Project Manager

Atif Khan, M.D., MHP, CRA.

**Evergreen Ave,

Blackwood, NJ 08012

Tel: 856-***-****

Email: ***************@*****.***

EDUCATION

M.D., Universidad Tecnologica De Santiago-UTESA, 1999

Took elective courses of study in:

Legal Medicine and Ethics, Human Sex and Child Abuse Tropical Medicine and Geriatrics, Research Methods

Associates in Science, Camden County College, Jan 1996

Kriger Research Group International, Clinical Research Associate, 2006

SPECIALTIES:

Experience across therapeutic areas with strengths in:

Psychiatry, Internal Medicine, Hypertension, Hyperlipidemia, Female Hormonal Study, OB/GYN, Women's Health, Pediatrics, Endocrinology.

Phase I-III experience in all clinical trial monitoring visits, coordinating and managing of trial sites ranging from small and large scale National and International studies & Trials.

Over all CRA experience more than 5 year.

Over all Adverse Events specialist experience 3 years.

Over all observational study experience is more than 3 year, targeted toward endocrinology, internal medicine, geriatrics, CNS.

Experience handling maintenance and support operations for multiple applications in pharma space as well as experience of working in CDMS application.

SOFTWARE EXERIENCE:

Microsoft Windows & Office Suite software’s advanced, Phase Forward InForm EDC, AFGA CardioNow, Clarix IVRS, CTMS, Avatar (EMR) (EHR), MedDRA, CDMS, MedRA, WHO-DRL, Documentum, ARISg.

EMPLOYMENT EXPERIENCE

Multiple positions held through various companies that overlapped most contracted through NHS Human Services Inc and Community Behavioral Health system:

Drexel University Medical College, Children’s Hospital of Philadelphia, and community Mental Health Clinic, and Belmont Center for Comprehensive treatment.

NHS Human Services, Inc

Program Manager Nov 07 – Current

Managed all aspect of running the psychiatric department and research projects for psychiatric pediatric department.

Responsibilities included but are not limited to following;

Maintains an attitude and philosophy consistent with the Company’s standards.

Internal monitoring of study data for preventable complications, adverse events, system and process vulnerabilities, and patient safety risks present in the documentation of the medical care delivery process.

Improve inter-rater reliability and ensure congruency of researcher’s findings by monitoring data quality through bi-weekly meetings with other researchers.

Developed questionnaires and conducted conference calls to gather interdisciplinary information from each study center.

Analyze and develop Action plans to address protocol compliance, safety, data and administrative Issues.

Facilitated the implementation and testing of an online E-CRF to capture data for future analysis.

Responsible for financial management of study & department’s budget, including cost containment, contract negotiations, inventory management, continuing review, and fiscal projections.

Create and conduct training & educational presentations to educate clinical research professionals on study recruitment and retention.

Facilitate staffing, training, and study initiation at sister site in Philadelphia.

Hired, trained, and oversaw team members.

Held responsibility for coordinating data management, preparing review and protocol revision submissions, reviewing informed consents and source documents, and managing study staff at two clinic study centers.

Monitored source documents and case report forms, ensuring the timely resolution of queries.

Conducted one-on-one training of study staff on proper documentation of study data and the informed consent process.

Collaborated with study sponsors, physicians, investigators, and staff at monthly study meetings.

Provide over sight to quality control of patient records.

Maintaining effective working relationships with other federal agencies, provincial and municipal governments.

Develop and direct clinical monitoring plan and priorities.

Analyze and develop action plans to address protocol compliance, safety, data and administrative issues.

Monitor and plan to meet monthly budgetary obligations.

Conduct monthly supervision with psychologist / psychiatrists to review cases admitted in program.

Organizing/compiling/leading the preparation of various regulatory documents including CSR appendices.

Writing and compiling of protocols and protocol amendments and ICFs.

Writing clinical sections of CSR (clinical study reports), PSURs, DSURs, Investigator Brochures (IBs).

Overall management of CSR and DSUR documents.

Perform other duties as assigned or required.

NHS HUMAN SERVICES

Project Manager EMR/EHR July 2010 – Dec 2011

Project management and implementation of Avatar, NHS’s clinical electronic medical/health record system.

