Description
NextGen Research Group is seeking a bilingual (English/Spanish), highly organized, proactive, and experienced Clinical Research Operations Manager to oversee the daily operations of our growing clinical research site. This leadership role is responsible for ensuring the efficient management of office operations, supporting business development and study startup activities, maintaining regulatory compliance, and providing clinical research coordination support when needed. The ideal candidate is an experienced clinical researcher who enjoys building relationships with sponsors and CROs and can balance operational oversight with hands-on study coordination.
Responsibilities include, but are not limited to:
Research Operations
- Oversee the day-to-day administrative and operational functions of the clinical research site.
- Develop and maintain efficient workflows to support research operations.
- Ensure compliance with FDA, GCP, HIPAA, IRB, and sponsor requirements.
- Assist with the implementation and maintenance of Standard Operating Procedures (SOPs).
- Monitor site performance and identify opportunities for operational improvements.
- Coordinate office resources, vendors, supplies, and equipment to support research activities.
Study Startup & Business Development
- Complete feasibility questionnaires and sponsor surveys.
- Assist with study feasibility assessments and site selection activities.
- Prepare and submit study applications to sponsors and CROs.
- Support study startup activities, including regulatory document collection and essential document preparation.
- Assist with site qualification, initiation, and monitoring visits.
- Maintain positive relationships with sponsors, CROs, investigators, and research partners.
- Attend local and national clinical research conferences, investigator meetings, and industry events to represent NextGen Research Group and cultivate relationships with sponsors, CROs, and research partners.
Clinical Research Coordination
- Coordinate assigned clinical research studies as needed.
- Screen, recruit, consent, enroll, and retain study participants.
- Schedule participant visits and ensure protocol-required procedures are completed.
- Maintain accurate source documentation, electronic case report forms (eCRFs), and regulatory files.
- Ensure protocol compliance and timely resolution of data queries.
- Conduct participant follow-up and maintain excellent participant engagement.
- Serve as a liaison between investigators, sponsors, CROs, and study participants.
Leadership & Administrative Support
- Assist with training and mentoring research staff.
- Support investigators and leadership with operational planning and project management.
- Track study milestones, enrollment goals, and startup timelines.
- Participate in quality assurance activities and prepare for sponsor audits and regulatory inspections.
- Maintain confidentiality of participant and study information.
Perform other duties as assigned.
Requirements
Qualifications
- Bilingual (English/Spanish) required.
- Bachelor's degree preferred; equivalent clinical research experience will be considered.
- Minimum of 2 years of clinical research experience, including experience coordinating clinical trials.
- Experience with study startup activities, regulatory submissions, and sponsor/CRO communications preferred.
- Thorough understanding of ICH-GCP, FDA regulations, HIPAA, and IRB requirements.
- Experience maintaining regulatory documentation and study essential documents.
- Strong organizational, project management, and problem-solving skills.
- Excellent written and verbal communication skills.
- Strong interpersonal skills with the ability to build relationships with sponsors, CROs, investigators, and participants.
- Ability to manage multiple projects and priorities simultaneously while meeting deadlines.
- Proficiency with Microsoft Office Suite and clinical research software (CTMS, eSource, eRegulatory, EDC systems preferred).
- Ability to travel occasionally for industry conferences and sponsor meetings (~10%).
- Must be able to pass a drug test and background screening. You may visit the Florida
Care Provider Background Screening Clearinghouse for more information.
We are a Drug-Free Workplace and are committed to providing equal employment opportunities to all applicants and employees without regard to age, disability, race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, national origin, veteran or military status, genetic information, or any other protected status under applicable federal, state, or local law.
Skills Required
- Minimum of 2 years of clinical research experience, including coordinating clinical trials.
- Bachelor's degree (preferred; equivalent clinical research experience considered).
- Experience with study startup activities, regulatory submissions, and sponsor/CRO communications.
- Thorough understanding of ICH-GCP, FDA regulations, HIPAA, and IRB requirements.
- Experience maintaining regulatory documentation and study essential documents.
- Proficiency with Microsoft Office Suite.
- Proficiency with clinical research software (CTMS, eSource, eRegulatory, EDC systems).
- Strong organizational, project management, and problem-solving skills.
- Excellent written and verbal communication skills.
- Strong interpersonal skills and ability to build relationships with sponsors, CROs, investigators, and participants.
- Ability to manage multiple projects and priorities and meet deadlines.
- Ability to travel occasionally (~10%).
- Bilingual English/Spanish.
- Ability to pass a drug test and background screening.
What We Do
La Colonia Medical Center is a South Florida health system serving primarily Medicare beneficiaries with more than 20 medical specialties. It provides integrated services including primary care, dental, diagnostics, an in‑house pharmacy with automation and home delivery, and complimentary transportation. The organization focuses on accessible, comprehensive senior care across multiple clinics and medical centers.
