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