Assistant: Iii-research

2 weeks ago

Elkins Park, United States Jefferson - Montgomery County, PA Full time

Works independently or with mínimal supervision to oversee the day-to-day activities of a clinical trial in accordance with Good Clinical Research Practice (GCP). Runs portions of clinical trials from startup to closeout, including protocol coordination (screening, recruiting, enrolling, consenting), feasibility planning, data management, biological specimen management, preparation for monitoring visits, and regulatory and/or IRB document preparation. Ensuring all study procedures are conducted according to the protocol and applicable regulations. May also assist with the orientation and training of new staff. Assists in the development of workflows, training documents, SOP/guidance document revision. Participates in work groups.

**Essential Functions**
- Interacts with co-workers, visitors, and other staff consistent with the values of Jefferson.
- Oversees the day-to-day activities of a clinical trial in accordance with Good Clinical Research Practice (GCP).

Trains and supervises research staff on the proper procedures for conducting a clinical trial per GCP.

Prepares and submits all materials for the Institutional Review Board (IRB) and other regulatory bodies as required by the protocol to ensure compliance in a timely fashion.

Performs regular quality control assessments to ensure that clinical trial data is collected and stored per GCP.
- Organizes and maintains documentation of all patient data.
- Designs electronic capture databases, if appropriate, and manage all the data collected.
- May provide clerical and technical support to ensure adherence to research protocols and quality of information received.

**Education**:
Bachelor’s degree in discipline relevant to the topic of research required, master’s degree preferred.
AND
Background in statistics and prior research experience is desirable.
Manager - Please indicate minimum level of education and experience for this job. Please indicate

Covid Vaccination is a requirement for employment at Jefferson for employees working at Jefferson’s clinical entities or at the University. If you are not currently vaccinated you will be required to receive the vaccination prior to hire date if you are offered employment, unless you request and receive an approved medical or religious exemption from Jefferson.

Jefferson includes Thomas Jefferson University and Jefferson Health, a dynamic university and health system with broad reach across the Delaware Valley. Jefferson is the second largest employer in Philadelphia and the largest health system in Philadelphia based on total licensed beds.

Through the merger of Thomas Jefferson University and Philadelphia University in 2017, our University includes ten colleges and four schools. We are an NCAA Division II university and an R2 national doctoral university offering undergraduate and graduate-level programs that provide students with a forward-thinking education in architecture, business, design, engineering, fashion and têxtiles, health, medicine and social science.

Jefferson Health, the clinical arm of Thomas Jefferson University, has grown from a three-hospital academic health center in 2015, to an 18-hospital health system through mergers and combinations that include hospitals at Abington Health, Aria Health, Kennedy Health, Magee Rehabilitation and Einstein Healthcare Network. We have over 50 outpatient and urgent care centers; ten Magnet®-designated hospitals (recognized by the ANCC for nursing excellence); the NCI-designated Sidney Kimmel Cancer Center (one of only 70 in the country and one of only two in the region); and one of the largest faculty-based telehealth networks in the country. In 2021, Jefferson Health became the sole owner of HealthPartners Plan, a not-for-profit health maintenance organization in Southeastern Pennsylvania. We are the first health system regionally to create an aligned payer-provider partnership.

Jefferson’s mission, vision and values create an organization that attracts the best and the brightest students, faculty, staff, and healthcare professionals, as well as the most visionary leaders to drive exceptional results.
- **OUR MISSION**:We improve lives.
- ** OUR VISION**:Reimagining health, education and discovery to create unparalleled value
- ** OUR VALUES**:Put People First, Be Bold & Think Differently and Do the Right Thing

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