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Pinnacle Clinical Research · 1 day ago

PRN Clinical Research Coordinator

Edinburg, TX

Full-time

Onsite

New Grad, Entry Level

Pinnacle Clinical Research is committed to driving innovation and advancing medical knowledge through clinical research. They are seeking a PRN Clinical Research Coordinator responsible for managing day-to-day operations of clinical trials, ensuring compliance with protocols, and collaborating with various stakeholders.

Clinical TrialsHealth CareHospitalMedical

Responsibilities

Exercise judgement within the allowable limits defined within clinical trial protocols, standard operating procedures, and the direction from the study investigator, Project Manager, and Director of Clinical Research Operations

Always maintain subject and document confidentiality, understand, and comply with the appropriate sponsor requirements and regulations which include the Food and Drug Administration, good clinical practices, International Conference on Harmonization, Health Insurance Portability and Accountability Act, institutional review boards, and institutional policies and procedures

Complete study directed assessments with patients which include, but not limited to, informed consent, subject history, adverse events, Fibroscan, test article handling, appointment scheduling, records review, treatment coordination, collecting vital signs, and subject health assessment

Create and complete study related documents and new study preparation

Function as a liaison with pharmaceutical sponsors and external vendors

Prepare for study monitor visits (onsite or remote), audit inspections, etc

Respond to internal and external requests for information in a timely manner

Perform subject screening and recruitment

Contribute to data management for research projects

Identify opportunities to improve patient care and satisfaction

Conduct patient-facing encounters with compassion, empathy, and thoroughness

Must be able to review medical records against Inclusion/exclusion criteria to identify potential subjects

Responsible for ensuring that subject qualifies for study prior to each dose and remains present for subject monitoring post-dose

Obtains and documents adverse event data on appropriate forms

Ensure source documents are transcribed to EDC platform per protocol on a timely manner

Ensure EDC queries are answered within the required time set by the Project Manager or Data Management team

Resolve other study-related queries within a reasonable time set by the Project Manager or Data Management team

Interact with internal and external personnel such as physicians, nurses, administration staff, sponsor representatives, central laboratory and imaging personnel, and clinical trial patients

Coordinate multiple projects with competing priorities and deadlines as needed based on clinical trial protocol directives and study volume

Attends the investigator’s meeting, pre-study site visit, study initiation visit, and all other study-related visits hosted by Monitors or Sponsor representatives as appropriate

Ensure that electronic case report forms are completed

Create memos, emails, and letters related to study activities

Create and maintain reports and/or spreadsheets as requested

Ensure that all patient data is entered into the clinical trial management system in a timely manner

Maintain study documents and ensure electronic regulatory documents are saved and uploaded in the appropriate sections

Responsible for reporting safety information to all regulatory agencies

Understand the aspects of Regulatory and IRB requirements for studies

Performs quality checks on source documents specific to the study

Assist with the Corrective Action Preventive Action Plan (CAPA) process as needed

Qualification

Clinical Trial ManagementICH/GCP GuidelinesCITI TrainingBLS TrainingMicrosoft OfficeClinical Research IOSpanish ProficiencyMedical TerminologyOrganizational SkillsCommunication SkillsProblem-Solving SkillsTeam Collaboration

Required

Highschool diploma or general education degree (GED) required

Proficient in all Microsoft Office applications and Clinical Research IO (CRIO) or equivalent CTMS

Must have strong knowledge of ICH/GCP guidelines

Must complete CITI training before interacting with participants and must re-certify every 3 years

Must be trained and certified in administration of Fibroscan, training provided during onboarding

Must have basic life support (BLS) training, provided during onboarding

Demonstrated organizational skills and outstanding time management, including keen attention to detail with the ability to track multiple projects at one time

Strong written and oral communication skills

Knowledge of basic medical terminology

Possess impeccable integrity and personal and professional values that are consistent with PCR's high standards and mission

Comply with the company policies, code of ethics, and guiding values always

Proficient in Spanish and English required

Valid driver's license and insurance

Must be able to effectively communicate with all levels of internal and external contacts

Ability to work independently and multi-task in a fast-paced team environment

Strong people skills including ability to interact with individuals from diverse backgrounds and to oversee confidential matters and sensitive information with discretion and judgment

Must possess a positive, friendly, and professional demeanor, particularly when interacting with patients

Must be able to work independently and collaborate with a team

Ability to interpret clinical research protocols

Strong problem-solving and decision-making skills, particularly when under pressure

Proactive at identifying, addressing, and solving issues in real time

Energetic self-starter, results oriented, and the ability to work effectively in an entrepreneurial environment

Preferred

Bachelor's Degree in scientific area of study preferred or equivalent combination of education, training, and experience, or promotion internally from Research Assistant role