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*Northern California Medical Associates is an Equal Opportunity Employer
Position Title: Research Coordinator – RN/LVN
Clinic: Redwood Family Dermatology; Research Department
Location: Santa Rosa, CA
Summary: A Research Coordinator utilizes a wide scope of basic clinical and clerical skills to assist the research team in the conduct of clinical trials. Tasks will vary from day to day, but will include assisting with patient screening, processing study documents and lab samples, scheduling patients, facilitating with patient visits, CFR completion, QA/document review, filing and other clerical work.
Duties and Responsibilities (includes, but is not limited to the following):
• Schedule subjects for study visits; meet with them to administer questionnaires, collect medical history and perform study procedures.
• Maintain rapport and relationships with subjects to ensure effective communication and retention.
• Obtain informed consent; review information with subjects; assess and advocate for patient safety throughout each protocol procedure.
• Negotiate study contracts and budget.
• Responsible for all tasks involved in recruiting subjects to participate in clinical trials.
• 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.
• Coordinate, communicate and network with other studies to ensure scheduling efficiency; communicate with any affiliated groups.
• Collect data during subject visits; enter data from visits, procedures, lab tests, and other subject-related participation into databases in a timely manner.
• Maintain data collection forms for effective data collection, entry, and analysis.
• Work with Supervisor to maintain complete and accurate data in the study database.
• Arrange the exchange of and transport of specimens with collaborating Investigators and staff.
• Oversee the incoming data interpreted from samples and ensure that it is utilized correctly for analysis and addition to study charts.
• Provide quality assurance checks to note need for updated source documents or ICFs based on protocol revisions.
• Responsible for maintaining accurate records of the location of each container of Investigational Medication.
• Ensure office is observing and adhering to all portions of industry good clinical practice (GCP) and International Counsel for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines.
• Maintain regulatory documents; monitor timelines for data submission; document adverse events and submit to appropriate departments.
• Participate in and cooperate with any internal and external audits or reviews of study protocols; prepare necessary documentation.
• Ensure that International Air Transportation Association (IATA) certification is maintained by all staff packaging and shipping lab samples.
• Ensure that all study staff have current certification from National Institutes of Health in the Protection of Human Research Participants.
• Conduct reviews of medical charts and electronic records to extract medical information and other data for use in studies.
• Collect blood samples, ECG’s, and mycology samples; take pictures and measurements.
• Instruct subjects on how to use study medication and electronic diary.
• Responsible for packaging and processing all lab specimens accordingly to correct protocol.
• Manage and process Pharmacokinetic samples.
• Responsible for monitoring temperature of locked freezer, locked refrigerator and locked Investigational Product storage.
• Responsible for ensuring all equipment is kept calibrated including but not limited to temp monitors, BP machine, centrifuge, patient thermometers; maintains records for review by Sponsors/CRO/FDA.
Education, Licensure and/or Certifications
• High school diploma
• Current Licensed Vocational Nurse (LVN) or Registered Nurse (RN) license
• Previous Clinical Trial/Research experience helpful.
Knowledge, Skills and Abilities
• Medical and research terminology.
• Knowledge of federal regulations and good clinical practice.
• Very strong organization skills & acute attention to detail.
• Strong interpersonal skills.
• Excellent oral and written communication skills.
• Ability to handle multiple projects simultaneously and prioritize logically.
• Ability to take ownership of tasks / projects and see them through to completion.
• Self-starter with the ability to work independently.
• Ability to use electronic health record and basic Microsoft Office applications.
Physical Demands: The physical demands described here are representative of those that may need to be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• Requires full range of body motion including handling patients, manual and finger dexterity and eye-hand coordination.
• Requires standing and walking for extensive periods of time.
• Occasionally lifts and carries items weighing up to 30 pounds.
• Requires corrected vision and hearing to normal range.
• May require working irregular hours.
Work Environment: The work environment characteristics described here are representative of those an employee may encounter while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• Frequent exposure to communicable diseases, toxic substances, ionizing radiation, medical preparations and other conditions common to a clinic environment.
• Work hours may vary according to the need of the team and specific studies.
• Requires some travel to investigator meetings.