in-house CRA (Clinical Operations Specialist) - EU wide, Sponsor-dedicated
- Syneos Health
- Jul 09, 2022
Full time
Engineering
Job Description
in-house CRA, Clinical Operations Specialist - Sponsor-dedicated
home - based
ocassional travel with CRA
Come discover what our 25,000+ employees already know: work here matters everywhere. We're a growing and evolving biopharmaceutical industry leader, which means you'll have endless opportunities to work with experts around the world and build the career you've dreamed of.
As a part of the Syneos Health team, you'll help us deliver results for a rewarding reason - we improve patients' lives around the world. Because to us, a patient isn't just a number, they're our family, friends, and neighbors.
Why Syneos Health
• means we're committed to our Total Self culture - where everyone can authentically be themselves. Our Total Self culture is what unites us globally, and we know every person's unique contributions make a difference.
• We believe our success is a direct result of the people who are driving it - you! We value your dedication to care for our customers and patients, so we want to focus on taking care of you. That's why we offer a comprehensive benefits program encompassing your total health - physical, mental and financial.
• 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
One per study/one per region
Actively contribute to site audit readiness through back-up activities with the primary site CRA, including but not limited to: periodic eTMF review, collection of documents from the site, escalation of identified issues, CTMS up-to-date, etc.
Collect and review site essential documents and update Regulatory Document Tracker
Send reminders and/or CTMS reports to CRAs re: open follow up items, protocol deviations, and quality issues
Support CRAs to ensure all site supplies are available on site for site initiation visits
Support requests from CRAs while they are onsite (document retrieval, vendor questions)
Support site training documentation collection and tracking of training documentation
Support in maintaining compliance of sponsor systems i.e., CTMS, TMF, Trifecta, etc.
Follow-up on outstanding site issues to resolution and/or document attempts to resolve issues upon closure of clinical trial sites
Undertake project related admin tasks to support the Lead CRA, i.e., meeting minutes, tracking, site document preparation
May attend clinical trial site co-monitoring visits to support clinical trial activities such as ISF/eTMF reconciliation and audit preparation, as needed.
Attends Investigator Meetings and study-specific training for assigned trials
What we're looking for
CTA backgrond or similar
Min 12 months of clinical research experience
Good understanding of study documentation
Ability to work collaboratively
Good communication and interpersonal skills
Ability to embrace new technologies
Ability to ocassional travel together with CRA
Get to know Syneos Health
We are the only full-service biopharmaceutical solutions company in the world. That means we bring together the best clinical and commercial minds to create a better, smarter, faster way to get medicines into the hands of patients who need it most. Learn more about Syneos Health.
- MB2
home - based
ocassional travel with CRA
Come discover what our 25,000+ employees already know: work here matters everywhere. We're a growing and evolving biopharmaceutical industry leader, which means you'll have endless opportunities to work with experts around the world and build the career you've dreamed of.
As a part of the Syneos Health team, you'll help us deliver results for a rewarding reason - we improve patients' lives around the world. Because to us, a patient isn't just a number, they're our family, friends, and neighbors.
Why Syneos Health
• means we're committed to our Total Self culture - where everyone can authentically be themselves. Our Total Self culture is what unites us globally, and we know every person's unique contributions make a difference.
• We believe our success is a direct result of the people who are driving it - you! We value your dedication to care for our customers and patients, so we want to focus on taking care of you. That's why we offer a comprehensive benefits program encompassing your total health - physical, mental and financial.
• 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
One per study/one per region
Actively contribute to site audit readiness through back-up activities with the primary site CRA, including but not limited to: periodic eTMF review, collection of documents from the site, escalation of identified issues, CTMS up-to-date, etc.
Collect and review site essential documents and update Regulatory Document Tracker
Send reminders and/or CTMS reports to CRAs re: open follow up items, protocol deviations, and quality issues
Support CRAs to ensure all site supplies are available on site for site initiation visits
Support requests from CRAs while they are onsite (document retrieval, vendor questions)
Support site training documentation collection and tracking of training documentation
Support in maintaining compliance of sponsor systems i.e., CTMS, TMF, Trifecta, etc.
Follow-up on outstanding site issues to resolution and/or document attempts to resolve issues upon closure of clinical trial sites
Undertake project related admin tasks to support the Lead CRA, i.e., meeting minutes, tracking, site document preparation
May attend clinical trial site co-monitoring visits to support clinical trial activities such as ISF/eTMF reconciliation and audit preparation, as needed.
Attends Investigator Meetings and study-specific training for assigned trials
What we're looking for
CTA backgrond or similar
Min 12 months of clinical research experience
Good understanding of study documentation
Ability to work collaboratively
Good communication and interpersonal skills
Ability to embrace new technologies
Ability to ocassional travel together with CRA
Get to know Syneos Health
We are the only full-service biopharmaceutical solutions company in the world. That means we bring together the best clinical and commercial minds to create a better, smarter, faster way to get medicines into the hands of patients who need it most. Learn more about Syneos Health.
- MB2
About Syneos Health