Clinical Research Coordinator

Job Summary

The Clinical Research Coordinator works closely with the Research/Sub-Investigator managing study conduct from study selection through study closeout. The Clinical Research Coordinator is responsible for the quality and integrity of their assigned clinical studies in accordance with Good Clinical Practice (GCP) and applicable regulations.

Key Responsibilities

· Maintain strict confidentiality in compliance with and FDA, ICH, GCP and HIPAA guidelines.

· Organize, coordinate, and help ensure the overall integrity of assigned research trials. The Principal Investigator provides the overall direction in a clinical study, but the Clinical Research Coordinator has a significant role in the clinical study activities.

· Identify, evaluate, and recruit study subjects for participation in clinical trials, according to protocol requirements.

· Perform tasks delegated by the Principal Investigator, including consenting, documenting medical history, collecting and tracking vital signs and adverse events, collecting and processing specimen, administering medications, maintaining sufficient inventory of investigational product and lab kits.

· Follow current Food and Drug Administration (FDA), International Conference on Harmonization (ICH) and Good Clinical Practices (GCP) regulations and guidelines.

· Ensure that all patient visit procedures and activities are conducted in strict compliance with the protocol and FDA, ICH, GCP and HIPAA guidelines

· Ensure the safety and welfare of the study subjects by providing subject care and data collection procedures in adherence with the assigned protocol and in accordance with good clinical research principles.

· Gain a detailed understanding of assigned study protocols and conditions under study in order to properly answer questions and discuss appropriate study details with patients, investigators, co-workers, individuals in the community, and Sponsor and/or CRO representatives.

· Recruit new study subjects for protocol participation via continuous interaction with the Investigator(s), routine review of medical records and database records, and screening of potential study subjects who respond to advertisements.

· Screen potential study candidates prior to enrollment according to the protocol’s inclusion and exclusion criteria.

· Obtain the study subjects' informed consent according to SOP 2-C, Informed Consent Process and in compliance with 21 CFR and ICH.

· Schedule study subjects' subsequent study visits.

· Report all serious adverse events to the Principal Investigator, Director of Clinical Operations and Business Development, and Regulatory.

· Keep investigators informed of the status of all current studies, participating study subjects and enrollment status.

· Maintain adequate and accurate case histories (i.e., source documentation) for each study subject.

· Promptly complete and maintain (electronic) case report forms for each study subject per Sponsor requirements and respond to all queries in a timely fashion.

· Maintain accurate and complete records of the receipt, inventory, dispensing, and return of all clinical supplies (e.g. study drug, Holter monitors, electronic diaries, etc.) in strict accordance with protocol requirements.

· Assist the Investigators as directed.

· Communicate with the Sponsor/CRO regarding study activities as necessary.

· Meet with the Sponsor's representatives to discuss the conduct of the study and review study data.

· Handle and process specimens for laboratory analysis as described in the laboratory manual and the protocol and ship the specimens according to IATA Dangerous Goods and Hazardous Materials Regulations.

· Perform additional duties and projects as assigned

Qualifications

· Excellent communications skills, strong familiarity with medical terminology and medications, and the ability to understand and communicate protocol requirements to others.

· Able to work effectively and professionally with patients, other research personnel, physicians/investigators, monitors, and others involved in the clinical study.

· CPR-certified or is willing to become CPR-certified.

· Able to perform the following: ECGs, phlebotomy, blood pressure, vitals, medical history evaluation.

· Willing to travel to investigator offices and potentially sponsor conferences, and be willing to participate in health fairs.

· Detail-oriented person with the ability to collect, complete, compile, and analyze information.

· Able to work independently and efficiently on multiple tasks, with strong time management skills.

Education and Experience

· Associate or bachelor’s degree in related field

· Medical background and knowledge

· Experience in clinical research preferred