CRA

RESUME

DR. SYED HAFEEZUDDIN

A highly personable, competent and team spirited Physician recognized for excelling in fast track, high stress environments. Able to put patients at ease and establish subtle and often difficult to make diagnoses. A patient advocate known for working closely with staff and administration in enforcing all policies and procedures and exceeding regulatory compliance standards- local, state and federal.

SPECIFIC STRENGTHS

Superior diagnostic skills and treatment planning and execution proficiency.

Outstanding bedside manner- strong interpersonal and relationship building skills.

A team player- work in harmony with medical staff, administration, patient, and family members to ensure high quality medical attention consistent with organizational standard operating procedures.

Effective trouble shooting and problem solving skills in high pressure (life/ death) environments.

Clinically sound incorporating good decision making skills, no payment of any kind as a result of legal action.

EDUCATION

Institution Degree Earned Year

1. Kriger Research Center, Inc. CRA Professional Development Program, 2008

 -ICH GCP Training

 -Clinical Site Monitoring (site selection, initiation, monitoring and close out)

 -Adverse Event Reporting

 -Pharmacology for Clinical Research Professionals

2. Gulbarga University, Karnataka, India M.B.B.S. 1983

3. Osmania University, Hyderabad India B.Sc. 1978

PROFESSIONAL MEMBERSHIP:

Member of A.C.R.P.( Association of Clinical Research Professionals)

EXPERIENCE

 Kavya Hospital and Research Center

o Worked as a Resident Medical Officer and. Actively looked after the whole administration and patient care. Performed all minor and some major surgeries.

o Duration of work- ---------Jan.1985- Feb.1986

 South Centre Railway Hospital, Secunderabad, India

o Worked as a Senior House Surgeon in the department of surgery, a post recognized for PG training for National Board of Examinations, New Delhi in the discipline of Medicine and Surgery. Attended with efficiency emergency operations and routine general surgical problems.

o Duration of work--------March. 1986-May.1987

 Shifa General Hospital, India

o Gained valuable experience as a Resident Medical Officer in causality and other departments.

o Duration of work- -----June.1987-March.1988

 Chamraj Hospital, Nilgiris, India

o Was incharge of whole medical department of the company including administration. Skillfully managed the 50 bedded main hospital and 4 peripheral dispensaries for a labor force of 2000.

o Duration of work- -------April.1988- May.1991

 Salamatak Clinic, Mysore, India

o Gained valuable experience while running a private clinic.

o Own private clinic

o Duration of work- ------June.1991- Aug.1993

 Ghousia Nursing Home, Mysore, India

o Worked as a resident medical officer.

o Duration of Work- June.1991- Aug.1993

 Al- Masaudi Poly Clinic, Riyadh, Saudi Arabia

o Worked as a General physician while impressively handling day-to-day outpatients. Gained experience in a new atmostphere and new country.

o Duration of work- ---Sept. 1993- Sept.1995

 Al- Sharq Poly Clinic, Riyadh, Saudi Arabia

o Continued to build experience with outpatient care as a general physician. Gained experience in a new atmostphere and new country.

o Duration of work------- Sept.1995- present

Other Experience: As a Clinical Research Associate

Kriger Research Center Inc. (CRO)

Clinical Research Associate

Project: To determine efficacy and optimal dose of (confidential Compound)

Responsibilities:

 Member of clinical development team.

 Managed assigned investigational study sites and performed on-site quality reviews of case report form data

 Conducted routine monitoring visits to ensure investigator and staff were in compliance with protocol, TDP, FDA and ICH regulations, GCPs and pertinent SOPs.

 Verified case report form information against source documents and reconciled data entry queries.

 Reviewed site study files for completeness and up-to-date information, including IRB related documents.

 Ensured informed consent was administered properly and advised site of any execution issues.

 Performed drug accountability and reconciled counts with CRF, source data and dispensing logs.

 Oversaw and evaluated subject enrollment, and compiled and reviewed patients’ status tracking information.

 Developed and implemented site initiation, routine monitoring and closure checklists.

Clinical Research Associate skills----

• Extensive ICH GCP training. and In-depth knowledge of ICH GCP guidelines.

• Developing study timelines (IRB Approval, bulk drug manufacturing, etc.)

• Update Investigator Brochure.

• Identify and Interview potential investigators and plan Investigator meeting

• Prepare initial IND submission (if appropriate)

• Finalize and approve protocol. Submit request for investigational drug supplies. Participate in development of informed consent forms.

• Design, review and send CRFs, finalize and order CRFs and compare to source documents.

• Final site evaluations (pre-study visit) and Conduct site initiation visits.

• Collect, submit and get approval of regulatory-/company-required documents and place in study file.

• Letter of agreement/contracts and financial Disclosure information.

• Send study package(s) to field monitors (Protocol, Brochures, Consents, 1572, contracts/agreement letters, etc.)

• Submit initial grant payment request, Monitor grants payments/adjustments.

• Ship clinical supplies to investigative sites and confirm receipt of clinical supplies with each site.

• Review protocol requirements and sponsor policy on CRF completion and correction.

• Establish monitoring visit frequency and communicate to site.

• Assure all amendments or deviations are approved and filed with regulatory affairs.

• Visit sites as scheduled/required, Monitor site visits reports for any required action.

• Assure all adverse events are reported and reviewed as per regulations and company policy.

• Review protocol compliance, focusing on inclusion/exclusion requirements.

• Conduct source data verification.

• Review drug accounting, storage and dispensing.

• Prepare final study reports, ensure study file is complete and ready for audit.

Other Skills:

• Excellent communication skills shown with supervisors, colleagues and general public.

• Self starter, disciplined, confident and goal oriented.

• Adept at giving superior written and oral presentations to groups of experts.

• Self-motivated; able to set effective priorities and implement decisions to achieve immediate and long term goals and meet operational deadlines.

• Fluent in English, Hindi, Urdu, Arabic and also Telugu, Tamil, Kannada and Malayalam.

• Computer Skills include fast typing and MS Word, Excel and PowerPoint.

References and Supporting Documentation furnished upon request.

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