Study Start-Up Associate

Position Purpose:

Responsible for supporting operational activities related to site evaluation, activation, initiation, monitoring and close out for assigned investigator sites/studies to ensure compliance with study timelines and in accordance with prevailing laws, Goo d Clinical Practices, and Client standards. Will provide technical and logistical support to the Site Relationship Partners (SRPs) to deliver Investigator Initiation and Study Start Up.

Primary Duties:

• Responsible for supporting the SRPs 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 Client 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, Food and Drug Administration (FDA) 1572 revisions, for internal regulatory approval within required timelines.
• Communicate site approvals to the SRPs, 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 time frames all needed documentation, updates and tracking including, but not limited to, Trial Master File documentation, site activation status, protocol amendment status.

Skills and Education:

• 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: 2 years relevant experience in clinical site management.
• Experience in study activation and site management is an asset.
• Knowledge of clinical trial methodologies, ICH/GCP, FDA and local country regulations.
• 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 startup, conduct, close-out activities, reporting, etc.).