A Seventh-day Adventist Organization

About Research Affairs

The world-renowned scientists at Loma Linda University are striving to advance the understanding and care of human health in order to fulfill the institution’s mission “to make man whole.” The links to the right describe the pivotal role that Loma Linda has played in the history of health research and its current contributions to a wide variety of fields. Information about our clinical trials that are currently accepting patients can be found under For Patients & Their Families.

To search for specific services, see our Directory of Research Affairs Services

Office of the Vice President for Research Affairs (VPRA)

Post-Award Services

Human Studies

Animal Studies

Research Training and Education

Inventions and Commercialization of Intellectual Properties

Regulatory Compliance and Research Integrity

See also the Compliance Hotline page

Resolving a Service Problem

OFFICE OF THE VICE PRESIDENT FOR RESEARCH AFFAIRS

The Vice President for Research Affairs (VPRA) is responsible for promoting and managing research activities and guiding research in all entities and affiliates of Loma Linda University.

ASSOCIATE VICE PRESIDENTS

Anthony Zuccarelli, PhD, azuccarelli@llu.edu /x42772

  • Oversight and integration of Research Affairs activities and services
  • Coordination and planning for institutional research
  • GRASP research grants

Michael Kirby, PhD, mkirby@llu.edu /x88117

  • Review of grant proposals for scientific merit and institutional risk
  • Research training and education

Michael Samardzija, PhD, JD, msamardzija@llu.edu /x15920

  • Oversight of Technology Transfer
  • Coordination of institutional start up companies
  • Oversight of the institutional start up company incubator, N3eight, LLC.
  • Oversight of large research projects

Executive Assistant to Vice President and Associate Vice Presidents, 909-558-8544
Dorothy (Dottie) Messer, dmesser@llu.edu /x88544

  • Directions to sections and specialists
  • Scheduling meetings with Vice Presidents and Associate Vice Presidents

PRE-AWARD SERVICES (RESEARCH ADMINISTRATION)

Proposal Consultation

  • Identifying funding sources for proposed research
  • Assistance in planning and editing grant applications

Grant Pre-Award Management

  • Manages extramural grant submissions
  • Proposal development advisor
  • Obtains institutional approval
  • Identifies and interprets funding opportunities
  • Sponsor and institutional regulatory and policy review

Contact: Cindy Dickson, Pre-Award Grant Analyst (Research Administration), cdickson@llu.edu / x44571

Electronic Research Systems Management

  • Electronic submission of grant applications
  • eRA Commons and other sponsor registrations
  • Implementation and use of LLeRA modules
  • Maintaining your profile in the investigator database -- user name & password, etc.
  • Resource for general policy and procedure related questions

Contact Sherie Donahue, Electronic Research Coordinator (Research Administration, sdonahue@llu.edu/ x83911

Pre-Award Budget Approval

  • Assisting investigators with budget development and entry into electronic systems
  • Reviewing and approving budgets prior to submission

Contact Financial Management Coordinator, rafm@llu.edu / x44589

Research Conflict of Interest

  • Research conflict of interest disclosures and evaluations

Contact Sandra Figueroa, Administrative Assistant / x85794, researchcoi@llu.edu for COI forms and correspondence, sfigueroa@llu.edu for other communications.

POST AWARD SERVICES

Research Affairs - Financial Management (RAFM)

  • Central fiscal administration responsible for monitoring and managing internally and externally sponsored research awards, research related grants, contracts, and government allocations from the time of the award to close out. Each investigator is assigned a financial analyst.
  • Draw down of sponsor awards, monitor award expenditure and compliance with institutional and sponsor financial policies.

General Oversight of Financial Management

Contact:

To find your Financial Analyst

Contact the Financial Management Coordinator, rafm@llu.edu /x44589

Sponsored Projects Policy Development

Contact Trina Beckwith, Associate Director, tbeckwith@llu.edu /x87821

Contracts

  • Initiation, review and approval of research-related contracts (collaborative, subcontracts, amendments, confidentiality, material transfer, data agreements, professional service agreements, Federally-funded clinical trials, etc.)

Contact Elaine Moya, Financial Management Contract Analyst, racontracts@llu.edu / x44589

  • Assist faculty with clinical trial preparation
  • Initiation, review, approval of clinical trial contracts

Contact Amy Casey, Assistant Director of Operations, Clinical Trial Center, acasey@llu.edu / x55830

HUMAN STUDIES

Human Subject Protection Program (including IRB)

  • IRB Administrator
  • IRB applications for Administrative (Expedited or Exempt) Review
  • Determination of Non-Human Study Research

Contact Linda G. Halstead, Director [Research Affairs - Research Protections Programs (RPP)] & IRB Administrator, lhalstead@llu.edu / x43570

  • Submission of new applications to the Institutional Review Board (IRB) or Institutional Animal Care and Use Committee (IACUC) and screening for fulfillment of requirements
  • Deadlines for committee submission, status of applications
  • Scheduling appointments and consultations

Contact:

  • Consultations for full-board IRB reviews (except the two days after each IRB meeting)
  • Questions regarding change requests, new full board studies, full board renewals, and the results of full board reviews

Contact Anu Diekmann, Institutional Review Board Analyst, adiekmann@llu.edu / x43042

Clinical Trial Center (see the CTC website)

Cape Cod-Dover Bldg, 11374 Mountain View, Suite C
909-558-5830 / FAX 909-558-6087

The CTC plans and coordinates clinical trials (contract preparation, IRB submission, budget construction, compliance, and trial registration). It provides advice on trial budgeting and will coordinate negotiations with trial sponsors. It provides guidance on clinical trial billing and insurance coverage determinations.

