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.
Summarized Purpose:
Join our dedicated team at Thermo Fisher Scientific Inc. in Birmingham as a Nurse Practitioner in a research role. Serve as a sub-investigator while working closely with the Principal Investigator, providing medical oversight and insights for protocols to advance scientific research. Ensure compound safety and elevate medical data evaluation standards. Collaborate with clients to deliver exceptional service.
Essential Functions:
Reviews protocols for scientific, logistical, and safety feasibility.
Conducts specific roles and responsibilities as per the protocol and delegation of authority documents.
Ensures the trial's conduct aligns with informed consent and IRB approval requirements.
Reviews and signs off on regulatory information pertinent to study assignments.
Researches compounds for subject safety.
Assesses new technologies like automated scheduling and electronic informed consents.
Attends internal meetings related to logistics, training, and protocol discussions.
Engages in client meetings to discuss scientific and medical oversight.
Participates in internal/external training for licensure and medical malpractice requirements.
Consults with clients on new or ongoing projects.
Travels with operational or Business Development staff to conferences.
Prepares and/or reviews scientific papers and publications related to protocols.
Supervision Received:
Acts independently to determine methods and procedures for new or special assignments.
May supervise others and exercises independent judgment for acquiring results.
Business Relationships:
Serves as a consultant and spokesperson for significant matters relating to operations, scheduling, or specific phases of projects or contracts.
Creates formal networks involving coordination among groups.
Qualifications:
Education and Experience:
Master's Degree in Nursing or equivalent experience.
APRN Prescriptive Authority.
AANP Board Certified FNP.
Knowledge, Skills, and Abilities:
Knowledge of regulatory considerations.
Proven track record to assess drug safety and tolerability.
Familiarity with the drug development process and guidelines.
Ability to work independently with attention to detail and problem-solving skills.
Advanced analytical abilities.
Strong decision-making, negotiation, and influencing skills.
Excellent communication skills and English proficiency.
Strong social skills and diligent leadership.
Willingness to travel domestically and internationally.
Proficiency in basic computer applications.
Strong collaboration abilities.
Working Conditions and Environment:
Office environment with exposure to electrical equipment.
Occasional site visits and travel.
Occasional on-call coverage.
Physical Requirements:
Frequent stationary periods and repetitive hand movements.
Frequent mobility required.
Occasional bending, lifting, and carrying objects up to 20 lbs.
Ability to use various computer software.
Effective communication and interaction with diverse groups.
