Bilingual Site Supervisor (English and Spanish)

About the Role

The Site Supervisor is responsible for ensuring the study team performs assigned responsibilities in compliance with project plans, federal regulations, GCP, and good medical practice. This position collaborates with internal teams and external stakeholders to ensure all studies are adequately resourced and delivered efficiently to timeline, budget, and quality expectations. Reports directly to the Site Director.

Responsibilities

• Oversees leadership of the Clinical Operations team while ensuring site training and communications occur
• 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 CROs/sponsors; establishes quality guidelines to ensure clinical study vendors adhere to agreed-upon timelines
• Builds and maintains strong relationships with investigators, referring physicians, and community partners
• Ensures timely responses from clinical site staff and all regulatory agencies
• Develops strong, collaborative working relationships with CROs, sponsors, and investigators; escalates issues to Site Director as needed
• Allocates studies across teams with input from the Site Director
• Oversees all study Start-Up activities for new studies prior to consenting participants
• Monitors ongoing study progress, data collection, and cleaning activities for all trials under their purview
• Prepares reports, drives site KPIs, and provides ongoing updates for leadership meetings
• Provides oversight and mentors Clinical Research Coordinators (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 Corrective and Preventive Actions (CAPAs)
• Ensures adherence to Good Clinical Practice (GCP), FDA regulations, and IRB requirements
• Communicates out-of-scope activities to ensure billing compliance and timely communication of all study invoiceables
• Ensures staff work is “inspection ready” at all times
• Represents the site at industry meetings and conferences

Requirements

• Minimum 4 years of experience in clinical research
• Strong knowledge of relevant regulations (ICH/GCP and FDA guidelines)
• Effective site management and organizational skills 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 or medical assistant experience in a clinical setting (a plus)
• CCRC certification (a plus)

Skills and Competencies

• Demonstrated relationship-building skills through professional communication, interpersonal, analytical, and problem-solving abilities
• Ability to coordinate complex protocols with overlapping timelines
• Proficiency in Microsoft Office Suite and technologically skilled in various systems
• Strong study documentation skills in compliance with ALCOA+ principles
• Close attention to detail and strong organizational skills to deliver high-quality work within project timelines
• Strong analytical and problem-solving skills
• Results-oriented, multitasking, and quick learner
• Familiarity with electronic case report form systems such as Medidata Rave, Inform, Trial Kit, etc. (preferred)
• Demonstrated risk identification and mitigation abilities
• Ability to effectively lead a team
• Ability to prioritize and manage multiple projects simultaneously
• Previous experience training and mentoring others
• Strong time management skills
• Ability to travel as needed (to support other sites, attend audits, meetings, investigator meetings, conferences, etc.)
• Ability to explain the importance of GCP guidelines and their application
• Ability to train others on coordinating responsibilities and protocol adherence
• Able to clearly explain and enforce clinical research participant safety requirements, including ICF process, role of the IRB, and adverse event reporting
• Strong interpersonal skills with attention to detail
• Proven ethical and professional codes of conduct
• Demonstrated proficiency with word processing, spreadsheet, database, and presentation software (MS Office: Outlook, Word, Excel, PowerPoint, SharePoint) and regulatory filing systems

Physical Requirements

• Ability to sit, stand, walk, reach with hands and arms, and use hands along with fingers to handle or feel
• Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists
• Ability to lift and/or move up to 25 pounds

About JCCT

JCCT has provided exceptional customer service to clients, volunteers, and vendors for the last 20 years. Recognized as one of the best clinical research sites in the United States, JCCT is actively growing through acquisition and organic growth. Our clients come from all over the world to place studies at our research sites. We are committed to supporting, accepting, and respecting individuals in a family-focused environment. Our vision is to make a difference in global health and wellbeing through pharmaceutical research and drug development. Our impact is driven by genuine care, support, and customer service provided to employees, volunteers, and sponsors.