Advanced Practice Provider(NPPAMD) Sub-InvestigatorPrincipal Investigator
4 days ago
San Antonio
Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description At Thermo Fisher Scientific youll 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. Trialmed(a division of PPD Clinical Research Services) helps biopharmaceutical companies overcome patient enrollment and research site challenges by combining a powerful patient recruiting solution with more than 150 clinical research sites located 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. Working hours: M-F onsite day hours 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 Masters Degree in Nursing * APRN Prescriptive Authority * AANP Board Certified * Physician assistant(PA) 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 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, • 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., • 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. Discover Impactful Work: Conducts all clinical trials (studies) according to ICH GCP local regulations study protocol and company processes. Ensures the medical wellbeing and safety of the participants through the safe performance and execution of the studies. Maintains clinical oversight and quality on the studies registered on and delivers on study targets thereby contributing to the commercial success of the site which includes: recruitment enrolment and retention of study participants. A day in the Life: • Carries out clinical evaluation and assessment of participants to ensure eligible participants are enrolled onto studies., • Reviews enrollment progress pre-screening and screening success rates screen failure rates safety and retention of participants., • Interprets protocols and IB and participate in initiatives to strategize for patient recruitment., • Ensures and protect the welfare and safety of participants through ethical conduct; this should receive the highest priority at all times during all aspects of the study., • Fulfills and comply with all medical duties as per protocol SOP/COP and ICH GCP and local regulations., • Reports any safety threats that may impact stakeholders/participants and action complaints or QIs as per site processes., • Exercises meticulous attention to detail in recording information and source management., • Actively involved in audit preparations and site inspections., • Oversees the management of investigational medical product (IMP). Keys to Success: • A valid medical degree and registration within the country of practice, • A medical license in good standing with unrestricted ability to practice in place of work where applicable, • A valid ICH GCP certificate(can be obtained after employment), • Exceptional general medical practitioner diagnosis and treatment proficiency, • At least one-year experience working in clinical research or comparable research/clinical expertise to demonstrate the ability to work in clinical trials 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 Skills Abilities • Good understanding of medical terminology drug safety and interpretation of lab reports, • Computer proficiency and confident in using Microsoft Office and other sponsor related programs and portals, • Good administration skills and a passion for quality and detail, • Comprehensive attention to detail, • Capable of working well under pressure and meeting deadlines, • Good understanding of commercial and financial concepts and the impact thereof on the business, • Capable of consistently working well with others and assisting in other areas as needed, • Capable of learning new processes and systems quickly, • Strong cognitive skills with the ability to think read learn reason interpret and pay attention to detail in daily operations and tasks, • Capable of working independently, • Good prioritization and multitasking skills Required Experience: Staff IC Key Skills Epidemiology,Public Health,Bank Secrecy Act,Bioinformatics,Fraud,Genetics,Interviewing,Law Enforcement,Qualitative Research Interviewing,Research Experience,Next Generation Sequencing,Writing Skills Employment Type : Full-Time Experience: years Vacancy: 1