KHANMASOOD 09Sep2016

CURRICULUM VITAE
Masood M Khan, B.Sc., MD
1200 West Sturbridge Drive, Hoffman Estates, IL 60192
Cell-847-977-2211
janozai@hotmail.com
CAREER HIGHLIGHTS
THERAPEUTIC EXPERIENCE
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 Years in the Industry: 13 years in the clinical research industry in Oncology,
Gastrointestinal, Cardiovascular, Hematology, Genetics, Nephrology, Neurology and
Immunology indications and medical experience as a Medical Doctor and General
Surgeon in India.
 CRA Experience: 13 years of CRA experience
 Industry Experience: Experienced in CRO side of the industry
 Supervisory/Mentoring/ Training Experience: Trainer for any study as a Visit Leader
and trained new employees in medical terminology at former job.
 Clinical Experience: 7 years experience working as an MD in India and as a general
Surgeon in ER and Trauma centers.
 Additional Valuable Experience: Experience with site feasibility, site
selection/initiation/monitoring/close-out visits, study metrics tracking, EDC (Rave)

Updated 09Sep2016
EDUCATION
MD, March 1992
Deccan College of Medical Sciences, Hyderabad, India
Degree received thru Osmania University
B.Sc, March 1987
Anwar-Ul-Uloom College, Hyderabad, India
EMPLOYMENT
United BioSource Corporation
Blue Bell, PA
Senior Clinical Research Associate (Sr. CRA)
February 2016 - Present
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Oncology Neurology
Breast--Phase III MS – Phase II
Ovarian – Phase III AD – Phase III
NSCLC – Phase III
Melanoma—Phase 1b/II
Prostate – Phase III Genetics
Bladder– Phase III PKU–Phase II/III
Colorectal – Phase II/III ACH-Phase I/II
Multiple Myeloma—Phase II
Haematology Immunology -RA, Psoriasis, SpA-–Phase II/III
Anemia – Phase II
Gastrointestinal Nephrology-CKD-–Phase III
IBS study– Phase II/III
Cardiovascular Device--Breast Implant Follow-up Study Phase IV
Hypercholesterolemia– Phase II
Hypertension– Phase II/III
Heart Failure and Left Ventricular Systolic
Dysfunction – Phase II
Acute decompensated heart
Failure (ADHF)-Phase IIIb/IV

Updated 09Sep2016
• Thorough knowledge and application of project specific protocol
• Consistently completes on site monitoring in accordance with project specific timelines
• Consistently completes travel scheduling in accordance with project specific and UBC guidelines
• Attends project team meetings, department meetings and minimum of monthly 1:1 with manager;
responsible for content of these meetings
• Consistently completes site monitoring reports, confirmation/follow-up letters per UBC and/or
client SOPs; signs, scans and/or provides to CSS/RDS for filing in Trial Master File according to
UBC and/or sponsor timelines requiring minimal corrections
• Ensures follow-up of site issues and action items per UBC/sponsor timelines
• Enters site visits, confirmation/follow-up letters and site monitoring reports into CTMS
• Ensures completion of Call Log or Telephone Contact Report detailing communication with sites
per protocol
• Monitors within EDC data entry, if applicable, and assists sites with DCF resolution
• Completes Regulatory Binder and Investigational Product reconciliation
• Maintains regular contact with assigned sites per study requirements
• Consistently submits expense reports within UBC timelines; consistently follows UBC Travel
Guidelines
• Consistently completes SOP review and documentation within requested timelines
• Consistently completes sponsor specific training and documentation within requested timelines
• Assists PM and management team by being an AIM leader, upon receipt of AIM training
• A = Assess visit type, assess protocol specific and UBC SOP knowledge and assess individual’s
ability to perform visit type independently
• I = Instruct how to conduct visit, report/letter writing and manage issues and actions
• M = Mentor team member by sharing tips/tricks/tools reviewing process prior to and after visit
• Assists management team by mentoring other CRAs
• Assists with preparation and/or delivery of presentations for UBC Academy, departmental training
and/or sponsor specific training
Quintiles
Regional: Chicago, Illinois
Sr. CRA 3
September 2014 to 10Feb2016
Monitor (pre-study, initiation, routine, and close-out visits) at investigator sites (up to 80%
travel) for GCP compliance according to SOPs and/or client guidelines
o Perform routine site visits, including Pre-Study, Initiation, Routine, and Closeout visits. Visits
to include monitoring of proper informed consent procedures, compliance with protocol,
GCP/ICH Guidelines, and other applicable regulatory requirements, and assurance of good site
performance.
