Clinical Research Coordinator

Duties And Responsibilities

• Maintain inventories of study supplies, kits, equipment, and research materials
• Collects research data and prepares information for inputs and analysis
• Collect, review, validate, and enter research data into approved electronic systems
• Collaborate with data management personnel to ensure data quality and completeness
• Verify case report forms (CRFs) and source documentation
• Resolve sponsor, monitor, and data management queries
• Perform routine data quality control activities
• Generate study reports, workload reports, enrollment reports, and data summaries
• Affirm compliance with data management plans and quality standards
• Coordinate multiple clinical research studies simultaneously
• Screens, recruits, pre-screens, and schedules research participants according to protocol requirements
• Assess participant eligibility in accordance with approved inclusion and exclusion criteria
• Support informed consent activities for observational and interventional studies as authorized by the Principal Investigator (PI)
• Educate participants regarding protocol requirements, study procedures, investigational therapies, visit schedules, and participant responsibilities
• Respond to participant inquiries and provide ongoing study-related education
• Coordinate protocol-required visits, procedures, laboratory testing, diagnostic evaluations, imaging studies, and ancillary services
• Ensure protocol-required events are completed within protocol-defined visit windows
• Coordinate and track pharmacokinetic (PK), pharmacodynamic (PD), imaging, biomarker, quality-of-life (QoL), and patient-reported outcome (PRO) assessments
• Monitor participant compliance with study requirements and protocol procedures
• Document participant encounters in the electronic medical record (EMR) and other approved systems as required
• Maintain complete and accurate source documentation
• Obtain medical records from outside providers, laboratories, hospitals, and referring physicians
• Review medical records for protocol-relevant information
• Abstract clinical information from medical records for research purposes
• Review documentation for discrepancies and coordinate corrective actions
• Ensure collection and maintenance of progress notes, laboratory reports, pathology reports, imaging reports, and other source documentation
• Participate in quality improvement initiatives related to documentation practices
• Maintain study files and records in accordance with applicable requirements
• Coordinate collection, processing, tracking, storage, and shipment of research specimens
• Ensure proper chain-of-custody documentation and specimen accountability
• Coordinate specimen shipments to designated laboratories and repositories
• Obtain pathology materials, slides, tissue blocks, and laboratory reports required by protocols
• Coordinate receipt and processing of outside pathology samples
• Ensure required imaging studies, including CT scans, MRI scans, X-rays, PET scans, and other protocol-specific imaging, are obtained and documented
• Coordinate acquisition of outside imaging studies and reports
• Coordinate protocol-required clinical procedures
• Collaborate with clinical staff to ensure timely collection of: Pharmacokinetic samples, Pharmacodynamic samples, Blood specimens, Electrocardiograms (ECGs), Vital signs, Height and weight measurements, Wearable device data, Other protocol-specific procedures
• Ensure completion of protocol-required assessments within established timelines
• Facilitate administration of Quality-of-Life (QoL) and Patient Reported Outcome (PRO) instruments through paper, electronic, or interview-based methods
• Maintains participant’s progress and reports adverse events
• Afford support to prepare and submit regulatory documentation to Institutional Review Boards (IRBs), Protocol Support Offices, sponsors, and regulatory authorities
• Support continuing review, annual review, protocol amendment, and study closure submissions
• Maintain regulatory binders and study files
• Maintain delegation-of-authority logs and associated study documentation
• Track regulatory deadlines and submission requirements
• Afford support to adverse event reporting and protocol deviation documentation
• Ensure study records remain inspection-ready and audit-ready
• Serve as a primary operational contact for assigned studies during monitoring visits
• Prepare source documentation and regulatory records for monitoring visits
• Facilitate sponsor, CRO, internal, and external monitoring activities
• Respond to monitoring findings and requests for clarification
• Track monitoring action items and corrective actions
• Afford support to audit preparation and inspection readiness activities
• Afford support to assembly, development and review of new research projects
• Afford support to the creation and management of clinical websites and web-based tools
• Afford support to the development and maintenance of study tools, trackers, calendars, worksheets, and workflow documents that facilitate protocol execution and team communication
• Organize and perform clinical research, utilizing internet and other available clinical resources
• Document participant encounters in the electronic medical record (EMR) and other approved systems as required
• Provide assistance to staff in the collection, development and quality control of essential clinical research efforts
• Afford support to protocol activation, implementation, conduct, and closeout activities
• Coordinate protocol-specific procedures and operational requirements
• Identify and resolve protocol implementation issues in collaboration with the PI and study team
• Monitor study progress and participant accrual
• Participate in multidisciplinary clinical rounds and study team meetings
• Afford support to investigators in evaluating participant responses to investigational therapies
• Afford support to protocol amendments and operational implementation of approved protocol changes
• Afford support to the development and maintenance of study tools, trackers, calendars, worksheets, and workflow documents that facilitate protocol execution and team communication
• Afford support to ensure protocol conduct complies with NCI, NIH, FDA, ICH-GCP, and applicable regulatory requirements
• Maintain inventories of study supplies, kits, equipment, and research materials
• Order study-related supplies and equipment as needed
• Track inventory levels and expiration dates
• Coordinate receipt and distribution of study materials
• Maintain accountability records for study resources
• Afford support to clinical staff in developing, implementing, and maintaining clinical research data files and materials
• Maintain complete and accurate source documentation
• Develop and facilitate training to new research coordinators and mentors researchers in Good Clinical Practices
• Provide guidance and operational training to junior staff, trainees, students, and temporary personnel as requested by the Government
• Afford support to onboarding activities related to protocol operations and study procedures
• Afford support to continuity of operations and knowledge transfer efforts

Qualifications

• Bachelor’s degree in a relevant field such as biology, medicine, public health, or a related discipline
• Minimum of 2 years of experience in clinical research, preferably in a research coordinator role
• Experience with electronic data capture systems and data management software
• Strong organizational and time management skills
• Excellent written and verbal communication skills
• Ability to work independently and as part of a team
• Knowledge of Good Clinical Practices (GCP) and regulatory requirements
• Ability to manage multiple tasks and projects simultaneously
• Proficiency in Microsoft Office Suite