, NIH and IRB policies. This position will hold regular meetings with other study team members and serve as the main liaison between the study team and the PI, regulatory sponsor and other internal and external departments, companies. Overall responsibility for ensuring all regulatory work is properly submitted to the IRB, study sponsor, DSMB (if applicable) and for tracking regulatory documents/compliance. Assure that data entry is done in a timely and accurate manner and will oversee any monitoring/auditing visits that occur. Oversee billing resolution and work to address/resolve any research-related billing issues, working with CTFM, business manager and research finance as needed. Initiate and assist with reporting of adverse events to Sponsor and IRB. Help with complex scheduling. Coordinate with families. Provide coordination and support for other clinical research coordinators who are party of the cell therapy/transplant team and who will help with the overall clinical research.
• Oversee clinical trial(s) for a particular project to ensure studies are conducted following GCP and all local and federal regulations/policies governing the research.
• Responsible for research activities, including:
o Subject recruitment, confirmation of subject eligibility
o Verify documented informed consent prior to enrollment and treatment
o Maintain source documents for eligibility, pre treatment, and follow-up requirements
o Completion of case report forms, data query resolution in timely manner
o Ensure timely serious adverse event reporting according to regulations
o Specimen collection, processing, and shipment according to protocol requirements
o IRB submissions
o Monitor visits and audits
o Develop tools to aid in protocol adherence
o Functions independently in a clinical research setting and is responsible for the complete coordination of assigned clinical research activities.
o Ability to follow clinical research protocols
o Ensuring timeliness and accuracy of sample collection
• Ability and sensitivity to interact, collaborate, and communicate with a diverse group of persons (children, parents, physicians, nurses and medical personnel).
SKILLS AND ABILITIES:
Strong research skills
Effective problem solving/critical thinking skills
Ability to work independently
Ability to exercise discretion and judgment
Value for research integrity and collaborative research
High level of motivation
Good communication skills/Strong interpersonal skills
To learn more about the CHOP Research Institute, Dr. Stephen Grubb and the research programs visit: http://research.chop.edu.
Interested individuals should send a cover letter, CV, and three references and/or letters of recommendation and must also complete a profile on our website at www.chop.edu/careers .
Job ID: 11-25208