Sandra Duke Email & Phone Number

Lynden, Wa, Us

Washington, United States

United States

Home Based

Home Based

Responsible for participating in the planning, implementation, training, monitoring and management of clinical trials. Serves as the primary clinical point of contact for Client representatives as well as Synteract team members in order to ensure the timely initiation and completion of clinical trials. Assists with department initiatives and management as needed.

Home Based - Michigan

• Interfaced cross-functionally to ensure that expectations and deliverables were met on 7 trials across 4 programs (1 ROW)• Contributed to decisions and process development within the GMO Management Team• Collaborated cross-functionally to manage serious site issues in a timely and appropriate manner• Prepared two programs for FDA Inspection and provided back-room support for one program that has since been approved by the agency• Trained on Risk Based Monitoring via the TransCelerate model• Summary:o Phase III pivotal hypertension trial with PK component (assigned for 2 years) –114 monitors; 7 lead RSMs; 471 sites; screened 13,250 patients; randomized 4,161 patients o Phase III long term safety and efficacy hypertension trial (assigned for 1 year) - 60 monitors; 3 lead RSMs; 143 sites; screened 2,264 patients; randomized 812 patients o Phase III long-term safety and efficacy in chronic constipation or IBS (assigned for 1.25 years) - 29 monitors; 1 lead RSM; 150 sites; 1200 randomized patientso Two Phase IV hypertension trials (assigned for 1 year total) - ~25 monitors per study; 1 LRSM per study;~125 sites per study; ~600 patients per study o Phase III Pseudomonas aeruginosa infection in pediatrics patients with Cystic Fibrosis (8 months) - Oversaw site selection and study-start-up activities assigned to a CRO for a 13-country trial planned for 100 patients across 40 sites.o Phase IIIb hypertension trial planned for Risk Based Monitoring (assigned for 6 months) - 32 monitors; 1 Lead RSM; 100 sites (through site selection only)

Home Based - Michigan

In August 2010, I was converted to full-time employment with Forest.• Reviewed trip reports and wrote Monitoring Plans• Oversaw data collection for Phase II and III trials, tracked metrics and timelines• Conducted project-specific training for in-coming RSMs/LRSMs and supported RSMs in project-related tasks• Liaised with Vendors • Produced agendas and meeting minutes RSM teleconferences and presented at Investigator Meetings

Marshall, Mi

• Monitored Phase IV in-patient and out-patient multi-center clinical trials• Conducted Site Initiation Visits and Ongoing Monitoring Visits • Study breakdown:o Monitored intra-operative analgesia hemorroidectomy trial – 2 sites; 13 subjects o Monitored intra-operative analgesia total knee arthroplasty trial - 11 sites; 67 subjects

Home Based In Michigan

• Monitored Phase II and IV in-patient and out-patient multi-center clinical trials• Comprehensive site management including budgets and grant payments, timely data entry and complete regulatory files.• Conducted Pre-study Site Visits, Site Initiation Visits, Ongoing Monitoring Visits and Close-out Visits• Study breakdown:o Monitored aerodigestive tract cancer treatment trial – 5 sites; 12 subjects; 39 screen failures (2 years)o Monitored pediatric allergy treatment trial - 2 sites; 9 subjects (9 months)o Monitored adult allergy treatment trial – 2 sites; 16 subjects (9 months)o Monitored diabetes treatment trial – 9 sites; 140 subjects (1 year)o Conducted pre-study visits for prostate cancer, breast cancer and leukemia trials (6 months)• Maximum protocol/site/subject load at any given time = 4 protocols; 14 sites; 152 subjects

Home Based - Michigan

• Managed multi-center Phase IIIB & IV US and International Trials according to ICH, GCP guidelines and all other required country specific regulations• Co-authored and implemented plans for enrollment enhancement, monitoring, CRF completion guidelines, and data cleaning • Provided cross functional support to Investigator Services to support the regulatory document collection effort and with Data Management to provide review support of key study documents including edit checks, tables & listings, Data Management Plan• Collaborated in meeting planning and presented at Investigator Meetings, Bid Defense Meetings, and Client Face to Face Meetings. Facilitated Study Coordinator and Investigator Teleconferences/Webcasts• Responsible for CRA budgets and resources• Actively involved in all aspects of trial management from study start up through study close down• Managed vendors including IVR and clinical labs • Summary:o Phase III thrombosis prevention following TKA (assigned for 1 year) – Managed 6 monitors with 10 US/Canadian sites; Liaisoned with sponsor to manage 3 countries including Israel, Brazil, Mexico. Oversaw the enrollment and completion of 1/3 of the subjects in a 2100 subject trial.o Phase IIIB MRSA in-patient pneumonia treatment trial (assigned for 3 years) – Managed 5 monitors with 25 sites in the US. Oversaw the enrollment of 200+ subjects.

