Clinical Study Manager

IRAM KHAN

**** ****** **** • Newburgh, New York • 12550

Phone: (480) 773•3810

***********@*****.***

EDUCATION

Central Connecticut State University, New Britain, CT

Bachelor of Science, Biology

EMPLOYMENT HIGHLIGHTS

Clinical Study Manager

Mid Hudson Medical Research December 2011 – Present

• Ensure all investigative sites adhere to clinical protocols, Standard Operating Procedures, Good Clinical Practices, ICH guidelines, and FDA regulations

• Enforce HHS Policy for Protection of Human Research Subjects

• Create, maintain and update company SOPs

• Carry out all Pre-Study, Site Initiation, Interim and Close-Out monitoring visits

• Participate in study acquisitions for business development

• Negotiate contracts and budget for new clinical trials

• Coordinate and supervise study visits for assigned protocols

Quality Assurance Monitor

Mid Hudson Medical Research December 2011 – Present

• Develop and manage Quality Improvement strategies to enhance overall company productivity

• Perform internal Sponsor and FDA preparedness audits; document findings and corrective actions

• Resolve data discrepancies by ensuring they are accurate and complete through source document verification

• Execute site-wide training sessions to achieve desired operational outcomes

Regulatory Affairs Manager

Hope Research Institute November 2010 – December 2011

• Managed and maintain regulatory documents of pharmaceutical and device research studies for all Investigators

• Obtained Institutional Review Board and Sponsor/CRO approval for all studies

• Prepared regulatory submissions and reports to the IRB, FDA and other regulatory authorities

• Performed quality assurance audits of regulatory and source binders to ensure quality data

• Maintained CV’s, licenses and certification for all Investigators and site staff

• Developed and implement new regulatory SOPs to maintain AAHRPP accreditation

• Established professional relationships with Site Staff, Sponsors, CROs and IRBs

• Provided regulatory training for all staff according to site SOPs

• Monitored all studies in various stages from start-up to completion

• Archived all study records after study close-out

Clinical Research Coordinator

Hope Research Institute January 2010 – December 2011

• Worked directly with Investigators to implement pharmaceutical trials using SOPs, ICH and GCP guidelines

• Assisted in recruitment and patient retention on trials

• Conducted Informed Consent process

• Screened subjects for eligibility using protocol specific inclusion and exclusion criteria

• Performed drug accountability, phlebotomy, specimen preparation, ECG’s and vital signs

• Prepared and completed source documentation and Case Report Forms

• Aided PI with scientific and compliance reporting requirements in accordance with Federal regulations

• Maintained confidentiality and strict guidelines for protection of human subjects

Office Assistant

NS Family Dental Care January 2009 – March 2009

• Verified and billed insurance companies

• Executed accounts receivable tasks

• Managed patient profiles

• Developed and prepared x-rays, impressions, alginates and Proforms

• Performed up to date sterilization techniques

Research Assistant

Weill Medical College of Cornell University May 2008 – December 2008

• Assisted in researching “The Detection of Mutations in Colon Cancer”

• Performed expression profiling of RNA

• Measured the relative activities of target genes

• Analyzed and collected pertinent data

• Prepared and edited scientific manuscripts

• Aided in writing patents for the research at hand

• Conducted general medical investigations

• Organized and maintained laboratory instruments and surroundings

SPECIAL CAREER ACHIEVEMENTS

• Successful FDA audit with No Findings on a study I conducted with over 360 subjects

CERTIFICATES

• Certified Clinical Research Coordinator (CCRC)

• QUINTILES Good Clinical Practice Training

• CITI Good Clinical Practice Training

• National Institute of Health (NIH) “Protecting Human Research Participants”

• Mayo Clinic Laboratories “IATA, Class/Div 6.2 & 9, Transportation of Dangerous Goods”

• Certified Clinical Assessor for “Multiple Sclerosis Functional Composite” (MSFC)

• Certified in Psychiatric Rating Scales for Alzheimer’s Disease and Dementia:

Clinical Dementia Rating (CDR)

Disability Assessment for Dementia (DAD)

Clinician’s Interview Based Impression of Change (CIBIC)

Clinician’s Interview Based Impression of Severity (CIBIS)

MEMBERSHIPS

• Association of Clinical Research Professionals (ACRP) 2012

• Humanity First 2004

TECHNICAL SKILLS

• Proficiency in Microsoft Office, Google Docs, Dropbox, and OpenOffice

• Commanding knowledge of clinical Electronic Data Capture programs such as IMPALA, InForm, Phase Forward Oracle, OmniComm, ClinPlus, Medidata Rave and ClinTrak

VOLUNTEER AND COMMUNITY SERVICE

• Collect donations for Humanity First, a disaster relief organization

• Guided and counseled community children at Salvation Army

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