Certified Clinical Research Coordinator I (CCRC/CCRP)

Certified Clinical Research Coordinator (CCRC/CCRP)

Position Type: Full-Time
Location: Houston, Texas | On-Site
Department: Clinical Research
Reports To: Director of Research

Position Overview

CrofootMD Clinic and Research Center is seeking an experienced, nationally certified Clinical Research Coordinator to join our growing research team.

Our clinical research program focuses primarily on HIV, infectious diseases, investigational treatments, and vaccines. We conduct multiple clinical trials simultaneously and are seeking a highly qualified professional who can independently coordinate assigned studies, manage participant visits, and maintain compliance with study protocols, sponsor requirements, and applicable regulatory standards.

This position is intended for an experienced clinical research professional who can assume primary responsibility for ongoing clinical trials and assist with the implementation of newly awarded studies with minimal supervision following required study-specific orientation and training.

The ideal candidate will hold an active Certified Clinical Research Coordinator (CCRC) certification through ACRP or Certified Clinical Research Professional (CCRP) certification through SOCRA, have substantial hands-on experience managing clinical trials, and demonstrate exceptional organizational skills, accountability, attention to detail, and a commitment to providing outstanding participant care.

Essential Duties and Responsibilities

Clinical Trial Coordination and Management

• Independently coordinate and manage multiple assigned clinical research studies from startup through closeout.


• Serve as the designated primary study coordinator for assigned clinical trials, maintaining accountability for study timelines, participant visit coordination, documentation completeness, data entry, query resolution, and timely communication with investigators and sponsors.


• Assume responsibility for ongoing studies, including reviewing existing study documentation, participant status, pending activities, and upcoming protocol requirements.


• Review and interpret study protocols, schedules of assessments, investigator brochures, and other study-related documents.


• Coordinate study startup activities, including site initiation visits, required training, regulatory documentation, and study-specific preparations.


• Develop and maintain participant visit schedules, ensuring protocol-required procedures are completed within established visit windows.


• Track enrollment goals, participant status, study milestones, and outstanding study activities.


• Maintain timely, accurate, and complete study documentation in accordance with applicable regulations, ICH-GCP guidelines, and sponsor requirements.


• Identify, document, and promptly escalate protocol deviations, participant safety concerns, and other study-related issues.


• Serve as a primary point of contact for assigned studies with sponsors, Clinical Research Associates (CRAs), CROs, and internal research personnel.


• Prepare for and actively participate in monitoring visits, audits, and inspections, including timely resolution of findings and action items.

Participant Recruitment and Coordination

• Recruit, prescreen, screen, and enroll eligible participants in accordance with study protocols and IRB-approved procedures.


• Conduct and document the informed consent process as authorized and delegated by the Principal Investigator.


• Coordinate participant appointments, follow-up visits, and retention activities.


• Obtain and document medical histories, vital signs, and other protocol-required information within the coordinator's training and authorized responsibilities.


• Coordinate protocol-required clinical procedures with qualified nursing staff, investigators, and other authorized clinical personnel.


• Perform permitted research procedures, including specimen collection, when appropriately trained, authorized, and qualified under applicable regulations and site policies.


• Monitor and document participant-reported symptoms, adverse events, and changes in condition, promptly communicating concerns to the Principal Investigator or appropriately delegated clinical provider.


• Educate participants regarding study procedures, visit expectations, medication instructions approved by the investigator, potential side effects, and reporting requirements.


• Maintain a professional, welcoming, confidential, and respectful environment for participants from diverse backgrounds.

Research Documentation and Regulatory Compliance

• Maintain accurate, complete, and contemporaneous source documentation for all assigned studies.


• Enter and review study data in Electronic Data Capture (EDC) systems and respond to data queries within required timelines.


• Maintain participant records, study logs, and required documentation within electronic and paper-based research systems.


• Assist with regulatory submissions, protocol amendments, continuing reviews, and other IRB-related documentation.


• Ensure adherence to ICH-GCP, HIPAA, institutional policies, and applicable federal and state regulations.


• Maintain accurate documentation of investigational product accountability activities and other delegated study responsibilities.


• Support continuous inspection readiness through proactive documentation review and resolution of outstanding items.


• Ensure appropriate reporting and escalation of adverse events, serious adverse events, protocol deviations, and other reportable occurrences according to applicable requirements.

Laboratory and Specimen Management

• Collect biological specimens when appropriately trained, authorized, and permitted by applicable requirements.


• Process, package, and prepare biological specimens for shipment according to protocol-specific laboratory manuals and applicable safety requirements.