Home Based - Michigan

Monitored Phase II-III trials from a regional office • Trained site, sponsor and CRO staff to use MACRO remote data entry system• Conducted Site Initiation Visits, Ongoing Monitoring Visits and Close-out Visits• Study Breakdown:o Phase III pediatric ADHD treatment trial – 15 sites; 150 subjects (6 months)o Phase II opioid-induced constipation treatment trial – 3 sites; 14 subjects (8 months)o Phase III hypertension treatment trial – 3 sites; 75 subjects (6 months)• Maximum protocol/site/subject load at any given time = 2 protocols; 18sites; 164 subjects

Home Based - Michigan

Monitored Phase II, III and IV trials from a regional office • Monitored and managed clinical sites including: conducting site initiations and closure visits, monitoring regulatory and IRB files, reporting of adverse events and Serious Adverse Events, SDV of source documents, negotiation of $1.2 mill in site contracts, monitoring drug compliance and inventory, acting as a liaison between the site and study management team at Roche to provide direction regarding various subject issues, and insuring that sites adhere to timelines• Actively participated as a Lead CRA on the “Global Study Management Team” and provided feedback to and from the Regional Monitoring Team. Responsible for reviewing the following draft documents prior to circulation: protocols, CRFs, and study procedures manual. • Collaborated on the development of the Roche MACRO remote data entry (RDE) System. Persuaded international trial team to forgo paper CRF entry and utilize RDE which resulted in an earlier NDA submission.• Study Breakdown:• Phase III colorectal cancer treatment trial – 3 sites; 33 subjects (2.5 years)• Phase III breast cancer treatment trial – 1 sites; 3 subjects (6 months)• Phase II osteoarthritis treatment trial – 3 sites; 35 subjects (1.5 years)• Phase II rheumatoid arthritis trial – 2 sites; 16 subjects (1 year)• Phase II hepatitis C treatment trial – 1 site; 12 subjects (1 year)• Lead CRA for Phase IV pediatric obesity treatment trial – 1 site; 21 subjects (2.5 years)• Maximum protocol/site/subject load at any given time = 4 protocols; 9 sites; 87 subjects

Kalamazoo, Michigan

Formerly Pharmacia & Upjohn.• Collaborated to set up a central system for credentialing Investigator regulatory packages • Wrote and assisted in development of protocols for a Phase IV OTC-conversion, cholesterol-lowering, international trial

Skokie, Il

Monitored Phase I and III clinical trials • Wrote protocols and monitored Phase I Pharmacokinetic/Pharmacodynamic Trials as follows:• Single Dose Tolerability, Bioavailability/ Bioequivalence, Food Effect, Controlled Release Projects, ADME, Drug/Drug Interaction, Elderly vs. Young, Obese vs. Normal Trial, Renal Impairment Trial, Hepatic Impairment Trial, Absolute Bioavailability Trial, Mechanism of Action Trials• Served as PK representative to STAR teams and 3 different Project Teams • Managed completion of projects that had been contracted to Clinical Research Organizations. • Drafted pharmacokinetic sections for inclusion in the product labeling; co-authored quarterly updates to clinical development plans; prepared pharmacokinetic updates/reports for the FDA and Canadian regulatory authorities• Worked with Clinical Services to insure timely availability of study drug• Study Breakdown:• Phase I anti-coagulant trials (combined for simplicity) – 24 sites; 200+ subjects (2.5 years)• Phase I HIV trials – 4 sites; 97 subjects (1.25years)• Phase I H. pylori trial – 1 sites; 36 subjects (6 months)• Phase III URI treatment trial – 3 sites; 33 subjects (6 months)• Wrote protocols for Phase I oncology trials, but drug did not move into clinical development• Maximum site/subject load at any given time = 8 protocols; 8 sites – 150 subjects (approximation)

Chicago, Il

Northbrook, Il