Sub-Investigator

Posted 14 Days Ago
Be an Early Applicant
Memphis, TN
5-7 Years Experience
Other
The Role
The Sub-Investigator will oversee clinical study protocols, ensuring compliance with regulatory standards and managing study subjects' medical issues during visits. Responsibilities include reviewing documentation, reporting adverse events, and conducting physical examinations. This role involves regional travel and telemedicine work.
Summary Generated by Built In

Sub-Investigator

Department: US Site Network

Level: Individual Contributor

Work Location: On Site

Updated Last: 09/27/2024

______________________________________________________________________________________

 

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 Sub-Investigator will be responsible for regional travel mixed with remote tele-medicine work to support our clinical research. Care Access is looking for Nurse Practitioners or Physicians Assistants to support clinical trial related activities in states throughout the USA.

 

What You'll Be Working On

Duties include but not limited to:

Work closely with the Principal Investigator to oversee the execution of study protocols, delegating study related duties to site staff, as appropriate, and ensuring site compliance with study protocols, study-specific laboratory procedures, standards of Good Clinical Practice (GCP), Standard Operating Procedures (SOPs), quality (QA/QC) procedures, OSHA guidelines, and other state and local regulations as applicable

Attends and participates in meetings with the director, other managers, and staff as necessary

Complies with regulatory requirements, policies, procedures, and standards of practice

Read and understand the informed consent form, protocol, and investigator's brochure

Be available to see subjects virtually or in-person as dictated by project design, answer their questions, and resolve medical issues during the study visit

Sign and ensure that the study documentation for each study visit is completed

Perform all study responsibilities in compliance with the IRB approved protocol

Review screening documentation and approves subjects for admission to study

Review admission documentation and approves subject for randomization

Provide ongoing assessment of the study subject/patient to identify Adverse Events

Ensure that serious and unexpected adverse events are reported promptly to the Pl

Review and evaluates all study data and comments to the clinical significance of any out of range results

Perform physical examinations as part of screening evaluation and active study

Conduct

Provide medical management of adverse events as appropriate

*Perform other duties as trained for and assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.

Physical and Travel Requirements

· This is an on-site position with regional commute requirements. Regularly planned travel within the region will be required as part of the role.

 

What You Bring

Knowledge, Skills and Abilities:

Excellent working knowledge of medical and research terminology

Excellent working knowledge of federal regulations, good clinical practices (GCP)

Ability to communicate and work effectively with a diverse team of professionals

Strong organizational skills: Able to prioritize, support, and follow through on assignments

Communication Skills: Strong verbal and written communication skills as evidenced by positive interactions with coworkers, management, clients and vendors

Team Collaboration Skills: Work effectively and collaboratively with other team members to accomplish mutual goals. Bring positive and supportive attitude to achieving these goals

Strong computer skills with demonstrated abilities using clinical trials database, IVR systems, electronic data capture, MS word and excel

Ability to balance tasks with competing priorities

Critical thinker and problem solver

Curiosity and passion to learn, innovate, able to take thoughtful risks and get things done

Friendly, outgoing personality; maintain a positive attitude under pressure

High level of self-motivation and energy

Ability to work independently in a fast-paced environment with minimal supervision

Must have a client service mentality

 

Certifications/Licenses, Education, and Experience:

Nurse Practitioner or Physician Assistant with 5+ years of clinical experience

Currently licensed in good standing in one or more states listed above

A minimum of 1 year of relevant work experience as Sub-Investigator (preferred) in a Clinical Research setting

 

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. Our team of experts is paving the way to take this vision forward through innovation and a unique technology-enabled.

 

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.

 

 

 

 

 

 

 

 

 

 

The Company
HQ: Boston, MA
818 Employees
On-site Workplace

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].

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