The Role
The Principal Investigator manages clinical trial studies, ensuring protocol compliance, team training, and patient safety, while liaising with sponsors.
Summary Generated by Built In
What We Do
Care Access is a unique, multi-specialty network of research sites which operates as one connected team of physician investigators, nurse coordinators, and operations managers. By removing this bottleneck, Care Access is helping accelerate the approval and delivery of critical and life-saving therapies.
Who We Are
We care. Our people are the engines behind our mission: to revolutionize access to clinical trials for the benefit of patients everywhere. We care for one another, find new ideas to accelerate medicine, and seed a long-term impact for generations.
Position Overview
The Principal Investigator is responsible for ensuring that all research team members have appropriate education, training, and qualifications to assume delegated study tasks. The Principal Investigator is responsible for ensuring that the conduct of the study complies with federal and industry guidance and regulations.
The Principal Investigator manages Phase 1 – Phase 4 studies with demonstrated decision-making capabilities. They will also engage with the sponsor’s monitor to discuss findings and ensure timely correction and documentation of any identified issues
This is a hybrid role stationed at the Indianapolis, IN site, with responsibilities including supporting decentralized clinical trials (DCTs) and periodic visits to other sites as needed.
What You'll Be Working On (Duties include but are not limited to):
- Review the inclusion/exclusion criteria, endpoint criteria, and investigational article use with the internal research team.
- Determine whether inclusion/exclusion criteria apply to the study population.
- Maintain protocol compliance on all clinical trials/studies according to the International Conference on Harmonization-Good Clinical Practice (ICH-GCP), local regulations, and study protocol.
- Oversee IRB review of study and ensure written IRB approval is obtained before initiating the study or instituting any changes to the protocol as approved.
- Assess subject response to therapy, evaluate and address adverse experiences
- Meet regularly with the research team to discuss subject participation and protocol progress.
- Meet with study assigned monitors at regular intervals.
- Train Sub-Investigators and study staff members on protocol and protocol specific procedures. Provide medical support to sub-investigators and study staff for protocol-related issues including protocol clarifications, inclusion/exclusion determinations, and issues of patient safety and/or eligibility.
- Maintain essential documents and records necessary for conduction of study.
- Train on and implement Care Access Standard Operating Procedures.
- Review sponsor provided safety reports.
- Review and maintain accurate case report forms.
- Sign off electronic case books as required by the study sponsor.
- Provide clinical oversight and quality of the studies
- Ensure the medical well-being and safety of the study participants, through the safe performance and execution of the clinical trials/studies.
- Participate and engage in driving delivery of study targets, such as: participant recruitment, enrollment and retention. Perform other duties as assigned.
- Attend regularly scheduled meetings.
Physical and Travel Requirements
- This is a hybrid position, stationed at the Indianapolis, IN site, with approximately 25% travel requirements. Occasional planned travel to study sites or for sponsor and investigator meetings may be required as part of the role.
Certifications/Licenses, Education, and Experience:
- MD/DO
- License in good standing. Willing to obtain multi-state licensure as needed
- Board Certification in any of the following areas: Internal Medicine, Cardiology, Gastroenterology, Dermatology, Endocrinology
- Prior research experience required
- Possess a thorough understanding of the requirements of each clinical protocol.
Benefits (US Full-Time Employees Only)
- Paid Time Off (PTO) and Company Paid Holidays
- 100% Employer paid medical, dental, and vision insurance plan options
- Health Savings Account and Flexible Spending Accounts
- Bi-weekly HSA employer contribution
- Company paid Short-Term Disability and Long-Term Disability
- 401(k) Retirement Plan, with Company Match
Diversity & Inclusion
We serve patients and researchers from diverse cultures and communities around the world. We are stronger and better when we build a team representing the people we aim to support. We maintain an inclusive culture where people from a broad range of backgrounds feel valued and respected as they contribute to our mission. We value diversity and believe that unique contributions drive our success. At Care Access, every day, we are advancing medical breakthroughs. We’re uniting standard patient care with cutting-edge treatments and research. Our work brings life-changing therapies to those in need and paves the way for newer and greater treatments to reach the world. We’re proud to advance these breakthroughs and work with the big players while engaging with the best physicians and caring for patients.
We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law.
Care Access is unable to sponsor work visas at this time.
Employment Statement
Care Access complies with all employment laws and regulations with respect to its employment practices, terms and conditions of employment, and pay equity and wages. Care Access does not engage in any unfair or forced labor practice and does not tolerate, under any circumstances, the use of any form of forced or involuntary labor, child labor, or human trafficking. This extends to suppliers, partners, or other third parties with whom Care Access does business. Care Access values and promotes the protection of human rights everywhere.
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The Company
What We Do
Care Access is a leading decentralized research organization (DRO) that breaks down traditional barriers in clinical research for patients, sponsors, and physicians. Its innovative model brings decentralized trials, Sites On Demand™, Virtual PIs, and Mobile Sites to previously-unreachable patient populations to expand the impact of clinical research. Supported by top pharmaceutical and biotech partners across 20 different therapeutic areas, Care Access is scaling and globalizing its new model for clinical trial delivery, where more physicians and patients can engage in life-saving research to develop new therapies faster.
To find out how Care Access is transforming the future of clinical trials, visit www.careaccess.com or email [email protected].
