Clinical Research Director jobs in Mobile, AL

Clinical Research Director directs and oversees the clinical research function for a healthcare organization. Develops research studies and creates standards and guidelines for clinical research services and programs. Being a Clinical Research Director ensures adherence to standard operating procedures, good clinical practice and FDA regulations. Requires an advanced degree. Additionally, Clinical Research Director typically reports to top management. The Clinical Research Director manages a departmental sub-function within a broader departmental function. Creates functional strategies and specific objectives for the sub-function and develops budgets/policies/procedures to support the functional infrastructure. Deep knowledge of the managed sub-function and solid knowledge of the overall departmental function. To be a Clinical Research Director typically requires 5+ years of managerial experience. (Copyright 2024 Salary.com)

V
Principal Investigator
  • Velocity Clinical Research, Inc.
  • Mobile, AL FULL_TIME
  • Overview

    Velocity Clinical Research is an owned and integrated research site organization, providing excellence in patient care, high quality data and fully integrated research sites. At Velocity, we align our values and behaviors to give our employees the best chance of delivering on our brand promise: to bring innovative medical treatments to patients. We are committed to making clinical trials succeed by generating high quality data from as many patients as possible, as quickly as possible while providing exemplary patient care at every step.

     

    As an employee of Velocity, you are the most integral part of our mission. For talented candidates who perform at a high level, Velocity will invest to support career advancement and reward performance. Whether you are new to clinical research or are an industry veteran, we invite you to apply to Velocity.

     

    Benefits include medical, dental and vision insurance, paid time off and company holidays, 401(k) retirement plan with company-match, and an annual incentive program.

     

    Summary:

    • The Principal Investigator responsibilities are centered around the execution, planning and management of assigned studies. Communicate succinctly with clients, study directors and technicians are key as is a cross-functional, flexible, and collaborative spirit. The Principal Investigator is responsible for the conduct of the clinical trial at a trial site

    Responsibilities

    Duties/Responsibilities:

    • Provide overall medical direction and medical review of protocols in conformance with the investigational plan and good clinical practice
    • Provide medical expertise and scientific feasibility for new sponsor inquiries
    • Ensure that the safety and well-being of all participants in the study at the trial site are protected
    • Ensure data collected at the study site is credible and accurate
    • Ensure the rights, integrity, and confidentiality of all participants in the trial at the site are protected
    • Assist and provide guidance to clinical operations, research staff, and to sponsor client managers as required
    • Obtain and/or review participants’ medical history
    • Perform physical assessments, examinations and study procedures as required by study protocols
    • Evaluate and interpret clinical data and diagnostic information such as X-rays, ECGs and lab work.
    • Immediately report Serious Adverse Events (SAEs)—or any abnormalities affecting participants’ safety—to sponsors and to the IRB as required by study specific reporting guidelines
    • Oversee the administration of Investigational Product
    • Review and adhere to study protocol
    • Maintain proper documentation
    • Ensure accuracy, completeness, legibility, and timeliness of data reported and be consistent with source documents
    • Prior to starting a study and while a study is ongoing, ensure that the study, clinical trial protocol, informed consent form, recruitment materials, and other documents provided to the subject are approved by the IRB and comply with GCP (Good Clinical Practices) and other regulatory requirements as required.
    • Ensure that the IRB is provided with a copy of the Investigator’s brochure, product monograph, or information about the product or intervention to be studied so the IRB can fully assess the risks involved
    • During the study, ensure the IRB is informed of any changes to the protocol, Investigator’s brochure (or other safety information about the product/intervention), protocol deviations, or unanticipated problems
    • Be thoroughly familiar with the appropriate use of the investigational product (study drug) as described in the protocol and Investigator’s brochure/product monograph and other documents provided by the sponsor
    • Be aware and comply with ICH GCP (International Conference on Harmonization – Good Clinical Practice) and all applicable regulatory requirements
    • Maintain trial documents as specified by guidelines and applicable regulatory requirements
    • Ensure retention of essential documents until at least two years after the last approval of a marketing application or at least two years since formal discontinuation of the investigational product
    • Participate in monitoring visits and sponsor meetings; allow monitoring and auditing by sponsors and inspection by appropriate regulatory agencies
    • Provide access to research-related records to monitors, auditors, representatives of the IRB, and regulatory authorities
    • Ensure participants are informed and receive appropriate therapy and follow-up if the trial is prematurely terminated or suspended for any reason
    • Inform and provide a detailed written explanation of the termination/suspension of the trial to the IRB and, if the investigator terminates the trial without prior agreement, to the study sponsor

    Qualifications

    Required Skills/Abilities:

    • Understanding of regulatory requirements, principles of GCP and biomedical research ethics.
    • The ability to communicate effectively in a flexible and collaborative manner
    • Critical thinking, dynamic problem-solving skills, and attention to detail
    • Ability to travel for work related purposes (Up to 10% travel, as needed, for project team meetings, client presentations and other professional meetings/conferences as needed.)

