Site Feasibility and Activation Manager

INNOVO RESEARCH INC•Champaign, IL

2d•Remote

About The Position

The Site Feasibility & Activation Manager will work closely across Innovo Research site network to identify, contact, build, and maintain relationships with study teams and sites leadership for the efficient and appropriate activation of clinical research/trials. Reporting will include accountability to the COO, Director of Clinical Operations, Administrator, PI, and others, as necessary. You are accountable for conduct of feasibility, determining interest in potential study participation, and site activation project management. Project activities include site identification, investigator and site contracts, central IRB submissions, and any other study specific activities necessary for site activation in accordance with Good Clinical Practices (GCPs), applicable local and international regulations, and Standard Operating Procedures (SOPs). The candidate will have overall responsibilities for coordinating efforts with other study team members in order to activate qualifying sites.

Requirements

Strong organization/prioritization skills for the management of multiple concurrent projects
Good knowledge of clinical research process related to study start-up and medical terminology
An understanding of Regulatory and Central/Local ethic submission processes
Strong written and verbal communication skills to express complex ideas to study personnel, internal and sponsor team members
Excellent organizational and interpersonal skills
Positive attitude and ability to interact with all levels of staff to coordinate and execute study activities
Ability to manage multiple competing priorities within various clinical trials
Working knowledge of current ICH GCP guidelines and applicable regulations
Excellent verbal and written communication skills required
Ability to work independently, prioritize and work with a matrix team environment is essential
Extensive use of telephone, Zoom/Teams and face-to-face communication requiring accurate perception of speech
Extensive use of keyboard requiring repetitive motion of fingers
Regular sitting for extended periods of time
Bachelor’s degree (or equivalent), preferably in science or related field and 3 - 5 years relevant experience including 2 years of regulatory & study-start up experience
Equivalent combination of education, training, and experience
Previous GCP training and certification required
Demonstrated ability in positive relationship building, with strong verbal and written skills required.
Strong interpersonal skills with attention to detail a must
Proficiency with word processing, spreadsheet, database, MS Office skills such as Outlook, Word, Excel, PowerPoint, SharePoint, and with clinical trial master filing systems.

Nice To Haves

Ability to travel periodically if needed

Responsibilities

Serve as a Sponsor point of contact for feasibility, start-up and regulatory submissions items
Work with both internal and external teams to assure effective communication regarding study start-up processes, expectations, and timely completion of requisite documents
Assures documents maintained are following (ICH-GCP) regulatory requirements or industry standards, and procedures set forth by Innovo Research and its Clients.
Understand scope of work for all studies and help with resource forecasting in the finance system
Collect and disseminate Essential Documents (ED) and Investigator Site Files (ISF) during start-up
Send regulatory document packets to sites and Sponsors/CROs, follow up with sites on document completion, review regulatory documents for completeness, compile in a packet for Innovo Research retention
Perform quality checks on submission documents and site essential documents
Complete feasibility surveys/assessments on behalf of Innovo Research and Practice Sites
Engage in feasibility meetings with perspective sponsors and CROs
Complete site registration information for Sponsor/CRO investigator databases
Responsible for multiple simultaneous start-up projects, and typically can work independently with minimal supervision.
Review of the site informed consents and negotiate through an acceptable IRB approved document.
Escalate issues regarding ICF to COO and appropriate legal reviewer.
Complete study level Central IRB submissions, support sites for IRB submission, provide updates to team/Sponsor on calls and via email.
Assist in processing invoices to sponsors for work completed to ensure timely cash flow
Facilitate the follow-up on outstanding invoices, payment of Practice Sites, and study participant stipends
Hand off studies to Site Operations once IRB approved or based on other milestones
Assist with site amendments, protocol amendments, continuing review (IRB progress reports), and other tasks to support continuity of operations, if required
Responsible for executing CRIO build out of Source Documents and other operational needs within CRIO (or another vendor as appliable)
Manage CITI account to ensure completion of requisite training and appropriate documentation of training credentials