Syneos Health, Inc.
CRA II/Sr CRA - Sponsor-dedicated (Poland)
Syneos Health, Inc., Poland, New York, United States
CRA II/Sr CRA - Sponsor-dedicated (Poland)
Updated:
Yesterday Location:
POL-Remote Job ID: 25103244
Description CRA II/Sr CRA - Sponsor-dedicated (Poland)
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
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
Conduct on-site and remote monitoring of clinical research studies to ensure compliance with widely accepted clinical practices, including verifying the accuracy and completeness of data collected and ensuring adherence to study protocols
Develop and implement tools, procedures, and processes to ensure quality monitoring, including creating standardized templates for monitoring reports and checklists for site visits
Contribute to the design, implementation, and delivery of processes, programs, and policies, including participating in the development of clinical trial protocols and providing input on study design and methodology
Manage and direct the work of lower-level professionals or manage processes and programs, including providing guidance and support to junior staff members and overseeing the day-to-day activities of clinical trial sites
Ensure accurate and timely documentation and reporting of clinical trial data, including maintaining detailed records of site visits and monitoring activities and preparing comprehensive reports for regulatory submissions
Collaborate with cross-functional teams to support clinical trial activities, including working closely with data management, biostatistics, and regulatory affairs teams to ensure the successful execution of clinical trials
Identify and resolve issues related to clinical trial conduct and data integrity, including troubleshooting problems with data collection and addressing discrepancies in study records
Provide training and mentorship to junior staff members, including conducting training sessions on monitoring techniques and best practices and offering ongoing support and guidance to help them develop their skills and expertise
Qualifications:
Bachelor's degree in a related field
Minimum of 3-5 years of experience in clinical research or a related field
In-depth knowledge of clinical trial processes and regulations
Strong analytical and problem-solving skills
Excellent communication and interpersonal skills
Ability to work independently and as part of a team
Certifications:
Certified Clinical Research Professional (CCRP) or equivalent certification preferred
Necessary Skills:
Proficiency in clinical trial management systems and software
Strong organizational and time management skills
Attention to detail and accuracy
Ability to manage multiple projects and priorities simultaneously
Knowledge of Good Clinical Practice (GCP) guidelines and regulatory requirements
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. ... 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 at the P22 level are responsible for monitoring clinical research studies to ensure that trials are conducted in accordance with widely accepted clinical practices. ... These roles involve individual contributors with responsibility in a professional or technical discipline or specialty, who may manage two or fewer employees and direct the work of lower-level professionals or manage processes and programs. ...
Impact and Contribution Roles within Clinical Monitoring/CRA job family at the P22 level have a significant impact on the success of clinical research studies. ... They also provide recommendations regarding site‑specific actions, communicate serious issues to the project team, and develop action plans. ...
Core Focus
Ensure regulatory, ICH‑GCP, and protocol compliance during site qualification, site initiation, interim monitoring, site management, and close‑out visits
Evaluate overall performance of site and site staff, provide recommendations regarding site‑specific actions, and communicate serious issues to the project team
Verify the process of obtaining informed consent, protect the confidentiality of subjects/patients, and assess factors affecting subject/patient safety and clinical data integrity
Conduct Source Document Review, verify clinical data accuracy and completeness, and apply query resolution techniques
Verify site compliance with electronic data capture requirements and investigational product (IP) inventory, reconciliation, storage, and security
Review Investigator Site File (ISF) for accuracy, timeliness, and completeness, and reconcile contents with the Trial Master File (TMF)
Document activities via confirmation letters, follow‑up letters, trip reports, communication logs, and other required project documents
Manage site‑level activities and communication to ensure project objectives, deliverables, and timelines are met
Act as primary liaison with study site personnel, ensure training and compliance with applicable requirements, and provide guidance towards audit readiness standards
Provide direct supervision, training, and mentorship to junior level CRAs
At Syneos Health, we are dedicated to building a diverse, inclusive and authentic workplace. If your past experience doesn’t align perfectly, we encourage you to apply anyway. At times, we take into consideration transferrable skills from previous roles. We also encourage you to join our Talent Network to stay connected to additional career opportunities.
Discover what our 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 you’re guaranteed to:
Syneos Health® (Nasdaq: SYNH) is a leading 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.
Phone: 919 876 9300 Fax: 919 876 9360 Toll-Free: 866 462 7373
Equal Opportunity Employer Syneos Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, marital status, ethnicity, national origin, sex, gender, gender identity, sexual orientation, protected veteran status, disability or any other legally protected status and will not be discriminated against. If you are an individual with a disability who requires reasonable accommodation to complete any part of our application process, including the use of this website, please contact us at: Email: jobs@syneoshealth.com One of our staff members will work with you to provide alternate means to submit your application.
