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Women’s Health Counselor 1985-1994

Part-time position, 24 hours/week. I initiated this position. It took the state mandated requirement of screening women admissions for pap smears and made it into a comprehensive screening program to include pap smears, education on breast self exam, mammography and counseling on women’s health issues.

Part-time position, 10 -15 hours/week. Assessing and triaging patient telephone calls, patient education and counseling on birth control, pre and post-natal care, sexually transmitted diseases, menopause, osteoporosis, breast health and human sexuality. Responsibilities include venipuncture and non-stress testing, as well as assisting physicians when necessary.

Implementation, supervision, coordination, evaluation and management of clinical trials as per FDA/GCP and ICH guidelines and regulations; responsible for drafting and creating informed consent forms and negotiating budgets as well as verbal and written communication to the various Internal Review Boards. Trained research fellows in the conduct of clinical trials. Responsible for recruiting, enrolling and tracking research patients as well as establishing and maintaining standards of patient care and management, including the administration of investigational medications and completing study documentation accurately and in a timely manner. Direct and facilitate the work performance of the staff and in-service them regarding new study protocols and recruitment strategies; managing and scheduling patient appointments and clinical assessments; creation and preparation of advertisements for newspapers and direct mail campaigns; liaison with pharmaceutical companies, physicians, clinical monitors. Developed and implemented advertisements and recruitment materials, data collection documents and patients instruction and education materials. Collaborated in the creation of study related database.

• Spearheaded NIH and pharmaceutical trials from initial visits and meetings through completion in accordance with schedule and budget demands.
• Managed clinical research trials involving women's health and wellness.
• Gathered, prepared and maintained appropriate information required by FDA regulations and guidelines.
• Recruited volunteers for studies by mail radio and community outreach
• Obtained informed consent from research subjects and guardians to explain possible side-effects and potential outcomes of research.
• Collaborated with sponsors and investigators to carry out efficient and fully compliant research trials.
• Collected, processed and delivered specimens from trial participants.
• Kept patient care protocols and clinical trial operations in compliance.
• Adhered to standards in all areas, including data collection, research protocols and regulatory reporting.
• Assessed records of each patient, reviewed databases and checked referrals to locate potential research study participants.
• Conducted informed consent presentations and maintained documentation.
• Monitored multiple databases to keep track of all company inventory.
• Successfully led key projects which resulted in FDA approval of several new medications for osteoporosis.