Mayra P. Email & Phone Number

San Diego, California, United States

San Diego, California, United States

All duties defined in level one, and in addition: • Performs tasks independently, consistently, and accurately, and demonstrates a moderate level of expertise in all skills and abilities, resulting in high quality work.• Provides guidance to less experienced staff.• Coaches and mentors other CTSS members on duties and responsibilities.• Plans, leads, and conducts training meetings with CTSS members based on new procedures, or as deemed necessary.• Assists CTSS Manager in leading CTSS members to ensure CTSS duties and responsibilities are being conducted per SOPs/WIs and in a timely manner based on study timelines.• Demonstrates proficient knowledge of eTMF Wingspan and project management skills.• Applies critical thinking and creative problem-solving skills in the department.• Identifies appropriate resources and support and discerns when to escalate issues needing additional intervention.• May be responsible for review and approval of designated employee ADP timesheets and expense reports (pass-through only) in accordance with ProSciento policies, with escalation to management for non-conforming submissions.

San Diego, California, United States

· Assists Clinical Project Managers (CPMs) with study start-up activities, including study-specific form development, regulatory binder/investigator package set and ship up, communications and correspondence, regulatory document submissions, equipment or supply procurement or shipping.· Assists CPMs with internal and external meeting coordination and generates meeting agenda and minutes.· Manages workflow for confidentiality disclosure agreement (CDA) review, submission, and execution; study form reviews by client; regulatory document receipt/review; and eTMF (Wingspan) document upload, maintenance, and review.· Contributes to the periodic review of the study files for accuracy and completeness.· Assists with upkeep of the clinical trial management system (CTMS) site database and sends feasibility questionnaires to new prospective investigators and/or sites that may participate in a specific project, and with export of applicable study data for eTMF set up.· Assists CPMs with the selection of investigators, as well as with site issue resolution.· Works with investigative sites and ad-hoc team members to complete all documentation necessary.· Determines completeness and readiness to support clinical supplies/investigational product shipment.· Aids in laboratory sample reconciliation and sample management as needed.· Assists in preparing submissions for independent ethics committees (IECs) or institutional review boards (IRBs) by compiling the package of documents for IEC/IRB and forwarding to either the investigator or IEC/IRB as directed.· Supports the CPM with third-party vendor oversight activities.· Assists with electronic data capture (EDC) query resolution activities, particularly with sites external to ProSciento.· Assists clinical teams in evaluating the investigator’s performance at closeout to facilitate future site identification activities.· Aids the CPM completion of all required tasks to meet departmental and project goals.

San Diego, California, United States

• Held primary responsibility for performance and analytics reporting, and provided internal quality control and compliance audits.• Developed study-specific subject recruitment performance reports to Sponsors, CRO, and/or internal CRU departments within ProSciento as assigned.• Tracked data and reports analytics on a regular schedule to the Associate Director, Recruitment Services and CRU leadership to inform strategic decisions and resource allocation.• Conducted presentations of metrics and associated analyses to subject recruitment and/or CRU leadership as requested to support or propose initiatives that serve the department or company’s mission or goals.• Conducted subject database queries for recruitment feasibilities, study start-up, protocol amendment proposals, and ad hoc, as needed.• Conducted regular database data-cleaning and develops and implements procedures to ensure all subject data is valid and reporting is consistent and verifiable. • Recommended process improvements and training modules to Associate Director, Recruitment Services to systematize and standardize QC initiatives. • Conducted monthly compliance reviews for current training requirements. Kept up to date with all training requirements for the subject recruitment department and assigned new training initiatives, as needed.

San Diego, Ca

• Supervised and managed subject recruitment staff in timely recruitment, screening, and enrollment of qualified subjects for ongoing research studies to ensure milestones were achieved.• Ensured efficacy and accuracy of recruitment, screening, and enrollment processes. Managed workflow and ensured productivity of employees. • Ensured subject data was entered into the database according to departmental guidelines.• Partnered with Manager, Subject Recruitment, Project/Study Managers, and Recruitment Marketing Specialist to develop study specific, effective recruitment strategies.• Provided input to Manager, Subject Recruitment on department specific objectives and structure, department procedural documentation, staffing of projects and design, and implementation of tools for recruitment activities.

San Diego, Ca

• Worked with Associate Director, Recruitment Services in strategic planning for the prescreening campaign• Assisted with training or managing oversight of training compliance of specific prescreening related items• Reviewed subject source for completion and prescreening compliance• Kept the Clinical Trial Management System (CTMS) updated with pertinent information• Responsible for completion of logs (Informed Consent Forms, training, screen failure, etc.)• Monitored and recorded subject prescreening lab values in the Volunteer Database and Excel algorithm documents• Responsible for compiling and generating data reports for the scientific team to review all prescreening data

San Diego, Ca

• Spoke professionally to potential subjects to obtain data and detailed medical history information and inputs into Volunteer Database (VDB). Explained studies and procedures and determined study eligibility based on inclusion and exclusion criteria. • Performed study specific queries from VDB. Scheduled screening appointments for pre-qualified study subjects. Tracked all study related recruiting activity. Ensured that recruitment plan milestones were achieved and communicated with supervisor regarding status and needed modifications.• Participated in database revisions and maintenance planning and implementation.• Supported staff and management with recruitment ideas and participates in the development and implementation of study and site specific recruiting materials and branding activities. • Worked alongside recruitment manager on recruitment feasibilities. Assessed available resources, identified potential challenges, used historical data and study tracking tools to determine feasible enrollment rate, and suggested changes to inclusion/ exclusion criteria to aid recruitment efforts and ensure recruitment success of trials.• Provided weekly recruitment updates and call metrics to the Project Manager and Clinical Research Coordinator.• Participated in community outreach programs such as health fairs.

Los Angeles, Ca

• Prepared materials and rooms to conduct studies• Worked alongside the lab manager and graduate students to improve the execution of the studies• Trained other Research Assistants to run new studies • Kept detailed notes on unusual events that occurred during studies• Performed data entry into excel spreadsheets• Ran studies with approximately 30 participants weekly

• Checked in and scheduled patients for their appointments• Answered phones using multi-line phone system• Kept record of X-ray receipt in Excel• Filled applications for Medi-Cal payment approvals

• Actively listened and provided support to people who struggled with a wide range of problems, including mental illness, through online chats • Worked on 3 chats at a time and assisted about 30 people a day

Bachelor Of Arts (Ba), Psychology

Activities and Societies: Active Minds, Psi Chi, Cultural Affairs CommissionMinors: Music History and Film/TV/Digital Media

Diploma Programme, High School

The International Baccalaureate (IB) Diploma Programme is a rigorous assessed program for High School students aged 16 to 19 that create.