| Department: MED-Cancer Center
Salary/Grade: NEX/11 Job Summary: Coordinates collection, analysis, processing & reporting of data & assists Principal Investigator (PI) in judging the validity of test data obtained in regard to biomedical &/or social-behavioral research study(ies) of limited complexity involving co-investigators, multiple campuses &/or universities. Completes all activities by strictly following Good Clinical Practices (GCP) & all relevant current local, state, & federal laws, regulations, guidance, policy & procedure developed by the NU Institutional Review Board (IRB), Food & Drug Administration (FDA) Code of Federal Regulations (CFR), & the International Conference on Harmonization (ICH). The Research Study Coordinator works within the Clinical Trials Laboratory of the Pathology Core Facility. They support open clinical trials on the Northwestern campus by providing the correct collection kits to areas of patient care when patients are enrolled on a clinical trial. The specimens are then retrieved and basic processing is performed in the lab. Samples are stored and/or shipped out to central laboratories as per protocol. Specific Responsibilities: Technical - Administers tests &/or questionnaires following protocols.
- Collects, compiles, tabulates & processes responses.
- Gathers information.
- Extracts & analyzes data from medical charts. – Triages requisitions assembles and distributes clinical trials collection kits; understands clinical trial lab manuals, ensures collection kit is complete and correct and for the associated time, makes rounds dropping off and retrieving collection kits after the patient has been drawn, returns to the lab with specimens.
- Processes blood and bone marrow specimen in accordance with study protocols
- Obtains fresh tissue biopsy specimens from clinicians in accordance with study protocols. Processes clinical trial specimens according to the specific lab manual instructions, ensuring the timing and temperature is as directed in the protocol, aliquots specimens for ambient, refrigerated, and frozen samples, stores and or ships samples to central laboratories as directed by the lab manual. Attends site initiation visits, meetings, hosts monitors, provides information necessary for auditing purposes.
- May review new protocols for scientific merit and feasibility.
Administration - Collects, records, reviews & summarizes research data.
- Collates relevant mathematical results & prepares tables, charts & graphs reflecting relationships of multiple tests.
- Completes documents associated with current local, state, & federal regulatory guidelines, requirements, laws & research protocols.
- Maintains inventory of study kits and lab manuals for assigned pharmaceutical studies.
Miscellaneous - Performs other duties as assigned.
Minimum Qualifications: - Successful completion of a full 4-year course of study in an accredited college or university leading to a bachelor's or higher degree in a major such as social or health science or related; OR appropriate combination of education and experience and 2 years' research study or other relevant experience required; OR
- Successful completion of a full course of study in an accredited college or university leading to a master's or higher degree in a major such as social or health science or related; OR appropriate combination of education and experience.
- Must complete Northwestern's IRB CITI training before interacting with any participants & must re-certify every 3 years.
Minimum Competencies: (Skills, knowledge, and abilities.) - Communication-Oral and Written: Communicates effectively one-to, in small groups and in public speaking contexts; writes precise, well-organized emails, letters and proposals while using appropriate vocabulary and grammar.
Preferred Qualifications: - 4 years practical research study or related experience.
Northwestern University is an Equal Opportunity, Affirmative Action Employer of all protected classes, including veterans and individuals with disabilities. Women, racial and ethnic minorities, individuals with disabilities, and veterans are encouraged to apply. Hiring is contingent upon eligibility to work in the United States.
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