Torrance, US-CA 90502
Part-time position; work less than 30 hours per week (no benefits)
# of Openings:
Minimum education requirements:
GED or high school diploma
2/12/19 2:07 PM
RA will be provided with all the available training and assistance at the beginning to master the skills for carrying out the duties, responsibilities and expectations of this position, which include (but may not be limited to) the following:
- Understand the main workflow of standard operations of COG clinical studies
- Understand the structure of COG protocols to be competent of using appropriate sections for gathering information, for bio-specimen and data submission and processing, eligibility, adverse event reporting, etc.
- Preparation of patients’ charts (hardcopies) for registration and therapeutic studies, including labeling, data flagging, preparation of clear-completed roadmaps, etc.
- Be able to timely process the updates of existing, or prepare new study consent forms with collaboration with local IRB. Provide investigators with most up-to-date consent forms for time sensitive enrollments. Co-review of signed consents for addressing any gaps, making copies and labeling for medical records and families.
- Obtain access and proficiency for using required multiple e-systems such as Imed-iRIS, OPEN, RAVE, imedidata, CTEP/NCI, CIRB, COG and other relevant websites
- Close follow-up and timely data entry to avoid/address delinquencies and queries
- Adverse event reporting/data entry with investigators’ help and supervision to CTEP/NCI, COG and LABiomed IRB via Imed-iRIS when applicable
- Label/Ship bio-specimens and maintain shipment log and address book
- Review eligibility criteria per study with investigators
- Review baseline studies before enrollment and follow-up throughout therapy
- Continuous maintenance and at least yearly update of Annual PI Worksheet
- Maintain patient database for COG studies
- Keep minutes from divisional COG meetings
- Communication with current CRA, COG CRAs and occasionally study chairs for specific studies (including weekends as needed)
- Communication/collaboration with investigational drug pharmacy, assisting in pharmacy documentation maintenance including DARFs, etc.
- Site’s COG roster follow-up, reminder e-mails and guidelines for appropriate annual renewals to maintain active membership for required staff
- Support with preparation of COG Audits, including scheduling/organization, regulatory part with IRB/ICFs e-documents, pharmacy documentation part, as well as hardcopy-charts for all the patients. Be present for Audits and guidance of inspectors. Follow-up Audit reports and actively participate in response preparation/delivery.
- Plan to attend COG meetings, especially CRA related sessions - desirably once a year (Travel and related expenses will be compensated separately from COG funds).
- Additional COG study related tasks maybe required for new studies, changing rules and regulations, and as field evolves.
Required Skills & Qualifications
- High School or GED required
- Relevant work experience is desired but not required