BRIGHT Research Partners is a Clinical Research Organization (CRO) primarily focused on medical device clinical studies. BRIGHT offers an upbeat, refreshing environment where creative collaboration and quality consultation thrive. Whether you are an early-stage start-up or a large, global organization, we are confident we can help you achieve your strategic goals through sound clinical and regulatory planning and execution.
By leveraging the broad experience of our seasoned team, BRIGHT understands and effectively manages the risks and challenges of clinical research as well as the evolving regulatory landscape in the medical industry.
Founded in 2008, BRIGHT has partnered with numerous clients to provide strategic and effective solutions to clinical and regulatory questions. We are particularly proud that the vast majority of our business relationships developed through referrals from existing business partners. This is a testament to the confidence our clients have in BRIGHT’s experienced and personable team.
Quality of life is at the core of our culture. We encourage flexibility and balance, empowering our employees to bring their best selves to work so they can excel in providing high quality services and deliverables to our clients. Our corporate headquarters provides an open, collaborative workspace located in the heart of Minneapolis.
Our Services and Experience
BRIGHT is an experienced Clinical Research Organization (CRO) with extensive knowledge of many therapeutic areas, including cardiovascular, neurology, orthopedics, and urology. The transferable skills, paired with the aptitude and desire to learn, ensure BRIGHT is poised to provide comprehensive clinical and regulatory support for projects involving new conditions, devices, and therapies.
Clinical and Regulatory Strategy
- Statistical Strategy and Analysis
- Study Design and Approval
- Study Site Establishment
- Study Start-up and Launch
- Regulatory Assessment
- Global Regulatory Strategy Development
Clinical and Regulatory Execution
- Study Execution
- Study Management
- Study Close-Out
- Global Market Authorization, Registration, and Licensure
- Labeling, Marketing Claims, Promotional and Advertising Materials
- Ongoing Regulatory Support
- Auditing (IRB, Study) and Inspection Preparedness Activities (FDA and Notified Body)
- Board and Executive Presentations
- Venture Capital (VC) Investment Due Diligence
- Key Opinion Leader (KOL) Introductions and Networking
- Literature Reviews
- Medical Coding (MedDRA and WHO-DDE)
- Procedure Development (Sponsor, Core Lab, Study-Specific)
- Study Rescue
- Clinical Evaluation Reports (CERs)
- Other Documentation, Registrations, and Administrative Support
View a full list of clinical and regulatory services here
We are best known for our personal and conscientious approach to managing projects. Your goals are of utmost importance, and we strive to meet them by using creative strategies and providing quality deliverables. Our highly adaptable team responds to change (both planned and unanticipated) with positivity and thoughtfulness.
BRIGHT manages relationships across all functional groups of a company as well as with the executive team, board of directors, and physicians. We collaborate with the best-in-class preclinical and database service providers, and we closely maintain those relationships to ensure successful trial and business outcomes.
Working at BRIGHT spans beyond joining a collaborative and inspired team. We believe that our quality work stems from team members who find balance and fulfillment in their job. We emphasize the importance of our team’s work-life balance and strive to enable everyone to bring their best self to work.
If you are a personable and adaptable clinical research professional who excels in a team-driven environment, look no further.
Please inquire at email@example.com
Clinical Project Manager
The clinical project manager is responsible for managing project teams and driving processes to meet the milestones of clinical research trials in compliance with applicable clinical and regulatory standards and in alignment with the client agreement scope of work. The clinical project manager focuses on clinical trial management including, but not limited to, the design, initiation, management, monitoring and closing of clinical trials.
