Clinical Research Co-ordinator / Associate

WORK EXPERIENCE

DOSHI DIAGNOSTIC IMAGING SERVICES 2012~CURRENT

Job Title: Clinical Pharmacologist / Study Coordinator

Job Responsibilities: Responsible for monitoring ailment related studies using contrast materials in MRI, CT’s and Nuclear Medicine. Monitoring all Breast Imaging Studies for BIRADS 4 and higher. Recruiting and scheduling patients and obtain informed consents for the breast biopsy procedures.

Evaluate medical imaging contrast agents for efficacy in both clinical and medical research applications.

Implement and monitor to prevent any adverse drug reaction as per SOP.

Work closely with Radiologist, referring doctors and technicians for the study start-up.

Identify site issues and initiate correction plans based on monitoring reports.

Verify data with the referring doctors before proceeding with the stud

Verify contrast accountability logs and storage requirements.

Respond to request from testing sites in a timely fashion.

Develop contrast application procedures, safety standards, monitoring and reporting.

Evaluate potential drug interactions of contrast agents and nuclear isotopes with patient prescription medications. Clinical emphasis on interactions should be on patient with known drug sensitivities and those with diabetes, heart disease, hypertension and seizure disorders.

Lead in clinical operation of multiple studies related activities including review, tracking, and filing of essential study documents.

Prescreen potential subjects for MRI studies for ACR inspection and Breast Imaging.

Schedule patient appointments, obtain informed consent.

Active role in consultation of study participants along with performing doctors and surgeons.

Clearly explain the study goals and objectives to patients, families to obtain informed consent.

Drug-drug interactions in prescribed medications in relation with the patient disease condition.

Pharmacovigilance, Pharmacokinetics, Pharmacodynamics and Pharmacological research.

Computer skills: Windows 2000/XP, MS Word, Excel, Power Point, Micro-merchant Systems, EMR: Sage - Intergy

SYNCHRON RESEARCH SERVICES 2009 - 2011

Job Title: Clinical Research Associate - 1

Job Responsibilities: Oversaw and reviewed routine site activities for clinical research trials with guidance, through monitoring activities, including on-site visits and/or in-house assessments, including telephone contact and other technologies, according to the trial-specific monitoring plan to assess protocol, regulatory and SOP compliance with guidance from experienced CRA or clinical trial lead.

Reviewed ICFs submitted by sites for consistency with study model ICF and required element of ICF and HIPAA Authorization; assist PIs and study coordinators with IRB submissions.

Reviewed electronic Case Report Form (eCRF) for completion and accuracy.

Performed remote Study drug accountability.

Conducted Remote Periodic Monitoring Visits (PMVs) and Close Out Visits (COV).

Ensured compliance with protocol guidelines and requirements.

Reviewed and provide feedback to management on site performance metrics.

Attended weekly core meetings and project related meetings as directed by project leader.

Individualized Informed Consent Forms (ICFs) for study sites. Reviewed protocol specific ICF templates as directed by Lead CRA for completeness; identify typographical errors and erroneous reference date.

Participated in Site Initiation Training via webcast/teleconference; present information regarding GCPs and the Informed Consent Form process.

Performed Regulatory, Start-up, and Maintenance activities according to applicable regulations.

Collected and provide information regarding site enrollment readiness to the Executive C

Established communication with sites regarding unclear data on clinical read reports.

EDUCATION

Master of Science Degree, Long Island University (GPA - 3.44) 2006~2009

Major: Pharmacology Minor: Toxicology

Bachelor of Science Degree, Dr. MGR Medical University (GPA - 3.94) 2000~2005

Major: Pharmacy Minor: Industrial Business Management

OTHER ACADEMIC ACTIVITIES

GRADUATE RESEARCH ASSISTANT, DEPARTMENT OF PHARMACOLOGY/TOXICOLOGY 2007~2008

Studied action of dietary phytochemicals quercetin, catechin, resveratrol and naringenin on estrogen-mediated gene expression.

Responsibilities Included:

•Data preparation and adherence to SOPs.

•Perform experiments such as PCR, Northern Blotting, and Western Blotting.

•Preparing / ordering necessary materials for research

•Knowledge of GLP and Clinical Trials.

UNDERGRADUATE RESEARCH ASSISTANT, DEPARTMENT OF PHARMACOLOGY 2003~2004

Responsibilities Included:

•Executing pharmacological experiments on mice and rats and monitoring.

•Data preparation and analysis.

•Preparing materials necessary for experimental studies.

•Adherence to SOP's.

•Purchasing new laboratory equipment and supplies.

PUBLICATIONS / CERTIFICATIONS

DEPARTMENT OF PHARMACOLOGY 2003~2004

Pre-clinical Research works were carried out independently and the following was selected for

National Presentation in India:

Wound Healing Activity of Zizyphus onepholia in Mice was presented at Southern Regional Conference of Pharmacology.

The goal of this research was to preliminary study and investigate the wound healing property of aqueous and methanol extract of Sisyphus onepholia. In-vivo Cicatrizan Model and Excision Wound Model were performed in mice and rats respectively.

Gastrointestinal Effects of Certain Dihydroxy Substituted Flavones and its Structure

Activity Relationship was presented at Annual Conference of Indian Pharmacological Society (IPS).

The second study shows the effects of various Dihydroxy Substituted Flavones on Gastric emptying (Phenol Red Meal Method) and castor oil induced intestinal hypermotility in mice. Earlier work of this study revealed delayed small intestinal transit and analgesic activity through opiod mechanism.

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