Syneos Health

Sr CMA I (Site Activation Partner) - Poland, Sponsor-dedicated

4 days left

Location
Home Based, POL
Salary
Competitive
Posted
24 May 2021
Closes
23 Jun 2021
Ref
21006193
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)
Senior Central Monitoring Associate I (Site Activation Partner II)

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
• #SyneosHealthLife 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.

Responsible for supporting the Site Relationship Partners and investigator for Targeted Sites:

Clinical Trial Site Activation & Conduct
  • Assist with study site activation activities to ensure timely site activation.
  • Register investigator sites in Sponsor registries as required.
  • Support and/or coordinate central Investigator Review Board (IRB) submissions when needed.
  • Work with investigator sites to complete critical information for site activation; inclusive of, but not limited to, Investigator Initiation Packages (IIP), confidentiality agreements, study contracts, clinical supply shipment information, payment information, IRB submission and status.
  • Support local IRB workflow from submission through approval and support reporting of updates to safety information.
  • Follow-up with investigator sites on status of study documentation and resolve or escalate issues in a timely manner.
  • Prepare, validate and submit regulatory documents such as completed IIP, IRB approval forms, FDA 1572 revisions, for internal regulatory approval within required timelines.
  • Communicate site approvals to the Site Relationship Partners, Study Start Up Project Managers (where applicable) and relevant study team members.
  • Assist with preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information as needed.
  • Work with investigator sites throughout the study to complete required ongoing study documents such as documents for protocol amendments and FDA 1572 revisions.
  • Assist with the tracking and management of Case Report Forms (CRFs), queries and clinical data flow.
  • Submit within required timeframes all needed documentation, updates and tracking including, but not limited to, Trial Master File documentation, site activation status, protocol amendment status.
  • Problem solve identified issues with appropriate timely escalation to the Site Relationship Partner.
  • Assist the Site Relationship Partner with the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures.
  • Support investigator sites, Site Relationship Partners, Study Managers and study teams in preparation for and providing responses to site audits/inspections.

Communication
  • Act as a point contact for the GSSO team members for designated project site communications, correspondence and associated documentation.
  • Maintain ongoing contact and communication with the GSSO team members as needed.
  • Respond promptly to GSSO team member and investigator site requests.
  • Establish tools for efficient updates to the GSSO Study Team members as needed regarding site status, issues, delays, and approvals.

Clinical Trial Monitoring Support
  • As needed, support the Site Relationship Partner with coaching and training of site personnel to ensure ongoing compliance with study documentation is in accordance with prevailing laws, Good Clinical Practices, and Sponsor standards.
  • In collaboration with the Site Relationship Partner, conduct or oversee investigator site activation activities, IIP completion, site budget and contract negotiation, and ensure timely management of emerging issues that may compromise time to site activation.
  • In collaboration with Site Relationship Partner and Outsourcing Lead, facilitate site payments as needed and as per contracts and work with the appropriate groups to resolve issues.
  • In support of Site Relationship Partner, conduct remote monitoring activities, with a focus on Trial Master File/Site Master File reconciliation, investigational product reconciliation or other technical or logistical supportive activities that facilitate inspection readiness.
  • Identify and resolve in collaboration with Site Relationship Partner investigator site issues within required timeframes; agree and develop corrective and preventative actions with investigator and site personnel to close open issues and to prevent recurrence/persistence of issues.
  • Assist to resolve data queries within required timelines; support database release as needed for supported sites/functions.
What we're looking for
• School diploma/certificate or equivalent combination of education, training and experience; BS/BA or Bachelor's degree in life sciences preferred. In general, candidates for this job would hold the following levels of education/experience:
o 2 years relevant experience in clinical site management
o Experience in study activation and site management is an asset
o Knowledge of clinical trial methodologies, ICH/GCP, FDA and local country regulations
o Must be fluent in English, and the regulatory language of the appointed location
• Demonstrated knowledge of clinical research and development processes and ability to gain command of process details
• Demonstrated knowledge of global and local regulatory requirements
• Demonstrated understanding of key operational elements of a clinical trial (e.g., study start-up, conduct, close-out activities, reporting, etc.)
• Understand the quality expectations and emphasis on right first time. Demonstrate compliance with all applicable company, regulatory and country requirements. Attention to detail evident in a disciplined approach to document review, adherence to SOPs, metrics, etc.
• Proven ability to work independently and, also as a team member
• Ability to organize tasks, time and priorities, ability to multi-task
• Understand basic medical terminology, GCP requirements and proficient in computer operations.
• Effective verbal and written communication skills in relating to colleagues and associates both inside and outside of the organization
• Required to support multi-national team members, and flexibility in working hours may be needed occasionally

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.

#LI - MB1

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