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Clinical Research

Location:
Clarksburg, MD
Posted:
October 14, 2018

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Resume:

Surbhi Kanotra, MS, CCRP

ac7dsc@r.postjobfree.com

240-***-****

PROFESSIONAL EXPERIENCE

Virginia Commonwealth University Richmond, VA

Graduate Student 2006 – 2016

Obtained M.S. in Psychology (2010) and continued doctoral work in Counseling Psychology.

VCU Division of Hematology, Oncology & Richmond, VA Palliative Care at Massey Cancer Center

Regulatory Affairs Specialist I December 2010 – June 2014

- Primary regulatory point of contact for up to 60 cooperative groups (sponsored by NIH), industry, and investigator initiated oncology clinical trial studies conducted at VCU Massey Cancer Center and Hunter Holmes McGuire VA Medical Center.

- Provided protocol and study site support to study sponsors and study personnel.

- Collaborated with study teams and IRBs (local VCU IRB, WIRB, and CIRB) to address all regulatory and compliance issues.

- Managed and guided project-specific activities from site initiation to close-out.

- Ran weekly status reports from clinical research management module (OnCore®) to track status of current protocols to present to the regulatory and study teams.

- Monitored and maintained communication tools (Group regulatory inbox, clinical trial database communication queue, Institutional Review Board queries on assigned studies).

- Documented all protocol updates (including: informed consents, protocol amendments, Investigators Brochure, Prompt reporting) in OnCore® to document of project status for the center and study teams.

- Prepared documents and study materials for monitoring visits and sponsor audits.

- Lead regulatory team on transition from paper to electronic submissions for local IRB.

- Obtained SOCRA’s Certification for Clinical Research Professionals in 2013.

American Red Cross Rockville, MD

Research Compliance Associate August 2004 – July 2006

- Coordinated all IRB submissions and managed IRB reviews (full, expedited, or administrative), renewals, and terminations according to federal regulations.

- Prepared summary of submissions for full IRB Board review, finalized meeting agenda, oversaw the preparation of meeting materials, and prepared meeting minutes.

- Coordinated and attended all Institutional Review Board (IRB) meetings. Sent memorandums and correspondences to investigators regarding the Board’s decisions regarding their studies.

- Coordinated with facilities and catering departments for monthly meetings.

- Maintained all research study files, IRB Administration files, and database of all submissions and actions. Maintained Access database of active protocols to track submission deadlines for investigators. Sent submission reminders to investigators.

Human Genome Sciences, Inc. Rockville, MD

Research Associate I September 2002 – December 2003

- Maintained stable and transient cell lines for both transient and stable transfections to generate antibodies and protein.

- Applied several techniques, including sub-cloning, cell-mediated cytotoxicity assay, antibody phage display technology, ELISA, flag-tagged protein purification, in support of projects related to drug development.

Human Genome Sciences, Inc. Rockville, MD

Manufacturing Associate I October 2001 – September 2002

- Setup a new cGMP Microbial Clinical Production Suite (MiCPS): participated in Factory and Site Acceptance Test of B. Braun Biotech bioreactors; involved with validation of equipment; ordered lab supplies; wrote and reviewed SOPs.

- Learned the SOP documentation process and managed all draft and final SOPs being written for the MiCPS start-up. Coordinated training on the new SOPs as they are approved.

PUBLICATIONS

Foster, R. H., Kanotra, S., Stern, M. & Elsea, S. H. (2011). Education and occupational aspirations among mothers caring for a child with Smith-Magenis syndrome. Journal of Developmental and Physical Disabilities, 23 (6), 501-514. doi 10.1007/s10882-011-9241-5

Kanotra, S., Foster, R., Kozachek, S., Stern, M., and Elsea, S. (Winter 2009). Smith-Magenis Syndrome Caregiver Study: Results and Recommendations - Part 3: SMS Caregiver Education and Career. PRISMS: Spectrum, 13(1), 4-6.

Foster, R., Kozachek, S., Kanotra, S., Stern, M., and Elsea, S. (Fall 2008). Smith-Magenis Syndrome Caregiver Study: Results and Recommendations - Part 2: SMS Caregiver Well-Being. PRISMS: Spectrum, 12(4), 1, 4-8.

