Nicole D. Email & Phone Number

San Diego, Ca, Us

Menlo Park, California, United States

Leading a global phase II/III open-label extension study for Corcept's pivotal program. With a dedicated team I'm fostering cross-functional collaboration to successfully navigate resource challenges and achieve our goals.

• Manages global study sites from start-up through closeout of the study• Reviews, tracks, and communicates lab results to ensure eligibility to medical monitor and sites for timely patient enrollment • Ensures monitoring trip reports are reviewed and tracks the resolution of all action items• Creates protocol clarification memos, training material and conducts site and personnel training as needed• Exercises sound judgment to resolve issues with the protocol, drug dispensation,… Show more • Manages global study sites from start-up through closeout of the study• Reviews, tracks, and communicates lab results to ensure eligibility to medical monitor and sites for timely patient enrollment • Ensures monitoring trip reports are reviewed and tracks the resolution of all action items• Creates protocol clarification memos, training material and conducts site and personnel training as needed• Exercises sound judgment to resolve issues with the protocol, drug dispensation, vendor systems, safety, regulatory, legal questions and escalates as appropriate• Reviews vendor invoices for accuracy and provides financial updates as needed• Experience with regulatory submission packets for Ex-US countries, including initial submissions and amendments • Conducts booster visits and provides support on co-monitoring visits• Assists the team in planning, executing, and presenting at global investigator meetings and represents the company at indication-related conferencesIndication Experience: Endocrinology - Cushing Syndrome and Adrenal Adenomas or Hyperplasia Show less

Menlo Park

• Negotiates and reviews site budgets, confidentiality agreements, and Clinical Trial Agreements and coordinates targeted review with the legal department for sites globally• Develops and reviews study documents such as study manuals, training materials, and study trackers • Reviews informed consent forms and documents including patient-facing material to ensure accuracy and readability• Oversees clinical sites from start-up through closeout of studies• Performs ongoing in-house… Show more • Negotiates and reviews site budgets, confidentiality agreements, and Clinical Trial Agreements and coordinates targeted review with the legal department for sites globally• Develops and reviews study documents such as study manuals, training materials, and study trackers • Reviews informed consent forms and documents including patient-facing material to ensure accuracy and readability• Oversees clinical sites from start-up through closeout of studies• Performs ongoing in-house review of eCRF data for completeness, accuracies, inconsistencies, and adverse events• Partners with clinical vendors and other functional area team members to meet study goals• Manages vendors, including the review of agenda and minutes, leading meetings and escalating any issues to the Study Lead• Provides reviews of vendor agreements, budgets, manuals and documents as well as user acceptance testing for applicable systems• Conducts pre-study, initiation, interim, and closeout visits independently or in conjunction with CRO to ensure protocol compliance, accurate and thorough data collection and appropriate site conductIndication Experience: Endocrinology - Adrenal Adenomas or Hyperplasia Show less

Menlo Park, Ca

•Supervises study preparation, site preparation and the in clinic phases directly or through a CRO for assigned studies.•Ensures that Good Clinical Research Practice (GCPs) and Corcept clinical SOPs are met throughout the clinical program.•Acts as liaison with clinical vendors and other functional area team members to meet project goals.•Coordinates cross- functional components of the clinical trials process such as drug product supplies, etc.•Participates in the preparation of… Show more •Supervises study preparation, site preparation and the in clinic phases directly or through a CRO for assigned studies.•Ensures that Good Clinical Research Practice (GCPs) and Corcept clinical SOPs are met throughout the clinical program.•Acts as liaison with clinical vendors and other functional area team members to meet project goals.•Coordinates cross- functional components of the clinical trials process such as drug product supplies, etc.•Participates in the preparation of study site budgets drafting informed consent forms ensuring that they are in agreement with the protocols.•Coordinates all study start up activities, potentially with and through the CRO.•Monitors study sites in the field with the CRO or independently on an as needed basis.•Collects, reviews and tracks essential trial documents.•Provides the clinical team and the program team with information regarding CRO and clinical site performance and recommend remediation when needed.Indication Experience: Endocrinology - Cushing Syndrome Show less

San Mateo, California

• Maintain and manage appropriate study documentation under the direction of a CPM or CRA • Maintain tracking systems and tools to support the clinical study under the direction of CPM or CRA• Assist with clinical supply requisition and maintenance• Assist with the collection of study related documents in collaboration with the CRA• Assist with vendor management in collaboration with the CPM• Perform general administrative functions such as scheduling and organizing meetings… Show more • Maintain and manage appropriate study documentation under the direction of a CPM or CRA • Maintain tracking systems and tools to support the clinical study under the direction of CPM or CRA• Assist with clinical supply requisition and maintenance• Assist with the collection of study related documents in collaboration with the CRA• Assist with vendor management in collaboration with the CPM• Perform general administrative functions such as scheduling and organizing meetings (including Investigator meetings), and/or travel arrangements, etc.• Provide project support in Clinical Trial Management Systems• Contributed to Protocol Design• Conduct Feasibility Research and Out Reach to Potential Sites• Create PowerPoint Presentations for Internal Overview, Client Presentations and Internal/External Training• Conducted database User Acceptance Testing and review • Other duties as assignedIndication experience in:• Oncology- Leukemia• Hematology• Metabolic Disease- Amyloidosis, Diabetes• Orphan Drug/Disease• Neurological Disease- ALS• Infectious Disease- ABSSI, C. diff, Impetigo, Nasal Polyps, UTI• Pulmonary-Cystic Fibrosis• Genetic Disorders- VEDs, Prader-Willi• Device Experience with blinded and unblinded studies Show less

San Jose Ca

Worked directly with the CEO to implement policies and procedures, streamline and organized AP/AR

Ecology Lab

Worked with a UCSB doctoral candidate in a parasitology laboratory. Dissected and examined specimens to draw conclusions about parasite biomass in intertidal food webs. Prepared specimens and slides, examined under dissection and compound microscopes to reach classification according to lab procedures

Plant Ecology Lab

Worked with a UCSB post doctorate on research dealing with serpentine grassland plants. Helped increase efficiency in execution of experimental treatments. Conducted primary literature research, sample cleaning, biomass collection and treatment

Santa Barbara, California Area

Worked with head horticulturist to meet hard deadlines for contracts. Planted and cared for plants used for the grounds and for purchase

Bachelor'S Degree, Biology/Biological Sciences, General

Activities and Societies: Collegiate Panhellenic Council, Gamma Phi Beta Coursework: General and Organic Chemistry w/ Lab; Calculus.

High School