Clinical Research Coordinator

Ampcus Inc. is a certified global provider of a broad range of Technology and Business consulting services. We are in search of a highly motivated candidate to join our talented Team.

Job Title: Clinical Research Coordinator

Location(s): San Francisco, CA

(4 days onsite)

• 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, UCSF 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 trainings (E.g., UCSF trainings, Departmental trainings, 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, monitor timelines for data submission.
• Interface with departments to obtain UCSF 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 supervisor and/or PI.
• Provide quality assurance checks to note if protocols or UCSF CHR applications need to be modified; evaluate protocols on an ongoing basis and implement improvements as needed; ensure reporting of protocol violations to study sponsors and reporting of adverse events to the CHR within stated timelines.

• 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 to the Institutional Review Board, the University, and corporate or government sponsors.
• Enter all existing and new study protocols into the Committee on Human Research (CHR) online system; seek assistance on maintaining all protocols in the system by communicating with CHR Analysts.
• Renew, modify, and submit CHR applications and protocols; ensure that protocol applications are submitted in a timely manner; serve as a liaison between CHR and study Investigators.
• Develop and enhance case report forms and data collection forms as assigned.
• Develop and maintain systems for assuring protocol adherence and data quality.
• Create/submit IDE application and act as an FDA liaison for investigator led clinical trial.
• Initiate and follow-up on CHR submissions and modifications as assigned; track approval status.
• Order and maintain supplies required for study kits, track spending in this area, and make day-to-day decisions in support of assigned studies.

• Prepares and presents study materials to members of the interdisciplinary team regarding general research procedures and study specific elements of a protocol.
• Actively participate in regular team meetings.
• May assist in training new staff in preparation and conduct of clinical trials by providing oversight and guidance.
• Provide ongoing study specific training to other staff members to assure patient safety and adherence to the protocol.
• Helps develop strategies to ensure increased study awareness and subject screening and enrollment.

• Bilingual
• Attention to detail; strong interpersonal skills; excellent, effective verbal and written communication skills to coordinate with subjects, team members, other departments and outside institutions; and the ability to multi-task in a fast-paced environment while working with a diverse subject population.
• Ability to work well independently, complete projects in a timely manner, and prioritize multiple projects to ensure the completion of essential tasks by deadlines.
• Fluency in the usage of Committee of Human Research (CHR) online iRIS system for submission, renewal, and modification of protocols through this system.
• Understanding of patient population to create rapport and a relationship, while also giving insight to what is realistic and appropriate for patient participation.
• Knowledge of medical terminology and experience with electronic medical records.
• Knowledge of UCSF and departmental policies for dealing with reimbursement, guidelines for research, confidentiality and HIPPA regulations, following the UCSF 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.).
• Knowledge of research policies and guidelines.
• Knowledge of Computer programs needed: RedCap, Advanced EXCEL or like programs.

• HS graduation and sufficient experience and demonstrated skills to successfully perform the assigned duties and responsibilities.
• 2 years' experience in a clinical research environment.
• Experience applying the following regulations and guidelines:
  
  
  
  • 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.
• BA/BS with a major in biology, public health, psychology, sociology, or related field.