Sub Investigator (Nurse Practitioner) (4559)

Dm Clinical Research Group; Dallas, Irving (TX, TX); Presencial; USD 120.000 - 180.000; Tempo integral

Resumo da vaga

DM Clinical Research Group is seeking a Sub-Investigator (Physician Assistant or Nurse Practitioner) at our Dallas, TX site. You will ensure protocol adherence, protect subject welfare, and direct study conduct under the Principal Investigator.

The role requires active nursing licensure, clinical research experience, and strong communication skills. Knowledge of FDA regulations and ICH guidelines is essential; bilingual English/Spanish is preferred.

Qualificações

• Strong communication and interpersonal skills.
• Solid understanding of clinical research processes and GCP.
• Active nursing licensure (PA/NP) in good standing.

Responsabilidades

• Complete DMCR-required training, including GCP and IATA.
• Maintain knowledge of FDA regulations, GCP/ICH guidelines, SOPs and study protocols.
• Maintain an up-to-date CV and current licensure to practice.
• Assist in managing the activities of clinical staff at the site.
• Perform clinical procedures and trial-related decisions delegated by the Principal Investigator.
• Conduct clinical safety assessments and monitor trial participation per protocol.
• Ensure documentation of study-related procedures and events; attend investigator meetings as needed.

Conhecimentos

Strong communication

Clinical research knowledge

Nursing background

Bilingual English/Spanish

Formação

Bachelor's or Master's in Nursing

Descrição da vaga

Job Details: Job Location: Dallas, TX - Irving, TX 75061, The Sub-Investigator (Physician Assistant or Nurse Practitioner) is accountable and responsible for ensuring adherence to protocol requirements, protecting the rights and welfare of subjects, assuring the integrity of subject generated data and directing the conduct of research according to federal and state regulations and guidance documents.

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.
• Assisting in managing the activities and performance of the clinical staff affiliated with the site.
• Performing clinical-related procedures and/or making important trial-related decisions delegated by the Principal Investigator.
• Performing clinical safety assessments and monitoring for study trial participation to include such items as: physical exams, EKGs, phlebotomy, and lab work evaluation
• Possessing a thorough understanding of the requirements of each protocol.
• Managing the medical care of subjects; protecting the rights and welfare of subjects.
• Ensuring documentation of study-related procedures, processes, and events.
• Attending investigator meetings as necessary for study participation.
• Any other matters as assigned by management

KNOWLEDGE & EXPERIENCE

Education:

• Bachelors or Masters in Nursing

Experience:

• Previous clinical research experience
• Nursing experience in a clinical setting

Credentials:

• Current nursing licensure in good standing (Physician Assistant or Nurse Practitioner)

Knowledge and Skills:

• Basic clinical and patient care skills
• Knowledge of nursing and medical principles and techniques
• Clinical research knowledge
• Strong communication skills, both written and verbal
• Strong diagnostic skills
• Ethical and legal healthcare principles in patient care
• 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.

Qualifications: