Clinical Research Associate I, Dcri

0-3 years

Not Disclosed

Remote, USA

10 Sept. 27, 2024

Job Description

Job Type: Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences 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

Duke University School of Medicine

Established in 1930, the Duke University School of Medicine is the youngest of the nation’s top medical schools, currently ranked sixth. We take pride in fostering an inclusive community of exceptional learners, researchers, clinicians, and staff. Our focus on interdisciplinary collaboration accelerates the translation of fundamental scientific discoveries into solutions that improve human health both locally and globally. With over 2,600 faculty physicians and researchers, nearly 2,000 students, and more than 6,200 staff members, the Duke University School of Medicine, alongside the Duke University School of Nursing and Duke University Health System, forms Duke Health—a world-class academic medical center comprising Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Health Integrated Practice, Duke Primary Care, Duke Home Care and Hospice, Duke Health and Wellness, and multiple affiliations.

Position: Clinical Research Associate I

Occupational Summary
The DCRI Megatrials domain is dedicated to designing and executing large-scale global commercial clinical trials aimed at evaluating new drugs and devices for regulatory approval. Our team collaborates closely with senior clinical and operational executives from major pharmaceutical sponsors to develop comprehensive operational plans that include protocols, risk-based monitoring, quality data surveillance, and data collection and analysis strategies. These pivotal international phase 3 and phase 4 studies are essential for new drug approvals or modifications to existing drug labels.

Megatrials team members are chosen for their ability to work independently in complex, high-pressure, cross-cultural environments across multiple time zones, delivering high-quality programs aligned with the Megatrials Guiding Principles.

Note: This position may offer remote work opportunities, but candidates must reside in specific states, including Arizona, California, Florida, Georgia, and others as listed.

Position Responsibilities

Study Organization

Conduct study start-up activities for multiple sites, ensuring compliance with regulatory requirements, including informed consent reviews.
Manage project-specific plans for start-up activities, including the distribution and collection of essential study documents and negotiation of site contracts and budgets.
Assess protocol and regulatory compliance, identifying and reporting deviations to the supervisor.
Perform feasibility assessments of site personnel and facilities for study conduct.
Provide guidance to site personnel for adherence to protocols, SOPs, and regulations.
Document ongoing follow-ups and resolutions of identified issues.

Study Training

Assist with initial and ongoing training for site personnel regarding study conduct and compliance.
Escalate any issues impacting patient safety or data integrity to the lead CRA.

Site Management and Monitoring

Document routine site management and monitoring activities using standard templates and trial documents.
Conduct monitoring activities, including on-site visits and remote assessments, to ensure protocol compliance.
Regularly review study and site status and maintain accurate reports.
Develop action plans to resolve identified site issues and ensure data integrity.

Trial Conduct

Build effective relationships with site personnel and study contacts.
Provide timely notifications regarding site status and trial needs.
Contribute to team dynamics through effective communication and participation in meetings.
Report updates to supervisors regarding site activities and study issues.

Administrative

Support the DCRI and Commercial Mega Trials functional group.
Maintain job knowledge through self-study and fulfill training needs promptly.
Complete administrative tasks, including time tracking and attendance reporting.

Required Qualifications

Education/Training:

Graduation from an accredited program providing clinical training as a Registered Nurse (RN), Physician's Assistant (PA), or Pharmacist with one year of healthcare experience; or an allied health degree with three years of healthcare experience; or a master’s degree in Public Health or related area with no experience; or a bachelor’s degree with one year of clinical trials research experience.

Experience:

At least one year of closely related clinical research experience or two years of clinical experience in a relevant therapeutic area.

Preferred Experience:

Roles such as Clinical Research Associate, Study Coordinator, or Clinical Trials Assistant, or direct patient care.

Knowledge, Skills, and Abilities:

Strong technical writing and communication skills.
Interpersonal skills to foster positive relationships.
Proficiency in MS Word and Excel.
Organizational skills and attention to detail.
Ability to manage multiple tasks and gather information for effective problem solving.
Basic knowledge of clinical research processes and Good Clinical Practices.

Licensure:

Valid U.S. driver's license.

Working Conditions

Extensive use of telephone and electronic communication.
Repetitive keyboarding and prolonged focus on a computer monitor.
Occasional lifting of heavy documents.

Duke University is an Equal Opportunity Employer

Duke is committed to providing equal employment opportunities without regard to age, color, disability, gender identity, genetic information, national origin, race, religion, sex, sexual orientation, or veteran status. We aim to create a collaborative, innovative, and inclusive community where all contributions are valued, and every voice is heard. Each member of our community is responsible for upholding these values.

For positions that require specific physical or mental abilities, we provide information and accommodations as necessary.

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