Website Ampcus Incorporated
Ampcus Incorporated
Company : Ampcus Incorporated
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
Job Overview:
Incumbent will provide clinical research coordination for a variety of health policy, observational, and clinical outcomes studies as assigned. The CRC will be responsible for recruiting study participants through screening in person, via Epic, and by phone. The CRC will collect data as required by study protocols from the enrolled participants. The CRC will assist with IRB submission and other regulatory documentation maintenance needed for each study supported.
The incumbent will work under the direction of their supervisor in support of Department PI. The selected individual will play a critical role in coordinating aspects of clinical research daily operations on assigned studies within the Department of Orthopaedic Surgery. The Clinical Research Coordinator (CRC) will ensure successful implementation of and adherence to clinical research protocols regarding planning, administration, participant confidentiality, timeline management enrollment, participant engagement, data/sample collection, and reporting. The CRC will demonstrate competence in clinical research skills, problem solving, priority-setting and serve as a resource for others in the department for all aspects of conducting a clinical trial. This requires close interaction with patient care staff, research team members and study personnel at other sites. Study duties include the coordination of research protocols, including coordination of the data/specimen collection and operations of several concurrent clinical research studies under the guidelines of research protocols, University and regulating agency policies. This includes but is not limited to collecting and reporting on study results; create, clean, update, and manage databases and comprehensive datasets and reports; and coordinate project workflow with research team members. Critical duties include preparation, coordination and/or maintenance of regulatory documentation in the CHR system as well as all other reporting / compliance requirements.
Key Responsibilities:
Study Coordination:
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, University 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., University 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 University 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 University 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.
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 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.
Study Communications and Education:
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.
Knowledge, Skills and Abilities:
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 University and departmental policies for dealing with reimbursement, guidelines for research, confidentiality and HIPPA regulations, following the University 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.
Education, Training and Experience:
HS graduation and sufficient experience and demonstrated skills to successfully perform the assigned duties and responsibilities.
2 years’ experience in a clinical research environmen.
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 fiel.
Ampcus is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veterans or individuals with disabilities.