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Updated 09Sep2016
o Document each visit with a quality written monitoring visit report and submit to the reviewer
for review and approval within contractual guidelines
o Author and send follow up letter to investigative site documenting the visit and any outstanding
items to be addressed within contractual timelines.
o Review and approve monitoring visits reports ensuring finalization within contractual
obligations
o Assist Project Managers in study execution by acting as Lead CRA on projects and facilitating
communication with Clinical Monitoring team
o Perform monitoring evaluation visits with CRAs
o Develop and facilitate training for colleagues on clinical, regulatory, administrative, and
company procedures and processes
o Develop study specific tools for tracking and reporting for Clinical Monitoring team
o Participate in feasibility studies
o Develop and write Clinical Monitoring Plans
o Present study materials at Investigator/study launch meetings with required
o Support project management team with assessment of workload and site assignments within the
project team
o Assist project management team with review of monitoring reports and study documents with
required
o Participate in company-required training programs
o Participate on BID defense meetings
o Perform necessary administrative functions (e.g. submission of expense reports, entering time).
o Train/Mentor junior CRAs on monitoring, internal procedures, and query resolution
o Perform regulatory activities, if applicable
InVentiv Health Clinical
Senior Site Manager
February 2014 to September 2014
Monitor (pre-study, initiation, routine, and close-out visits) at investigator sites (up to 80%
travel) for GCP compliance according to PharmaNet SOPs and/or client guidelines
o Perform routine site visits, including Pre-Study, Initiation, Routine, and Closeout visits. Visits
to include monitoring of proper informed consent procedures, compliance with protocol,
GCP/ICH Guidelines, and other applicable regulatory requirements, and assurance of good site
performance.
o Document each visit with a quality written monitoring visit report and submit to the reviewer
for review and approval within contractual guidelines
o Author and send follow up letter to investigative site documenting the visit and any outstanding
items to be addressed within contractual timelines.
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Updated 09Sep2016
o Review and approve monitoring visits reports ensuring finalization within contractual
obligations
o Assist Project Managers in study execution by acting as Lead CRA on projects and facilitating
communication with Clinical Monitoring team
o Perform monitoring evaluation visits with CRAs
o Develop and facilitate training for colleagues on clinical, regulatory, administrative, and
company procedures and processes
o Develop study specific tools for tracking and reporting for Clinical Monitoring team
o Participate in feasibility studies
o Develop and write Clinical Monitoring Plans
o Present study materials at Investigator/study launch meetings with required
o Support project management team with assessment of workload and site assignments within the
project team
o Assist project management team with review of monitoring reports and study documents with
required
o Participate in company-required training programs
o Participate on BID defense meetings
o Perform necessary administrative functions (e.g. submission of expense reports, entering time).
o Train/Mentor junior CRAs on monitoring, internal procedures, and query resolution
o Perform regulatory activities, if applicable
ReSearch Pharmaceutical Services, Inc.,
Fort Washington, PA
Senior Site Manager
June 2010 to February 2014
Responsible for monitoring of study sites, as laid out in ICH/GCP Chapter 5.18 ‘Monitoring’. Duties
and Responsibilities (including but not limited to):
o Adhere with corporate internal polices and requirements, including submission of timesheets
and expense reports in a timely manner.
o Conduct study feasibility and site selection activities
o Develop and implement innovative approaches for and participates in site recruitment, selection
and initiation activities.
o Assist with investigator meeting activities including organization, preparation and attendance
o Conduct site management activities including but not limited to site selection visits, site
initiation visits, site training, site routine monitoring visits, and site close out visits.
o Ensure the integrity of clinical data and adherence to applicable regulatory, protocol, and
company guidelines.
o Establish and maintain good rapport with study sites.
