Description
Sr CRA II / Lead CRA (Cape Town) Sponsor dedicated
Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress.
Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape.
Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to deliver – for one another, our customers, and, most importantly, for those in need.
Discover what your 25,000 future colleagues already know:
Why Syneos Health
- We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
- We are committed to building an inclusive culture – where you can authentically be yourself. Central to this is our purpose – Driven to Deliver – which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone’s life.
- We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress.
Job Responsibilities
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Performs site qualification, site initiation, interim monitoring, site management and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology 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. Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes.
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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.
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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 via review of site source documents and medical records
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.
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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.
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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 action items to resolution.
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Understands project scope, budgets, and timelines for own and others’ activities in the clinical team; 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.
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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.
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Prepares for and attends Investigator Meetings and/or sponsor face to face meetings. Participates in and may lead global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements.
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Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions.
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May provide direct supervision, training and/or mentorship to more junior level CRAs. Performs training and sign off visits for junior CRA staff, as assigned. May be mentored and assigned lead tasks under supervision of an experienced Clinical Operations Lead (COL) or operational line manager. This could include participation in business development proposals and/or defense meetings.
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For Real World Late Phase (RWLP), the Sr. CRA II will use the business card title of Sr.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
As required, collaborate and build relationship with Sponsor and other 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.
Identify operational efficiencies and process improvements
Develop study and country level informed consent forms
Collaborate with RWLP Regulatory team to ensure updated regulatory information is applied and shared
Participate in bid defense meetings
Provide input into Requests for Proposals (RFPs), scope and budgeting. Develop site management strategy.
Participate in Case Report Form design and edit check development.
Qualifications:
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Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience
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Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
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Must demonstrate good computer skills and be able to embrace new technologies
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Excellent communication, presentation and interpersonal skills. Moderate level of critical thinking skills expected.
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Ability to manage required travel of up to 75% on a regular basis
Get to know Syneos Health
Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.
No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.
http://www.syneoshealth.com
Additional Information
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.
Summary
Lead CRA (Sr CRA II): You have significant monitoring experience and a passion for training and mentoring other CRAs. You are adept at developing and maintaining relationships with clinical trial sites and demonstrate the ability to execute monitoring with a strong knowledge of Good Clinical Practice and clinical trial regulations to ensure subject safety, data integrity and inspection readiness. You are a strong collaborator across clinical functional areas with a demonstrated ability to creatively and independently resolve complex issues that impact sites. You are able to successfully develop and maintain positive site relationships in parallel with ensuring optimal trial conduct and quality at Eikon clinical trial sites. You are able to objectively assess monitoring quality and compliance with the Clinical Site Monitoring Plans to drive Eikon’s oversight of monitoring activities and deliverables. Qualifications/Requirements Typically requires a minimum of 6+ years of experience with a Bachelor's Degree, or 4+ years of experience with a post graduate degree. Significant experience monitoring Oncology (solid tumor) trials with proven experience monitoring phase I Oncology is required. Previous experience independently conducting on-site and remote monitoring visits (site qualification, initiation, monitoring, and close-out) is required. Experience utilizing Veeva CTMS, CDMS, RTSM and TMF (a minimum of 2 years) is required. Experience supporting site and/or sponsor inspections is required. Experience auditing sites and TMF is preferred. Site travel of approximately 50-75% is required; this travel percentage could increase to meet urgent business needs or decrease in cases when remote monitoring and Oversight Visits occur.
