7528- OBG OBGYN
The primary role of this position is to support clinical research involving reproductive health and contraception.
Job duties include:
- Preparation and completion of feasibility surveys
- Contribute to the grant application process
- Develop plans for protocol implementation, identify necessary resources and request as appropriate. This includes instruments, equipment and staff.
- Determine recruitment objectives and develop systems to monitor and track achievement
- Carry out required staff training and provide the direct supervision for research assistants and other staff
- Develop all day to day plan and procedures for data collection as well as data confidentiality and data security.
- Responsible for mechanisms and details of protocol adherence and for providing administrative back-up to PI
- Preparation and submission of annual reports and regulatory information to funding and regulatory agencies
- Develop local systems for secure storage of drugs and supplies and be the point of contact for the research pharmacy
- Preparation of IRB applications
- Preparation and submission of regulatory documentation to the regulatory bodies as relevant
- Assist investigators with validation and editing of collected data
- Analyze study data and assist in preparing manuscript
- Regular collaboration with the PI and other research staff
- Lead CRC of project or network
- Develop and maintain procedures for organizing work and staff
- Attend investigator meetings as needed
- Carry out required staff training and provide the direct supervision for assigned staff
- Maintenance of study documents and files, such as regulatory binders and CVs etc.
- Completion of GCP, HIPPA and applicable regulatory training
- Complete certification requirements for assigned protocols
- Screen designated schedules or patient lists for eligible subjects
- Approach and verify eligibility subjects
- Consent and enroll eligible subjects
- Complete research study visits as delineated in assigned protocol and manual of operations set forth by sponsor and supervisor.
- Complete Telephone follow-up and telephone reminder calls for study participants, during these phone calls the person will need to administer study questionnaire as assigned
- Coordinate the collection of all research data points as assigned, whether through research visits, chart abstraction or telephone.
- Scheduling of research visits
- Collection through venipuncture of biological specimens
- Processing, transporting and shipping of biological specimens as assigned and following of instructions as delineated in the protocol or manual of operations.
- Completion of study documents and files; some examples might include case report forms, worksheets and medical record notes.
- Maintain confidentiality of documents and files such as HIPPA.
- Informing relevant clinical staff regarding subject protocol participation.
- Assist in other research related activities and projects as needed
Additional Requires:
ACRP or SOCRA certification
Phlebotomy certificate within 6 months of hire.
Experience in a clinical research setting, especially randomized controlled trials
Capable of working on multiple studies and multi-tasking
Knowledge of medical terminology specifically related to reproductive health and contraception
Excellent interpersonal, written/oral communication, and organizational skills are required
Proficiency in Microsoft Office
Knowledge of SPSS
Complete proficiency in written and spoken English
Requires a bachelor's degree or equivalent in education and experience, plus four years of related experience.
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