Clinical Trials Coordinator (Sidney Kimmel Cancer Center)

The Sidney Kimmel Comprehensive Cancer Center (SKCCC) Clinical Trials Office (CTO) is seeking a Clinical Trials Coordinator dedicated to supporting all Applicable Clinical Trials (ACTs) requiring registration and results reporting on ClinicalTrials.gov. The position reports to a Regulatory Program Manager within Research Support Services and will work to execute the necessary steps to remedy any registration or reporting issues.

The Clinical Trials Coordinator is responsible for the accurate registration of ACTs in ClinicalTrials.gov and submission of results at the time of anticipated completion date. The Clinical Trials Coordinator will work with their manager to prioritize tasks and track their work. In addition, they will be expected to give input on the development of guidance documents and workflows essential to successful execution of the responsibilities for the role.

• Serves as the primary contact for ClinicalTrials.gov for ACTs within the SKCCC scope of trial management

• Maintains a tracker to document the tasks assigned by the manager

• Communicates with the Principal Investigators, Clinical Operations Project Managers, Data Managers, and Statistician to ensure trial registration is accurate.

• Collaborates with the study team to ensure all results data is provided for data entry.

• Aggregates all data needed to satisfy results reporting including but not limited to demographic data, AE and SAE data, and outcome measure data analysis, and enters this data into the system.

The ideal candidate will have a Bachelorrsquo;s degree or higher in a scientific or healthcare-related field and at least 1 year of experience working in the clinical research field.

Additional qualifications include:

• Strong written and oral communication skills, attention to detail, customer service orientation and proven ability to perform work accurately and efficiently.

• Experience working with grant funded and Investigator Initiated clinical trials is preferred

• Knowledge of Good Clinical Practices, FDA Rules and Regulations in relation to clinical trials, NIH guidelines, ICH guidelines and HIPAA regulations in relation to clinical trials.

• Familiarity with terminology and processes associated with the conduct of clinical research.

• Experience with clinical trial management systems, preferably ClinicalTrials.gov

• Demonstrated ability to work independently and with a team.

• Demonstrated proficiency with Microsoft Office, including Outlook, Word, and Excel

About Jefferson

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#39;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 educashy;tional 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.