CRA - Future Roles (US)

CRA - Future Roles US in Morrisville NC - Syneos Health

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CRA - Future Roles US Updated Yesterday Location: Morrisville NC, United States Job ID: 25107117 Not ready to apply Join our Talent Network

Description: CRA - Future Roles US

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. Every day we perform better because of how we work together as one team, each the best at what we do. We bring a wide range of talented experts together across a wide range of business-critical services that support our business. Every role within Corporate is vital to furthering our vision of Shortening the Distance from Lab to Life®.

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 - were 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 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, with guidance, 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 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 relabelled, imported, 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/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 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

• Bachelors 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.

US ONLY: 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.

We are always excited to connect with great talent. This posting is intended for a possible upcoming opportunity rather than a live role. By expressing your interest, youll be added to our talent pipeline and considered should this role become available.

At Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop, and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include:

• A 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.
• Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements.

Salary Range 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 candidates qualifications, skills, competencies, and proficiency for the role.

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, youll 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: Roles within Clinical Monitoring CRA are responsible for overseeing and ensuring the integrity of clinical research studies by monitoring data and processes from a centralized location. This includes conducting remote monitoring of trial sites to verify compliance with regulatory requirements and clinical protocols. Utilizes data analytics and risk-based monitoring techniques to identify potential issues and trends, ensuring that trials are conducted in accordance with established clinical practices. Collaborates with site teams to develop and implement tools, procedures, and processes that enhance quality monitoring and support the overall success of clinical trials.

Impact and Contribution Individual contributors with responsibility in a professional or technical discipline or specialty but may manage two or fewer employees. May direct the work of lower-level professionals or manage processes and programs. The majority of time is spent contributing to the design, implementation, or delivery of processes, programs, and policies using knowledge and skills typically acquired through advanced education. Entry to developing individual contributor. Delivers work of limited scope, typically smaller, less complex projects. Requires theoretical knowledge of a professional area, typically obtained through education and/or prior experience.

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Inside Syneos Health Our Values Who We Are Our Solutions Diversity, Equity, and Inclusion Why Work Here

Discover what our more than 29,000 employees already know: work here matters everywhere. We work hard and smart, all in the name of getting much-needed therapies to those who need them most. A career with Syneos Health means your everyday work improves patients lives around the world.

Selecting us as an employer secures a career in which youre guaranteed to:

• Collaborate with passionate problem solvers.
• Partner with the most diverse team of experts in the industry.
• From the top down, our people are inspiring. Everyone has a voice and is encouraged to use it.
• Be empowered and thrive. Here, theres no shortage of challenging work, learning, and opportunities.
• Evolve in a growing global company that is always looking for ways to work smarter and more efficiently.
• Over-deliver and out-perform. Challenge the status quo in a highly competitive and ever-changing environment.
• Be agile and take initiative to find new solutions reflective of the high-quality standards we and our customers expect.
• Help change lives. We take our work seriously. Each day youll contribute to improving patients lives around the world by shortening the distance from lab to life. Its powerful and fulfilling work of which you can be proud.

Interested in Syneos Health? Get In Touch.

Syneos Health® (Nasdaq: SYNH) 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. Together, we share insights, use the latest technologies, and apply advanced business practices to speed our customers delivery of important therapies to patients. We support a diverse, equitable, and inclusive culture.

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