Job Duties
The Study Coordinator will coordinate all research activities as part of a clinical research team. Responsible for the coordination of clinical trials to include: ensuring that protocol procedures have been completed accurately, safely, and in a timely manner; research chart documentation.
The Study Coordinator will take an active role in study selection and study initiation, including administrative start-up support, regulatory document collection, drafting informed consent documents for submission to the IRB, and other study start-up activities. This position will oversee and manage study coordination activities, including but not limited to: subject screening, recruitment and enrollment, participant scheduling, coordination of research measures and clinical care, accurate and safe completion of protocol required procedures and the prompt and accurate collection and reporting of data in accordance with applicable laws, institutional policies, and study specific protocol, case report form completion, participation and management of monitoring visits, query resolution, source documentation and research record development and maintenance, study drug accountability, specimen collection, processing and shipment, etc. Incumbent will be expected to problem solve potential system barriers with determination and professionalism.
Job Qualifications
Required:
A bachelor's degree in Science or related field strongly preferred. Ability to travel to more than one site, travel to participating clinics and attend off-site staff meetings, conferences and investigators meetings. Demonstrated understanding of confidential information, how it is defined, and demonstrated skill in maintaining confidential status of such information including completion of pertinent training (ie, HIPAA). Ability to work efficiently and complete tasks with a high degree of accuracy. Ability to organize multiple projects for efficiency and cost-effectiveness. Ability to work flexible hours to accommodate research procedures (some weekends and holidays will be required). Strong interpersonal communication skills to effectively and professionally interact with others. Strong English writing skills to general original correspondence, including reports, using correct grammar, syntax and punctuation. Strong computer skills and experience working with Microsoft Office applications and able to perform the following tasks effectively: word processing, use and development of spreadsheets, e-mail and data entry (MAC, PC, MS WORD, MS EXCEL, MS OUTLOOK). Bilingual read/write/speak REQUIRED.
Preferred:
Clinical research experience as a Study Coordinator in research involving human subjects. Demonstrated working knowledge of current medical terminology to accurately read entries in patient charts and record accurately and timely information into study records and other appropriate research data forms. Working knowledge of "Good Clinical Practices" (GCP) for clinical research as defined by the FDA, including completion of pertinent training. Knowledge and experience of working with regulatory agencies, i.e., IRB and other regulatory agencies and/or communities. Working experience of the start-up and closure of clinical research studies and patient randomization. Demonstrated knowledge of all components of the research process as it pertains to clinical trials and studies, ie, IRB procedures and processes, data management, etc.
Job Types: Full-time, Part-time
Pay: $22.28 - $48.04 per hour
Expected hours: 40 per week
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Health insurance
- Life insurance
- Paid time off
- Vision insurance
Medical specialties:
Schedule:
Ability to Commute:
- Sylmar, CA 91342 (Required)
Ability to Relocate:
- Sylmar, CA 91342: Relocate before starting work (Required)
Work Location: In person