Clinical Research Coordinator

Software Guidance & Assistance, Inc., (SGA), is searching for a Clinical Research Coordinator for a Contract assignment with one of our premier Healthcare clients in San Francisco, CA .

Responsibilities :

• 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

Required Skills:

• 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 with Clinical Research Trials (Drug and Device, Retrospective, prospective, randomized, open labels, etc.)

Preferred Skills:

• Bilingual
• 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 research policies and guidelines
• Knowledge of Computer programs needed: RedCap, Advanced EXCEL or like programs
• 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
• APeX/Epic (EMR), RedCaP, ONCORE, and various EDC(Medrio, Medidata, etc)

SGA is a technology and resource solutions provider driven to stand out. We are a women-owned business. Our mission: to solve big IT problems with a more personal, boutique approach. Each year, we match consultants like you to more than 1,000 engagements. When we say let's work better together, we mean it. You'll join a diverse team built on these core values: customer service, employee development, and quality and integrity in everything we do. Be yourself, love what you do and find your passion at work. Please find us at .

SGA is an Equal Opportunity Employer and does not discriminate on the basis of Race, Color, Sex, Sexual Orientation, Gender Identity, Religion, National Origin, Disability, Veteran Status, Age, Marital Status, Pregnancy, Genetic Information, or Other Legally Protected Status. We are committed to providing access, equal opportunity, and reasonable accommodation for individuals with disabilities in employment, and our services, programs, and activities. Please visit our company to request an accommodation or assistance regarding our policy.

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