Clinical Research Coordinator

2 days ago

Philadelphia, United States Thomas Jefferson University & Jefferson Health Full time

Job Details

Job Description

The Clinical Research Coordinator works with remote and limited supervision, assists with running Investigator initiated research studies including the recruiting and entollment and retention of research participants. The CRC is expected to have knowledge of Good Clinical Practice guideline and complies with the Code of Federal Regulations. In addition to interacting with study participants will assist with completion of regulatory documentation and reporting to and tracks TJU IRB submission and approvals. May assist in the enrollment of human subjects. May provide clerical and technical support to ensure adherence to research protocols and quality of information received. The CRC will assist with contacting and scheduling study patients, data collection and database management, and assisting with study related materials including regulatory documents and study binders. The candidate will work with research leadership and investigators to facilate all aspects of human subjects particiation for study visits. Duties will include subject management, documentation in study databases, administering surveys and assessments and tracking participants in the clinical trial management system (Oncore). Additional assists with maintaining data and imaging analysis and extracting the relevant outcome measures from those images.The CRC will work with the Investigators and the project manager on a regular basis to discuss progress of the project and provide updates on the progress of the project in terms of subject recruitment, data collection and analysis. Knowledge regarding appropriate study conduct with experience in with patient populations in a setting that uses radiological imaging is recommended. Knowledge and experience with adult human subjects experience and knowledge of the duties and regulations to ensure compliance are required. Prior experience with direct patient contact, good oral and writen communication skills, ability to work with multiple constituencies and the ability to perform duties with initiative and high standard for quality and integrity are required, knowledge of REDCAP, Oncore, EPIC, iRIS, Excel systems, ClinCard; Certification with SOCRA or ACRP are preferred.Minimum of 2 years of prior experience in human subjects research is required. ESSENTIAL FUNCTIONS: Functioning as an effective member of a research team, performs a variety of research duties in support of research objectives.Assist with regulatory, operational, clinical and technical aspects of the research.Assist investigators and designated staff in organizing, gathering and compiling clinical research data, , biospecimen collection and processing.Assist in the recruiting enrollment, retention and tracking of human subjects for a variety of different research projects. Conduct prescreening and assist in conducting informed consent in face-to-face and virtual consent.Organizes and maintains documentation required for clinical research studies.Informs the Investigator and/or designated individual on any issues concerning study participation ro response to treatment/medication/ any adverse effects. Assists in data base, documentiaton and data collection duties.Assists with regulatory body filings including IRB submissions,amendments, continuing reviews, Annual Reports to the IRB and/or FDA safety and safety and adverse event reporting.May provide and technical and instructional support to study participants to ensure adherence to research protocols and quality of information received. Interacts with co-workers, visitors, and other staff consistent with the iSCORE values of Jefferson. EDUCATIONAL/TRAINING REQUIREMENTS:Bachelors degree, CITI TrainingCERTIFICATES, LICENSES, AND REGISTRATION:CCRP or CCRA preferredEXPERIENCE REQUIREMENTS:Experience in research or clinical settings with direct patient contact

Work Shift

Rotating (United States of America)

Worker Sub Type

Regular

Primary Location Address

130 S 9th Street, Philadelphia, Pennsylvania, United States of America

Nationally ranked, Jefferson, which is principally located in the greater Philadelphia region, Lehigh Valley and Northeastern Pennsylvania and southern New Jersey, is reimagining health care and higher education to create unparalleled value. Jefferson is more than 65,000 people strong, dedicated to providing the highest-quality, compassionate clinical care for patients; making our communities healthier and stronger; preparing tomorrow's professional leaders for 21st-century careers; and creating new knowledge through basic/programmatic, clinical and applied research. Thomas Jefferson University, home of Sidney Kimmel Medical College, Jefferson College of Nursing, and the Kanbar College of Design, Engineering and Commerce, dates back to 1824 and today comprises 10 colleges and three schools offering 200+ undergraduate and graduate programs to more than 8,300 students. Jefferson Health, nationally ranked as one of the top 15 not-for-profit health care systems in the country and the largest provider in the Philadelphia and Lehigh Valley areas, serves patients through millions of encounters each year at 32 hospitals campuses and more than 700 outpatient and urgent care locations throughout the region. Jefferson Health Plans is a not-for-profit managed health care organization providing a broad range of health coverage options in Pennsylvania and New Jersey for more than 35 years.

Jefferson is committed to providing equal educational and employment opportunities for all persons without regard to age, race, color, religion, creed, sexual orientation, gender, gender identity, marital status, pregnancy, national origin, ancestry, citizenship, military status, veteran status, handicap or disability or any other protected group or status.

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