Niccole Robertson

760-***-**** adv6rg@r.postjobfree.com El Paso, TX 79938

SUMMARY

Highly motivated clinical research professional with over 10 years' experience contributing to and leading global clinical trials operations.

SKILLS

Microsoft Office Suite, Access, Outlook, Power Point, MS Project, Veeva Vault TMF and CDMS, EClinical EDC, Trium EDC, IBM EDC, Meta Data Rave EDC, Budget and Contract Negotiation

EXPERIENCE

Remote In-House Sr. CRA, Actalent Contractor, August 2021-May 2022

San Diego, CA

Contributed to study and site start-up activities in the planning and execution of a global Phase II study

Drafted annotated reports

Conducted CRO CRA training

Reviewed CRO study-specific training records and Sponsor-specific training

Reviewed, filed, and tracked site PSV, SIV, IMV, COV reports

Provided regular study updates to internal clinical project team

Facilitated communication between central lab, clinical testing laboratories, clinical project team, and cross functional groups

Ensured collection and review of required essential study documents and reports by having CRO oversight

Coordinated ordering, shipment, and disposition of clinical trial materials and samples

Coordinated EDC data entry (manual or programmatic) for study sites

Coordinated data transfers from central laboratory facilities, sample collection sites, and testing laboratories

Drafted and prepared trial-related documentation (study logs, forms, protocols, monitoring plans, study reference manuals, consent documents, letters of agreement, confidentiality agreements, etc.)

Reviewed study data to identify, document, and elevate data queries to the clinical testing laboratories or internal clinical project team

Primary liaison for contract and budget negotiations

Remote Lead CRA/Data Monitor, Hydrogen Group Contractor, July 2020-August 2021

San Diego, CA

Contributed to the planning and execution of US Phase II clinical trials, by providing in-house clinical support for diagnostic product development to achieve clearances and approvals globally

Managed the planning, implementation, and monitoring of multiple clinical trials in collaboration with the project team to meet study enrollment, testing, and delivery timelines per regulatory requirements, protocol, GCP and standard operating procedures, with a focus on clinical data

Reviewed, assessed, and interpret data from clinical studies and investigator led collaborations

Monitored clinical testing laboratories and ensure site compliance with protocol and overall study objectives, monitoring plans, SOPs, regulations, and ICH/GCP guidelines

Conducted site qualification, site initiation, routine monitoring, close-out visits and generated follow up reports

Lead teleconferences and remote site trainings with site personnel

Provided regular study updates to internal clinical project team

Facilitated communication between clinical testing laboratories, clinical project team, cross functional groups, IRB/EC, and pharmaceutical partners

Submitted protocols to IRB/EC, assisted clinical testing laboratories with IRB/EC submissions, and ensured collection and review of required essential study documents and reports

Coordinated site ordering of device reagents, shipment, and disposition of clinical trial materials and samples

Coordinated EDC data entry (manual and programmatic) for select internal clinical trials

Coordinated data transfers from central laboratory facilities, sample collection sites, and testing laboratories

Prepared and drafted trial-related documentation (study logs, forms, protocols, monitoring plans, study reference manuals, ICF, LOA, CDA, etc.)

Reviewed study data to identify, document, and elevate data queries to the clinical testing laboratories or internal clinical project team

Maintained project files and electronic Trial Master Files by uploading, classifying documents, and conducting periodic QC reviews

Assisted Clinical Trial Management System Coordinator with eTMF, CTMS, and EDC platform management and issue tracking.

Remote Clinical Trials Manager, Winsantor Biotech, September 2019-February 2020

San Diego, CA

Contributed to the planning and execution of global Phase I clinical studies from study start-up and maintenance

Managed the initiation of a large Phase I study in Canada, which required facilitation of communication between the sponsor, clinical site personnel and vendors, while ensuring vendors were executing activities according to signed contracts and agreed upon timelines

Daily duties focused on clinical site initiation, i.e., facilitation of site CTA and budget negotiation to final execution, sponsor monitoring oversight of CRO and organization of study documentation, including requirements for the sponsor's TMF, and medical monitor training initiation/ escalation

Facilitated and maintained FAQ log management and escalation by triaging and escalating to appropriate internal clinical department

In-House Clinical Research Associate II, Conatus Pharmaceuticals, June 2017-September 2019

San Diego, CA

Ensured protocol and planned protocol amendments were updated and provided to the CRO in a timely manner

Lead CRA for two complex NASH protocols with over 105 active sites globally

Supported efforts to plan, monitor and execute clinical research projects

Presented at investigator meeting for IP portion of trial

Maintained eTMF for active and archived studies

Ensured appropriate site follow-up for study participants where protocol-required lab triggers for monitoring liver function were generated

Provided support to the Liver Monitoring Adjudication Committee by ensuring that all required supporting documentation was available, complete, and translated as needed

Reviewed and reconciled all investigational product shipments at study completion

Reviewed and reconcile all laboratory samples throughout the study and at study completion across all studies

Provided oversite of the Central Lab across all studies

Contributed to site activation activities by reviewing essential documents to ensure they are complete to facilitate IP release and EDC access for all sites

Developed and drafted site recruitment material to provide to CRO for site distribution

Ensured that final timelines for randomization efforts were met by working closely with CRO

Made substantial efforts by ensuring goal of having a certain number of subjects randomized by first quarter by liaising with the CRO to encourage the sites to early recruit eligible subjects

Reviewed monitoring reports to identify issues and trends and escalate as needed

Tracked and review protocol deviations and worked with CRO to ensure appropriate action is taken to diminish or eliminate recurring deviations

Reviewed site specific Informed Consent Forms to ensure they are compliant with the regulations and include all Sponsor-specific language

Assisted with line listing reviews, EDC UAT, and subject eCRF review for consistency and completeness to generate and close queries

Actively participated and contributed to vendor sponsor project team meeting.