• Ensure proper specimen identification, handling, storage, and chain-of-custody documentation.


• Coordinate specimen shipments in accordance with applicable IATA requirements.


• Maintain laboratory supplies, specimen collection materials, and study-specific equipment as assigned.

Team Collaboration and Operational Support

• Collaborate closely with investigators, research nurses, study coordinators, clinical staff, and administrative personnel to ensure efficient study operations.


• Communicate participant needs, study updates, upcoming visits, and outstanding responsibilities to appropriate team members.


• Assist with onboarding, mentoring, and training research personnel as appropriate.


• Maintain organized clinical research workspaces and ensure adequate study-related supplies.


• Demonstrate accountability, initiative, professionalism, and the ability to manage competing priorities.


• Perform additional research-related responsibilities as assigned by the Director of Research or designee.

Required Qualifications

Education

• Associate degree or higher from an accredited college or university.

Professional Experience

• Minimum of 3 years of direct clinical research coordination experience, including independent responsibility for clinical trial management, participant visits, study documentation, and protocol execution.


• Demonstrated experience serving as the primary study coordinator for multiple clinical trials.


• Experience managing concurrent interventional clinical research studies.


• Experience working directly with sponsors, CROs, CRAs, and Principal Investigators.


• Experience with informed consent, participant recruitment, adverse event documentation, protocol deviations, and regulatory compliance.


• Experience with electronic data capture systems, electronic medical records, and clinical trial management systems.


• Demonstrated ability to assume responsibility for ongoing studies and manage established participant cohorts.

Required Certifications

Candidates must possess an active, current, and verifiable national clinical research certification in at least one of the following:

• Certified Clinical Research Coordinator (CCRC) through the Association of Clinical Research Professionals (ACRP).


• Certified Clinical Research Professional (CCRP) through the Society of Clinical Research Associates (SOCRA).

Candidates must also possess current certifications or documented training in:

• Good Clinical Practice (GCP).


• Human Subjects Protection (HSP) / Human Research Protection (HRP).


• IATA Dangerous Goods Training applicable to biological specimen shipments.

Required Skills and Competencies

• Strong understanding of clinical research operations and ICH-GCP requirements.


• Ability to independently prioritize responsibilities and manage multiple studies simultaneously.


• Excellent documentation, organization, time management, and problem-solving skills.


• Strong verbal and written communication skills.


• Proficiency with Microsoft Office applications, including Outlook, Teams, Word, and Excel.


• Ability to work effectively with individuals from diverse backgrounds, including diverse gender identities, sexual orientations, cultures, and communities.


• Demonstrated professionalism, reliability, accountability, and commitment to participant safety and research integrity.


• Ability to identify operational challenges, communicate concerns proactively, and implement appropriate solutions within assigned responsibilities.

Preferred Qualifications

• Bachelor's degree in nursing, biological sciences, healthcare administration, public health, or a related field.


• Experience coordinating HIV, infectious disease, vaccine, or investigational therapeutic clinical trials.


• Experience with Phase I–IV interventional clinical research.


• Bilingual proficiency in English and Spanish, including the ability to communicate effectively with Spanish-speaking participants.


• Experience with RealTime CTMS, Veeva SiteVault, eClinicalWorks, and electronic informed consent systems.


• Familiarity with Interactive Response Technology (IRT/IWRS), electronic Clinical Outcome Assessment (eCOA), and investigational product accountability processes.


• Experience transitioning into existing studies and independently managing established participant cohorts.


• Experience supporting regulatory inspections, sponsor audits, and corrective and preventive action processes.

Work Schedule and Expectations

• Full-time (40hrs/week), primarily on-site position in Houston, Texas.


• Standard work schedule established by the research department.


• Occasional early morning, evening, or weekend availability may be required based on protocol-specific procedures, participant needs, or study requirements.


• Must be able to maintain assigned work schedules, meet study deadlines, and provide dependable coverage for research activities.

Benefits

Eligible regular full-time employees are offered:

• Medical, dental, and vision insurance options.


• Participation in the company's 401(k) retirement plan, subject to plan eligibility requirements.

About CrofootMD

CrofootMD Clinic and Research Center is a Houston-based healthcare and clinical research organization dedicated to advancing medical care through clinical research, with a particular emphasis on HIV, infectious diseases, and emerging treatment options.

We are committed to delivering high-quality participant care, maintaining rigorous research standards, and fostering a welcoming and inclusive environment for the diverse communities we serve.

Join our research team and play an important role in advancing innovative treatments while making a meaningful difference in the lives of research participants.