project specialist for clinical trial
Resume:
Ester Rita
Seal Beach, CA *0740
*********@*****.***
Education :
****-****: AtmaJaya Catholic University, Jakarta, Indonesia
Medical Doctor Degree
Professional experience:
2000-2002: Assistant to Prof Rustam Effendi Harahap, M.D, PhD, Jakarta, Indonesia
Assisting him in practice as a gynecologist.
2003-2005; Department of Neuroscience, UCLA, California
Visitor researcher/observant in Phase I study for electrode implant to
Epilepsy Patient’s Brain
2006-2007; Department of Colorectal Surgery, USC, California
Project assistant of industrial clinical trial and in house study
Conducting clinical trial in three affiliate facilities; USC/Norris Cancer
Hospital, LAC General Hospital and USC/University Hospital.
Make sure that the trials compliant to the protocol guidelines, USC SOP,
GCP and FDA guidelines. Collecting data and samples .
2007-current; Department of Colorectal Surgery, USC, California
Project specialist of industrial clinical trial [phase 1,2,3 and 4) and in house
Study in three affiliate facilities; USC/Norris Cancer, LAC General
Hospital and USC/University Hospital .
Responsible for IRB submission to open, continue and close the trials
Reporting the SAEs, protocol violations, new amendment and investigators
to IRB, creating the ICF and HIPAA , match it with IRB and sponsor
template. Review the budget, make sure it can cover the cost of the whole
project. Once the trial get approved by IRB, collaborate with sponsor to
have Site Initiation Visit and make sure that the team runs the study
as the protocol and GCP guidelines. Data and samples collections.
Online data submission . And closing the trial when it is done.
Publication : Digestive Disease Week, Washington, DC – May 2007
A.M. Kaiser, E Sie , R.W. Beart, P. Vukasin, G. Ault. Negative prognostic parameters associated with fatal outcome of Clostridium difficile colitis.
Current research project at Colorectal Surgery Department USC/Norris Cancer Center, LAC General Hospital and USC/ University Hospital :
• NCI/NSABP R04- A Phase II clinical trial comparing pre-operative radiation therapy and Capecitabine with pre-operative radiation therapy and continuous intravenous infusion (CVI) of 5-Fluorouracil (5-FU) in the treatment of patients with operable carcinoma of the rectum.
• ACOSOG Z6041 ; A Phase II trial of neoadjuvant Chemoradiation and Local Excision for uT2uN0 Rectal Cancer
• A Phase 3 Randomized, Controlled, Phase 3 Study of Gentamicin-Collagen Sponge [ Collatamp G] in General Surgical subjects at Higher Risk for Surgical Wound Infection.
• A Phase 3 Multicenter, Randomized, Double-Blind, Parallel-Group, Active-Control, Dose-Ranging Study to Evaluate the Safety and Efficacy of a Single Administration of SKY0402 for Prolonged Postoperative Analgesia in Subjects Undergoing Hemorrhoidectomy.
• A Phase 3 Evaluation of SurgiWrapTM to Minimize Soft Tissue Attachment & Reduce the Incidence of Early Post-Operative Bowel Obstruction in Colorectal Surgery.
• A Phase 4 Open Label, Milticenter, Randomized, Controlled Study to Evaluate Efficacy and Safety of PROCRIT in Subjects Undergoing Elective Major Abdominal and/or Pelvic Surgery
• A Phase 3 Multicenter, Open-Label, Randomized Comparative Study of Tigecycline vs Ceftriaxone Sodium Plus Metronidazole for the Treatment of Hospitalized Subjects with Complicated Intra-abdominal Infection.
• A Phase 2 Multicenter, Randomized, Double-Blind, Placebo Controlled, Parallel Group Study of Intravenous Methylnaltrexone (MOA-728) for the Treatment of Post-Operative Ileus
• A Phase II, Double-Blind, Placebo-Controlled, Multiple-Dose Study to
Evaluate the Safety and Efficacy of Ipamorelin Compared to Placebo
for the Management of Post-Operative Ileus in Patients Who Have
Undergone Partial Bowel Resection Surgery
Current in house study at Department of Colorectal Surgery at USC/Norris Cancer Center , LAC General Hospital and USC/University Hospital :
• The efficacy of antibiotics in patients with previous protocolectomy and ileo pouch anal anastomosis for ulcerative colitis
• Seton placement vs. Surgisis AFP Insertion for Perirectal Fistula
• The Success of Trans Anal Excision Surgery on Rectal Prolapse
• Quality of Life after Management of Recurrent Rectal Cancer by Pelvic Exenteration
• Sexual Dysfunction Variations Between Patients after Right Hemicolectomy versus Low anterior resection - the Impact of the Cancer vs. the Pelvic Treatment
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