Syneos Health, Inc.
Updated:
December 12, 2025 Location:
Morrisville, NC, United States Job ID: 25104336
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:
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
Perform 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 Practice (GPP) and protocol compliance. Use judgment and experience to evaluate overall performance of site and site staff and provide recommendations regarding site‑specific actions; immediately communicate/escalate serious issues to the project team and develop action plans. Maintain a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes.
Verify the process of obtaining informed consent has been adequately performed and documented for each subject/patient as required/appropriate. Demonstrate diligence in protecting the confidentiality of each subject/patient. Assess 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): Assess site processes. Conduct Source Document Review of appropriate site source documents and medical records. Verify required clinical data entered in the case report form (CRF) is accurate and complete via review of site source documents and medical records. Apply query resolution techniques remotely and on site, and provide guidance to site staff as necessary, driving query resolution to closure within agreed timelines. Utilize available hardware and software to support the effective conduct of the clinical study data review and capture. Verify site compliance with electronic data capture requirements.
May perform investigational product (IP) inventory, reconciliation and reviews storage and security. Verify the IP has been dispensed and administered to subjects/patients according to the protocol. Verify issues or risks associated with blinded or randomized information related to IP. Apply knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned.
Routinely review the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconcile contents of the ISF with the Trial Master File (TMF). Ensure the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations.
Document 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. Support subject/patient recruitment, retention and awareness strategies. Enter data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution.
Understand project scope, budgets, and timelines for own and others’ activities in the clinical team; manage 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 project site personnel, or in collaboration with Central Monitoring Associate. Ensure all assigned sites and project‑specific site team members are trained and compliant with applicable requirements.
Prepare for and attend Investigator Meetings and/ or sponsor face‑to‑face meetings. Participate, and may, with supervision, lead, global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attend clinical training sessions according to the project specific requirements.
Provide guidance at the site and project level towards audit readiness standards and support preparation for audit and required follow‑up actions.
May provide training or mentorship to more junior level CRAs. May perform training and sign off visits for junior CRA staff, as assigned.
May be mentored and assigned clinical operations lead tasks under supervision of an experienced Clinical Operations Lead (COL), or operational line manager. For Real World Late Phase (RWLP), the Sr. CRA I will use the business card title of Sr. Site Management Associate I. 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
Collaborate and build relationships with Sponsor and other affiliates, medical science liaisons and local country 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 country level informed consent forms
Collaborate with RWLP Regulatory team to ensure updated regulatory information is applied and shared
Participate in bid defense meetings
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. Basic level of critical thinking skills expected.
Ability to manage required travel of up to 75% on a regular basis
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, and 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: $80,600.00 - $145,000.00
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 job family are responsible for monitoring during clinical research studies to ensure that the trials are being conducted in accordance with widely accepted clinical practices. This includes conducting on‑site and remote monitoring, developing tools, procedures, and processes to ensure quality monitoring. 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. Individual contributor with developing subject matter expertise and responsibility for processes. In‑depth knowledge and skills within a professional discipline, understanding the impact of work on related areas. May be responsible for entire projects or processes within area of responsibility.
#J-18808-Ljbffr
December 12, 2025 Location:
Morrisville, NC, United States Job ID: 25104336
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:
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
Perform 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 Practice (GPP) and protocol compliance. Use judgment and experience to evaluate overall performance of site and site staff and provide recommendations regarding site‑specific actions; immediately communicate/escalate serious issues to the project team and develop action plans. Maintain a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes.
Verify the process of obtaining informed consent has been adequately performed and documented for each subject/patient as required/appropriate. Demonstrate diligence in protecting the confidentiality of each subject/patient. Assess 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): Assess site processes. Conduct Source Document Review of appropriate site source documents and medical records. Verify required clinical data entered in the case report form (CRF) is accurate and complete via review of site source documents and medical records. Apply query resolution techniques remotely and on site, and provide guidance to site staff as necessary, driving query resolution to closure within agreed timelines. Utilize available hardware and software to support the effective conduct of the clinical study data review and capture. Verify site compliance with electronic data capture requirements.
May perform investigational product (IP) inventory, reconciliation and reviews storage and security. Verify the IP has been dispensed and administered to subjects/patients according to the protocol. Verify issues or risks associated with blinded or randomized information related to IP. Apply knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned.
Routinely review the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconcile contents of the ISF with the Trial Master File (TMF). Ensure the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations.
Document 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. Support subject/patient recruitment, retention and awareness strategies. Enter data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution.
Understand project scope, budgets, and timelines for own and others’ activities in the clinical team; manage 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 project site personnel, or in collaboration with Central Monitoring Associate. Ensure all assigned sites and project‑specific site team members are trained and compliant with applicable requirements.
Prepare for and attend Investigator Meetings and/ or sponsor face‑to‑face meetings. Participate, and may, with supervision, lead, global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attend clinical training sessions according to the project specific requirements.
Provide guidance at the site and project level towards audit readiness standards and support preparation for audit and required follow‑up actions.
May provide training or mentorship to more junior level CRAs. May perform training and sign off visits for junior CRA staff, as assigned.
May be mentored and assigned clinical operations lead tasks under supervision of an experienced Clinical Operations Lead (COL), or operational line manager. For Real World Late Phase (RWLP), the Sr. CRA I will use the business card title of Sr. Site Management Associate I. 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
Collaborate and build relationships with Sponsor and other affiliates, medical science liaisons and local country 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 country level informed consent forms
Collaborate with RWLP Regulatory team to ensure updated regulatory information is applied and shared
Participate in bid defense meetings
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. Basic level of critical thinking skills expected.
Ability to manage required travel of up to 75% on a regular basis
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, and 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: $80,600.00 - $145,000.00
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 job family are responsible for monitoring during clinical research studies to ensure that the trials are being conducted in accordance with widely accepted clinical practices. This includes conducting on‑site and remote monitoring, developing tools, procedures, and processes to ensure quality monitoring. 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. Individual contributor with developing subject matter expertise and responsibility for processes. In‑depth knowledge and skills within a professional discipline, understanding the impact of work on related areas. May be responsible for entire projects or processes within area of responsibility.
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