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Updated 09Sep2016
o Write study visit reports and follow up letters within the timeline established by applicable
SOPs and guidelines
o Representation of CRAs during an audit or inspection when assigned
o Coordinate timely shipment of clinical supplies and study drug to sites.
o Ensure proper storage, dispensation and accountability of clinical supplies and study drug.
o Maintain adequate site tracking records
o Follow up of drug safety issues and safety reports in timely manner, if applicable
o Communicate site study issues, concerns, and progress to Project Manager, Clinical Team Lead
and Clinical Research Manager accordingly
o Develop and implementation of corrective actions when appropriate
o Assist with data query form (incl. query process)
o Prepare /review all patients tracking records
o Input and maintain study information concerning subject status of financial reimbursement to
sites.
o Conduct and assist with administrative activities as a member of the project team.
PRA International
Sr. Clinical Research Associate
February, 2007-June, 2010
• Implements and monitors clinical trials to ensure sponsor and investigator obligations are being
met and are compliant with applicable local regulatory requirements and ICH guidelines
O Visits sites to assess the qualification of potential investigative sites, initiate studies,
instruct site personnel on the proper conduct of studies, to review data and ensure
accuracy of data collected and to terminate studies
O Provides regular clinical status information to team members and project management
O Performs billable work in accordance with company policies, procedures, and Standard
Operating Procedures (SOPs)
O Works closely with other team members to ensure timely resolution of project and/or
clinical issues and obtains direction from more senior clinical operations staff
O Communicates common site trends to Lead CRA and other project team members
• Performs investigative site file reconciliation; requests any new or updated site-related essential
and non-essential documents and reviews them for content, consistency with other documents, and
compliance with appropriate local regulatory requirements, ICH guidelines, project SOPs, and
sponsor requirements
O Performs source document verification, retrieves Case Report Forms (CRFs) and
performs query resolution in a timely manner and oversees drug accountability and
safety at investigative sites
O Ensures Serious Adverse Event (SAE) reporting according to project specifications
O Responds to requests from investigative sites in a timely fashion
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Updated 09Sep2016
• May serve as a resource for and interact with other functional areas to resolve site issues and
facilitate project timelines
• Assisted as SWAT CRA in resolution of outstanding DCFs (Queries). And collected case report
forms. Performed COVs, and motivational visits for non-enrolling sites.
• Mentor to new CRA’s and as a Visit Leader. (Trained and evaluate CRAs of all levels on all visit
types)
• Assisted Functional Manager with administrative duties as required
• Identifies processes/contractual obligations creating obstacles to timely and accurate completion of
monitoring activities, proposes solutions to LCRA/PM/FM
• Identify and resolve complex monitoring issues.
PRA International
Clinical Research Associate II
May, 2006-February, 2007
• Managed the activities of clinical investigative sites across multiple protocols and multiple
therapeutic areas with the ability to manage, with minimal supervision, sites participating in more
complex clinical studies and/or sites requiring more oversight of operational issues.
• Managed the overall activities of site personnel over whom there is no direct authority and
motivate/influence them to meet study objectives.
• Ensured quality of data submitted from study sites and assures timely submission of data, including
appropriate reporting and follow-up for all safety events by site personnel.
• Ensured safety and protection of study subjects according to the monitoring plan, SOPs, ICH
Guidelines, and federal regulations.
• Train study site personnel on the protocol and applicable regulatory requirements in collaboration
with pertinent project team members.
