Overview

Bilingual Site Supervisor (English and Spanish)Position Summary:The Site Supervisor is responsible for assuring the study team is accountable for performing assigned responsibilities in compliance with project plans, federal regulations, GCP and good medical practice. This position collaborates and participates with internal teams and external stakeholders to ensure all studies are adequately and appropriately resourced and delivered efficiently to timeline, budget and quality expectations. This position reports directly to the Site Director.Key Responsibilities:Oversees leadership of the Clinical Operations team while ensuring site training/communications are occurringActively participates in the coordination of clinical trialsEnsures study compliance against protocol, SOPs, regulations and ICH/GCP guidelinesActs as a primary liaison with CRO/sponsors; establishes quality guidelines to ensure clinical study vendors are adhering to the agreed upon timelinesBuild and maintain strong relationships with investigators, referring physicians, and community partnersEnsures timely responses from clinical site staff and all regulatory agenciesDevelop strong, collaborative working relationships with CROs, sponsors, investigators, escalates to Site Director as neededWith input from the Site Director, allocates studies across teamsOversees that all study Start-Up activities are in place for any new study prior to consenting participants. Oversees ongoing study progress, data collection, and cleaning activities for all study trials under their purviewPrepares reports, drives site to hit KPIs and provides ongoing updates for leadership team/meetingsProvides oversight and mentors CRCs on source qualityInterviews and onboards new hiresConducts continuing performance management and annual reviewsWorks with QA to write, resolve and identify all CAPAsEnsure adherence to Good Clinical Practice (GCP), FDA regulations, and IRB requirementsCommunicates out of scope activities to ensure billing compliance and communicates all study invoiceables timelyEnsures staff work is "inspection ready" at all timesRepresent the site at industry meetings and conferencesSkills and Competencies:Demonstrated relationship building skills through professional communication, interpersonal, analytical and problem-solving skillsDemonstrated ability to Coordinate complex protocols with overlapping timelinesMicrosoft Office Suite proficiency, technologically skilled in various systemsStrong study documentation skills in compliance with ALCOA+ preferredClose attention to detail and strong organizational skills to deliver high-quality work within project timelinesDemonstrates strong analytical, problem-solving skillMust be results oriented, multi-tasking and a quick learnerFamiliarity with electronic case report form systems such as Medidata Rave, Inform, Trial Kit, etc. preferredDemonstrated risk identification and mitigationAbility to effectively lead a teamAbility to prioritize and manage multiple projects simultaneouslyPrevious experience training and mentoring othersTime management skills Education and Experience:Minimum 4 years of experience in clinical researchStrong knowledge of relevant regulations ICH/GCP and FDA guidelinesEffective site management and organizational skills/ability to meet key study milestonesBS/BA in Life Science or related discipline or equivalent work experience Basic understanding of regulations governing clinical research (CFR, GCP, HIPAA)Previous nursing, medical assistant experience in a clinical setting a plusCCRC certification a plusDemonstrated relationship building, with strong verbal and written skills.Ability to successfully coordinate protocols with overlapping timelinesAbility to travel as needed: to support other sites, attend audits, attend meetings (Investigator Meetings, conferences, etc.)Ability to explain importance of GCP guidelines and their applicationAbility to train others on coordinating responsibilities and protocol adhe