Clinical Research Coordinator Senior (HYBRID) - Einstein

Jefferson Health Plans•Philadelphia, PA

2d•Hybrid

About The Position

Works independently or with minimal supervision to oversee the day-to-day activities of a clinical trial in accordance with Good Clinical 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. Maintains accurate subject log, tracks expense, submits appropriate documentation to Grant Administrator on a monthly basis for payment due for visits on all studies. 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.

Requirements

Minimum High School Diploma or equivalent.
SoCRA certification preferred.
6 years of clinical research experience (with High School Diploma or equivalent).
2 years of clinical research experience (with bachelor’s degree).
1-year clinical research experience (with master’s degree).

Nice To Haves

SoCRA certification

Responsibilities

Oversees the day-to-day activities of a clinical trial in accordance with Good Clinical 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.
Maintains accurate subject log, tracks expense, submits appropriate documentation to Grant Administrator on a monthly basis for payment due for visits on all studies.
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.
Assists in the development of workflows, training documents, SOP/guidance document revision.
Participates in work groups.

Benefits

medical (including prescription)
supplemental insurance
dental
vision
life and AD&D insurance
short- and long-term disability
flexible spending accounts
retirement plans
tuition assistance
voluntary benefits
tuition discounts at Thomas Jefferson University after one year of full time service or two years of part time service.