Advanced Practice Provider; NP​/PA

Work Schedule

Standard Office Hours (40/wk)

Office

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies.

With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.

AES(a division of PPD Clinical Research Serivces) helps biopharmaceutical companies overcome patient enrollment and research site challenges by combining a powerful patient recruiting solution more than 150 clinical research sites throughout the world. As a business of PPD, we are committed to optimizing each step in the patient journey and delivering best-in-class site performance to bring our customers greater certainty to clinical trial delivery.

As part of our continued commitment to the environment, and through our partnership with One Tree Planted, we will plant a tree for every patient enrolled in one of our sites.

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.

• Reviews protocols for scientific, logistical and safety feasibility.
• Conducts specific roles and responsibilities as per the protocol and delegation of authority 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 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.
• 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

• Master’s Degree in Nursing
• APRN Prescriptive Authority
• AANP Board Certified

physician assistant degree is also acceptable

• Previous experience that provides the knowledge, skills, and abilities to perform the job. Candidates with clinical research or sub-Investigator experience are preferred.

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…