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SalaryJOB SUMMARY
A Research Coordinator is responsible for reviewing, processing, and managing Clinical Research data and documents, both regulatory and patient records. The CRC performs a variety of clinical procedures, and assists with daily workload planning; ie; collect, record, report, and interpret data on patients enrolled in and/or seeking enrollment in clinical studies according to the protocol, SOPs and GCPs.
ESSENTIAL DUTIES/RESPONSIBILITIES
- Provide Clinical Research support to investigators to prepare for and execute assigned research studies, including:
- Collect, record, and maintain research subject study data according to study protocols and SOPs, preserving quality control for content, accuracy, and completeness.
- Collect and submit regulatory/ethics documentation as required by the FDA and other regulatory bodies governing the conduct of Clinical Research.
- Recruit and screen participants for clinical trials and maintain subject screening logs.
- Assist in the initial and ongoing consent process; orient research subjects to the study, including the purpose of the study, procedures, and research process.
- Maintain source documentation based on protocol requirements.
- Schedule and execute study visits and perform study procedures.
- Handle lab testing and analysis, including preparation of specimen collection tubes, shipment, and lab logistics.
- Monitor subject safety and report adverse events/reactions to the Principal Investigator and/or appropriate medical personnel.
- Correspond with research subjects and troubleshoot study-related questions or issues.
- Participate in “huddles” to confirm daily study tasks are assigned to team members and are executed to the expected standards.
- Assist with study data quality checking and query resolution.
- Perform a variety of complex Clinical Research procedures including but not limited to ECG, sample collection, spirometry, vital signs, dose verification, cannulation, and cardiac telemetry monitoring, if needed.
- Assist investigator in verifying that research study objectives are met on time, within budget and according to applicable protocol requirements, Clinical Research regulations and quality standards.
- Provide training to new investigator site staff members on study-specific topics and requirements. Assist in maintaining adherence to investigator site staff training requirements by auditing and maintaining training records.
- Prepare for and attend study monitoring visits, study audits, and regulatory inspections with Clinical Research regulatory agencies.
- Assist research site with coverage planning related to staffing and scheduling for research studies.
- Performs other duties and projects as assigned.
Required:
- Bachelor's degree in a related field
- 1-2 years’ Clinical research experience
Preferred:
- Relevant work experience in a clinical environment or medical setting, e.g., medical assistant, assistant nurse, laboratory technician; or equivalent combination of education, training, and experience
- Proficient in the use of Microsoft Office applications
- Understanding of medical terminology
- Strong organizational skills
SKILLS AND ABILITIES
- Working knowledge of clinical trials
- Knowledge and ability to apply GCP/ICH and all applicable FDA regulations and guidelines for human subject protection, drug, and device.
- In-depth knowledge of departmental, protocol and study-specific operating procedures, consent forms, and study schedules
- Skilled in carrying out required clinical procedures such as phlebotomy and vital signs.
- Strong written and verbal communication skills including good command of the English language.
- Excellent organizational and problem-solving skills.
- Effective time management skills with the ability to multi-task and manage competing priorities with exceptional attention to details.
- Ability to establish and maintain effective working relationships with physicians, coworkers, managers, and clients.
- Practice a high level of integrity, honesty, and in maintaining confidentiality.
