In This Issue (click to link): Study Opportunities Who's Who at HRA HRA Special Projects Training Opportunities Upcoming Survey Payroll Dates Employment Listings

Study Opportunities

Investigators:
Are you seeking clinical trial study opportunities? Please take a moment to review the latest clinical trial opportunities from CenterWatch.

Phase I/II Affinium Pharma James Pan Email: jpan@afnm.com Drug name: Not available Specialty: bacterial infections, becteremia, endocarditis, cUTI, cSSI, CAP Indication: bacterial infections Phase III BioCure Medical LLC Neil Frazier, MD Email: nfrazer@biocuretech.us Drug name: tetra-methyl NDGA (M4N) Specialty: Oncology, head and neck Indication: Refractory head and neck cancer Notes: Patients required to have failed existing therapies or to be ineligible for standard therapy. SMO-USA, Inc. Richard Turner, PhD Email: rich@smo-usa.com Device name: Not available Specialty: Any licensed MD or DO with a minimum of 7 years clinical practice. Indication: Development of Normative Database for a proprietary device that measures Heart Rate Variability (HRV) Wyeth Research Louise Rochon E-mail: lrochon@wyeth Drug Name: Not available Specialty: Oncology Indication: Non small cell lung cancer

Phase III (cont.) Amgen, Inc. Web: www.amgentrials.com Drug name: Not available Specialty: Pulmonology, Internal Medicine Indication: Dyspnea and quality of life in chronic obstructive pulmonary disease (COPD) Notes: If interested, please CLICK HERE to complete and submit the email form. Amgen, Inc. Web: www.amgentrials.com Drug name: Not available Specialty: Pulmonology, Internal Medicine Indication: Must have access to cycle ergometry equipment and experience with exercise testing protocols. If interested, please CLICK HERE to complete and submit the email form. Cleveland Clinical Cardiovascular Coordinating Center Anne Castellano Email: castela@ccf.org Drug name: Not available Specialty: Cardiology with clinical trial experience in Intravascular Ultrasound Indication: Coronary Heart Disease JBA Research Natalie Lawrence Email: nlawrence@jbaresearch.com' Drug name: Not available Specialty: Internist, Anesthesiologist Indication: Osteoarthritis Notes: Specify whether your patients are opioid or non-opioid based.

Other study opportunities:

If you would like help finding studies or have questions about the listings below, please contact Laura Recchi at (323) 223-4091 for assistance. You may also send an email including detailed information about your research interests and most reliable contact information to info@health-research.org.

Phase: III
Disease: Agitation and Bipolar Disorder
Description: Inpatient, double blind, 24 hour intramuscular treatment with investigational drug, control drug or placebo. # Patients per Investigator: 5 enrolled in 7 months.
Investigator Grant: $7,780 per patient for a total possible grant of $38,900.

Phase: III
Disease: Agitation and Schizophrenia
Description: Inpatient, double blind, 24 hour intramuscular treatment with investigational drug, Haldol or placebo followed by double blind 4 day tablet study of investigational drug or Haldol.
# Patients per Investigator: 5-15 enrolled in 5 months.
Investigator Grant: $10,640 per patient for a total possible grant of $53,200-159,600.

Phase: IIIb
Disease: Pediatric Hypertension
Description: Double blind, 4 week study of three dose levels of an angiotensin II receptor blocker in pediatric patients between 6 and 16 years of age with seated systolic blood pressure = or > 95th percentile for their age, gender and height. Minimum weight = or > 20 kg. This will be followed by a 26 week open label extension.
# Patients per Investigator: 5 enrolled in 14 months. 60% of the subjects enrolled must African American.
Investigator Grant: $4,500 per patient for a total possible grant of $22,500.

Phase: III
Disease: Pediatric RSV Bronchiolitis
Description: A leading pharmaceutical company is seeking investigators to participate in a double-blind, multicenter 6-month study of an investigational drug in children aged 6 to 18 months who are hospitalized for an initial episode of RSV Bronchiolitis.
# Patients per Investigator: 10 enrolled in 4 months.
Investigator Grant: $2942 per patient for a total possible grant of $ 29,420.

