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Clinical Research Coordinator II - Division of Orthopedic Surgery
Philadelphia, PA, US, 19104
Location: LOC_WOOD_CTR-Wood Building
Req ID: 145213
Employment Status: Regular
This role will participate in research activities which may include: divisional/multi-center studies subject recruitment, confirmation of subject eligibility, informed consent process, data clarification, study procedure documents such as The Institutional Review Board (IRB), maintain and monitor study group databases/registries and medical record abstraction.
The role also will play an important role in the preparation and maintenance of study protocols, will assist in training and mentoring clinical research assistants, enhance collaboration and administrative coordination between investigators and ancillary departments, sponsoring organizations, and/or regulating bodies, and assist the Principal Investigator(s), Research Manager, and other Clinical Research Coordinators in all aspects of research projects.
This role coordinates all clinical research activities within the scope of clinical research protocols Under minimal supervision.
The CRC II performs all CRC core and additional responsibilities as detailed in the CRC I job description. The CRC II Also may be responsible for any of the following:
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
Document investigational product (drug/device) accountability
Self-monitor and self-audit responsibilities
Develop informed consent document
Maintain Clinical Trial.gov
Develop Case Report Forms
Assignments to include more complex studies
Required Education and Experience
Required Education: Bachelor's degree
Required Experience: Three (3) years of clinical research coordinator experience
Preferred Education, Experience & Cert/Lic
Preferred Education: Master's degree in a related field
Preferred Experience: Five (5) years of relevant clinical research coordination experience
Additional Technical Requirements
Detail-oriented with knowledge of scientific, medical, and regulatory terms.
Knowledge of international and government guidelines and regulations regarding research including the International Conference on Harmonisation's Good Clinical Practices (ICH / GCP) and the US Food and Drug Administration (FDA).
Knowledge of supporting and assisting with multi-center studies along with the PI and research manager.
Understanding of the drug/device development process.
Computer skills, including MS Office and Adobe Photoshop; ability to learn new software if required.
Excellent oral, written and communication skills as well as the ability to interact professionally with physicians, residents, and hospital staff
Extremely organized, reliable and meet project deadlines in timely manner.
Expertise in handling multi-center study databases
Ability to multi-task and problem solve in fast paced environment is essential.
Ability to function in a team environment under time and resource pressures.
Ability to train and lead clinical research coordinators I and clinical research assistants.
Ability to manage, organize, and make decisions.
Ability to collaborate with stakeholders at all levels
All CHOP employees who work in a patient building or who provide patient care are required to receive an annual influenza vaccine unless they are granted a medical or religious exemption.
Children's Hospital of Philadelphia is committed to providing a safe and healthy environment for its patients, family members, visitors and employees. In an effort to achieve this goal, employment at Children's Hospital of Philadelphia, other than for positions with regularly scheduled hours in New Jersey, is contingent upon an attestation that the job applicant does not use tobacco products.
Children's Hospital of Philadelphia is an equal opportunity employer. We do not discriminate on the basis of race, color, gender, gender identity, sexual orientation, age, religion, national or ethnic origin, disability or protected veteran status.
VEVRAA Federal Contractor/Seeking priority referrals for protected veterans. Please contact our hiring official with any referrals or questions.
Human Resources Manager
3401 Civic Center Blvd.
Philadelphia, PA 19104
CHOP EMPLOYEE? SEARCH FOR JOBS HERE.
Nearest Major Market: Philadelphia
Job Segment: Orthopedic, Clinic, Medical, Medical Research, Healthcare, Research
Children's Hospital Of Philadelphia