Role Description

Experienced CRA I - Sponsor Dedicated | Oncology / Neurology | 6 months of monitoring experience required (Home-Based - Miami, FL)

• Performs site qualification, site initiation, interim monitoring, site management activities, and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiological Practices (GPP) and protocol compliance.
• Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and develops action plans with guidance.
• Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes.
• Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate.
• Demonstrates diligence in protecting the confidentiality of each subject/patient.
• Assesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues.
• For the Clinical Monitoring/Site Management Plan (CMP/SMP): Assesses site processes.
• Conducts Source Document Review of appropriate site source documents and medical records.
• Verifies required clinical data entered in the case report form (CRF) is accurate and complete.
• Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines.
• Utilizes available hardware and software to support the effective conduct of the clinical project data review and capture.
• Verifies site compliance with electronic data capture requirements.
• May perform investigational product (IP) inventory, reconciliation, and reviews storage and security.
• Verifies the IP has been dispensed and administered to subjects/patients according to the protocol.
• Verifies issues or risks associated with blinded or randomized information related to IP.
• Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported, and released/returned.
• Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness, and completeness.
• Reconciles contents of the ISF with the Trial Master File (TMF).
• Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations.
• Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan.
• Supports subject/patient recruitment, retention, and awareness strategies.
• Enters data into tracking systems as required to track all observations, ongoing status, and assigned action items to resolution.
• For assigned activities, understands project scope, budgets, and timelines; manages site-level activities/communication to ensure project objectives, deliverables, and timelines are met.
• Must be able to quickly adapt, with the oversight of the Lead CRA, to changing priorities to achieve goals/targets.
• May act as primary liaison with project site personnel, or in collaboration with another CRA or Central Monitoring Associate (CMA).
• Ensures all assigned sites and project-specific site team members are trained and compliant with applicable requirements.
• Prepares for and attends Investigator Meetings and/or sponsor face-to-face meetings.
• Participates in global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project-specific requirements.
• Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions.
• For Real World Late Phase, the CRA I will use the business card title of Site Management Associate I.
• Additional responsibilities include:
  • Site support throughout the study lifecycle from site identification through close-out.
  • Knowledge of local requirements for real world late phase study designs.
  • Chart Abstraction activities and data collection.
  • Collaboration with Sponsor affiliates, medical science liaisons, and local country staff.

Qualifications

• Bachelor’s degree or RN in a related field or equivalent combination of education, training, and experience.
• Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements.
• 6 months of independent monitoring experience required.
• Must demonstrate good computer skills and be able to embrace new technologies.
• Excellent communication, presentation, and interpersonal skills.
• Ability to manage required travel of up to 30% on a regular basis.

Requirements

• As part of your employment with Syneos Health, you may be deployed to Sites that require certain medical and other personal information to gain facility access.
• Pursuant to our Employee Privacy Notice, Syneos Health can provide the Sites with the information necessary for you to gain such access.
• Further, a Site may ask you for additional information beyond that which Syneos Health has in its possession.
• You are required to comply with any such Site requests as a condition of your employment with Syneos Health.
• Please note that failure to provide requested information may result in a Site barring you from entry, which could put your ongoing employment at risk.

Benefits

• Company car or car allowance.
• Health benefits to include Medical, Dental, and Vision.
• Company match 401k.
• Eligibility to participate in Employee Stock Purchase Plan.
• Eligibility to earn commissions/bonus based on company and individual performance.
• Flexible paid time off (PTO) and sick time.

Salary Range

$62,000.00 - $108,600.00

The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate’s qualifications, skills, competencies, and proficiency for the role.