Rabia R. Ali

adiw16@r.postjobfree.com

703-***-****

PROFILE

ACRP-CP Certified Administrative Research Professional with extensive 12+ years of experience in all different aspects of Clinical Research. Experience as a Lead Clinical Research Regulatory Coordinator and an in-house CRA at the Inova Orthopedic Trauma Research department and managing multinational cardiac trials at the Inova Heart and Vascular Research Institute. Wide range of experience in regulatory maintenance of the studies, start-up, expansion and maintenance of the clinical studies. Retained close relationship with clinical investigators to improve protocol compliance, improved serious adverse event reporting, met timelines by closely working with clinical coordinators. Trained and supervised new research staff members to ensure protocol compliance and adherence to GCP principles. Adheres to ICH-GCP DHHS (OHRP and FDA) and Inova Health System policies when implementing research studies to ensure highest quality research and human subject protection. Excellent interpersonal, phone, and digital communication skills.

Research/Work Experience

Lead Clinical Research Coordinator June 2017 – Present

Inova Center for Personalized Health/ Inova Schar Cancer Institute

Provided oversight of multiple cancer disease groups’ clinical trials including Proton Therapy, Head and Neck cancers, Gastrointestinal and Basket research studies. This includes studies with Investigational New Drug (IND)s, Devices and Investigator Initiated studies applications, compliance, and submission tracking

Prepared and coordinated all regulatory activities from pre-site selection visits, site tours, initial applications, site initiation, monitoring, Amendments & Continual Reviews including protocol review, document compiling, electronic regulatory submission and timeline tracking for pharmaceutical, cooperative group and investigator-initiated studies.

Worked directly with Sponsors and CROs with Pre-site Selection Visits, Site Initiation Visits, close-out visits and audits.

Lead and participate in projects to efficiently optimize regulatory processes and facilitate best practice approaches to ensure compliance in accordance with GCP, ICH, FDA and Institutional and Alternate Review Bards regulations.

Directed, trained and assisted fellow Clinical Research Coordinators and Research Project Associates with protocol compliance, subject data submission requirements, SAEs and deviations submissions.

Provided oversight for regulatory activities to ensure that records are complete, accurate, and current for Trial Master Files (TMF) (e.g., Financial Disclosures, Delegation Logs, Training Logs, 1572, approved protocol, Investigator’s Brochure, consent forms, safety reports, investigator and staff CV’s and professional licenses, etc.)

Analyzed and Merged ICF’s to ensure regulatory, IRB and protocol compliance

Supervised and managed new team members training to ensure regulatory tasks, goals and timelines are met for ongoing trials

Partnered with project managers to discover and resolve potential issues and deviations

Identified areas of improvement for work process tools including regulatory templates, SOPs, work instructions, checklists, trackers, etc.

Effectively communicated with internal executive leadership and team members with trials updates and requirements.

Presented Basket Trials at the Molecular Tumor Boards for staff.

Worked with the new research office database (Oncore) and (eReg) to reflect all current versions of study related documents (e.g., protocol, consents, Investigator’s Brochure, QOL’s, patient diaries, etc.)

Experienced with WIRB, CIRB, and the Advarra institutional review boards

Experienced with working remotely, troubleshooting, prioritizing, and working in a fast-paced environment

Performed searches, attend meeting and calls to gain regulatory intelligence, strategy development in order to support research portfolio, regulatory document preparation, submissions and identification of regulatory policy changes

Clinical Research Associate May 2016 – December 2016

Inova Ortho-Trauma Research Department

Provided cross-functional support to the Ortho-Trauma Research department by collaborating with surgery team, anesthesia, residents, physician assistants, outside institutions and organizations, including administrative staff, surgeons, nurses, and patients.

-Work as a study coordinator for the following studies; REGAIN - A Randomized Controlled Trial of Regional Versus General Anesthesia For Promoting Independence After Hip Fracture

-VANCO - Local Antibiotic Therapy to Reduce Infection after Operative Treatment of Fractures at High Risk Infection

-CiDUCT - Comminuted Intra-Articular Distal Tibia Fracture Fixation Using Computer Surgical Planning and 3D Prototyping Techniques

-POvsIV - A Prospective Randomized Trial to Assess PO versus IV Antibiotics for the Treatment of Early Post-op Wound Infection after Extremity Fractures

Effectively prepared and oversaw regulatory documents – regulatory files, and study conduct logs for multiple ongoing projects.

Identified, recruited, and consented eligible patients for numerous studies.

Established and maintained relationships with, and acted as primary point of contact for, principal investigators, clinical staff, and site personnel with hospital departments, as well as other participating institutions and organizations.

Collected, validated, and entered data using established tools, technology and databases such as INOVA REDCap, EpicCare EHR, METRC REDCap, Oracle RDC, and APEX as well a strong understanding of MS Office suite to create spreadsheets and presentations

Research Project Associate April 2014 – April 2016

Inova Cardiac Surgery Research Department

Provided cross-functional support to the Cardiac Surgery Research department by collaborating with teams from different hospital units, outside institutions and organizations, including administrative staff, surgeons, nurses, and patients.

Work as a study coordinator for the del-Nido cardioplegia study.

Create and Enter the Valve surgery chart

Effectively prepared and oversaw regulatory documents – consent forms, amendments to studies, annual review documents, letters to patients, regulatory files, and study conduct logs for multiple ongoing projects.

Identified, recruited, and consented eligible patients for numerous studies.

Established and maintained relationships with, and acted as primary point of contact for, principal investigators, clinical staff, and site personnel with hospital departments, as well as other participating institutions and organizations.

Created, scheduled, and presented in-services to department staff for education, understanding, and cooperation with studies, as needed.

Successfully prepared clinical staff for specimen collection specifications and times.

Maintained proper storage, usage, and accountability of research supplies and specimens.

Collected, validated, and entered data using established tools, technology and databases such as Apollo and EpicCare EHR, as well a strong understanding of MS Office suite to create spreadsheets and presentations.

Trained and supervised new research assistants to ensure protocol compliance and adherence to GCP principles.

Research Assistant August 2012 – March 2014 George Mason University/Center of Applied Proteomics and Molecular Medicine

Assisted Dr. Virginia Espina and Dr. Lance Liotta on a proteomic research study of the Triple Negative Breast Cancer.

Performed experiments to distinguish Antibodies to specific proteins.

Used techniques such as Microarrays, Autostainers, Western Blott and Cell Cultures.

Worked with a team of great leaders in the molecular biotechnology field.

Learned many techniques such as Reverse Phase Arrays, Laser Capture Microdissection, analyzing samples using nanoparticles, and cell cultures.

Research Assistant January 2008 – August 2012

George Mason University/Department of Neuroscience

Assisted Dr. Jane Flynn and Post-Doctoral students on multiple Alzheimer’s research study.

Performed experiments to distinguish different cognitive and behavioral changes in mice.

Worked with a team of great leaders in the molecular biotechnology field.

Worked with lab team on collecting data on the effects of Zinc in Alzheimer’s disease.

Education:

Georgetown University

Masters of Science, September 2015

Physiology and Biophysics

George Mason University/Georgetown University

Advanced Biomedical Sciences Graduate Certificate (George Squared), May 2013

George Mason University

Bachelors of Science May 2011

Major: Neuroscience Minor: Psychology

Contact this candidate