Program Manager, Clinical Research Operations - Remote - Nationwide

Remote, Nationwide - Seeking Program Manager, Clinical Research Operations

Everybody Has A Role To Play In Transforming Healthcare

At Vituity you are part of a larger team that is driven by our purpose to improve lives.

We are dedicated to transforming healthcare through our culture by working together to tackle healthcare's most pressing challenges from the inside.

Join the Vituity Team.

At Vituity we've cultivated an environment where passion thrives, and success comes through shared purpose.

We were founded in a culture that values team accomplishments more than individual achievements, an approach we call "culture of brilliance." Together, we leverage our strengths and experiences to make a positive impact in our local communities.

We foster this through shared goals and helping our colleagues succeed, and we also understand the importance of recognition, taking the time to show appreciation and gratitude for a job well done.

Vituity Locations: Vituity has opportunities at 475 sites across the country, serving 9 million patients a year.

With Vituity, if you ever need to move, you can take your job with you.

The Opportunity


* Coordinates operational aspects for the execution of study activities from study start-up through study closure while ensuring GCP and relevant Standard Operating Procedures (SOPs) are met.


* Prepares IRB submissions and maintains up-to-date IRB compliance including approvals, continuing reviews, amendments, and post-approval reports.


* Provides input into and/or develops study-specific documents such as Informed Consent Forms (ICF), protocol, study participant-facing material, Case Report Forms (CRFs), study plans etc.


* Performs site qualification, initiation, activation, monitoring, and closeout visits.


* Creates and maintains Trial Master Files (TMF) and regulatory binders while adhering to data retention policies.


* Assists with data entry, database management, and use of Electronic Data Capture (EDC) systems.


* Communicates with and supports Investigators and site staff throughout the study and tracks metrics for site performance such as enrollment.


* Manages internal and external tools such as study trackers, dashboards, insurance, training, document control, etc.


* Supports development and execution of study contracts (e.g., Statements of Work).


* Manages Purchase Orders (POs) and approvals for clinical research studies.


* Supports SOP development and implementation activities for the clinical research operations team.


* Works both independently and collaboratively with cross-functional teams.


* Performs related duties as required.

Required Experience and Competencies


* Bachelor's degree and a minimum of four years' experience in Industry-sponsored clinical research required.


* Experience with IRB/Independent Ethics Committee (IEC) activities from study start-up to closeout required.


* Ability to utilize critical thinking to a...