Clinical Research Associate, Arora Group Contractor - NMCSD Balboa Hospital, July 2015-June 2017

San Diego, CA

Managed protocol plans, timelines, and revisions of protocols, and ensured all were updated and submitted on time to Naval Medical Clinic IRB

Contributed to all aspects of study initiation, execution, maintenance, and close-out of studies for all department ophthalmology residents

Monitored CRFs, questionnaires and analyzed data according to research protocols and report results.

Contributed to all aspects of study initiation, execution, maintenance, and close-out of studies for all department ophthalmology residents

Managed data according to prescribed standards and transcribed data in case reports or data forms

Prepared documents for statistical analysis and descriptive data

Collaborated with other members of the research team to ensure consistent practice in patient care management

Ensured compliance with subject consenting and reporting of adverse events and side effects

Adhered to legal, professional, and ethical codes of conduct with respect to confidentiality and privacy

Ensured that all research efforts followed FDA and IRB-specific requirements and regulations

Clinical Specimen Acquisition - Scientist II, Siemens Healthcare Diagnostics, March 2012-June 2014

Newark, DE

Managed all human bodily fluids acquisition, to include full oversight of the Sponsor site's IRB approved Body Fluid Donor study

Processed all blood and urine samples to specification for instrument testing, to help facilitate placing instrumentation (medical device assays) on the market for OUS and US medical device sales

Managed obtaining samples from US vendors to help develop designs for a variety of assays, processes, and components

Provided guidance and trained junior support staff

Prepared weekly status update reports for projects, including graphs or data tables

Coordinated clinical logistics and managed donor and vendor reimbursements

Experience in handling imports / export of clinical samples

Knowledge of clinical trial logistics import/export and customs document requirements

Knowledge of IATA, DOT and Cold Chain UN-Packaging for shipping and storing requirements and FDA and USDA import requirements

Some knowledge of DEA regulations and can be certified for handling of Controlled Substances

Experience in process improvement and problem solving

Experience in SOP writing

Clinical Project Assistant, Aerotek Contractor, August 2010-October 2010

San Diego, CA

Managed organizing, scanning, and uploading general trial master files, central files, and investigator study files into the Sponsor's TMF

Created electronic folders and sub-folders for regulatory binders for study archival

Clinical Research Coordinator, Capital Medical Clinic, November 2006-November 2007

Austin, TX

Coordinated for all duties involved with overseeing a study site, to include being a medical assistant to eleven Internal Medicine Physicians

Provided secondary coordination of pharmaceutical research studies, focusing on, but not limited to, internal medicine

Recruited, educated, and obtain study subject enrollment and consent

Performed multiple procedures during the screening process, as well as throughout the course of the studies

Scheduled and conducted all study visits for participating subjects

Obtained donor vital signs, specimens, phlebotomy/EKG processing, packaging, and shipment of study specimens according to IATA Packing Instruction 650

Helped to dose study medication and maintained accurate records of dosing times, focusing on adverse events, which may or may not be related to the study drug

CRO and IVRS experience

Submitted all paperwork that was specific and pertinent to the IRB

Assured that all vital information and data was captured in a confidential and factual manner, and verified to complete casebooks, which are sponsor specific, for future review, by the FDA

Ordered and stocked inventory of study supplies, and specimen collection kits

EDUCATION AND TRAINING

Vocational Nursing Maric College, Vista CA August 2002

Phlebotomy/EKG Technician

Academy of Health Care Professions, Austin TX November 2006

Associate of Applied Science

General Studies, Colorado Technical University, Colorado Springs CO July 2009

Bachelor of Science

Business Administration w/focus in Healthcare Management, Colorado Technical University, Colorado Springs CO September 2011

ACCOMPLISHMENTS

US Army Combat Medic - April 1996 to April 1998

Association of Clinical Research Professionals (ACRP)

Certified Phlebotomy Technician 2006-2012

Electrocardiograph Technician

Who's Who Among American High School Students 1994-1995

Medical Device: Oncology - EGFR (IVD) and COVID – 19

Pharma: Cardiovascular Disease, NASH liver disease including portal hypertension, fibrosis, cirrhosis, respiratory including asthma insufficiencies, diabetes, hypertension, high and low cholesterol, glaucoma, TBI, rheumatoid arthritis and fibromyalgia

PROFESSIONAL CONFERENCES: Clinical Trials Supply Conference – Arena Clinical Trial Conference – 2018 & 2019

University of Delaware Lab Tech Basic Training Conference, 2013

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