Principal Investigator at Care Access Research | Powderkeg

Location: Atlanta, GA

Employment Type: Part Time - Regular

Team: Principal Investigator

What We Do

Care Access is delivering the future of medicine today! Care Access has a revolutionary model that breaks down traditional barriers to clinical trials that limit participation among physicians and patients to 3%. 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 tests. Principal Investigator is responsible for ensuring that the conduct of the study is compliant with federal and industry guidance and regulations. Principal Investigators manage 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.

The administrative structure of investigational sites under the decentralized site model requires a nontraditional approach. The Principal Investigator will be responsible for the oversight of trial conduct at one or more facilities where participants are located. Since the facilities may not be in proximity, oversight will be provided in accordance with a well laid out Decentralized Clinical Trials Oversight Plan.

This is a remote position for oversight for Sub Investigators, Research Coordinators, Laboratory Coordinators etc., is provided over email, phone, video conferencing etc.

What You'll Be Working On

Duties include but 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 virtually.

● 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.

Physical and Travel Requirements

This is a remote positions with less than 10% travel requirements. Occasional planned travel may be required as part of the role

What You Bring

Role Requirements:

● Prior research experience required

● Possess a thorough understanding of the requirements of clinical protocols.

Certifications/Licenses, Education, and Experience:

● Board Certification in any of the following areas: Internal Medicine, Cardiology, Gastroenterology, Dermatology, Endocrinology

● MD/DO License in good standing.

Benefits (US Full-Time Employees Only)

● PTO/vacation days, sick days, holidays.

● 100% paid medical, dental, and vision Insurance. 75% for dependents.

● HSA plan

● Short-term disability, long-term disability, and life Insurance.

● Culture of growth and equality

● 401k retirement plan

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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