The Clinical Trial Research Coordinator I (CTRC-I) is a novice level position which, under the clinical direction of the Principal Investigator (PI), assists in the operational & administrative research support of the Kaiser Permanente Northern California (KPNC) PI & KPNC Clinical Trials Operations Director or designee, & other research staff conducting multiple FDA-regulated clinical trials. This is a non-licensed position which works under the daily supervision of an experienced Clinical Trial Nurse, Clinical Trial Research Coordinator, and/or KFRI-designated, licensed clinical trial research staff member. This position must adhere to the position''s scope of practice as outlined in the Major Responsibilities below. This position is also responsible for assisting in protecting the health, safety, & welfare of research participants. Essential Functions: - Compliance Support & comply with the Principles of Responsibility (Kaiser Permanente Code of Conduct). With guidance from PI, assist with ensuring compliance with KPNC IRB Standard Operating Procedures (SOP) & document applications. Adhere to Guideline for Good Clinical Practice (GCP), federal, state, & local regulations, & KP policies & procedures. With supervision, assist with preparation for inspections, audits & monitoring visits. - Study Implementation Maintain the security & confidentiality of participants'' paper or electronic data (e.g., case report forms kept in a secure, locked space). Assist with scheduling participants for study assessments/visits, required tests including visit-specific laboratory kits and/or paperwork preparation. Prepare packets for participants (e.g., instructions, phone numbers, calendars, diaries, etc.). Assist with obtaining medical records & test results for all projects/participants. With supervision & certification, perform packaging & shipping of protocol specimens to the Sponsor lab in accordance with IATA/DOT regulations & Sponsor shipping guidelines. Direct issues requiring medical decision-making to the appropriate licensed staff member promptly. Provide PI and/or Clinical Trial Nurse with the ongoing informed consent process by coordinating the current consent documents. According to protocol and/or IRB-approved telephone script, collect & document research data in a timely manner, & report the information to the appropriate licensed staff member & PI for assessment. Assist in the collection of protocol-required data with timely & accurate submissions as required by Sponsor (e.g., weekly screening log, routine electronic data submissions). Under specific direction, assist with data entry of study activity onto a case report form (paper or electronic), & maintain a database program to track all study activity (i.e., study enrollment & consents). Assist in maintaining research charts & site regulatory files. Assist in ensuring that study related, non-test article supplies are shipped & re-supplied according to protocol, including tracking expiration dates. Assist in obtaining protocol specific regulatory documents including MDs/RNs licenses & CVs. Report any potential protocol violations/deviations to the PI in a timely manner. Support the regulatory team in the maintenance & storage of critical documents required to be maintained & provided to the Sponsor during the conduct of the trial. With supervision, assist in study closure activities including preparation & collection of close-out documentation, & preparation of study files for distribution to longterm storage. - This job description is not all encompassing. Secondary Functions: Primary responsibilities are to provide data management in a timely manner for patients on cancer trials including facilitating patient entry into programs and managing and collecting data for submission to research centers. Will manage all screening, active treatment and follow up data form submissions, xrays, and pathology specimens for all protocols patients. Will assist in the oncologists’ in ordering/scheduling specific protocol tests/appointments as directed by physician or research nurse. Will require travel by own reliable transportation to different centers and interactions with pharmacists, oncologists’ surgeons, oncology nurses and patients to assist in patient enrollment and adherence to all research requirements. Maintain IRB regulatory material at the local site level. Coordinate adverse event/serious adverse event submissions to the IRB and sponsors. Prepare and assist in any required audits. Assist the Director and Manager of the Program in other assigned projects as required by the KP Clinical Trials Program. Required to attend all program meetings and national (out of state) conferences (when possible). This job is in adult, radiation and medical oncology. Home base in Sacramento, CA. Must be willing and able to travel within the Northern California region with own dependable transportation. Willing to abide by Good Clinical Practice Guidelines and all FDA regulations. CPR-certified required. Qualifications: Basic Qualifications: Experience - N/A. Education - Associate''s degree or higherOR two (2) years of work experience in an ambulatory and/or acute health care setting required (LVN may be substituted for an AA degree). - High School Diploma or General Education Development (GED) required. License, Certification, Registration - Current BLS certification required. - Willingness to obtain IATA/DOT certification. Additional Requirements: - Must be proficient in electronic health systems and databases used in research environment and word-processing or willingness to learn within three (3) months of hire. - Satisfies requirements for career advancement/maintenance as defined by the Clinical Trial Career Ladder Program. - Demonstrate organizational and communication skills. - Demonstrate written, verbal, and interpersonal communication skills. - Demonstrate proficiency in medical terminology. - Demonstrate attention to detail and accuracy. - Ability to manage multiple tasks. - Demonstrate good prioritization and organizational skills. - Ability to be flexible and dependable. - Ability to work effectively on cross-functional teams. - Present professional manner and appearance. - Demonstrated skill in administrative tasks (i.e., filing, photocopying, faxing, etc.). - Knowledge of GCP, federal, state, and local regulations including HIPAA and KP policies and procedures. - Must be able to work in a Labor Partnership environment. Preferred Qualifications: - Clinical trials experience preferred. - CPR certification, ONC a plus. - Preferred one plus years experience in cancer research and or adult oncology. - Knowledge of medical terminology; especially cancer related information. - Ability to abstract data from medical charts and computer for research records. - Computer literacy strongly recommended. - Excellent communication skills both written and verbal needed and experience working with cancer patients, families and medical personnel. - Accurate, detail oriented; handles multiple tasks. - Dependable, reliable; organized; flexible; team player, quick learner a must. - Ability to problem solve appropriately, ability to work under stringent time deadlines; ability to work independently in promotion of cancer research at other medical centers. - Prefer experience with Excel, Microsoft word, & internet use. ++This job is in adult, radiation and medical oncology. Home base will be Sacramento. Must be willing and able to travel within the Northern California region with own dependable transportation (travel is only for training and once a month meetings). Willing to abide by Good Clinical Practice Guidelines and all FDA regulations.++
*REQNUMBER:* 233030
*JOBCOMPANY:* Kaiser Permanente
*JOBLOCATION:* Sacramento, CA