Clinical Research Director jobs in Richardson, TX

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)

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Site Director
  • DM Clinical Research
  • Dallas, TX FULL_TIME
  • Site Director

    The Site Director will ensure study enrollment to meet or exceed Sponsors' expectations, and company goals are achieved on a timely basis. The site director will also ensure that quality research is conducted at assigned investigative sites in accordance with the sponsor protocol, FDA Regulations and ICH/GCP guidelines and to provide the best quality data to the sponsor.

    DUTIES & RESPONSIBILITIES

    • Completing all the DMCR-required training, including but not limited to ICH-GCP Certification and IATA Certification on a timely basis.
    • Maintaining a working knowledge of current FDA regulations, ICH-GCP guidelines, all the organizational SOPs, all the guidance documents and assigned study protocol(s).
    • Responsible for immediate supervision and performance of the assigned site staff.
    • Completing all the relevant training prior to study-start and on a continued basis in a timely manner. This will include, but is not limited to: 
      • sponsor provided and IRB approved Protocol Training
      • All relevant Protocol Amendments Training, any study specific Manuals Training as applicable
      • Sponsor-specified EDC and/or IVRS
      • Any other relevant Electronic Systems training.
    • It is the responsibility of the Site Director to make sure all the relevant training is completed prior to performing any applicable tasks on the assigned study.
    • Working knowledge of the recruitment and relevant cross functional departmental processes for their assigned protocol(s) at their respective site(s).
    • Ensuring visit preparedness for all the relevant sponsor and CRO visits for their assigned protocol(s) and appropriate as well as timely follow up on the action items,  at their respective sites. 
    • Making sure that the most recent versions  of the Protocol, Informed Consents, Study Manuals and all the other relevant study related documents are utilized and implemented at all times for the assigned protocol(s) at their respective site(s).
    • Working with the Regulatory Team to ensure maintenance of Essential Clinical Trial Documents and maintenance of the Investigator Site Binders for their assigned protocol(s) at their respective site(s)
    • Working with the cross functional team(s) and site team(s) to ensure study start readiness on all the aspects and adequate training completed by all the relevant site staff prior to FPFV. 
    • Ensuring clinical trial management from FPFV to study close out with strict adherence to study protocol, adherence to all other relevant study manuals, study documents, ICH-GCP Guidelines, FDA Regulations, and ALCOA-C standards, organizational SOPs and guidance documents. 
    • Responsible for providing guidance to the site team on planning and monitoring the conduct of the clinical trials.
    • Accomplishing site objectives by managing staff; facilitating staff training as applicable; communicating job expectations
    • Coaching, counseling and disciplining the employees as applicable.
    • Collaborating with both internal and external cross-functional stakeholders for the successful conduct and management of assigned protocol(s) at their respective sites.
    • To develop, coordinate, and enforce site specific systems, policies, procedures, and productivity standards.
    • Communicating and effective implementation of strategic goals from senior management
    • Striving to meet Sponsor subject enrollment goals for their assigned protocols at their respective site(s).
    • Striving to ensure weekly, monthly and quarterly assigned goals are met for their respective site(s).
    • Being prepared for and available at all required company meetings.
    • Submitting required administrative paperwork per company timelines.
    • Occasionally attending out-of-town Investigator Meetings.
    • Any other matters as assigned by management.

    KNOWLEDGE & EXPERIENCE

    Education:

    • Bachelor’s Degree in a field of Medicine, Science, Behavioral Science, Nursing, or related field required
    • Masters degree preferred
    Experience:
    • 5-7 years experience in a managing high growth clinical research sites required 
    • 3 years in multi study management required
    • 3 years in team management required

    Credentials:

    • ACRP- PM, ACRP-CP or equivalent preferred

    Knowledge and Skills:

    • Excellent communication, organizational and problem-solving skills
    • Strong skills with MS Office and/or Google Suite
    • Expertise in Trial management and ICH-GCP guidelines and FDA Clinical Trial Guidelines
    • Strong attention to detail
    • Strong skills in multi-tasking and delegating tasks 
    • Strong People Management skills
  • 12 Days Ago