Phase: Not Applicable
Disease: Advanced (Stage IV) cancer
1. Determine which cancers shed the largest number of cells into the circulation.
2. Perform additional assay development and refinement of the CellSearch System,
3. Assess the ability of various preservatives and/or stabilizers added to the blood tube to maintain cellular stability and integrity of genetic material.
4. Characterize circulating cells captured from metastatic cancer
patients using protein analyses and/or gene expression.
Description: Donor must be able to provide up to four 10 mL CellSave tubes of whole blood (approximately 8 teaspoons).
INCLUSION CRITERIA:
1. Diagnosis of advanced (Stage IV) cancer (i.e. prostate, breast, colorectal, lung, ovarian, pancreatic, etc.)
2. First line or later lines of salvage therapy eligible.
3. Minimum of seven (7) days since last administration of chemotherapy, radiotherapy or hormonal therapy.
4. Signed informed consent.
EXCLUSION CRITERIA:
1. Patients with early stage disease.
2. Patients unwilling or unable to give consent
# Patients per Investigator: 50-100 enrolled in 6 months.
Investigator Grant: $100 per patient for a total possible grant of
$5,000 to $10,000.

Grants for research on Alzheimer's disease
The American Health Assistance Foundation is accepting applications for grants to support research on Alzheimer's disease.
Who is eligible: nonprofit universities, medical centers, and independent research institutions. Principal investigators must be at least assistant professors.
Deadline for applications: October 15.
Total amount to be awarded and number of awards: not specified.
Amount of individual awards: up to $150,000 each year for up to two years.
View the full text of the announcement on the foundation's Web site. http://www.ahaf.org/alzdis/research/adresrch.htm

AMA Foundation seeks applicants to grant programs
The American Medical Association Foundation is seeking applicants for the Seed Grant Research Program, which provides funding to support medical research programs led by medical students and residents. The program awards grants of $1,500 to $2,500 towards the conduct of small projects in applied and clinical research. Applications must be received
by Nov. 15.

The AMA Foundation is also seeking applications for the Health Literacy Grants to Community Organizations and Alliances Program, which provides funding for projects that advance the field of health literacy through coalition building with medical societies, community organizations, educational healthcare institutions, health professionals, and patients.
Grant recipients are eligible to receive up to $1,000 per project. Applications must be received by Sept. 30.

Information: AMA Foundation, 312.464.4200, seedgrants@ama-assn.org, or
go to http://www.amafoundation.org
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HRA Special Projects

Last month's newsletter introduced the several projects taking place at HRA's administrative office. This article will provide you with more information about each project as well as an opportunity to provide comments or ideas you might have about any of the projects.

HRA would also like to recognize the several research project staff members who have agreed to take time out of their busy schedules to be a part of the teams. We appreciate your dedication, and your input is invaluable!

Training
The training team has developed a plan, to be implemented in January 2004, that is intended to meet the training needs of our project employees, PI's and the greater research community. The basic program will include a variety of topics and formats, including casual brown bag lunch discussions with internal speakers and more formal, quarterly training sessions. The team is currently compiling a list of speakers and appropriate organizations to provide these training sessions and researching sources for funding.

Thank you to External Team Members: Kathy Kassar and Jennifer Benna

If you have any ideas or comments for the Training Team,
please contact team lead Debbie Waters at dwaters@health-research.org

Project Close-out
The Project Close-out team is researching and closing accounts of completed research projects and transferring funds to various accounts to be used appropriately for general research purposes. The team is also determining the best way to perform this task in a timely manner with respect to compliance and efficiency. The result will be a clear procedure for HRA to close inactive accounts manually until such time as the process can be automated with new software.

If you have any ideas or comments for the Project Close-out Team,
please contact team lead Vikki Jenkins at vjenkins@health-research.org

Research Policy & Procedures
The Research Policy and Procedures team is examining the current manual and conducting best practice research to design a set of policies and procedures that will be consistent with LAC + USC Medical Center Policies and IRS guidelines. The new manual will be clear and concise so that all research activities can be conducted and monitored more efficiently.

Thank you to External Team Members: Susie Nakao and Poornima Shobhakar

If you have any ideas or comments for the Research Policies and Procedures Team,
please contact team lead Jackie Battle at jbattle@health-research.org

External Assessment
The External Assessment Team will produce a comprehensive research report that will include results of a written survey of research project staff, focus groups with a random selection of Principal Investigators, and phone surveys with Pharmaceutical sponsor representatives. The team will also produce a written summary of trends in the clinical trials industry with a special focus on academic health centers. The report will be used as part of the strategic planning effort of HRA Management and Board of Directors. The team will also determine the best way to conduct such evaluations in the future so that we can stay informed of the changing needs of our customers.