Responsibilities included but were not limited to:

Define and establish end user requirements for configuration and implementation of Avatar EMR.

Provides healthcare leading practices to improve business & clinical operational efficiencies.

Establishes a strong working relationship with end user and to function as the end users’ representative on interface issues.

Draft training and support roadmap for all new applications and fixes applied to the EMR system.

Develops a strong working knowledge of all applications responsible for.

Proactively works with IT and the business to manage and resolve application issues – from identification through resolution.

Plans and prepares business documents, reports, memoranda, and instructional manuals as documentation of project requirements and workflows.

Assists developers in identification of system problems related to clinical documentation as well as business billing.

Prepares project timelines, schedules, estimates and resource planning to support EMR project.

Confers with business to define and establish end user requirements for existing and new application systems.

Documents configuration & customizations decisions and produces comprehensive and thorough documentation for the final product.

Provides regular updates on project tasks, schedules and estimates of work to be completed.

Assists in training development as needed to support other training resources.

As needed, provides support to training efforts by being part of training classes and functioning as a product expert to support the training delivery.

Provides Go Live Support including time on site at the billing and clinical operation locations.

Additional internship & clinical rotation experience in following specialties:

Oncology, Psychiatry, Women’s Health, Internal Medicine, Rheumatology, Orthopedics, Neurology, Rheumatology, GI, Cardiology, Radiology, Immunology, Neonatology, Pediatrics.

Experience ranges from 1 year to 2 years in each specialty.

Drexel University Medical College - Contracted through NHS.

Clinical Research Associate March 08, 2009, 2010,Current

Autism Spectrum Disorder Study, in collaboration with NHS Human Services.

Study geared toward identifying environmental triggers or socioeconomic risk factors which may increase incidents or probability child getting diagnosed with autism.

Responsibilities included but were not limited to:

Maintains an attitude and philosophy consistent with the Drexel’s standards.

Oversight of the feasibility questionnaires to investigators being considered for study participation tracks and summarizes results.

Check investigators against FDA OAI and debarment list.

Assisting senior staff in planning study conduct, investigator selection & site evaluation and designing case report forms.

Obtains final documents from LTM (investigator list, IB, protocol, ICF template, FDF) for distribution to sites.

Initiates and tracks confidentiality agreements with sites.

Initiates and maintains investigator and site contact information.

Initiates sites in CTMS.

Updates and ensures accuracy of sites in CTMS.

Worked closely with study teams to set up and maintain required information within CTMS and related applications

Maintains and updates CTSRS contact information to ensure appropriate SUA distribution.

Reviews documents received from sites for accuracy and completeness. Ensures that they comply with SOP’s and regulations. Confers with LTM regarding changes or inaccuracy.

Reviews Informed Consent modified by investigator site in conjunction with LTM. Secures approval of changes.

Works with sites to ensure that necessary corrections are made to expedite the document collection process.

Experience with reviewing, revising, and archiving protocols, regulatory documentation, and systems related forms for compliance with all regulatory compliance.

Assembles Trial Center File Binder and study start-up materials with minimal input from LTM.

Maintains Trial Master File (IF).

Retrieval of CRFs from study sites.

Processing CRFs including Data cleanup and classification of data, and completion of study Summary.

Protocol GCP/Regulatory compliance, SAE reporting.

Managed, tracked and updated SAE’s follow up, and for reporting them to LTM, by using CTMS, Avatar (EMR)(EHR), MedDRA, CDMS, MedRA, WHO-DRL, Documentum, ARISg, as directed by GTM.

Monitoring of investigational sites to ensure protocol adherence, assuring timely enrollment of patients.

Establishes and maintains good working relationships with the site investigational staff.

Achieved all study objectives by partnering with study physician investigators, nurses, research assistant, sponsor, and monitor.

Coordinates central IRB submissions.

Ensures accuracy of central IRB invoices and obtains LTM approval for payment.

Processes, tracks, and distributes documents as required for protocol amendments.

Tracks SUA receipt acknowledgment letters from investigators.

Obtains revised 1572’s as needed during study conduct.

Transmits 1572’s and CV’s to regulatory and for imaging in the electronic Trial Master File.

Participates in Investigator Document Associate process improvement activities.

Attends status updating meetings with project managers and/or project teams.