• Appropriately escalate serious or outstanding issues to senior level CRA/Regional Manager (RM)
or the appropriate project team member(s).
• Facilitate Quality Assurance Audit processes as indicated.
• Ensured regulatory inspection readiness at assigned clinical sites.
• Report monitoring activities and study site conduct accurately and completely. Prepare and submit
written reports, both monitoring and administrative, in a timely, concise and objective manner.
• Participate in field training and mentoring of new/junior CRAs. May provide input relative to
performance review and development opportunities.
• Identify, evaluate and recommend new/potential investigators/sites on an on-going basis.
PRA International
Clinical Research Associate I
May, 2005-May, 2006
• Participated in identification of potential qualified investigators and clinical sites as required,
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Updated 09Sep2016
including contacting potential investigators and conducting pre-study site visits; assist in the
collection, review and tracking of essential pre-study documents as required.
• Conducted all activities in accordance with ICH, GCP, PRA SOPs and applicable country
regulations and all assigned trials in accordance with contractual timelines and specific project
team requirements
• Conducted routine monitoring visits in a way which efficiently supports the site throughout its
participation in a trial and to provide feedback on site performance and develop resolution plans
with LCRA/PM assistance
• Demonstrated ability to work independently and as team member prioritizes and completes tasks as
required and to perform drug accountability at investigator sites
• Demonstrates an ability to review and report outstanding site issues to Project Manager or Lead
CRA in a way that facilitates resolution and reviewed CRF to ensure it is complete and accurate
• Reviewed regulatory documents to ensure accuracy and completeness and has complete
understanding of the project protocol and a good understanding of the relevant therapeutic area
• Performed Investigative site file reconciliation, source document verification to sponsor
expectations and reported investigative site status in a way that facilitates accurate and efficient
trial conduct
ICON Clinical Research, Inc
Deerfield, Illinois
Clinical Research Associate I
August, 2003-February, 2005
• Monitored phase II/III Oncology, Gastrointestinal and Cardiovascular studies in Canada,
Australia, Singapore and the USA
• Presented at investigator’s meetings; assisted in site selection; performed site initiation,
monitoring, close out and co-monitoring visits
• Prepared for sponsor and FDA audits; mentored and trained study coordinators and Clinical
Research Associate colleagues.
• Managed time, expenses and visit frequency per study guidelines.
• Assisted in the resolution of data queries.
• Assisted with follow-up of adverse events (AEs) and serious adverse events (SAEs) as necessary;
reconcile SAEs with the clinical data (CRF/RDE).
• Communicated with study sites to ensure that all clinical aspects of the trial are adhered to in
accordance with the protocol and Sponsor directives as well as state and federal regulations,
guidelines and/or policies; provide on-going instruction to research site personnel, as necessary, on
proper conduct of the trial. Ensure timely and proper completion of data by assigned clinical sites.
• Prepared comprehensive and detailed reports documenting study status, site issues and monitoring
activities within specified timeframes.
Computer literacy: Proficiency in MS Office, eCRF/Electronic Data Capture: (Medidata) RAVE,
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Updated 09Sep2016
iMedidata, UBC Track, UBC Capture 2.0, Siebel/CTMS; Data Labs, ClinPhone, IXRS and IVRS.
LANGUAGES
English
Urdu, Hindi (Indian languages)—fluent
Arabic, Farsi, Pashtu (Dari)--basic
PRESENTATIONS
“Hypertension and Hypercholesterolemia” indications for Cardiovascular study 2004 at
Investigator meeting
JOB TITLE HISTORY
Clinical Research Associate, Level III, June 2010 to present
Clinical Research Associate, Level III, February 2007 to June 2010
Clinical Research Associate, Level II, May 2006 to February 2007
Clinical Research Associate, Level I, May 2005 to May 2006
Clinical Research Associate, Level I, August, 2003-February, 2005
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KHANMASOOD 09Sep2016

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