#J-18808-Ljbffr
Yesterday Location:
POL-Remote Job ID: 25103244
Description CRA II/Sr CRA - Sponsor-dedicated (Poland)
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
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
Conduct on-site and remote monitoring of clinical research studies to ensure compliance with widely accepted clinical practices, including verifying the accuracy and completeness of data collected and ensuring adherence to study protocols
Develop and implement tools, procedures, and processes to ensure quality monitoring, including creating standardized templates for monitoring reports and checklists for site visits
Contribute to the design, implementation, and delivery of processes, programs, and policies, including participating in the development of clinical trial protocols and providing input on study design and methodology
Manage and direct the work of lower-level professionals or manage processes and programs, including providing guidance and support to junior staff members and overseeing the day-to-day activities of clinical trial sites
Ensure accurate and timely documentation and reporting of clinical trial data, including maintaining detailed records of site visits and monitoring activities and preparing comprehensive reports for regulatory submissions
Collaborate with cross-functional teams to support clinical trial activities, including working closely with data management, biostatistics, and regulatory affairs teams to ensure the successful execution of clinical trials
Identify and resolve issues related to clinical trial conduct and data integrity, including troubleshooting problems with data collection and addressing discrepancies in study records
Provide training and mentorship to junior staff members, including conducting training sessions on monitoring techniques and best practices and offering ongoing support and guidance to help them develop their skills and expertise
Qualifications:
Bachelor's degree in a related field
Minimum of 3-5 years of experience in clinical research or a related field
In-depth knowledge of clinical trial processes and regulations
Strong analytical and problem-solving skills
Excellent communication and interpersonal skills
Ability to work independently and as part of a team
Certifications:
Certified Clinical Research Professional (CCRP) or equivalent certification preferred
Necessary Skills:
Proficiency in clinical trial management systems and software
Strong organizational and time management skills
Attention to detail and accuracy
Ability to manage multiple projects and priorities simultaneously
Knowledge of Good Clinical Practice (GCP) guidelines and regulatory requirements
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. ... 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 at the P22 level are responsible for monitoring clinical research studies to ensure that trials are conducted in accordance with widely accepted clinical practices. ... These roles involve individual contributors with responsibility in a professional or technical discipline or specialty, who may manage two or fewer employees and direct the work of lower-level professionals or manage processes and programs. ...
Impact and Contribution Roles within Clinical Monitoring/CRA job family at the P22 level have a significant impact on the success of clinical research studies. ... They also provide recommendations regarding site‑specific actions, communicate serious issues to the project team, and develop action plans. ...
Core Focus
Ensure regulatory, ICH‑GCP, and protocol compliance during site qualification, site initiation, interim monitoring, site management, and close‑out visits
Evaluate overall performance of site and site staff, provide recommendations regarding site‑specific actions, and communicate serious issues to the project team
Verify the process of obtaining informed consent, protect the confidentiality of subjects/patients, and assess factors affecting subject/patient safety and clinical data integrity
Conduct Source Document Review, verify clinical data accuracy and completeness, and apply query resolution techniques
Verify site compliance with electronic data capture requirements and investigational product (IP) inventory, reconciliation, storage, and security
Review Investigator Site File (ISF) for accuracy, timeliness, and completeness, and reconcile contents with the Trial Master File (TMF)
Document activities via confirmation letters, follow‑up letters, trip reports, communication logs, and other required project documents
Manage site‑level activities and communication to ensure project objectives, deliverables, and timelines are met
Act as primary liaison with study site personnel, ensure training and compliance with applicable requirements, and provide guidance towards audit readiness standards
Provide direct supervision, training, and mentorship to junior level CRAs
At Syneos Health, we are dedicated to building a diverse, inclusive and authentic workplace. If your past experience doesn’t align perfectly, we encourage you to apply anyway. At times, we take into consideration transferrable skills from previous roles. We also encourage you to join our Talent Network to stay connected to additional career opportunities.
Discover what our 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 you’re guaranteed to:
Syneos Health® (Nasdaq: SYNH) is a leading 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.
Phone: 919 876 9300 Fax: 919 876 9360 Toll-Free: 866 462 7373
Equal Opportunity Employer Syneos Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, marital status, ethnicity, national origin, sex, gender, gender identity, sexual orientation, protected veteran status, disability or any other legally protected status and will not be discriminated against. If you are an individual with a disability who requires reasonable accommodation to complete any part of our application process, including the use of this website, please contact us at: Email: jobs@syneoshealth.com One of our staff members will work with you to provide alternate means to submit your application.
#J-18808-Ljbffr