Technical Specialist Level II - Clinical Research Associate

JOB DESCRIPTION:

The Clinical Research Associate will join our quality team experts in ensuring research quality by conducting study site monitoring (80%), database development (10%), and data management (10%) for multiple research protocols funded by the NIH and pharmaceutical companies.

JOB DUTIES:

• Coordinate all necessary activities required to set up and monitor a study, including completing accurate study status reports, conducting on-site and remote site visits.
• Ensure the investigator and study staff follow applicable regulations, ICH-GCP Guidelines, and the approved protocol.
• Prepare letters and reports to communicate all findings to the PI, the Project Manager, and the Sponsor.
• Review regulatory documentation as required by the Study Monitoring Plan.
• Define data collection methods based on protocol aims.
• Collaborate with study team members and investigators to determine data collection specifications.
• Program forms/CRFs within the EDC system per protocol specifications.
• Identify and program edit checks and logic specifications.
• Perform internal/external database acceptance testing.
• Prepare CRF and/or EDC entry completion guidelines.
• Create standard, study-specific, and ad hoc reports.
• Perform database updates as needed per protocol amendments.
• Perform quality control review checks to ensure data integrity.
• Serve as a resource for site research staff to ensure adherence to protocol specifications.
• Review IP shipment and distribution as required by the Study Monitoring Plan.
• Verify that informed consent was obtained and documented appropriately.
• Attend teleconferences and provide consultation as required.
• May participate in co-monitoring and/or training visits with other team members for training purposes.
• Assist with the organization and management of internal team meetings, investigator meetings, and other research-specific meetings, as required.
• Maintain completion of required training on standards, policies, and work instructions.
• Perform other work-related duties as assigned and under the direction of the Division Director.

JOB QUALIFICATIONS:

Minimum Qualifications:

• Bachelor's degree.
• Willingness and ability to travel

Preferred Qualifications:

• Certification by SOCRA, SCDM, ACRP or similar entities.
• BA/BS or equivalent degree in a scientific discipline or related healthcare field.
• Well-organized, proactive, and have excellent interpersonal and communication skills.
• Ability to work independently under limited supervision.
• Research experience and interest.
• Knowledgeable of clinical research operations, including interpretation and implementation of FDA regulations/ICH-GCP guidelines
• Good computer skills (MS Office products, word processing, spreadsheets).
• Familiarity with SAS programming and electronic data collection methods.

Background Investigation/Justice Center Review Requirements:

Prospective appointees will be: 1) Checked against the Staff Exclusion List (SEL) maintained by the Justice Center for the Protection of People with Special Needs. Prospective employees whose names appear on the SEL as having been found responsible for serious or repeated acts of abuse or neglect will be barred from appointment. 2) Screened against the Statewide Central Register of Child Abuse and Maltreatment (SCR). Prospective employees whose names are indicated on the SCR may be barred from appointment.

• The Research Foundation is a private not-for-profit corporation and is not an agency or instrumentality of the State of New York. Employees of the Research Foundation are not state employees, do not participate in any state retirement system, and do not receive state fringe benefits. Excellent Benefits Package. Affirmative Action/Equal Opportunity Employer/Minority/Women/Disabled/Veteran Employer. VEVRAA 41 CFR 60-300.5(a) compliant.

Applications will only be accepted through website at: http://corporate.rfmh.org - Click on Employment Opportunities. Applications will be accepted only during the posting dates as listed at the top of the job announcement.

Questions regarding this position please email: hrprocessing@nki.rfmh.org