Clinical Research Coordinator

Clinical Research Coordinator 57877996

A leading medical institution is seeking a Clinical Research Coordinator. The successful candidate will be responsible for coordinating multiple Clinical Research studies simultaneously including multicenter clinical trials, NIH and industry-sponsored studies, and local investigator-initiated clinical trials. The ideal candidate has fluency in the usage of the Committee of Human Research (CHR) online iRIS system for submission, renewal, and modification of protocols through this system. The company offers a great work environment!

Clinical Research CoordinatorPay and Benefits:

• Hourly pay: $35/hr
• Worksite: Leading medical institution, (San Francisco, CA 94143 - Onsite)
• W2 Employment, Group Medical, Dental, Vision, Life, Retirement Savings Program, PSL
• hours/week, Month Assignment

Clinical Research CoordinatorResponsibilities:

• Responsible for coordinating multiple Clinical Research studies simultaneously including multicenter clinical trials, NIH and industry-sponsored studies, and local investigator-initiated clinical trials.
• Identify subjects, develop recruitment and retention strategies, obtain informed consent, screen and enroll study subjects.
• Schedule subjects for study visits and/or coordinate the scheduling of required laboratory tests and/or exams; meet with participants to administer questionnaires, collect medical history and perform study procedures according to the study protocol.
• Monitor participants for evidence of study-related adverse events.
• Document adverse events and protocol deviations and submit to appropriate departments.
• Document study participants' progress in electronic medical record and study records as per protocol.
• Maintain data collection forms for effective data collection, entry, and analysis.
• Maintain subject data and address study-specific data queries promptly.
• Maintain rapport and relationships with subjects to ensure effective communication and retention; respond to their diverse needs, schedule follow-up appointments, and become their intermediary; discuss study outcomes with providers to ensure continuity of care.
• Oversee subject reimbursement; work to resolve discrepancies and issues.
• Work with staff to ensure procedures are completed, specimens properly stored, and required data collected at visits; and ensure correct shipping and labeling measures.
• Develop and maintain required documentation for clinical trials.
• Reconciliation of subject encounters with billing to ensure correct billing practices and avoid improper billing of Medicare, private insurance, or patients.
• Assure studies are carried out in accordance with all relevant regulations including Code of Federal Regulations, Good Clinical Practice, regulations, and in accordance with Departmental SOPs.
• Assist in the development of databases and participant trackers needed to capture specific protocol-required data.
• Remain up to date on all required training (E.g., Departmental training, study specific trainings, etc.)
• Serve as a resource for investigators and Clinical Research staff for all aspects of conducting a clinical trial for complex and multi-center trials.
• Ensures proper collection, processing, storage, transport, and handling of biological specimens.
• Coordinate, communicate and network with other studies and technicians to ensure scheduling efficiency;communicate with any affiliated groups.
• Conduct reviews of medical charts and electronic records to extract medical information and other data for use in studies.
• Implement needs assessments and recommendations for enhancements on patient coordination, data collection, data management, protocol adherence and study collaboration.
• Ensure optimal systems are in place to ensure compliance with regulatory requirements for the safe conduct of Clinical Research.
• Participate in and cooperate with any internal and external audits or reviews of study protocols; prepare necessary documentation.
• Maintain patient confidentiality when communicating with agencies, healthcare providers, other studies, and outside departments.
• Maintain regulatory documents, and monitor timelines for data submission.
• Interface with departments to obtain approval prior to study initiation.
• Responsible for the maintenance and integrity of the patient-reported outcomes Collect data during subject visits; enter data from visits, procedures, lab tests, and other subject-related participation into databases in a timely manner.
• Manage database structure for each study protocol; update databases to improve data analysis and management. Create and maintain comprehensive data sets as requested by the supervisor and/or PI.
• Provide quality assurance checks to note if protocols or our applications need to be modified; evaluate protocols on an ongoing basis and implement improvements as needed.
• Update and maintain a procedure manual documenting all study-related procedures; help develop a plan to ensure consistency in data collection and data entry.

Clinical Research CoordinatorQualifications:

• 2 years of experience in a Clinical Research environment preferred.
• HS graduation and sufficient experience and demonstrated skills to successfully perform the assigned duties and responsibilities.
• BA/BS with a major in biology, public health, psychology, sociology, or related field preferred.
• Study activity coordination and administrative study management experience required.
• Experience applying the following regulations and guidelines preferred: Good Clinical Practice Guidelines, Health Information and Accountability Act (HIPAA), The Protection of Human Research Subjects, CHR regulations for recruitment and consent of research subjects.
  
• Fluency in the usage of Committee of Human Research (CHR) online iRIS system for submission, renewal, and modification of protocols through this system preferred.
• Effective Cash Handling Procedures preferred.
• Clinical research associate preferred.
• Environmental Health and Safety Training preferred.
• Fire Safety Training preferred.
• Must be able to maintain thorough documentation and be dedicated to keeping accurate and up to date records.