Clinical Research Coordinator

Job Description

The Clinical Research Coordinator will work under the guidance of the Principal Investigator, Sub-Investigators, and/or Director/Manager of Clinical Research Operations to participate in the planning, implementation, and overall direction of clinical research projects conducted on behalf of the sponsors at the institute.

• Evaluate protocol feasibility at the research site and develop strategy for implementing study procedures in compliance with study protocol.
• Prepare and submit documents to institutional review board, attend and participate in investigator meetings as directed, and initiate query requests to sponsors for the study.
• Recruit and screen research participants to evaluate eligibility for a clinical study by reviewing medical record source documents, inclusion/exclusion criteria, and participants’ willingness and capability to follow required clinical research procedures, processes, and follow up appointments.
• Obtain informed consent documentation from research participants prior to any study-related procedures, maintain patient screening enrollment logs, and follow randomization procedures per protocol, ensuring protection of patients' confidentiality and privacy during initial and follow-up interviews and visits.
• Dispense study drugs per protocol, review participants' diaries and questionnaires as appropriate, and collect, batch, and ship specimens as required.
• Adhere to HIPAA requirements when transmitting data via fax, mail, or electronically as requested by the sponsor or CRO, and resolve data queries and maintain files for all study related documentation.
• Complete and maintain all study drug accountability records, including drug dispensing and returned drug compliance and findings.
• Contact primary care providers to discuss and inform patient enrollment and study progress as directed, and meet regularly with investigator and research team to discuss participant participation and protocol progress.
• Timely notify the investigator, sponsor, and IRB of adverse events as outlined in the protocol.
• Schedule sponsor monitoring visits as directed by the Director of Clinical Research Operations, prepare case report forms and collect source documents for sponsor / audit review.
• Meet with research team during routine visits to discuss case report form completion, query resolution and other protocol-related issues and prepare for and participate in FDA inspections.
• Schedule participants for follow-up visits and assess participants' compliance with the test drugs on follow-up visits.
• Recognize and report abnormal laboratory values, and, if adverse events occur, collect and document this information for evaluation by the investigator.
• Abstract data from medical records, clinic, consultation, and referral notes to study forms and flow sheets; record data onto case report forms; and maintain source documentation for all case report entries.

Qualifications

• Bachelor's degree in a scientific discipline preferred or equivalent experience.
• Clinical Research Coordinator (CCR) certification preferred.
• 2+ years of clinical research experience.
• Medical and scientific knowledge preferred.

Skills And Competencies

• Patient Care: Demonstrated ability to work effectively with a diverse population, including individuals who of differing races, ethnicities, sexual orientations, gender identities, socio-economic backgrounds, religions, ages, English-speaking abilities, immigration statuses, and physical abilities.
• Knowledge of FDA Regulations and GCP Guidelines: An understanding of applicable federal regulations for clinical trial participation.
• Strong Communication Skills: Demonstrates strong written and verbal communications skills.
• Ability to establish and maintain positive relationships with study participants and team members.
• Computer Skills: Working knowledge of MS Office Suite, electronic Health Records (EHR), Clinical Trial Management Systems (CTMS), and Electronic Data Capture (EDC).
• Maintains Professionalism, Ethics, and Integrity in all actions: Fosters teamwork, collaboration, cooperation, and flexibility in all aspects of the role.
• Adaptability to a rapidly changing work environment.
• Ability to use good judgment in decision-making.
• Language: Ability to communicate in English (verbal and written).
• Bilingual in Spanish a plus.