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 analyze problems which may require multiple factors and approaches required.
• Strong project management skills including the ability to plan, organize, prioritize, and manage multiple tasks and deadline required.
• Great verbal and written communication skills required.
• Excellent organizational skills along with strong attention to detail required.
• Ability to work independently and collaboratively required.
• One (1) year of work experience monitoring at a clinical site, CRO or Sponsor company preferred.
• Working knowledge of FDA and/ or EMA Regulations, ICH Guidelines, 510k guidelines, and GCPs governing the conduct of clinical trials preferred.
• Experience with FDA-regulated devices preferred.
• CITI and HSP training preferred.
• Certifications from organizations like the Association of Clinical Research Professionals (ACRP) or the Society of Clinical Research Associates (SoCRA) preferred.
• Proficient in Google workspace preferred.
• Health care professional with health research and/or technology engineering background preferred.
  
  

The Community

Even when you are working remotely, you are an important part of the Vituity Community. We offer plenty of opportunities to engage with other Vitans through a variety of virtual meet-and-greets, events and seminars.

• Monthly wellness events and programs such as yoga, HIIT classes, and more
• Trainings to help support and advance your professional growth
• Team building activities such as virtual scavenger hunts and holiday celebrations
• Flexible work hours
• Opportunities to attend Vituity community events including LGBTQ+ History, Dia de los Muertos Celebration, Money Management/Money Relationship, and more
  
  

Benefits & Beyond*

Vituity cares about the whole you. With our comprehensive compensation and benefits package, we are mindful of what matters most, and support your needs of today and your plans for the future.

• Superior health plan options
• Dental, Vision, HSA/FSA, Life and AD&D coverage, and more
• Top Tier 401(k) retirement savings plans that offers a $1.20 match for every dollar up to 6%
• Outstanding Paid Time Off: 3-4 weeks' vacation, Paid holidays, Sabbatical
• Student Loan Refinancing Discounts
• Professional and Career Development Program
• EAP, travel assistance, and identify theft included
• Wellness program
• Vituity community initiatives including LGBTQ+ History, Dia de los Muertos Celebration, Money Management/Money Relationship, and more
• Purpose-driven culture focused on improving the lives of our patients, communities, and employees
  
  

We are excited to share the base salary range for this position is $91,130 - $113,915, exclusive of fringe benefits or potential bonuses. This position is also eligible to participate in our annual corporate Success Sharing bonus program, which is based on the company's annual performance. If you are hired at Vituity, your final base salary compensation will be determined based on factors such as skills, education, and/or experience. We believe in the importance of pay equity and consider internal equity of our current team members as a part of any final offer. Please speak with a recruiter for more details.

We are unified around the common purpose of transforming healthcare to improve lives and we believe everyone has a role to play in that. When we work together across sites and specialties as an integrated healthcare team, we exceed the expectations of our patients and the hospitals and clinics we work in. If you are looking to make a difference, from clinical to corporate, Vituity is the place to do it. Come grow with us.

Vituity appreciates differences; our dedication to diversity, equity and inclusion is at the heart of our organization. Vituity does not discriminate against any person on the basis of race, creed, color, religion, gender, sexual orientation, gender identity/expression, national origin, disability, age, genetic information (including family medical history), veteran status, marital status, pregnancy or related condition, or any other basis protected by law. Vituity is committed to complying with all applicable national, state and local laws pertaining to nondiscrimination and equal opportunity.

• Benefits for part-time and per diem vary. Please speak to a recruiter for more information.
  
  

Applicants only. No agencies please.