Clinical Research Coordinator Sr

Davita Inc.; Philadelphia (Philadelphia County); On-site; USD 75,000 - 95,000; Full time

Job summary

A leading healthcare organization seeks a Clinical Trial Manager to oversee daily clinical trial operations. This role requires strong leadership and data management skills along with extensive experience in clinical research. The position entails ensuring trials comply with Good Clinical Practice, training staff, and managing documentation and regulatory submissions. Join us in improving healthcare delivery in the Philadelphia area!

Benefits

Competitive pay

Health and retirement benefits

Paid time off

Educational benefits

Mental health resources

Qualifications

• 6 years of clinical research experience or 2 years with a Bachelor's degree.
• 1 year of clinical research experience with a Master's degree is acceptable.
• SoCRA certification required.

Responsibilities

• Oversees daily activities of clinical trials ensuring compliance with GCP.
• Trains research staff on trial procedures.
• Prepares materials for IRB and maintains accurate subject logs.

Skills

Attention to Detail

Leadership

Data Management

Education

High School Diploma or equivalent

SoCRA certification

Bachelor's Degree

Master's Degree

Job description

Job Details

Works independently or with minimal 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.

Job Description

Essential Functions:

• 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 expenses, 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.

Education Requirements:

High School Diploma or equivalent and SoCRA certification and 6 years of clinical research experience or Bachelor's degree and 2 years of clinical research experience or Master's Degree and 1 year clinical research experience.

Work Shift

Workday Day (United States of America)

Worker Sub Type

Regular

Primary Location Address

1015 Walnut 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.

Benefits

At Jefferson, we offer a comprehensive total rewards package designed to support the health and well-being of our colleagues and their families. It includes a wide range of benefits including competitive pay, health and retirement benefits, life and disability insurance, paid time off, educational benefits, financial and mental health resources and much more. Our diverse benefits offerings ensure you have the coverage and access to services you need to thrive both personally and professionally.