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Clinical Research Coordinator
  • Delricht Research
  • Prosper, TX FULL_TIME
  • Why DelRicht Research? Would you love to be a part of the cutting edge of healthcare and science innovation? Do you want to be an influential part of a rapidly growing team? Are you looking for a posi...
  • 11 Days Ago

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Clinical Research Coordinator
  • Delricht Research
  • Mc Kinney, TX FULL_TIME
  • Why DelRicht Research? Would you love to be a part of the cutting edge of healthcare and science innovation? Do you want to be an influential part of a rapidly growing team? Are you looking for a posi...
  • 1 Month Ago

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Clinical Research Medical Assistant
  • Revival Research Institute, LLC
  • Sherman, TX FULL_TIME
  • Unique opportunity to make an Impact in the healthcare industry…IMPROVE THE FUTURE AS OUR MEDICAL ASSISTANT!Revival Research Institute, LLC is a Clinical Research organization with multiple sites loca...
  • 20 Days Ago

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Clinical Research Assistant (PRN)
  • Evolution Research Group
  • Carrollton, TX FULL_TIME
  • Title: Clinical Research Assistant Night shift PRN Location: Carrollton, TX About us: ERG is a leading U.S. based, privately held, independent clinical research site company, and provider of clinical ...
  • Just Posted

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0 Clinical Research Director jobs found in Richardson, TX area

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Nurse Educator- Critical Care
  • Medical City Plano
  • Plano, TX
  • Description Introduction Do you have the career opportunities as a(an) Nurse Educator- Critical Care you want in your cu...
  • 3/29/2024 12:00:00 AM

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Business Development Consultant (Remote)
  • M3 Global Research
  • Dallas, TX
  • Company Description M3 is the global leader in digital solutions in healthcare. We work with a range of sectors includin...
  • 3/29/2024 12:00:00 AM

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Patient Financial Specialist
  • Christus Health
  • Irving, TX
  • Description Summary: Responsible for the duties and services that are of a support nature to the RCBS High Performance W...
  • 3/29/2024 12:00:00 AM

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Practice Director, Regulatory Affairs (Pharma)
  • Kaye/Bassman International
  • Plano, TX
  • Recruiting Practice Director, Regulatory Affairs (Pharma) Kaye/Bassman’s Pharmaceutical and Biotech Practice is experien...
  • 3/28/2024 12:00:00 AM

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Practice Director, Clinical Ops (Pharma)
  • Kaye/Bassman International
  • Plano, TX
  • Recruiting Practice Director, Clinical Ops (Pharma) Kaye/Bassman’s Pharmaceutical and Biotech Practice is experiencing g...
  • 3/28/2024 12:00:00 AM

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Advanced Practice Practitioner- Pediatric Pulmonary Medicine
  • Children's Health
  • Plano, TX
  • Job Title & Specialty Area: Advanced Practice Practitioner- Pediatric Pulmonary Medicine Department: Pediatric Pulmonary...
  • 3/27/2024 12:00:00 AM

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Licensed Professional Counselor or Licensed Psychologist
  • Better Living Center for Behavioral Health
  • Allen, TX
  • Job Description Job Description Job Responsibilities: As a Licensed Psychologist or Licensed Professional Counselor, you...
  • 3/27/2024 12:00:00 AM

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Mobile Healthcare Paramedic
  • Acadian Health
  • Dallas, TX
  • Acadian Health JOB DESCRIPTION Job Title: Paramedic Alternate Job Title(s): N/A Division/Department: Acadian Health Stat...
  • 3/25/2024 12:00:00 AM

The cities of Dallas, Plano and Garland, Texas constitute almost all of the Richardson border apart from the municipality's extreme northeastern "panhandle." The Lake Highlands area of northeast Dallas borders Richardson to the south, North Dallas to the southwest, Far North Dallas to the west, West Plano to the northwest, East Plano to the north, the city of Murphy to the northeast, Sachse to the east, and Garland to the southeast. Richardson is located at 32°57′56″N 96°42′57″W / 32.965628°N 96.715707°W / 32.965628; -96.715707. According to the United States Census Bureau, the city has a t...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Clinical Research Director jobs
$141,576 to $191,125
Richardson, Texas area prices
were up 2.2% 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