Clinical Research Coordinator - Division of Orthopedic Surgery - Children’s Surgical Associates - Children’s Hospital of Philadelphia

LOCATION: Philadelphia, PA

CLOSING DATE: May 29, 2021

OPPORTUNITY TYPE: Job

JOB #: 17289

POSTED: April 29, 2021

Description:

Job Responsibilities (Continued)

 

  • Prepare study documents required by the IRB, ensure adherence to protocol requirements, track and manage IRB protocols submission, renewal as well as study completion for multiple research projects. 
  • Perform subject recruitment, consents and enrollments, collecting data and abstracting medical record as requested by the Principal Investigator(s) [PIs].
  • Assist with making presentation slides and posters, performing searches in literature and patient databases, shooting photographs of patients in a clinical and operative setting. 
  • Support manuscript and grant preparation tasks such as drafting, referencing, formatting tables and charts, basic medical illustrating, and preparing submissions for publication.
  • Ability to monitor and maintain data for study group databases/registries including data entry, data audits, and abstract data. 
  • Create or edit standard operating procedures, data collections forms, and informed consent forms.
  • Coordinate day-to-day activities of research projects, including maintaining meeting agendas and the delegation of research activities.
  • Manage study instruments and databases (SurveyMonkey, Qualtrics, REDCap).
  • Identify and implement improvements in collection, processing, and analysis of data.
  • Assist in preparation of project deliverables including progress reports, final reports, manuscript preparation and submission, creation of datasets and execution of basic statistical analyses.
  • Work with study team, research coordinators, research manager and others across the organization on relevant research studies.
  • Assists with collaboration and administrative coordination between investigators and ancillary departments, sponsoring organizations, and/or regulating bodies.
  • Participate in other related duties
Skills/Eligibility:

Required Experience:

  • One (1) year of clinical research coordinator experience
  • Three (3) years of coordination related, clinical related or research related experience.

Preferred Education, Experience & Cert/Lic

Preferred Education: Bachelor’s degree in related field

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

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