If you have any ideas or comments for the Project Close-out Team,
please contact team lead Laura Recchi at lrecchi@health-research.org

Systems
The Systems Team will analyze and assess the needs of both internal (HRA Admin office) and external users (LAC + USC) in the Clinical Trials management process. Based on the assessment, criteria will be established for the selection of a vendor(s) that will fulfill our internal requirements while providing a valuable tool for the conduct of trials managed by HRA. The expected result of the new system will be improved budget and contract negotiations, resulting in better expense recoveries. There will also be a mechanism to track study payments during the entire study trial and not just at the initial payment stage. Processes will be integrated in one system rather than fragmented across departments and projects. This will provide streamlined services as well as reliable reporting to each study.

Thank you to External Team Members: Flavio Beas, Gloria Regalado, and Elaine Sawitskas.

If you have any ideas or comments for the Systems Team,
please contact team lead Alan Wong at awong@health-research.org

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Upcoming Training Opportunities

Morley Foundation is offering several training opportunities November 13-16, 2003, in Las Vegas, NV including:
Basic Training for Clinical Research Coordinators
Site Management Training
Financial Management Training

For additional information see http://www.morelyfoundation.org.

DIA Center for Career & Professional Development
October 13-15, 2003 - Introduction to Good Clinical Practices & Auditing
Offers Nursing credits. Click Here for details

October 15-17, 2003 - Drug Safety Surveillance & Epidemiology Click Here for details

October 27-28, 2003 - Clinical Statistics for Non-Statisticians Click Here for details

October 27-29, 2003 - Entry Level Clinical Research Associate
Offers Nursing credits. Click Here for details

Space is limited for these courses, so don't wait. If you are unable to attend these dates, check DIA's website for future offerings. www.diahome.org

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Upcoming Survey for Project Staff

Coordinators/Research Staff:
HRA will be distributing a paper survey to assess the current level of satisfaction with HRA services and determine which services are most important to you. The results will be used as part of HRA's strategic planning process. Your input is greatly appreciated.

The surveys will come by mail and will include detailed instructions on how to return them to HRA. If you have questions about the survey process, please call Laura Recchi at (323) 223-4091 or email lrecchi@health-research.org
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Who's Who at HRA

New Staff
HRA would like to announce the new Research Operations and Development Manager, Matthew Purner. Mr. Purner will join the staff September 15 to oversee the Grants & Contracts department as well as the HRA Pharmacy. October's newsletter will include a formal introduction and statements from Mr. Purner.

The HRA Pharmacy welcomes new IDS Pharmacist Helen Kou. Ms. Kou is working with John Sang to oversee IDS activities and will soon be the pharmacist of record at the facility.

Current Who's Who at the Administrative Office
HRA would like to re-introduce the administrative staff to clear up any questions you might have about who is providing service in various areas. The following is a general "who to call" contact list. The list will soon be available on HRA's website and updated as necessary. In the meantime, save this table as a reference.

If you have further questions about HRA's organization, please contact Laura Recchi, Staff Assistant (ext. 201).

HRA Main Phone Line (323) 223-4091
Management Information

Employment Opportunities

Attorney
Health Research Association is seeking an attorney with 1-3 years general corporate/business transactional experience within the medical research, healthcare, or academic arena. Will act as principal negotiator for contracts and grants in clinical trials research business. Must have comprehensive knowledge of the biomedical and pharmaceutical industries, the clinical trials research business, and associated industry regulations. Experience negotiating contracts with pharmaceutical companies is essential. Must be customer service oriented, have excellent verbal and written communication skills, effective problem-solving and analytical skills, and strong academic credentials. HRA offers a competitive compensation and benefits package, along with a pleasant work environment. We are conveniently located across the street from the LAC+USC Medical Center. Fax resume, cover letter, and salary requirements to 323-342-0947, or email to: jobs@health-research.org.

Financial Analyst II
HRA is seeking a financial analyst responsible for producing regular and ad-hoc financial and operating reports, evaluating and analyzing reports and data, auditing internal projects/contracts and providing assessment and reports to management. The financial analyst will also establish and coordinate implementation of accounting and accounting control procedures. Bachelor's degree in Accounting or Finance, a Certified Public Accountant license, and a minimum of 3+ years related experience. Strong GL and Accounting concepts background is required. Some supervisory experience preferred. Knowledge of research grants and contracts accounting is highly preferred. Some supervisory experience preferred. Submit a copy of your resume and salary history to: Attn: Health Research Association, 1640 Marengo St. 7th Fl, LA, CA 90033. Fax (323) 342-0947. Email: jobs@health-research.org EOE/M/F/D/V

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