Clinical Research Coordinator II

Thomas-Jefferson-University-; Philadelphia (Philadelphia County); On-site; USD 45,000 - 65,000; Full time

Benefits offered by this job

Medical Insurance

Tuition assistance

Retirement plans

Job summary

Thomas Jefferson University in Philadelphia, PA, seeks a Clinical Research Support role to oversee daily trial activities under GCP, manage data, and assist investigators in collecting and organizing clinical research data.

Responsibilities include regulatory filings, patient consent support, study visits, and potential enrollment assistance, with a focus on accurate documentation and compliant procedures.

Qualifications

• High School Diploma/GED or equivalent.
• 4 years of relevant experience.
• Knowledge of technology tools to organize, store and manage database systems.
• Knowledge of legislation and regulatory bodies affecting healthcare practices.
• Ability to manage multiple concurrent objectives, projects, groups, or activities.

Responsibilities

• Interacts with co-workers, visitors, and other staff consistent with Jefferson values.
• Performs research activities for clinical trials including database management and biospecimen processing.
• Organizes and maintains documentation required for clinical trial(s).
• Informs Principal Investigator and/or designated individual on any issues concerning patients. response to treatment/adverse effects.
• Assists Principal Investigator with regulatory filings including IRB submissions.
• May assist in the enrollment of human subjects.

Skills

GCP knowledge

Database management

Regulatory knowledge (IRB)

Data collection/processing

Clerical duties

Education

High School Diploma/GED or equivalent

Tools

Database software

Job description

Number of Positions In Requisition1Job DetailsWorks under limited supervision and oversees the day-to-day activities of a clinical trial in accordance with Good Clinical Research Practice (GCP). Performs a variety of research activities in support of clinical trials (including database management, biological specimen processing, and clerical duties) to assist investigators in organizing, gathering and compiling clinical research data. Recruits, assists with consenting subjects, and conducts study visits.Job DescriptionSummaryWorks under limited supervision and oversees the day-to-day activities of a clinical trial in accordance with Good Clinical Research Practice (GCP). Performs a variety of research activities in support of clinical trials (including database management, biological specimen processing, and clerical duties) to assist investigators in organizing, gathering and compiling clinical research data. Recruits, assists with consenting subjects, and conducts study visits.Job DutiesInteracts with co-workers, visitors, and other staff consistent with the values of Jefferson.Performs a variety of research, data base, biospecimen collection and processing, as well as clerical duties in support of clinical trials to assist investigators in organizing, gathering and compiling clinical research data.Organizes and maintains documentation required for clinical trial(s).Informs Principal Investigator and/or designated individual on any issues concerning patients response to treatment/medication/ any adverse effects overall to patients.Assists Principal Investigator with regulatory body filings including IRB submissions.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.Minimum QualificationsHigh School Diploma/GED or equivalent.4 years of relevant experience.Knowledge of and the ability to utilize technology tools to organize, store and manage database systems.Knowledge of and ability to utilize tools, techniques and processes for gathering and reporting data in a particular department or division of a company.Knowledge and understanding of legislation and regulatory bodies affecting healthcare practicesKnowledge of principles and practices associated with the rights and responsibilities of patients and caregivers.Ability to manage multiple concurrent objectives, projects, groups, or activities, making effective judgments as to prioritizing and time allocation.Physical DemandsLift and carry 40-50 lbs. Examples: Push/pull patients on bed, stretcher (requires 29 lbs. push force), lateral transfers up to 50 lbs. of the patient's weight. Frequent to continuous standing/walking. Patient transporters can walk 8-10 miles per shift. *Patient care providers may be required to perform activities specific to their role including kneeling, bending, squatting and performing CPR.Job Description Disclaimer: This position description provides the major duties/responsibilities, requirements and working conditions for the position. It is intended to be an accurate reflection of the current position, however management reserves the right to revise or change as necessary to meet organizational needs. Other responsibilities may be assigned when circumstances require.Work ShiftWorkday Day (United States of America)Worker Sub TypeRegularEmployee EntityThomas Jefferson UniversityPrimary Location Address800-803 Walnut Street, Philadelphia, Pennsylvania, United States of AmericaNationally 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.BenefitsJefferson offers a comprehensive package of benefits for full-time and part-time colleagues, including medical (including prescription), supplemental insurance, dental, vision, life and AD&D insurance, short- and long-term disability, flexible spending accounts, retirement plans, tuition assistance, as well as voluntary benefits, which provide colleagues with access to group rates on insurance and discounts. Colleagues have access to tuition discounts at Thomas Jefferson University after one year of full time service or two years of part time service. All colleagues, including those who work less than part-time (including per diem colleagues, adjunct faculty, and Jeff Temps ), have access to medical (including prescription) insurance.