     

    Education and Experience:

    • Minimum qualifications include an M.D or D.O with an active medical license (medical license must be valid in the state in which the research is conducted).
    • Training and certification in Good Clinical Practice (GCP)
    • Board certification or board eligibility in a specialty appropriate to the type of research being conducted at the site.
    • Medical licensure (license must be valid in the state in which the research is conducted).
    • Training and certification in Velocity required trainings and Standard Operating Procedures (SOP’s).
  • 1 Month Ago

A
Clinical Research Coordinator (RN or Medical Assistant)
  • Alliance for Multispeciality Research, LLC
  • Mobile, AL FULL_TIME
  • Alliance for Multispecialty Research is a fast-growing clinical research organization that conduct trials for the development of pharmaceuticals. AMR offers competitive pay, 401K matching, health/dent...
  • 1 Month Ago

A
Clinical Research Coordinator (RN or Medical Assistant)
  • Alliance for Multispeciality Research, LLC
  • Daphne, AL FULL_TIME
  • Alliance for Multispecialty Research is a fast-growing clinical research organization that conduct trials for the development of pharmaceuticals. AMR offers competitive pay, 401K matching, health/dent...
  • 1 Month Ago

I
RN Clinical Research Coordinator
  • Infirmary Health
  • Mobile, AL FULL_TIME
  • Overview Qualifications Minimum Qualifications: Graduate of an accredited school of nursing with minimum 1 of the most recent 3 years’ clinical oncology or research experience Problem solving, analyti...
  • 22 Days Ago

I
Clinical Research Coordinator--Onsite
  • Infirmary Health
  • Mobile, AL FULL_TIME
  • Overview Qualifications THIS POSITION IS ONSITE IN MOBILE, ALABAMA. Minimum Qualifications: One of the following: Associate degree with minimum 1 of the most recent 3 years’ clinical oncology research...
  • 1 Month Ago

H
Clinical Director
  • Hire Velocity
  • Daphne, AL FULL_TIME
  • Overview Our independently owned practice offers the perfect solution for someone who would enjoy the freedom to innovate and approach physical therapy treatments in non-traditional ways. With state-o...
  • 19 Days Ago

Filters

Clear All

  • Filter Jobs by companies
  • More

0 Clinical Research Director jobs found in Mobile, AL area

K
Licensed Practical Nurse (LPN) - Full-Time and Part-Time Varius Shifts Available
  • Kensington Health and Rehab
  • Mobile, AL
  • Currently Hiring for: Full-Time Part-Time 7:00 AM - 3:00 PM Shift 3:00 PM - 11:00 PM Shift 11:00 PM - 7:00 AM Shift This...
  • 3/28/2024 12:00:00 AM

K
Housekeeper - Full-Time and Part-Time Varius Shifts Available
  • Kensington Health and Rehab
  • Mobile, AL
  • General Purpose: The HOUSEKEEPER performs day-to-day housekeeping services ensuring a clean, attractive facility in acco...
  • 3/28/2024 12:00:00 AM

A
Insurance Sales Manager Fishers, AL
  • American Income Life AO - Bruce Viaje
  • Mobile, AL
  • Are you ready to join an exceptional company that offers comprehensive training, benefits, and flexible working hours al...
  • 3/27/2024 12:00:00 AM

U
Manager, Clinical Operations
  • USA Health
  • Mobile, AL
  • Overview: USA Health is Transforming Medicine along the Gulf Coast to care for the unique needs of our community. USA He...
  • 3/25/2024 12:00:00 AM

Q
Phlebotomist II
  • Quest Diagnostics
  • Mobile, AL
  • Overview: Phlebotomist II - Mobile, AL - Monday to Friday (Rotational Weekends 8:30 AM - 12:30 PM) Part-time employees (...
  • 3/25/2024 12:00:00 AM

H
Insurance Agent
  • HealthMarkets
  • Mobile, AL
  • HealthMarkets Overview If youre looking for an exciting opportunity where you can change peoples lives and achieve finan...
  • 3/25/2024 12:00:00 AM

U
Medical Student Education Director - Faculty
  • USA Health
  • Mobile, AL
  • Overview: USA Health is Transforming Medicine along the Gulf Coast to care for the unique needs of our community. USA He...
  • 3/24/2024 12:00:00 AM

U
Department Secretary -Sickle Cell Center
  • USA Health
  • Mobile, AL
  • Overview: USA Health is Transforming Medicine along the Gulf Coast to care for the unique needs of our community. USA He...
  • 3/24/2024 12:00:00 AM

Mobile (/moʊˈbiːl/ moh-BEEL; French pronunciation: ​[mɔ.bil]) is the county seat of Mobile County, Alabama, United States. The population within the city limits was 195,111 as of the 2010 United States Census, making it the third most populous city in Alabama, the most populous in Mobile County, and the largest municipality on the Gulf Coast between New Orleans, Louisiana, and St. Petersburg, Florida. Alabama's only saltwater port, Mobile is located on the Mobile River at the head of the Mobile Bay and the north-central Gulf Coast. The Port of Mobile has always played a key role in the economi...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Clinical Research Director jobs
$131,786 to $177,909
Mobile, Alabama area prices
were up 1.3% from a year ago

Clinical Research Director in Killeen, TX
We are Looking for an Assistant Director for the Center for Clinical Research Education.
December 07, 2019
Clinical Research Director in Springfield, IL
During the Clinical Research Operations Forum a few weeks ago, Stephen Sonstein, Ph.D., Professor & Program Director for Clinical Research Administration at Eastern Michigan University spoke on the shift in clinical research going from a focus on regulatory compliance to a standardization of competencies for professionals working in the field.
February 06, 2020
Clinical Research Director in Olympia, WA
You might occasionally be able to enter from the administration side - for example, you could start as a study-site coordinator in the NHS or as a clinical trials administrator.
January 28, 2020