Clinical Research Coordinator

2-4 years

Not Disclosed

Remote

10 Jan. 18, 2025

Job Description

Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Position: Clinical Research Coordinator II (2-4 Years of Experience)
Location: [Location not provided]
Employment Type: [Employment type not specified]
Job Category: Clinical Research
Job Number: [Job number not provided]
Is Job Remote?: [Remote status not specified]
Country: United States

Job Overview

The Clinical Research Coordinator II will play a key role in supporting clinical trials by coordinating study activities, ensuring compliance with regulatory requirements, and ensuring smooth operations across multiple phases of clinical research. This position requires 2-4 years of experience in clinical research and is ideal for a detail-oriented professional with a passion for advancing clinical research.

Key Responsibilities

Coordinate day-to-day activities of clinical research studies, including participant recruitment, enrollment, and follow-up.
Prepare and maintain study-related documentation, including informed consent forms, case report forms, and regulatory documents.
Ensure compliance with regulatory requirements, study protocols, and Good Clinical Practice (GCP) standards.
Monitor the progress of clinical trials, ensuring that study milestones are met on time.
Communicate regularly with the clinical research team, including investigators, sponsors, and other stakeholders, to ensure the successful execution of the study.
Collect, organize, and analyze data related to the study.
Conduct patient assessments and provide assistance in administering treatment protocols and clinical assessments.
Manage subject safety and ensure appropriate adverse event reporting.
Assist in the development of study-related training materials and support the training of study personnel.
Prepare reports on clinical research activities for review by the principal investigator and study sponsor.
Ensure accurate and timely entry of data into clinical trial databases.
Coordinate and schedule study visits and laboratory tests as required.
Participate in audits and inspections as required, ensuring that all documentation and processes are audit-ready.

Required Qualifications

Bachelor’s degree in Life Sciences, Nursing, or related field.
2-4 years of experience as a Clinical Research Coordinator or in a related role within clinical research.
Strong knowledge of Good Clinical Practice (GCP), regulatory requirements, and clinical research protocols.
Experience in coordinating clinical trials, including patient recruitment, data management, and documentation.
Proficient in using clinical trial management software and databases.
Excellent communication skills, both written and verbal.
Detail-oriented with strong organizational skills and the ability to manage multiple tasks simultaneously.
Ability to work independently and in collaboration with a team.

Preferred Qualifications

Certification as a Clinical Research Coordinator (CCRC) or Clinical Research Associate (CCRA) is a plus.
Experience in oncology, cardiology, or other specialized therapeutic areas.
Knowledge of electronic data capture (EDC) systems and clinical trial management software.

Additional Information

[Additional company and diversity-related information, if applicable.]

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Clinical Research Coordinator

Job Description

Job Overview

Key Responsibilities

Required Qualifications

Preferred Qualifications

Additional Information

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