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- Tasks: Join us as a CRA II, managing clinical sites and ensuring compliance with regulations.
- Company: Syneos Health is a global leader in biopharmaceutical solutions, dedicated to accelerating customer success.
- Benefits: Enjoy career development, a supportive culture, and the chance to work remotely.
- Why this job: Make a real impact in healthcare while collaborating with passionate problem solvers.
- Qualifications: A Bachelor's degree or RN in a related field is required; experience in clinical practices is a plus.
- Other info: Travel up to 75% is expected; embrace new technologies and challenge the status quo.
The predicted salary is between 36000 - 60000 ÂŁ per year.
CRA II – Sponsor dedicated – Colombia Client Based
Join to apply for the CRA II – Sponsor dedicated – Colombia Client Based role at Syneos Health
CRA II – Sponsor dedicated – Colombia Client Based
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Join to apply for the CRA II – Sponsor dedicated – Colombia Client Based role at Syneos Health
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Description
CRA II – Sponsor dedicated – Colombia Client Based
Description
CRA II – Sponsor dedicated – Colombia Client Based
Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.
Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.
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 accelerate the delivery of therapies, because we are passionate to change lives.
Discover what our 29,000 employees, across 110 countries already know:
WORK HERE MATTERS EVERYWHERE
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 our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
- We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong.
Job 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): o Assesses site processes o Conducts Source Document Review of appropriate site source documents and medical records o Verifies required clinical data entered in the case report form (CRF) is accurate and complete o Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines o Utilizes available hardware and software to support the effective conduct of the clinical study data review and capture o 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 MasterFile (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: o Site support throughout the study lifecycle from site identification through close-out o Knowledge of local requirements for real world late phase study designs o Chart abstraction activities and data collection o Collaboration with Sponsor affiliates, medical science liaisons and local country staff o The SMA II may be requested to train junior staff o Identify and communicate out of scope activities to Lead CRA/Project Manager o Proactively suggest potential sites based on local knowledge of treatment patterns, patient advocacy and Health Care Provider (HCP) associations
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
- 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
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.
Seniority level
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Seniority level
Mid-Senior level
Employment type
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Employment type
Full-time
Job function
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Job function
Research and Science
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Industries
Biotechnology Research, Pharmaceutical Manufacturing, and Research Services
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CRA II - Sponsor dedicated - Colombia Client Based employer: Syneos Health
Contact Detail:
Syneos Health Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land CRA II - Sponsor dedicated - Colombia Client Based
✨Tip Number 1
Familiarise yourself with ICH/GCP Guidelines and local regulations. Understanding these will not only help you in interviews but also demonstrate your commitment to compliance, which is crucial for a CRA role.
✨Tip Number 2
Network with current or former employees of Syneos Health on platforms like LinkedIn. They can provide valuable insights into the company culture and expectations, which can give you an edge during the interview process.
✨Tip Number 3
Prepare to discuss your experience with site management and monitoring activities. Be ready to share specific examples that highlight your problem-solving skills and ability to adapt to changing priorities.
✨Tip Number 4
Showcase your communication and interpersonal skills during the interview. As a CRA, you'll need to liaise with various stakeholders, so demonstrating your ability to build relationships is key.
We think you need these skills to ace CRA II - Sponsor dedicated - Colombia Client Based
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience and skills that align with the responsibilities of a CRA II. Focus on your knowledge of Good Clinical Practice (GCP) and any previous roles in clinical research.
Craft a Compelling Cover Letter: Write a cover letter that showcases your passion for clinical research and your understanding of Syneos Health's mission. Mention specific experiences that demonstrate your ability to manage site activities and ensure compliance.
Highlight Relevant Qualifications: Clearly outline your educational background, especially if you have a degree in a related field or nursing. Include any certifications or training related to clinical research that would make you a strong candidate.
Showcase Communication Skills: Since the role requires excellent communication and interpersonal skills, provide examples in your application that demonstrate your ability to liaise effectively with study site personnel and manage project communications.
How to prepare for a job interview at Syneos Health
✨Understand the Role Thoroughly
Before your interview, make sure you have a solid understanding of the CRA II role and its responsibilities. Familiarise yourself with ICH/GCP guidelines and the specific tasks mentioned in the job description, such as site qualification and monitoring.
✨Showcase Your Communication Skills
As a CRA, you'll need excellent communication skills. Prepare to discuss how you've effectively communicated with site staff and project teams in the past. Use examples that highlight your ability to convey complex information clearly and concisely.
✨Demonstrate Problem-Solving Abilities
Syneos Health values problem solvers. Be ready to share specific instances where you've identified issues at a site and how you took action to resolve them. This will show your proactive approach and ability to adapt to challenges.
✨Prepare Questions for the Interviewers
Having thoughtful questions prepared shows your interest in the role and the company. Ask about the team dynamics, training opportunities, or how Syneos Health supports career development. This not only helps you gauge if it's the right fit but also demonstrates your enthusiasm.
