Sandra West Email & Phone Number

Rosedale, Md, Us

Initiate clinical trial application with the Institutional Review Board (IRB)Maintain Clinical Trials Regulatory documents eIRB, Amendments, Protocol Events, Continuing Reviews, Investigational New Drug Safety Reports (IND), Investigational Brochures (IB).Coordinate diverse portfolio of Clinical trials including investigator initiated, sponsored and Investigational New Drug (IND) trials (Bristol-Meyers Squibb, Merck, Astra Zeneca, Audro, Curegenix.) studies.Initiate and maintain clinical trials.gov applicationsInitiate and maintain Clinical Research Management System (CRMS)Arrange/Coordinate/Host Sponsor Site initiation visits.Maintains good working knowledge of all assigned protocols and reporting requirements.Modify protocol and Informed Consent Forms in response to changing protocol.Maintains a research a physical/electronic chart for each patient.Maintain and report study Adverse Events and Deviation LogsData entry, management and calculations using computerized database, word processing and spreadsheet software; review data input for accuracy and completeness.Collect data via abstraction from paper and electronic medical records.Prepares reports on individual protocols and/or patients as required by principal investigators and/or external agencies.Responds in a timely matter to special projects and/or queries errors in database when necessary. Maintain filing system for electronic and paper-based research records.Actively communicate and update investigators on patient enrollment and data collection status via verbal and written communication.Prepares for and participates in monitoring and audits of studies.Prepare written responses to audit reports with input from principal investigator.Work independently and under the direction of the Program Manager to ensure completion of clinical research studies.Act as a back-up for coverage for other coordinators while they are out of the office.Train new team members

Oncology Gastrointestinal/Immunology

Initiate clinical trial application with the Institutional Review Board (IRB) Maintain Clinical Trials Regulatory documents eIRB, Amendments, Protocol Events, Continuing Reviews, Investigational New Drug Safety Reports (IND), Investigational Brochures (IB).Coordinate diverse portfolio of Clinical trials including investigator initiated, sponsored and Investigational New Drug (IND) trials (Bristol-Meyers Squibb, Merck, Astra Zeneca, Audro, Curegenix.) studies.Initiate and maintain clinical trials.gov applicationsInitiate and maintain Clinical Research Management System (CRMS)Arrange/Coordinate/Host Sponsor Site initiation visits. Maintains good working knowledge of all assigned protocols and reporting requirements.Modify protocol and Informed Consent Forms in response to changing protocol. Maintains a research a physical/electronic chart for each patient. Maintain and report study Adverse Events and Deviation Logs Data entry, management and calculations using computerized database, word processing and spreadsheet software; review data input for accuracy and completeness. Collect data via abstraction from paper and electronic medical records. Prepares reports on individual protocols and/or patients as required by principal investigators and/or external agencies. Responds in a timely matter to special projects and/or queries errors in database when necessary. Maintain filing system for electronic and paper-based research records. Actively communicate and update investigators on patient enrollment and data collection status via verbal and written communication. Prepares for and participates in monitoring and audits of studies. Prepare written responses to audit reports with input from principal investigator. Work independently and under the direction of the Program Manager to ensure completion of clinical research studies. Act as a back-up for coverage for other coordinators while they are out of the office. Train new team members

Oncology Upper Aero Digestive Group

Maintains good working knowledge of all assigned protocols and reporting requirements. Maintains a research chart for each patient. Data entry, management and calculations using computerized database, word processing and spreadsheet software; review data input for accuracy and completeness. Collect data via abstraction from paper and electronic medical records. Contact outside medical offices for patient data needed. Prepares reports on individual protocols and/or patients as required by principal investigators and/or external agencies. Responds in a timely matter to special projects and/or queries errors in database when necessary. Maintain filing system for electronic and paper-based research records. Actively communicate and update investigators on patient enrollment and data collection status via verbal and written communication. Prepares for and participates in monitoring and audits of studies. Prepare written responses to audit reports with input from principal investigator. Work independently and under the direction of the Program Manager to ensure completion of clinical research studies. New applications, continuing reviews, Protocol amendments, and SAE submissions into the eIRB. Working with Study Sponsor for Bristol-Meyers Squibb, Golden Biotech, VentiRX, PPD, ImmunoGen, Verstem, and PI initiated studies. Act as a back-up for coverage for other coordinators while they are out of the office.

Oncology Hematologic Malignancies

Maintains good working knowledge of all assigned protocols and reporting requirements. Maintains a research chart for each patient. Data entry, management and calculations using computerized database, word processing and spreadsheet software; review data input for accuracy and completeness. Collect data via abstraction from paper and electronic medical records. Contact outside medical offices for patient data needed. Develops and maintains a protocol spreadsheet for tracking patient activity. Prepares reports on individual protocols and/or patients as required by principal investigators and/or external agencies. Responds in a timely matter to special projects and/or queries errors in database when necessary. Maintain filing system for electronic and paper-based research records. Actively communicate and update investigators on patient enrollment and data collection status via verbal and written communication. Prepares for and participates in monitoring and audits of studies. Prepare written responses to audit reports with input from principal investigator. Assist in training and orienting new staff and students. Contact patients, consent and schedule labs according to protocol. Work independently and under the direction of the Program Assistant Manager to ensure completion of clinical research studies.

Wilmer Eye Institute At Johns Hopkins

Enroll and follow patients in ophthalmic clinical trials, including obtaining informed consent. Ensure patient has a pleasant experience while visiting JH-WEI.Comply with all regulatory and institutional requirements for conducting clinical trials.Become familiar with all aspects of study protocols prior to study involvement. Monitor study budgets via (BW) computer data base to ensure correct debit/credit posting to study accounts. Create and maintain study spreadsheets to ensure proper payment is received either by insurance companies or study sponsors. Perform various Ophthalmic Technician procedures according to protocol guidelines (refractometry, lensometry, tonometry, vision testing, and instillation of dilating drops, set up procedure room for treatments)Coordinate patient appointments at appropriate time according to study protocol using Cadence and verify insurance, get referrals as needed. Communicate all necessary information to sponsors, IRB, referring physicians, patients, families, faculty and staff involved with each specific clinical trial. Maintain safety and security of all study drugs. Prepare and participate in audits by study sponsors (Diabetic Retinopathy Clinical Research Network), Research Pharmacy and IRB. Maintain and organize accurate clinical research data for each patient. Enter data into clinical trial data base. Serve as Back-up Ophthalmic Technician for Retina Clinic when needed (history taking, visual acuity, perform PHP & Amsler Grid, lensometry, tonometry, instill dilating drops, properly assist visually and physically disabled patients

Rosedale, Md

Internship for Medix (Dec 2004) Hired Jan-Feb 2005Answer phones, used automated system to accurately expedite patient scheduling, pre-registration and check-in’s, assisted patients in making other necessary appointments (x-rays, labs), maintained patients charts, called in prescriptions to pharmacy with physicians permission, collected co-payments, verified insurance, directed patients to proper Radiologists, and labs according to insurance coverage, took telephone messages, relayed to proper individual in a timely matter as well as returned phone messages as directed, work as part of a team to complete assignments in a timely matter.

Various Locations In Baltimore

Maintained various positions through out 17 year career, Teller Manager for 12 of the 17 years, Customer service, answered phones, maintained various General Ledger accounts, cash handling main vault and cash drawer, created reports for various areas of the banking, managed 5 person teller line. Handle customer complaints.