NOTE: The scope of responsibilities is dependent on the client’s agreement with BRIGHT Research Partners and may include, but are not limited to, the following typical clinical research project management responsibilities:
- Collaborate with study sponsors, medical advisors, and other CRO study personnel to develop study documents including: study protocol, subject informed consent forms, investigator agreements, clinical trial agreements, database flow (design specifications) and edit logic, case report form content, monitoring plan, data management plan, interim or final study reports
- Work with sponsors to identify sites; manage the site qualification/selection, initiation, training, and launch process
- Monitor sites (and/or oversee team monitoring activities) to ensure compliance with the protocol, monitoring plan, and applicable regulatory, Ethics Committee (EC)/Institutional Review Board (IRB) and BRIGHT standards, guidelines and policies
- Facilitate investigator/coordinator meetings, Data Safety Monitoring Boards, and Clinical Events Committees,
- Manage study execution and operations with support from CRO team and sr. CRO leadership
- Manage sponsor and site communications
- Ensure study activities align with timelines and project schedules (i.e., startup, recruitment, closeout, etc.) and implement contingency plans as needed working with sr. CRO leadership
Required Qualification & Abilities
- Bachelor’s or master’s degree in a scientific or related field (or extensive clinical research experience working within industry)
- Must be able to work out of Downtown Minneapolis office
- Minimum of five years of industry clinical research experience
- Willing/able to travel up to 30% of time
- Must be a self-starter and have the ability to work well within a group environment or independently with little direction
- Clinical operations expertise
- Knowledge of Good Clinical Practices, and all relevant FDA regulations
- Exceptional written and verbal communication skills; exceptional interpersonal skills and emotional intelligence
- Able to cultivate collaborative relationships with colleagues and clients in a cross-functional environment
- Very effective organizational skills; highly detail oriented
- Proficient in the use of MS Office suite and Adobe
- Able to multi-task and collaborate with others without direct supervision
- Able to coordinate study-planning efforts within BRIGHT Research and able to manage customer requirements and expectations
- Able to identify study issues and implement solutions, including escalation of issues when required, and involve appropriate CRO management for resolution
- Able to anticipate study needs and implement tools for effective study management
- Able to motivate and hold individuals accountable for deliverables
- Able to achieve objectives and milestones
- Able to identify and adapt to shifting priorities and competing demands, and maintain composure in difficult circumstances
- Ability to provide performance feedback and ability to appropriately respond to feedback from clients, study personnel (e.g., sites), and colleagues
The biostatistician role will support multiple clinical research projects in a statistical and data management capacity with direction from a senior biostatistician. This role will work closely with senior and junior BRIGHT clinical research professionals and medical device manufacturers (clients). This is a great opportunity for a biostatistician with 2-3 years of industry or CRO experience. This role will gain exposure to multiple therapeutic areas, while working with a fun and collaborative team.
NOTE: The scope of responsibilities is dependent on the client’s agreement with BRIGHT Research Partners and may include, but are not limited to, the following:
- Generate analysis datasets, tables, figures, and listings to support the analysis of clinical trial data using SAS
- Prepare statistical sections of clinical study reports and data management reports and listings
- Develop table and listing shells based on statistical analysis plans or publication/presentation needs
- Perform quality control and validation for SAS programs and other study documents (e.g., presentations and reports)
- Provide statistical analysis and reports to Data Safety Monitoring Boards and Clinical Events Committees
- Review output across programs to ensure consistency
- Review data management reports for outliers and other data issues
- Generate randomization schedules
- Provide input into development of case report forms (CRFs)
- Interact directly with clients
Required Qualification & Abilities
- 2-3 years’ experience in a statistician role using SAS
- MS or equivalent degree in statistics; ideal candidate would have some relevant academic or industry clinical research experience
- Proficiency with SAS for statistical analysis and reporting; ideal candidate would have practical experience using SAS to analyze and report clinical data
- Willingness to learn industry standards, such as the ICH guidelines, CDISC data structures, 21 CFR Part 11, and FDA guidelines
- Excellent organizational skills, time management skills, and ability to coordinate workload and meet established deadlines
- Excellent communication and interpersonal skills
Join Our Team
730 Second Avenue South, Suite 500
Minneapolis, Minnesota 55402
Bright Research Partners
Minneapolis, Minnesota 55402