Clinical Research Nurse Practitioner - Onsite

Thermo Fisher Scientific - Birmingham, AL

Job Title: Clinical Research Nurse Practitioner - Onsite

Position: Medical Oversight for Trial Protocols

Job Type: Full Time

Pay:

Shift: Standard (Mon-Fri)

Work Type: On-Site

Location

Address:

City: Birmingham

State: AL

ZIP Code:

Job Responsibilities

Serves as Sub-Investigator for particular protocols and supports Principal Investigator in medical oversight for studies.
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.
Ensures the conduct of the trial complies with informed consent and IRB approval requirements.
Reviews and signs-off on regulatory information pertaining to study assignments.
Assesses new technology being implemented in the clinic.
Attends internal meetings related to logistics, training, and protocol.
Attends internal/external training related to licensure and medical malpractice requirements.
Trains staff on new procedures and processes.
Reviews and consults with clients on new or ongoing projects.
Travels with operational or Business Development staff to attend conferences.
Prepares and/or reviews posters, scientific papers, and publications related to conducted protocols.

Required Skills

Core Skills

Knowledge of important regulatory considerations
Proven ability to assess safety and tolerability of different drug classes
Knowledge of drug development process and familiarity with marketing authorization submissions
Demonstrated ability to work independently and analyze complex information
Strong decision-making, negotiation, and influencing skills
Excellent communication skills
Excellent organizational skills and detail-oriented leadership approach

Preferred Skills

Clinical research or sub-Investigator experience
Familiarity with guidelines for the conduct of clinical studies
Flexibility to travel domestically and internationally
Proficiency in basic computer applications

Requirements

Experience: Previous experience that provides knowledge, skills, and abilities for the job; candidates with clinical research or sub-Investigator experience preferred.

Education: Master's Degree in Nursing

License & Certification: