Stephen Plummer Email & Phone Number

Meridian, Idaho, United States

As a PCRA, worked on two Vaccine trials including RSV and COVID/FLU. Performs monitoring activities onsite from start up through close out in close collaboration with the Remote CRA including IP accountability, Investigator Site File review and source data review and verification. Follows-up onsite and addresses findings identified during remote review cycles. Updates systems and tracks activity in real time to facilitate monitoring team collaboration to ensure protocol, regulatory and SOP compliance and to guarantee subject safety, data integrity and site compliance. As an Onsite CRA, develops collaborative relationships with investigational sites and ensures site audit readiness. Builds relationships with site staff while onsite, complementing and supporting effective remote interactions that a site will have with the remote CRA as their primary contact. The Onsite CRA is the ‘site expert’ understanding site-specific processes, site staff dynamics and patient pathways. Demonstrates an understanding of the project-level processes and requirements necessary for the targeted disease and patient population under investigation. Attendance with FDA inspections at this site level. CRA Mentor and Accompanier. Used different Clinical and/or client specific systems for trial management, such as EDC, CTMS, IVRS, IWRS, eDiaries. Performed 100% or reduced SDV, on-site and remote visits. Familiar with AIM methodology and trained in Risk Based Monitoring.

Meridian, Idaho, United States

Serve as subject matter expert to design, develop, deliver and improve products, programs, and services to optimize process, behaviors, performance and audit readiness within Clinical Operations. Accountable for assigned initiatives aimed at supporting and/or ensuring quality operational delivery via efficient and effective processes, associated systems, training and communications. Interpret data on complex issues, leads teams and makes good business decisions following a risk-based approach. Oversight of global ACRA Academy and admin CRA Prep Program.

-Program lead for CRA mentor/CV process and development onboarding program-Accompany CRA’s for training visits and performance visits -Facilitate academy cra training mock SIV’s and Scenario sessions -Attend sponsor calls and internal team calls to stay informed of current study issues-Perform and coordinate assigned aspects of the clinical monitoring process in accordance with GCP's and global SOP's to assess the safety and efficacy of investigational products and/or medical devices-Conduct site visits to determine protocol and regulatory compliance, and prepared required documentation -Develop collaborative relationships with investigative sites, client company personnel and study vendors

Oakland, Ca

• Effectively coordinate and manage inpatient psychiatric pharmaceutical research trials adhering to ICH/GCP guidelines• Coordinate research studies dealing with patients diagnosed with Schizophrenia, Schizoaffective Disorder, Bipolar and Major Depressive Disorder• Manage multiple inpatient Psychiatric trials• Consult with patients and Principal Investigator to identify eligible candidates diagnosed with acute Schizophrenia who may benefit from a psychiatric clinical trial• Administer Cambridge Neuropsychological Test Automate Battery (CANTAB), CogState Schizophrenia Battery (CogState), Matrics Consensus Cognitive Battery (MCCB), UCSD Performance-Based Skills Assessment (UPSA)• Coordinate/conduct scheduled patient visits• Assure proper study medication administration with hospital nursing staff• Document medication compliance• Document and follow all Adverse Events and Concomitant Medications during the trial• Obtain all laboratory samples, ECG’s and vital signs• Enter visit data into electronic data capture system• Effectively train hospital staff and Research Assistants in collaboration with PI on all study procedures as defined in the protocol• Work with Clinical Research Associates to verify any data discrepancies, resolve data queries in a timely fashion• Prepare for and participate in sponsor audits and responses

Sarasota, Florida Area Gilbert, Az

• Opened and closed store, assuming responsibilities for daily accounting and sales reports• Recruited results driven individuals interested in success in the retail industry• Provided leadership and development opportunities to teammates• Delivered excellence in customer service generating repeat business, maintained sales in the top 15%

Sunrise, Fl

• Managed all aspects of on board golf operations for multiple cruise lines including Carnival, Princess, Norwegian, Silversea and Regent• Recruited, trained and managed daily revenue for 40+golf professionals• Designed sales initiatives and motivated golf professionals to meet & exceed targets• Provided daily, weekly, monthly, and annual revenue analysis• Managed on board sales for Nike in excess of $400K annually• Managed $500K on board fleet inventory• Coordinated and assisted with business development procuring contracts with additional cruise lines

Gilbert, Az

• Self marketing, sales and promotion of golf lessons that exceed monthly goals• Responsible for golf shop operations, tee sheet management, coordinating tournaments and corporate outings• Inventory management of over $100,000 in hard and soft goods, retail golf shop sales annual total $250,000• Key role in selling benefits of club membership during facility tours• Received awards for member retention /outstanding customer service• Teaching the members all aspects of the game of golf, private lessons, group lessons, playing lessons, junior – men - women’s clinics

Tempe, Az

• Senior level Phlebotomist responsible for performing venipunctures on any difficulty of vein averaging 30 per day• Responsible for monitoring donor floor activity and supervising Biomedical Technicians with an average of 40-50 donors on the floor at any given time• Initial and ongoing training of new hires and cross training of current employees in compliance with all federal regulations• Responsible for plasma processing, frozen storage and shipping frozen plasma specimens in accordance with local, state, and federal laws• Record keeping consistent with good documentation practices, local, state and federal regulations• Maintain the highest standards of Quality Assurance in compliance with ZLB as well as state and federal standards.

Walnut Creek, Ca

• Study and visit specific laboratory kit preparation, sample processing per protocol, sample packaging and shipping• Responsible for monitoring temperature of refrigerated and frozen samples and maintaining documentation/tracking logs • Assemble source documents, file lab reports, ECG’s and other source data• Case report form data entry in compliance with ICH/GCP • Telephone and reception coverage• Participant triage during clinic visits

Certificate, Phlebotomy Technician/Phlebotomist

Associates Of Applied Business, Golf Course Operation And Grounds Management

Bachelor'S Degree, Geography