Clinical Research Coordinator II

Job Title:Clinical Research Coordinator II Reports to:Research Regulatory/QC Manager Location: Sherman Oaks and Travel within Greater Los Angeles, CA Job Summary The Clinical Research Coordinator II is a critical, high-autonomy role that makes clinical research accessible to our patient population while providing administrative support to the clinic. Working on behalf of the Principal Investigator (PI), this individual independently manages the full study lifecycle—from feasibility and start-up, through patient recruitment, eligibility assessment, and follow-up, to the preparation and gathering of all data and documents for this highly regulated process. This role is best suited to a coordinator who has run trials with significant independence at a smaller or independent site, is comfortable owning multiple functions at once, and can train and mentor less experienced coordinators as our research program grows. Major Duties & Responsibilities Research Works with PI to meet or exceed study enrollment as per Sponsor’s inclusion/exclusion criteriaComplete feasibility questionnaires based on site information and all regulatory start up packagesRecruits and enrolls patents in a friendly and professional manner, screening for eligibility criteriaConducts patient visit, collects all required data in appropriate formats, and follows up with all subjects as appropriateReports, tracks and follows up on an all adverse events, protocol waivers, deviations and violationsComplies with all study protocol, SOP and reporting requirements in a timely mannerResponsible for completion of all required documentation with keen focus on the integrity of the data submitted by careful source document review, monitoring for missing data and/or inconsistencies. Maintains thorough and accurate records per regulatory/compliance standards at all times including but not limited to data for potential inspection; signed informed consents, source documentation, drug dispensing logs, subject logs, and all study related communicationCreates study specific tools for source documentation when not provided by sponsorCollects, completes and enters data into study specific forms and/or electronic data capture systemAppropriately handles and records all specimens; prepares specimens for shipment; tracks all shipments; tracks all inventory and calibrations. Attends relevant meetings (e.g. SIVs, PSSVs, IMVs, COVs, audits); assists Sponsor and FDA with any audits and responds to any monitoring/audit findingsActively communicate with stakeholders as appropriate (Sponsor, IRB, vendors) and maintain active communication on status of each study with PI and management as directedTrains, mentors, and provides day-to-day guidance to less experienced coordinators and clinic staff on research processes, GCP, and site systems; serves as a point of escalation for research-related questionsIndependently owns day-to-day research operations for the site with minimal oversight, exercising sound judgment to prioritize competing study demands Other Works in clinic to operate clinic cleanly, safely and efficientlyPrepares exam and treatment rooms per cleaning protocols; assists with all processes (within scope of certification) to maintain inventory of supplies, medication, and equipment necessary for the operation of the clinic. Keys data into EMR/forms to maintain accurate office and patient recordsOrganizes tasks to facilitate smooth work/patient flowSchedules and registers patients; referrals to specialists as appropriateHandles routine administrative tasks (filing, correspondence, mail) as needed to support clinic operationsAdheres to all company policies and procedures, business conduct and work compliance standardsWill be required to travel and work at multiple clinics within a reasonable driving distance from home clinicAny other task reasonably requested by company to meet its goals Job Related Skills/Competencies Effective use of computerized patient care systemKnowledge of medical terminologyKnowledge of all safety requirements when handling biohazardous specimens or contaminated instrumentsStrong interpersonal skills to interact with patients, families, ancillary departments, physicians and co-workers in a courteous and compassionate mannerStrong, courteous and professional verbal skills to effectively convey sensitive information in a courteous manner in person or on the telephone; effective written communication and computer skills for proper chartingAbility to work well under pressure and be quick on your feetHas a contagious and positive work ethic; models our core valuesAn effective team player who contributes valuable ideas and feedback and can be counted on to meet commitmentsProficient use of EMR and CTMS systems and ability to effectively use our systems within 2 weeksDemonstrated ability to train, mentor, and provide constructive feedback to less experienced coordinatorsAbility to independently manage multiple studies and competing priorities with sound judgment and minimal supervision, consistent with experience at a smaller or independent siteProficient use of Microsoft (e.g. Office, Excel, Word) Education/Qualifications High school diploma required; Bachelor's degree in a health science or related field preferredMinimum of 2-3 years of clinical research coordinator experience at an investigational site required, with solid knowledge of clinical trials terminology, processes, forms and reportingExperience at a smaller or independent site network, with broad ownership across regulatory, recruitment, data, and monitoring-visit functions, strongly preferredPrior experience training, onboarding, or mentoring other coordinators preferredCertification (e.g. CCRC via ACRP or CCRP via SOCRA) a plusPhlebotomy certificate preferredCurrent Medi-Waste Training for: Bloodborne Pathogens for Healthcare, GHS Hazcom, HIPAA, HITECH & OmnibusComputer skills Physical Requirements/Working Conditions Must maintain a clean, healthful and professional appearance at all times and adhere to our uniform guidelinesCenter Based: Requires working in a clinical setting. The noise level is moderate and there is a potential for exposure to infectious diseases and blood-borne pathogens as well as erratic/unpredictable patient behaviorThe ability to stand and sit for 5 hours at a time, (with some bending and stooping); ability to use manual dexterity in relation to clinical requirements; use hands to finger, key, handle, reach; some bending, kneeling and stooping; ability to bend; and ability to lift and carry up to 50 lbs. Ability to be punctual and maintain satisfactory attendance recordAbility to work flexible hours, including nights and weekends. Ability to work overtime should business need arise. This job requires access to confidential and sensitive information, requiring ongoing discretion and secure information managementSpecific vision abilities required by this job include Close vision, Distance vision, Peripheral vision, Depth perception and ability to adjust and focusMust be able to hear and speak effectively in English (bi-lingual in Spanish a plus)