Keilla Priscilla Teran Martinez

• Understand the main objectives of each ongoing study and the study procedures for which will be responsible.
• Proficient at performing clinical procedures such as (but not limited to) vital signs, ECGs, phlebotomy, and sample processing, as required in protocol Schedule of Events (SOE) from First Visit (Screening) through Last Visit (Follow-up).
• Proficient in documenting observations and study procedures following Good Documentation Practices (GDP) in source documents.
• Participate in day-to-day clinical and laboratory activities and procedures, ensuring efficient workflow, appropriate collection and management of research subjects’ data and laboratory samples, and adequate care and treatment of research subjects.
• Assist in the transcription of study data from source documents to Case Report Forms (CRFs)/ (eCRFs).
• Understand and complies with Good Clinical Practices (GCPs), particularly those regarding the protection of human subjects and integrity of clinical trial data.
• Understand and complies with ProSciento Standard Operating Procedures (SOPs) and Work Instructions (WIs).
• Understand advanced knowledge for multiple dedicated procedures such as administration of investigational product (IP), indirect calorimetry, clamp, others.
• Support in the creation of materials, tools or documents that will coordinate the operation of different areas.
• Assisting in leading other staff members, training, and mentoring of entry level staff.
• Ensure study-related clinical procedures are performed according to the study protocol and provide information and direction to other Research Assistants as needed.
• Review protocols and understand the main objectives of each ongoing study and the study procedures for all studies.
• Demonstrate proficiency in preparation, operation, troubleshooting, and maintenance of in-house clinical studies.
• Review study procedure documentation ensuring accuracy and legibility in source documents.

Company Overview: Supporting a biopharmaceutical company leader in RNA-targeted therapy for more than 30 years with a workforce of 700+ employees.

• Safety Specialist at the Pharmacovigilance department.
• Monitor and ensure uninterrupted operations and resolve complex technical issues promptly.
• Develop troubleshooting and problem-solving strategies to address Safety Issues, maintaining high levels of productivity and user satisfaction.
• Support a virtualized environment using ARGUS Safety Database, overseeing the configuration, optimization, and training of partners.
• Oversee virtual Adjudication operations for multiple studies, facilitating seamless communication and collaboration among employee and partners across various departments and locations.
• Establish transparent communication channels with decision-makers, providing regular updates on safety specifications, project statuses, and technical initiatives.
• Administer Pharmacovigilance email account management duties, optimizing telecommunication services.
• Collaborate closely with cross-functional teams to identify opportunities for improvement and drive enhancements in technical operations and system efficiency.
• Supporting a biopharmaceutical company leader in RNA-targeted therapy for more than 30 years with a workforce of 700+ employees.

Achievements:

Managed the migration of the Pharmacovigilance team to ARGUS Safety Database and application software to a virtual environment, ensuring a smooth transition and minimal disruption to operations. Helped maintain Queries up to date, guaranteeing uninterrupted access for all users and maintaining high levels of productivity across the organization.

Under the supervision of the Site Director, responsible for the conduct of research protocols, in accordance with Good Clinical Practice Guidelines.

Managed study conducts from planning through study closeout including all aspects from the informed consent process, coordinating and performing all visit study procedures per the protocol, entering data and query resolution, Investigational Product management, and managing all study related supplies and equipment, hosting monitoring visits, and attending Investigator Meetings, this providing the highest level of care for study patients and delivering excellent customer service to the Pharmaceutical clients.

Achievements:

• Managed a 450-patient Johnson & Johnson COVID-19 Vaccine Study.
• Responsible for communicating with participants regarding study objectives, obtaining informed consent and complete medical history.
• Monitoring the study to ensure that it complied with protocols and liaising with laboratories regarding research findings.
• Responsible for conducting all clinical research trials per the Company’s SOPs, Good Clinical Practice (GCP) and FDA/ICH/EMA guidelines.
• Planned, managed and tracked study through CTMS, Electronic Data Capture and Query Resolution.

• Performed study-related clinical and laboratory procedures while ensuring the integrity of the studies and the safety and well-being of human subjects.
• Assisted in study-specific data entry needs, as well as other activities related to the operational conduct of a trial, supporting in multiple departments such as Screening, Laboratory (including clinical procedures such as vital signs, ECGs, phlebotomy, and sample processing, as required in protocol SOE), Clinical Research Coordination, and site operations in general.