Advanced Practitioner (APP) Sub-Investigator

Thermo Fisher Scientific • Atlanta, GA

6d • Onsite

About The Position

The Specialist Nurse 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. We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years.

Requirements

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification in the clinical / medical field
• Must hold a valid Registered Nurse license 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’)
• 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
• Possess decision-making, negotiation and influencing skills
• Excellent communication skills and English fluency will be an advantage
• Great organizational skills
• Essential proficiency in basic computer applications
• Excellent interpersonal skills to work in a team environment

Responsibilities

• Review protocols for scientific, logistical, and safety feasibility.
• Conduct specific roles and responsibilities for specialized studies requiring expert nursing experience in a therapeutic area.
• Act according to the protocol and delegation of authority documents, ensuring the trial is conducted under requirements relating to obtaining informed consent and IRB approval of the protocol.
• Review and sign off on regulatory information pertaining to study assignments as applicable to Sub-Investigator.
• Perform appropriate clinical procedures which may include, but are not limited to: vital signs, blood collection, IV infusions, pain assessments, and safety assessments.
• Attend internal meetings related to logistics, training, protocol, and client meetings to discuss scientific and medical oversight of a particular protocol or the clinic in general.
• Attend internal and external training related to licensure and medical malpractice requirements and train staff on new procedures and processes.
• Review and consult with clients on new or ongoing projects within the clinic and with the investigator group on scheduling and study assignments.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior