Assuming responsibility for the conduct of clinical investigation protocols. * Possessing a thorough understanding of the requirements of each protocol. * Determining adequate resources available to ...
24 Dm Clinical Jobs Hiring Near You
Assuming responsibility for the conduct of clinical investigation protocols. * Possessing a thorough understanding of the requirements of each protocol. * Determining adequate resources available to ...
Phlebotomist (3781)
Irving, TX · On-site
$16.25 - $20.50/hr
The Phlebotomist ( or Certified Medical Assistant) will be responsible for assisting the clinical research staff in conducting clinical research trials. DUTIES & RESPONSIBILITIES * Assisting in the ...
Phlebotomist (3781)
Irving, TX · On-site
$16.25 - $20.50/hr
The Phlebotomist ( or Certified Medical Assistant) will be responsible for assisting the clinical research staff in conducting clinical research trials. DUTIES & RESPONSIBILITIES * Assisting in the ...
Site Manager (3819)
Phoenix, AZ · On-site
$100K - $120K/yr
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 ...
Site Manager (3819)
Phoenix, AZ · On-site
$100K - $120K/yr
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 ...
Research Assistant II (Non-Lab) (3773)
Brooklyn, NY · On-site
$24 - $28/hr
The Research Assistant II (Non lab) will be responsible for assisting the clinical research staff in conducting clinical research trials and assisting in the pre-screening process. DUTIES ...
Research Assistant II (Non-Lab) (3773)
Brooklyn, NY · On-site
$24 - $28/hr
The Research Assistant II (Non lab) will be responsible for assisting the clinical research staff in conducting clinical research trials and assisting in the pre-screening process. DUTIES ...
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Job description
DUTIES & RESPONSIBILITIES
- Completing DMCR-required training, including GCP and IATA.
- Maintaining a working knowledge of current FDA regulations, GCP/ICH guidelines, organizational SOPs, guidance documents, and study protocols.
- Maintaining a current, up-to-date curriculum vitae and current licensure to practice.
- Assuming responsibility for the conduct of clinical investigation protocols.
- Possessing a thorough understanding of the requirements of each protocol.
- Determining adequate resources available to conduct research protocols.
- Managing the medical care of subjects; protecting the rights and welfare of subjects.
- Ensuring the validity of the trial data reported to the sponsor.
- Ensuring documentation of study-related procedures, processes, and events.
- Ensuring the proper use and storage of Investigational Products.
- Attending investigator meetings as necessary for study participation.
- Assist with creating PI oversight plans for every study.
- Conduct and oversee ongoing staff training.
- Conduct patient consent discussions and ensure comprehension of medical procedures, risks, benefits, and alternatives
- Provide clear explanations of study protocols and ensure patients' understanding before obtaining their consent
- Facilitate effective communication between patients, healthcare providers, and research staff
- Any other matters as assigned by management
KNOWLEDGE & EXPERIENCE
Education:
- 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).
Experience:
- At least 2 years of experience as a Clinical Research Investigator
Credentials:
- Medical licensure (license must be valid in the state in which the research is conducted).
- Board certification or board eligibility in a specialty appropriate to the type of research being conducted at the site.
- Training and certification in DMCR required training and Standard Operating Procedures (SOP's).
- Training and certification in Good Clinical Practice (GCP)
Knowledge and Skills:
- Proficient communication and comprehension skills both verbal and written in the English language are required.
- Proficient Bi-lingual (English/Spanish) communication and comprehension skills both in verbal and written are preferred.