Medical Training

H E AT H E R R E D L I C H

831-***-**** *******.*******@*****.***

V OLUNTEER

E XPERIENCE

E XPERIENCE

Narconon of Northern California - Director of Public Affairs, 12/2012 – Present

Tahoe Truckee FWDD

Maintenance of all regulatory and legal information and documentation at the

Coalition

facility, pursuant to the California Department of Healthcare Services

Executive Board Member

regulations.

2014-Present

Responsible for all public relations and promotional activities. Planned and

Volunteer of the Year

executed community fundraisers and events as a member of two community

Award 2013-14

coalitions. Served as chairman of an event workgroup for the South Tahoe Drug

Free Coalition. Volunteer 2013-Present

Managed all communication and support services associated with clients’ legal

affairs; serving as the primary point of contact and information source for all

related external agencies, C ERTIFICATIONS

Developed and implemented departmental standard operating procedures. & T RAINING

Prepared and evaluated weekly statistics for the Department of External Affairs,

Clintrace / Argus Data

executing any necessary changes to operating procedures, and monitoring

Analysis Certification 2009

statistics to observe overall trends in the department.

National Institutes of Health

Compilation and submission of administrative documentation in accordance

(NIH) Certification 2009

with international organizational guidelines and deadlines.

Office of Human Research

Tracked clients' progress throughout duration of treatment; re-assessed

Participants Training 2009

progress at scheduled intervals.

Bayer Pharmaceuticals - Drug Safety Analyst/Case Processor, 5/20 09–11/2009

Receipt, assessment, processing, tracking and follow-up of all safety data

E DUCATION

submitted for assigned company products, specializing in hematology,

cardiovascular and diagnostics.

Quinnipiac University

Assisted with overall pharmacovigilence operations associated with products.

Hamden, CT 06518

Advanced familiarity with Argus, MedDRA, and Clintrace systems.

BS in Health and Science

Review of adverse event completion and accuracy prior to submission.

Studies, 2004

Medical coding, narrative writing, and complete case editing.

Minor in Psychology

Managed team workflow to ensure case processing completion within internal

Dean’s List

and external timelines.

Completed four-month

Clinical Neuroscience Research Associates - Safety Specialist/Clinical Research

research project concerning

Coordinator, 11/2006–5/2009

the cause, treatment, and

Provided safety and adverse event training to research staff for all site.

prevention of dual/cross

Managed & coordinated multiple Phase II/Phase III clinical trials and co-

addictions

coordinated vaccine clinical trials.

IRB submissions/reporting, FDA audits, and Sponsor-initiated audits: Acted as Berkshire Medical Center,

liaison for FDA and Sponsor-appointed auditors; Served as point of contact for Behavioral Sciences Unit

sponsor companies and auditors; Produced reports in accordance with ICH GCP Clinical Trials Internship

guidelines. 2004

Designed source documents; created document templates according to NIH guidelines, GCP

regulatory protocol. training, safety reporting

Regulatory responsibilities: obtaining all required ethics approvals, acquisition training, HIPAA education

and submission of documents required for study start-up and closeout, and

semi-annual and annual reviews for selected IRB.

Highly skilled in use of Meditech and Filemaker Pro database systems; amended

programs to increase efficiency and meet site objectives.

Berkshire Medical Center, Clinical Trials Program, Psychiatry and

Behavioral Sciences - Clinical Trials Research Coordinator, 3/2004–4/2005

Berkshire Medical Center, Department of Psychiatry - Program Improvement

Analyst, 10/2004–5/2005

REFERENCES AVAILABLE UPON REQUEST

Contact this candidate