Senior Nurse Practitioner ; AES

Pharmaceutical Product Development (PPD)

FL-Orlando-Orlando FL


Summarized Purpose:

Leads the execution and coordination of daily clinical activities according to organization’s SOPs, GCP and FDA/ICH guidelines. In collaboration with the site management, performs specialized clinical tasks within a therapeutic area and follows all safety and emergency procedures according to protocols. May assist with educating patients and their families about treatments and possible side effects of study medication.

· Conducts specific roles and responsibilities for specialized studies requiring expert nursing experience in a therapeutic area.

· Acts as per the protocol and delegation of authority documents, and ensures the conduct of the trial is conducted under the requirements relating to obtaining informed consent and IRB approval of the protocol.

· May review and sign-off on regulatory information pertaining to study assignments as applicable to Sub-Investigator.

· Performs appropriate clinical procedures which may include, but are not limited to: vital signs, blood collection, IV infusions, pain assessments, and safety assessments.

· Attends internal meetings related to logistics, training and protocol and client meetings to discuss scientific and medical oversight of a particular protocol or the clinic in general.

· Attends internal/external training related to licensure and medical malpractice requirements and trains staff on new procedures and processes. . Reviews and consults with clients on new or ongoing projects within the clinic and with the investigator group on scheduling and study assignments.

Summarized Purpose:

Leads the execution and coordination of daily clinical activities according to organization’s SOPs, GCP and FDA/ICH guidelines. In collaboration with the site management, performs specialized clinical tasks within a therapeutic area and follows all safety and emergency procedures according to protocols. May assist with educating patients and their families about treatments and possible side effects of study medication.

· Conducts specific roles and responsibilities for specialized studies requiring expert nursing experience in a therapeutic area.

· Acts as per the protocol and delegation of authority documents, and ensures the conduct of the trial is conducted under the requirements relating to obtaining informed consent and IRB approval of the protocol.

· May review and sign-off on regulatory information pertaining to study assignments as applicable to Sub-Investigator.

· Performs appropriate clinical procedures which may include, but are not limited to: vital signs, blood collection, IV infusions, pain assessments, and safety assessments.

· Attends internal meetings related to logistics, training and protocol and client meetings to discuss scientific and medical oversight of a particular protocol or the clinic in general.

· Attends internal/external training related to licensure and medical malpractice requirements and trains staff on new procedures and processes. . Reviews and consults with clients on new or ongoing projects within the clinic and with the investigator group on scheduling and study assignments.

Qualifications:

Education and Experience:

Bachelor's degree or equivalent and relevant formal academic / vocational qualification in the clinical / medical field

Must hold a valid Registered Nurse licence within the country operating. Must be registered with local health care authority.

Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8 years’).

Knowledge, Skills and Abilities:

· Excellent understanding of the clinical research process (i.e., GCP, SOPs, informed consent, safety monitoring, etc.)

· Capable of working independently, analyzing and working with attention to detail, processing and prioritizing sensitive complex information and problem solving

· Demonstrated ability to exercise discretion and sound judgement

· Excellent decision-making, negotiation and influencing skills

· Excellent communication skills and English fluency will be an advantage

· Excellent organizational skills

· Essential proficiency in basic computer applications

· Excellent interpersonal skills to work in a team environment

Qualifications:

Education and Experience:

Bachelor's degree or equivalent and relevant formal academic / vocational qualification in the clinical / medical field

Must hold a valid Registered Nurse licence within the country operating. Must be registered with local health care authority.

Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8 years’).

Knowledge, Skills and Abilities:

· Excellent understanding of the clinical research process (i.e., GCP, SOPs, informed consent, safety monitoring, etc.)

· Capable of working independently, analyzing and working with attention to detail, processing and prioritizing sensitive complex information and problem solving

· Demonstrated ability to exercise discretion and sound judgement

· Excellent decision-making, negotiation and influencing skills

· Excellent communication skills and English fluency will be an advantage

· Excellent organizational skills

· Essential proficiency in basic computer applications

· Excellent interpersonal skills to work in a team environment


2020-08-07 00:00:00


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