CRA II - Sponsor Dedicated - West Coast.

Syneos Health • Orange, CA

5d • Onsite

About The Position

Syneos Health is a leading fully integrated biopharmaceutical solutions organization focused on accelerating customer success. They translate clinical, medical affairs, and commercial insights into outcomes to address modern market realities. Their Clinical Development model prioritizes the customer and patient. Syneos Health aims to simplify and streamline operations, making the company easier to work with and for. Employees collaborate with passionate problem solvers in a team-oriented environment to help customers achieve their goals, driving the acceleration of therapies to change lives. With 29,000 employees in 110 countries, Syneos Health emphasizes that 'WORK HERE MATTERS EVERYWHERE'. The company is dedicated to developing its people through career progression, supportive management, training, peer recognition, and a total rewards program. They foster a 'Total Self' culture where employees can be authentic, uniting globally and prioritizing employee well-being. Syneos Health is committed to building a company that its people want to work for and its customers want to work with, believing that diversity of thoughts, backgrounds, cultures, and perspectives creates an inclusive environment where everyone belongs.

Requirements

• 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
• 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 75% on a regular basis
• 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.

Nice To Haves

• For Real World Late Phase, the CRA II will use the business card title of Site Management Associate II.
• The SMA II may be requested to train junior staff.

Responsibilities

• 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 Pharmacoepidemiology Practice (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.
• 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.
• Per 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 study 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 to changing priorities to achieve goals / targets.
• May act as primary liaison with study site personnel, or in collaboration with Central Monitoring Associate.
• 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.
• Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes; completes assigned training as required.
• For Real World Late Phase, the CRA II will use the business card title of Site Management Associate II. 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.
• The SMA II may be requested to train junior staff.
• Identify and communicate out of scope activities to Lead CRA/Project Manager.
• Proactively suggest potential sites based on local knowledge of treatment patterns, patient advocacy and Health Care Provider (HCP) associations.

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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level