Bilingual Site Supervisor (English and Spanish

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.

• Oversees leadership of the Clinical Operations team while ensuring site training/communications are occurring
• Actively participates in the coordination of clinical trials
• Ensures study compliance against protocol, SOPs, regulations and ICH/GCP guidelines
• Acts as a primary liaison with CRO/sponsors; establishes quality guidelines to ensure clinical study vendors are adhering to the agreed upon timelines
• Build and maintain strong relationships with investigators, referring physicians, and community partners
• Ensures timely responses from clinical site staff and all regulatory agencies
• Develop strong, collaborative working relationships with CROs, sponsors, investigators, escalates to Site Director as needed
• With input from the Site Director, allocates studies across teams
• Oversees 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 purview
• Prepares reports, drives site to hit KPIs and provides ongoing updates for leadership team/meetings
• Provides oversight and mentors CRCs on source quality
• Interviews and onboards new hires
• Conducts continuing performance management and annual reviews
• Works with QA to write, resolve and identify all CAPAs
• Ensure adherence to Good Clinical Practice (GCP), FDA regulations, and IRB requirements
• Communicates out of scope activities to ensure billing compliance and communicates all study invoiceables timely
• Ensures staff work is “inspection ready” at all times
• Represent the site at industry meetings and conferences

• Demonstrated relationship building skills through professional communication, interpersonal, analytical and problem-solving skills
• Demonstrated ability to Coordinate complex protocols with overlapping timelines
• Microsoft Office Suite proficiency, technologically skilled in various systems
• Strong study documentation skills in compliance with ALCOA+ preferred
• Close attention to detail and strong organizational skills to deliver high-quality work within project timelines
• Demonstrates strong analytical, problem-solving skill
• Must be results oriented, multi-tasking and a quick learner
• Familiarity with electronic case report form systems such as Medidata Rave, Inform, Trial Kit, etc. preferred
• Demonstrated risk identification and mitigation
• Ability to effectively lead a team
• Ability to prioritize and manage multiple projects simultaneously
• Previous experience training and mentoring others
• Time management skills

• Minimum 4 years of experience in clinical research
• Strong knowledge of relevant regulations ICH/GCP and FDA guidelines
• Effective site management and organizational skills/ability to meet key study milestones
• BS/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 plus
• CCRC certification a plus
• Demonstrated relationship building, with strong verbal and written skills.
• Ability to successfully coordinate protocols with overlapping timelines
• Ability…