CRC I

Clinical Trial Execution:

• Exercise judgement within the allowable limits defined within clinical trial protocols, standard operating procedures, and the direction from the study investigator and site manager
• 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, 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

Administration:

• 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

Qualifications:

• Highschool diploma or general education degree (GED) required
• Bachelor's Degree in scientific area of study preferred; OR Equivalent combination of education, training, and experience, or promotion internally from Research Assistant role
• Proficient in all Microsoft Office applications and Clinical Research IO (CRIO) or equivalent CTMS
• Must have strong knowledge of ICH/GCP guidelines
• Must complete GCP training before interacting with participants and must re-certify every 3 years
• Must have basic life support (BLS) certification (can obtain 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 DRI's high standards and mission
• Comply with the company policies, code of ethics, and guiding values

Competencies:

• 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

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