Reviews trip reports and provide feedback on reports under supervision of LTM.

Assists in setting up external vendors for study under supervision of LTM and GTM.

Compiles information required for completion of Financial Disclosure table for all sites under supervision of LTM.

Perform routine site visits, including pre-study, initiation interim, and closeout visits

Trains and Mentors Investigator Document Associates, Feasibility specialists or Project Support Specialist.

Participates in other projects and activities, as assigned by manager.

Coordinated and facilitated several study site initiations and study close-outs

Established and managed satellite research site

Perform other duties as assigned or required.

Children’s Hospital of Philadelphia - Contracted through NHS.

Clinical Research Associate June 09, 2010, 2011, Current

Autism Spectrum Disorder Study

In collaboration with NHS Human Service’s PACT Program, comprehensive study to track families with an autistic child through another pregnancy, birth, and the following three years. Hundreds of environmental factors from diet to infection, pesticides and medications were examined for possible interplay with genetic makeup.

Responsibilities included but were not limited to:

Responsible for assisting senior staff in planning study conduct, designing case report forms, training of investigator sites, planning and running study meetings, evaluation, selection and training of new study investigators and writing and assembling submissions.

Responsible for writing basic study protocols, monitoring & overseeing monitoring of investigational sites to ensure protocol adherence, assuring timely enrollment of patients and retrieval of CRFs from study sites, processing CRFs including data cleanup and classification of data, and completion of study summary.

Monitor enrollment and retention of study participants.

Perform routine site visits, including pre-study, initiation, interim, and closeout visits.

Report to research project team, client, and site personnel any findings noted at monitoring visits.

This is accomplished by completion of monitoring reports and follow-up letters within the project-specific timelines. Significant issues noted must be reported to appropriate personnel immediately.

Maintain eClinical or alternative project tracking system of Subject and site information.

Serve as back up for regional manager, clinical monitoring group when required.

Provide training for colleagues on clinical, regulatory, administrative, and company procedures and processes.

Participate in feasibility studies.

Assist with company’s quality control initiative.

Tracked subjects on Med treatments, and updated SAE’s follow up, and for reporting them to LTM, by using CTMS, Avatar (EMR)(EHR), MedDRA, CDMS, MedRA, WHO-DRL, Documentum, ARISg, as directed by GTM.

Present study materials at Investigator/study launch meetings when required.

Support project management team with assessment of workload and site assignments within the project team.

Assist project management team with review of monitoring reports and study documents when required.

Participate in the interview process of potential candidates when required.

Perform necessary administrative functions (e.g., tracking of expense reports, time and attendance).

Maintain home office (e.g., procurement of office supplies, submission of documents), if required.

Perform other duties as assigned.

Drexel University Medical College of Pennsylvania

Department of Internal Medicine, Katherine Sherif, M.D

Served as a Clinical Research Assistant and Sub Investigator/Study Coordinator,

Clinical Research Assistant May, 2003– June, 2004

Worked on number of different projects, listed below in summary; additional details available

Upon request;

Behavioral Health and Cardiovascular Risk Factors in Post-Menopausal Women,

(Sponsor Drexel University)

Investigated whether an emotional disclosure intervention was effective at decreasing psychological and physiological risk factor of cardiovascular disease in post-menopausal women.

Also examine the relationship between cardiovascular risk factors and psychological distress.

Female Testosterone Study Phase IV

(Sponsor P&G)

A randomized, double-blind, parallel group, placebo-controlled study

To evaluate the efficacy and safety of transdermal testosterone for 24 weeks and safety for a further 28 weeks in naturally menopausal women with hypoactive

Sexual desire disorder on concurrent oral hormone replacement therapy.

Dual Therapy for Hyperlipidemia and Hypertension Phase IV

(Sponsor Pfizer Pharmaceuticals)

A randomized, double-blind, placebo-controlled and open-label evaluation of the safety and efficacy of dual therapy with Atorvastatin plus Amlodipine when compared to either therapy alone in the treatment of patients with simultaneous Hyperlipidemia and hypertension.

Clinical Research on Poly Cystic Ovarian Syndrome Phase I-IV

Screened and followed up patients with PCOS, who were not on Hormonal replacement for a year.

