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JOB SUMMARY

A Clinical Research Coordinator (CRC) 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.

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 the 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 the research site with coverage planning related to staffing and scheduling for research studies.
• Monitor subject safety and report adverse reactions to appropriate medical personnel.
• Maintain confidentiality of data and PHI as required.
• Collaborate with provider offices to carry out research in the most efficient workflow possible.
• Maintains stock of supplies needed to carry out each study per protocol.
• Performs other duties and projects as assigned.

QUALIFICATIONS

• Bachelor's degree in a related field
• 1-2 years of clinical research experience
• 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
• 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.
• Skill in applying and modifying professional research principles, methods, and techniques to provide ongoing patient care.
• Skill in preparing/maintaining records, writing reports, and responding to correspondence.
• Ability to maintain quality control standards.
• Ability to react calmly and effectively in all situations.
• Excellent organizational and problem-solving skills.
• Effective time management skills with the ability to multi-task and manage competing priorities with exceptional attention to detail.
• 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.

WORKING CONDITIONS

This job operates in a professional and clinical environment with occasional visits to other Innovo Research partner sites/clinics. This role routinely uses standard office equipment such as computers, phones, and scanners. There is frequent exposure to communicable diseases, toxic substances, ionizing radiation, medicinal preparations, and other conditions common to a clinic environment. Varied activities include standing, walking, reaching, bending, and lifting. Requires full range of body motion including handling and lifting patients, manual and finger dexterity, and eye-hand coordination. Requires standing and walking for extensive periods of time. Occasionally lifts and carries items weighing up to 50 pounds. Requires corrected vision and hearing to normal range.

Due to the nature of this position, employees are expected to work in person. This is an exempt position under the federal and state wage and hour laws, which means you are not eligible for overtime pay beyond your salary. Employees are expected to work 40 hours a week. Occasional evening and weekend work may be required as job duties demand.

The above statements are intended to describe the general nature and level of work being performed by individuals assigned to this position. They are not intended to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel. More in-depth information can be found in SOP's, working guidelines, policies, etc. Innovo Research is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment. All employment decisions at Innovo are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic origin, sex (including pregnancy), age, physical, mental or sensory disability, HIV Status, sexual orientation, gender identity and/or expression, marital, civil union or domestic partnership status, past or present military service, family medical history or genetic information, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. Innovo Research will not tolerate discrimination or harassment based on any of these characteristics. In addition, Innovo will provide reasonable accommodations for qualified individuals with disabilities.

Applicants must be authorized to work for ANY employer in the U.S. Innovo Research is unable to sponsor or take over sponsorship of an employment Visa at this time.