Melissa M. Email & Phone Number

San Francisco, Ca, Us

San Francisco, Ca, Us

Foster City, Ca, Us

Foster City, Ca, Us

Foster City, Ca, Us

Foster City, Ca, Us

Plays a vital role in successful implementation and support of important Collaborative (CO) and Investigator-sponsored Research (ISR) projects. Serves as the key operational contact with external investigators and internal stakeholders. Evaluates a scientific proposal or protocol to identify logistical, regulatory and safety implications. Identifies potential operational challenges and in collaboration with senior team members provides solutions to ensure study remains on track. Collaborates with company's Clinical Contract and Finance /Business Dev Ops team and external investigator to ensure contracts are executed. Primary contact for study drug planning and shipping materials &logistics.Provides support and guidance to Affiliate clin ops and Medical Affairs personnel responsible for managing CO and ISR studies. Communicates and has relationship with other functional groups including but not limited to Medical Affairs, Regulatory Affairs, CCF, Materials and logistics, and Drug Safety and Public Health to ensure efficient management of study activities....

• Prepares and manages study start up for phase I-IV clinical trials start up at CPMCRI• Collaborates initial reviews and works with research regulatory team to start studies and manage them • Accountable for ensuring all protocol related regulatory processes and procedures are maintained forboth new and existing clinical trials including Oncology, Hepatology, GI, Gynecologic oncology, cardiology, ALS,Neurology, Kidney Transplant ,etc.• Drafts( Edits/writes) all relevant IRB(Central and local) and submission documentation in a timely manner. • Responsible for processing all protocol amendments, notices, suspensions, terminations, advertisements,and internal and external safety reports, (adverse event reports) for IRB submission.• Responsible for drafting all protocol related consents following strict guidelines given by both studysponsors and IRB's.• Works with IRBNET,Connexus, Allegro, and sponsor portals to manage submissions.• Processing IND/FDA submissions.• Manages Trial master files for multiple CRO’s• Collaborate directly with Clinical Research Managers and Director of Operations on the development of study specific plans and/or processe,CROs/vendors• Assist with site CDAs, Feasibilities, site selection visits, CTAs, budgets, and PSSV, SIV formultidisciplinary departments including but not limited to Hepatology and Oncology • Trains and updates research team on changes, presents at team meetingsAssist with the development of IRB guidance tools such as consent process of non-English speakers in clinical trials• Responsible for about 10-15amendments and 1-3 initials a month.• Coordinates responses to study questions or issues from health authorities or IRBs/IECs.• Provides operational input into the development and tracking of regulatory team goals.Proactively identifies potential operational challenges and in collaboration with senior team members provides resolution plans to ensure study remains on track

• Carries out the protocol requirements of clinical trials. • Maintains a a thorough familiarity of individual protocol procedures/requirements of all clinical trials • Assigned in the field of Hepatology, GI, OBGYN, Cardiology, and Stroke. • Conducts clinical trials to the standars of medical practice, the FDA guidelines for GCP and • Human Subject Protection and other regulatory governing bodies. • Creates, collects and maintains complete source docs for studies. • Prepares and maintains regulatory documents in compliance with CPMC and sponsors. • Attends investigator meetings. • Ensures research billing is compliant. • Works with clinical research team( PI,SUB-I, regulatory, IRB, physicians, industry) for the efficient • Management of clinical trials. • Participates in the informed consent process, adhering to GCP guidelines. • Conducts visit with study subjects in accordance with protocol. • Prepares and ships blood and bio specimens in accordance to IATA guidelines. • Ensures accountability for investigational product in accordance with CPMCRI policies and • Procedures and with study sponsor. • Scheduling study subjects procedures per protocol. • Coordinates monitoring visit and completes queries according to timelines. • Keeps up to date with all protocol amendments. • Enters data in EDC( Oracle, Trium, Medidata Rave, eClinical OS, Medrio, CT Engine, Sequana • Medical, Redcap, etc) systems assigned by sponsors. • Coordinated up to 15 studies at one time

Running the ins and outs of the art studio, including but not limited to office managing, Office Manager Job Duties: Maintains office services by organizing office operations and procedures; preparing payroll; controlling correspondence; designing filing systems; reviewing and approving supply requisitions; assigning and monitoring clerical functions. Digital marketing via social media networks and often works as Human Resources specialist.

Louisville, Kentucky, Us

Helping Humana members achieve health goals through telephone. Educate and advise members of Humana-approved educational materials and community. Organized and handled shipping and handling for all material being sent out. Collaborate daily with the care management team to meet goals and provide perfect services to members. Community Outreach, volunteered for various organizations to spread health awareness and resources available. Researching community resources as well as health related documents, referring member to services provided by Humana and around the community. Document all work per HIPPA regulations in CGX /HCAT program. Collaborating with committees inside company to engage employees, producing events, etc.

Assisted in productions such as concerts, conferences, festivals, videos, styling, live shows, photo shoots etc. Executive AssistantAssist in Managing budgetsCommunity OutreachSeek sponsors and sellers for productionHelped produced one of Tampa, Florida’s best Latin Festival Conga Caliente. Connections within Latin community and Latin organizations Assist in Accommodations for artist, making sure they receive right gearAssisted production with sales, marketing, locking down venues,etc.Book keeping/ Accounting

Bachelor Of Applied Science (B.A.Sc.), Psychology, Theater Arts, Spanish

High School Diploma, Performing Arts