Job Summary:
Under the general supervision of a physician and the clinical and clinical research team in an outpatient setting, the Clinical Research Coordinator I (CRC I) is responsible for executing study-related activities from study startup through closeout. All tasks are conducted in compliance with Good Clinical Practice (GCP), ALCOA-C principles, sponsor requirements, and USDP standards. The CRC I supports the Principal Investigator in the conduct of clinical trial visits, ensuring that participants are appropriately scheduled and that all protocol-specified procedures are completed accurately and in a timely manner.
Duties and Responsibilities:
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Maintain all aspects of study protocol during recruitment, screening, enrollment, and follow-up visits
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Assist the PI, and team when applicable, the informed consent process with patients and their families
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Conduct and coordinate patient visits including patient demography, vitals, EKG, phlebotomy, photography, administering investigational drug, assisting PI and sub-investigators with physical exam, and scheduling appropriate follow-up visits
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Communicate frequently with contract research organizations, IRB, Sponsors, Central Lab Facilities, and other outside vendors to manage the day-to-day needs for current and prospective trials
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Maintain all source documents and investigational drug accountability records
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Enter source data into EDC efficient and accurately
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Maintain regulatory documents related to ISF
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Follow SOPs, policies, and procedures as set forth by the company
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Review EDC for accuracy and completion, and resolve queries as they arise
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Assists with direct patient care procedures, as required by the study, including biopsies, surgeries, cosmetic procedures and related tasks
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Process prescriptions and prior authorizations as directed by physician. Address patient and/or pharmacy questions concerning medication. Enroll patients in patient education/assistance programs
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Ensure necessary study related documentation and correspondence study subjects, study teams, vendors, and sponsors
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Scans correspondence into EMR
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Practices safety, environmental, and/or infection control methods
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Assist clinical research manager in delegated tasks
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Performs miscellaneous job-related duties as assigned
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Process blood and urine samples in accordance with IATA and OSHA standards
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Prepare necessary documentation for SIV, IMV, COVs and other sponsor related meetings
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Working knowledge, at minimum, of all applicable protocols. Some team members may be assigned as the primary coordinator for a specific protocol, and should therefore have in-depth knowledge of that protocol
Experience Requirements:
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At least 1 year of research experience, preferred
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At least 1 year of direct patient experience, preferred
Knowledge, Skills and Abilities Requirements:
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Meticulously detail oriented, professional attitude, reliable
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Organizational skills to support accurate record-keeping
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Ability to follow verbal & written instructions
- Interpersonal skills to work as a team with patients and outside parties
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Able to communicate effectively in English, both verbally and in writing, with proper grammar and spelling skills to avoid mistakes or misinterpretations
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Mathematical and analytical ability for basic to intermediate problem solving
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Basic to intermediate computer operation
- Proficiency with Microsoft Excel, Word, and Outlook
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Specialty knowledge of systems relating to job function
- Knowledge of state and federal regulations such as ICH GCP, IATA; general understanding of HIPAA guidelines
Supervisory Responsibilities:
- This position has no supervisory responsibilities.
Benefits:
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Medical, Dental, & Vision
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401k
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PTO & Paid Holidays
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Company Paid Life Insurance
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Employee Perks Program
