Job Description

Job Description

Job Description

Direct Biologics is a market leading innovator and science-based cGMP manufacturer of regenerative biologic products. We are currently looking for a Clinical Research Associate (CRA), responsible for organizing and overseeing clinical studies/trials to contribute to advances in the medical community. The CRA will monitor the conduct and progress of the studies to ensure compliance with established protocols, appropriate research methodology, and study timelines. The CRA will manage quality controls and the execution of clinical protocol and data management for a number of clinical trials at multiple sites, ensuring compliance with all regulatory and contractual requirements. Expectation is for around 25- 50% travel to sites that do not support remote monitoring.

Requirements

• Assist in organizing and monitoring the different stages of clinical trials.
• Conducts clinical trial site initiation visits; advises and trains site personnel on sponsor and regulatory requirements for study conduct; participates and/or conducts site meetings and multicenter investigator meetings and prepares reports.
• Supervise study sites and activities to ensure adherence to appropriate industry protocols and terms of the study.
• Collect and authenticate data collection forms otherwise known as case report forms.
• Screen potential study participants through medical record reviews, interviews, and follow-ups with healthcare providers.
• Maintain specific records of research activity to include regulatory forms, drug dispensation records, case reports and consent forms.
• Prepare final reports and ensure proper transmission of clinical case data to the data management centers, review case reports questions and problems and clarify or obtain alterations to data as appropriate.
• Oversee research, technical and administrative staff, to include training, hiring, goal setting and distribution of workload.
• Assists in the termination of clinical studies by identifying items and issues for review and/or follow-up; assembles necessary documents, conducts site termination visits to include test article reconciliation and disposition, review of completeness and accuracy of files, and retrieval of relevant codes and documents; prepares study termination reports.
• Performs miscellaneous job-related duties as assigned.
• Qualifications
• Minimum Bachelor's degree in life sciences/data sciences/pharmacy/nursing or other health related disciplines.
• 2+ years of prior clinical research experience.
• Experience with randomized controlled clinical trials principles, methodology, and procedures, as well as federal/state regulations and guidelines pertaining to the conduct of clinical trials on human subjects.
• Knowledge of adverse medical event investigation, analysis, and reporting procedures and standards.
• Knowledge of industrial standards as applied to good clinical practices.
• Must possess superior analytical and creative thinking skills.
• Excellent attention to detail and the ability to keep detailed, accurate records.
• Strong interpersonal, written, and verbal communication skills.
• Advanced organizational and planning skills.
• Experience working in a self-driven capacity, with a sense of urgency, and an honest and ethical work approach to promote the development of life changing treatments for patients.

Benefits

• Health Care Plan (Medical, Dental & Vision)
• Company 401k match up to 4%
• Paid Time Off (Vacation & Sick)
• Holidays
• Remote or Hybrid work model
• Stock Option

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