Contact:

Accreditation of Human Subject Protection Program

  • Develop policies and procedures for the Human Subject Protection Program
  • Current practice in human subjects research, recommending and initiating movements

Contact Wesley James, Accreditation Coordinator (Research Administration), wjames@llu.edu / x44018

ANIMAL STUDIES

Institutional Animal Care and Use Committee (IACUC)

  • Submission of applications to IACUC
  • Consultations for IACUC reviews (except the two days after each IACUC meeting)
  • Status of Change Requests or Renewal Requests for animal research
  • Alternate to the director for general administration

Contact Obed B. Rutebuka, IACUC Administrator [Research Affairs - Research Protections Programs (RPP)], orutebuka@llu.edu or IACUC@llu.edu / x87130

Animal Care Facility

[coming soon]

RESEARCH TRAINING AND EDUCATION

  • Human Subjects Protections Certification
  • Curriculum and Course Development

Contact JR Krausz, Research Education Coordinator (Research Affairs - Research Integrity), jrkrausz@llu.edu / x87463

INVENTIONS AND COMMERCIALIZATION OF INTELLECTUAL PROPERTIES

Technology transfer (TT) and commercialization activities for intellectual property created by any entity affiliated with Loma Linda University.

  • Disclosure of new discoveries and inventions
  • Filing and prosecution of patents
  • Evaluating intellectual property for commercial potential
  • Negotiate licensing contracts
  • Payment of patent expenses and distribution of royalty income

Contact:

  • Michael Samarzija, PhD, JD, Associate Vice President for Research Development, msamardzija@llu.edu /x15920
  • Eric Gosink, Director (Research Affairs - Technology Transfer), / x87184 (egosink@llu.edu)
  • Zoran Zivanovic, Manager, Business Develoment, / x15089 (zzivanovic@llu.edu)
  • Tracy Lozano, Administrative Assistant, tlozano@llu.edu / x44831

REGULATORY COMPLIANCE AND RESEARCH INTEGRITY (RI)

  • Auditing or monitoring clinical trials, investigator-initiated studies and other research activities
  • Assist with registering trials with Clinicaltrials.gov, passwords and questions
  • Assist with export control issues including the shipping of hazardous research materials, disclosing information to international collaborators, investigators, and students; submission of export license applications
  • Investigation of alleged research misconduct and research complaints
  • Coordination of research-related education requirements
  • In conjunction with the Clinical Trial Center, assist with investigator-initiated IND or IDE submissions to FDA and associated reporting requirements
  • Assist principal investigator and study staff in conducting self assessments
  • Assist with investigator questions on responsibilities under the NIH Guidelines for recombinant DNA research
  • Assist in preparing sites for external audits, such as FDA audits

Contact:

  • Janice Quick-Wolfe, Director (Research Affairs - Research Integrity), jquick@llu.edu / x88166 or 558-8166
  • Jerry McIlhagga, Research Compliance Auditor, / x49408 or 558-9408
  • JR Krausz, Research Education Coordinator, jrkrausz@llu.edu / x87463 or 558-7463
  • See also: the Compliance Hotline page

RESOLVING A RESEARCH SERVICE PROBLEM

Pre-Award Services

Contact Anthony Zuccarelli, Associate Vice President for Research Affairs, azuccarelli@llu.edu / x42772

Post-Award Services

Contact Research Affairs -- Financial Management, rafm@llu.edu / x44589

Human Studies

  • Institutional Review Board (IRB)

Contact Linda G. Halstead, Director (Research Affairs - Research Protection Programs) & IRB Administrator, lhalstead@llu.edu / x43570

Clinical Trial Center

Contact Lila Dalton, Director of Operations, Clinical Trial Center (CTC), ldalton@llu.edu / x15002

Research Training and Education

Contact Janice Quick-Wolfe, Director (Research Affairs - Research Integrity), jquick@llu.edu / x88166

Invention and Intellectual Property

Contact Eric Gosink, Director (Research Affairs - Technology Transfer), / x87184

Unresolved Issues

Contact Anthony Zuccarelli, Associate Vice President for Research Affairs, azuccarelli@llu.edu / X42772

Contact _______________ Research Proposal Advisor (Research Administration)
*Interim contact: Cindy Dickson, Pre-Award Grant Analyst (Research Administration), cdickson@llu.edu / x44571