Senior Nurse Practitioner

Summarized Purpose:

Serves as Sub-Investigator for particular protocols and supports Principal Investigator in the medical oversight for the study. Provides scientific and medical insight for protocols. Researches compounds being considered by the clinic for subject safety. Evaluates and signs off on medical data collected.Fosters relationships with clients and supports operational and business development staff.

Essential Functions:

• Reviews protocols for scientific, logistical and safety feasibility.

• Conducts specific roles and responsibilities as per the protocol and delegation ofauthority document and ensures the conduct of the trial is conducted under the requirements relating to obtaining informed consent and IRB approval of the protocol.

• Reviews and signs-off on regulatory information pertaining to study assignments as applicable to Sub-Investigator.

• Researches compounds being considered by the clinic for subject safety.

• Assesses new technology being implemented in the clinic, such as, automated

scheduling, electronic informed consents or online Lab and ECG reviews.

• Attends internal meetings related to logistics, training and protocol and clientmeetings 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.

• Travels with operational or Business Development staff, attends conferences and prepares and/or reviews posters, scientific papers and publications related to protocols conducted in the Early Phase Clinical Research Unit.

Qualifications - External

Education and Experience: Master's Degree in Nursing APRN Prescriptive Authority AANP Board Certified FNP Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 4 years). In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Summarized Purpose:

Serves as Sub-Investigator for particular protocols and supports Principal Investigator in the medical oversight for the study. Provides scientific and medical insight for protocols. Researches compounds being considered by the clinic for subject safety. Evaluates and signs off on medical data collected.Fosters relationships with clients and supports operational and business development staff.

Essential Functions:

• Reviews protocols for scientific, logistical and safety feasibility.

• Conducts specific roles and responsibilities as per the protocol and delegation ofauthority document and ensures the conduct of the trial is conducted under the requirements relating to obtaining informed consent and IRB approval of the protocol.

• Reviews and signs-off on regulatory information pertaining to study assignments as applicable to Sub-Investigator.

• Researches compounds being considered by the clinic for subject safety.

• Assesses new technology being implemented in the clinic, such as, automated

scheduling, electronic informed consents or online Lab and ECG reviews.

• Attends internal meetings related to logistics, training and protocol and clientmeetings 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.

• Travels with operational or Business Development staff, attends conferences and prepares and/or reviews posters, scientific papers and publications related to protocols conducted in the Early Phase Clinical Research Unit.

Qualifications - External

Education and Experience: Master's Degree in Nursing APRN Prescriptive Authority AANP Board Certified FNP Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 4 years). In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role. Knowledge of important regulatory considerations Proven ability to assess the safety and tolerability of different classes of drugs Knowledge of the drug development process and familiarity with guidelines for marketing authorization submissions and international guidelines for conduct of clinical studies Demonstrated ability to work independently, analyze and work with attention to detail, process and prioritize sensitive complex information and problem solve Advanced analytical ability Demonstrated ability to exercise discretion and sound judgement Strong decision-making, negotiation and influencing skills Excellent communication skills and English fluency Excellent organizational skills and detail-orientated leadership approach Flexibility to travel domestically and internationally Proficiency in basic computer applications Strong ability to work in a team environment

Working Conditions and Environment: Work is performed in an office environment with exposure to electrical office equipment. Occasional drives to site locations with occasional travel both domestic and international. Occasional on-call coverage required.

Physical Requirements: Frequently stationary for 6-8 hours per day. Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists. Frequent mobility required. Occasional crouching, stooping, bending and twisting of upper body and neck. Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs. Ability to access and use a variety of computer software developed both in-house and off-the-shelf. Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. Frequently interacts with others to obtain or relate information to diverse groups. Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals. Requires multiple periods of intense concentration. Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task. Regular and consistent attendance.

Knowledge of important regulatory considerations Proven ability to assess the safety and tolerability of different classes of drugs Knowledge of the drug development process and familiarity with guidelines for marketing authorization submissions and international guidelines for conduct of clinical studies Demonstrated ability to work independently, analyze and work with attention to detail, process and prioritize sensitive complex information and problem solve Advanced analytical ability Demonstrated ability to exercise discretion and sound judgement Strong decision-making, negotiation and influencing skills Excellent communication skills and English fluency Excellent organizational skills and detail-orientated leadership approach Flexibility to travel domestically and internationally Proficiency in basic computer applications Strong ability to work in a team environment

Working Conditions and Environment: Work is performed in an office environment with exposure to electrical office equipment. Occasional drives to site locations with occasional travel both domestic and international. Occasional on-call coverage required.

Physical Requirements: Frequently stationary for 6-8 hours per day. Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists. Frequent mobility required. Occasional crouching, stooping, bending and twisting of upper body and neck. Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs. Ability to access and use a variety of computer software developed both in-house and off-the-shelf. Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. Frequently interacts with others to obtain or relate information to diverse groups. Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals. Requires multiple periods of intense concentration. Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task. Regular and consistent attendance.