Clinical Research Coordinator

Clinical Research Coordinator 2884704

A leading medical institution seeks a Clinical Research Coordinator to join the Department of Orthopaedic Surgery. The successful candidate will provide clinical research coordination for a variety of health policy, observational, and clinical outcomes studies as assigned, and recruit study participants through screening in person, via Epic, and by phone.

Clinical Research Coordinator Pay and Benefits:

• Hourly pay: $35/hr
• Worksite: San Francisco, CA 941584 - Hybrid, Must be 4 days onsite and the other day can work from home (Previously discussed with Supervisor)
• W2 Employment, Group Medical, Dental, Vision, Life, Retirement Savings Program, PSL
• 40 hours/week, 5 Month Assignment

Clinical Research Coordinator Responsibilities:

• Study Coordination:
  • Coordinate 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, and 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 the appropriate departments.
  • 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 students and technicians to ensure scheduling efficiency; communicate with any affiliated groups.
  • 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.
• Administrative:
  • Update and maintain a procedure manual documenting all study-related procedures; help develop a plan to ensure consistency in data collection and data entry.
  • Assist Principal Investigator in preparing clinical trial protocols and required documentation for the institutional review board, the University, and corporate or government sponsors.

Clinical Research Coordinator Qualifications:

• 2 years’ experience in a clinical research environment is preferred.
• A BA/BS with a major in biology, public health, psychology, sociology, or a related field is preferred.
• Experience with clinical research trials (drug and device, retrospective, prospective, randomized, open-label, etc.).
• Preferred experience with APeX/Epic (EMR), RedCaP, ONCORE, and various EDC(Medrio, Medidata, etc).
• HS graduation and sufficient experience and demonstrated skills to successfully perform the assigned duties and responsibilities.
• Knowledge of medical terminology and experience with electronic medical records is preferred.
• Experience applying the following regulations and guidelines is 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, effective cash handling procedures, environmental health and safety training, fire safety training
• CITI Training is preferred.
• Bilingual is preferred.
• Fluency in the usage of Committee of Human Research (CHR) online iRIS system for submission, renewal, and modification of protocols through this system is preferred.
• Understanding of patient population to create rapport and a relationship, while also giving insight to what is realistic and appropriate for patient participation is preferred..
• Knowledge of healthcare and departmental policies for dealing with reimbursement, guidelines for research, confidentiality and HIPPA regulations, following the our mission statement and purpose for research, and a clear understanding of policies and procedures on patient safety and confidentiality (electronic and hard copy medical records, patient charts, communication, etc.) is preferred.
• Knowledge of research policies and guidelines is preferred.
• Knowledge of computer programs needed: RedCap, Advanced EXCEL are preferred.

Shift:

• M-F 08:30 am - 05:00 pm Pacific Time office hours.