Patients were given Metformin to regulate their cycles and ovulation.

Belmont Center for Comprehensive Treatment – Contracted through NHS

Department of Psychiatry, Richard Jaffe, M.D. and Howard Waxman, PHD

Clinical Research Assistant March, 03-Aug 2003

Phase IV.

A randomized, double-study of the safety and efficacy of Depakote ER plus an atypical Antipsychotic vs. an Atypical Antipsychotic alone in the treatment of schizophrenia.

( Sponsor Abbott Laboratories)

Conducting of the clinical study in accordance with ICH-GCP and the required regulatory guidelines.

Obtaining the informed consent, and regulatory authorities, handling of adverse events (AE) / serious adverse events (SAE) and reporting to sponsor, ethics committee and regulatory authorities (leading the team of Pharmacovigilance).

Handling final check of reports with medical report writing group (MRW) and providing necessary inputs.

Tracked and updated SAE’s follow up, and for reporting them to LTM, CTMS, Avatar (EMR)(EHR), MedDRA, CDMS, MedRA, WHO-DRL, Documentum, ARISg, as directed by GTM.

Ensure the accuracy, completeness, legibility and timeliness of the reports and provide to the sponsor, the IRB/IEC with summary of the trial's outcome, and the regulatory authorities with any reports they require for the study.

Audits both internal and external documentations for compliance.

Manage assigned sites by regular contacts to ensure site compliance, adequate enrollment, and Understanding of study requirements.

COMHAR, Philadelphia;

Clinical Research Associate Oct, 01- Nov 04

Study to determine mental health psychiatric disorder trends for the Hispanic population in the United States.

Act as contact for project team and study sites.

Caribbean Institute of oncology 1997, 1998

Research Assistant,

Provided assistant to Clinical Research Associate with all aspect of clinical research

North Western Human Service (NHS)

Psychotherapist July, 06- Nov 07

Community Mental Health Clinic - Contracted through Community Behavioral Health (CBH)

Mental Health Professional March, 03-March 05

Nueva Vida Mental Health Center, Philadelphia May, 04 – Dec 08

Clinical Director.

Pediatrics Clinic, Dominican Republic June, 98- Feb, 99

Physician Assistant.

OBSERVERSHIP

Department of Medicine, Medical College of Pennsylvania August, 03-Sept, 03

Belmont Center for Comprehensive Treatment

Department of Psychiatry May, 03-June, 03

CERTIFICATIONS AND TRAINING

Certified By Drexel University in HIPPA & Research, HIPPA Security, and

Substituted (surrogate) consent, Human Subject Research. March 2005

CONTINUING MEDICAL EDUCATION ACTIVITIES (Partial listing)

Treatment options for Thyroid Disease Management. March, 2010

New advance in the treatment of the Alzheimer’s disease Aug, 2009

The Endocrine Society’s 85th annual meeting in Philadelphia June, 2010

Stem Cell Research, Ethics and Legal Debate Jan, 2009

Human Subject Research Advocates Jan, 2010

University of Nebraska, Novel Drugs in Advanced Clinical Trials Jan, 2010

The Dannemiller Memorial Educational Foundation, Signal Transduction

Inhibition in Cancer Therapy Jan, 2010

Antiretroviral Drugs Pharmacokinetic/Pharmacodynamic (AMA) Jan, 2010

*American Medical Association

ECHO systemic family therapy approach Jan2009, 2010-Current

LinkedIn profile link: http://www.linkedin.com/pub/atif-khan/28/872/47a

Indeed Link: http://www.indeed.com/me/atifkhanmd

Professional References:

1. Jorge Rodriguez-215-***-****

Group Specialist, Clinical Trainer – COMHAR, Juniata Community Center, Philadelphia, PA.

2. Luis Zamont- 267-***-****,787-***-****,267-***-****

Bi-lingual Psychotherapist, APAM, Adult Psychiatric Clinical Director, Philadelphia, PA.

3. Patricia Thomas- 215-***-****

Program Manager, Children’s Reach, NHS HUMAN SERVICES, Inc, Philadelphia, PA.

4. Christian Radford – 267-***-****

Family Psychotherapist – NHS Human Services, Out Patient Department

Philadelphia, PA 19125

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