Kozachek, S., Foster, R., Kanotra, S., Stern, M., & Elsea, S. (Summer 2008). Smith-Magenis syndrome caregiver study: Results and recommendations. PRISMS: Spectrum, 12(3), 1, 4-7. POSTER PRESENTATIONS

Kanotra, S., Stern, M. (Spring 2011). Health Behaviors of Mothers with Premature Infants Hospitalized in the Neonatal Intensive Care Unit (NICU). Poster session presented at the Graduate Student Association’s 10th Annual Research Symposium and Exhibit, Richmond, VA.

Kanotra, S., Foster, R., Kozachek, S., Stern, M., and Elsea, S. (Spring 2011). Educational and Career Aspirations Among Mothers Caring for a Child with Smith-Magenis Syndrome. Poster session presented at the Institute for Women’s Health’s 7th Annual Women’s Health Research Day, Richmond, VA.

Kanotra, S., Stern, M. (Spring 2011). Relations of Depression, Social Support, and Socio- Demographic Factors on Health Behaviors of Mothers with Premature Infants Hospitalized in a Neonatal Intensive Care Unit (NICU). Poster session presented at the Institute for Women’s Health’s 7th Annual Women’s Health Research Day, Richmond, VA.

Foster, R., Kozachek, S., Kanotra, S., Elsea, S. & Stern, M. (2008, April). Caring for a child diagnosed with Smith-Magenis Syndrome: Preliminary analysis of caregiver well-being. Poster session presented at the Institute for Women’s Health’s 4th Annual Women’s Health Research Day, Richmond, VA.

Foster, R., Kim, Hana, Durrette, M., Kanotra, S., Stern, M., Dillon, R., Bitsko, M., Dunn, N., Godder, K., & McClish, D. (2007, April). Academic aspiration, career self-efficacy, health behaviors, and quality of life in adolescents with cancer or sickle cell disease. Poster session presented at the Graduate Student Association’s 10th Annual Research Symposium and Exhibit, Richmond, VA.

Kanotra, S., Bailey, C., Smith, O.P., & Damsteegt, V.D. (2000, March). Cloning and partial sequence analysis of complementary DNA that corresponds to the 5' portion of the RNA genome of the dwarfing strain of soybean dwarf luteovirus. Poster session presented at Hood College and at the Potomac Division of the American Phytopathological Society (APS) Annual Meeting at University of Delaware.

CERTIFICATIONS & PROFESSIONAL ORGANIZATIONS

Society of Clinical Research Associates (SOCRA) Certified Clinical Research Professional (CCRP®): March 2013 – Present

SOCRA Member: March 2013 – Present

EDUCATION

Master of Science (MS) in Psychology December 2010 2006 – 2010 Virginia Commonwealth University Richmond, VA Graduate Coursework in Counseling Psychology: 2011 – 2015

Bachelor of Arts (BA) in Biochemistry and Psychology, Cum Laude May 2001 1997 – 2001 Hood College Frederick, MD

Surbhi Kanotra P a g e 4

CONTINUING EDUCATION & SKILLS

- “Military Cultural Competency and Treating Behavioral Health Needs of Service Members, Veterans, and Their Families.” The Maritime Institute, Linthicum Heights, MD. October 21, 2015.

- “The ABC’S of LGBTQ: Identifying, Supporting, and Meeting the Needs of LGBTQ Youth in Our Community.” Chesapeake College, Wye Mills, MD. September 30, 2015.

- “Good Clinical Practice and Clinical Trial Data Management.” Barnett Education Services (sponsored by VCU Massey Cancer Center). January 9 – January 10, 2014.

- “Foundations in Oncology – Intermediate.” VCU Massey Cancer Center, Richmond, VA. October 19 – October 20, 2011.

- “Foundations in Oncology – Beginners.” VCU Massey Cancer Center, Richmond, VA. October 11 – October 12, 2011.

- “Basic Forensic Evaluations: Principles and Practice.” The Institute of Law, Psychiatry and Public Policy, Charlottesville, VA (University of Virginia), October 5 – 9, 2009.

- 2005 Annual Institutional Review Board (IRB) Conference – PRIM&R and ARENA Conference, December 2 – 6, 2005 and October 28 – 31, 2004.

- 2004 Annual Institutional Review Board (IRB) Conference – PRIM&R and ARENA Conference, October 28 – 31, 2004.

- Computer Skills: Proficient with MS Office, OnCore®, SPSS, SAS.



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