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ORCA Monthly Meeting: March 16, 2010 - Requirements & Best Practices for Management Review

Conference on Biosimilars, University of Washington, Seattle - March 19-20. Sign up today!


ORCA Board Members

Join the Organization of Regulatory and Clinical Associates ORCA is a 501(c)(3) non-profit organization. Its affairs are conducted by a board of directors composed of elected (President, Secretary, and Treasurer) and appointed members. Elections are held at the annual business meeting and social generally held in September and open to members and guests. Newly elected officers take office thereafter.

Only members in good standing (those whose dues are paid up) can run for office and vote in the elections. No one individual can serve more than two consecutive terms in the same elected position. If a person cannot fill his/her responsibilities as an office of ORCA, special elections will be held to fill the position being vacated. The ORCA Chairperson will assign someone to assume the responsibilities in the interim.


President
Marcia Koren

President Elect
Erica Jonlin

Past President
Jary Krauser

Treasurer
Margie van Waardenburg

Secretary
Terry Trimingham

Membership Secretary
Lena Huerlimann

Lead Program Co-Chair
Allene Dodge

Meeting Manager
Judy Wallak

Lead Web/IT Co-Chair
Nammi Krishnakant

Contact ORCA

General Information: info@orcanw.org
President: president@orcanw.org
Membership Secretary: membership@orcanw.org

Mailing Address:

PO Box 3490
Redmond, WA 98073
Voicemail: 206.464.0825


Board Member Duties

President

Supervise overall activities of the organization and oversees budget with Treasurer and the Board. Introduce Co-chairs for Clinical Research, Biotechnology/Drug and Medical Device sub-groups at monthly meetings and support Co-chairs as needed. Act as liaison with DIA and FDLI for video satellite conferences. Work with Co Chairs and admin secretary to assure meeting notices go out in timely manner. Provide general information on upcoming meetings, seminars, courses, etc. and/or arrange for members to report on meeting recently attended. Chair FDA/Industry Partnering Committee meetings to represent ORCA. Represent ORCA at National FDA Grassroots Committee meetings. Act as liaison to WBBA; provide current WBBA news and report on activities to members monthly. Act as liaison to other professional organizations such as OCRA, RAPS, ASQC, DIA, PMA, FDLI, PDA, etc. Provide responses to regulatory/clinical inquiries and questions from outside organizations such as the media, WBBA or the Washington State Department of Trade. Works with legal representative on issues as needed.

Past President/President-Elect

Assist the president in the above duties, as needed. Act as Chair and attend meetings in president’s absence. The president-elect serves as president the following year(s).

Secretary

Take Board meeting minutes and distribute. Work with volunteers to respond to FDA’s promulgated regulations. Gather information for employment network and present it at monthly meetings. Manage correspondence (incoming and outgoing, mailbox). Maintain historical file for past meetings and correspondence. Provide backup for president and Co-Chairs at meetings. Respond to inquiries from other organizations, write thank-yous to speakers.

Treasurer

Collect membership dues; keep admin secretary informed of membership changes. Coordinate budget activities with President and Board. Maintain ledgers and monthly statements. Maintain non-profit license and tax-exempt documentation requirements (State and Federal). Make disbursements up to $1000.00 (amounts in excess of $1000.00 require two signatures).

Program Co-Chairs

  • Clinical Research
  • Biotechnology/Drug
  • Medical Device

Plan and recruit speakers for every third monthly ORCA meeting. Prepare meeting notice and send to admin secretary for timely distribution. Prepare biography for speaker and introduce speaker at meeting; generally lead the meeting and moderate Q&A. Obtain copy of speakers’ handouts and provide sufficient copies for meeting attendees. Keep members informed about major changes in the regulations affecting their specific areas. Write summaries of meetings for ORCA Notes.

Meetings Manager

Schedule meeting rooms for ORCA monthly meetings and videoconferences. Coordinate with registration secretary and president regarding anticipated attendance in order to provide for sufficient seating, food/beverage, audiovisual needs, downlink equipment, etc.

Membership Secretary

Receive info from co-chairs and president to compile and ensure that monthly and special meeting notices get out on time. Maintain membership and mailing database, provide updates to president and meeting registration secretary. Send out notices of dues renewal. Send out ORCA Notes and meeting announcements to the membership.

Meeting Registration Secretary

Check voicemail daily, refer to Board member when appropriate.
Maintain and coordinate meeting registrations correspondence/payments.
Man the registration desk at meetings.


ORCA Directory Spring 2008 (pdf 1610kB)

ORCA Benefits

 
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