Sub-Investigator
- Employer
- Syneos Health - USA
- Location
- Miami, Florida, United States
- Salary
- Competitive
- Start date
- 28 May 2023
- Closing date
- 30 May 2023
View more
- Discipline
- R & D
- Hours
- Full Time
- Contract Type
- Permanent
- Experience Level
- Experienced (non-manager)
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Job Details
Description
Why Syneos Health
Job Responsibilities
The Sub-Investigator assists the Medical Director by managing the day-to-day responsibilities for clinical conduct and assessments of the clinical trial and provides treatment and care to all volunteers who meet study eligibility criteria and are enrolled in the clinical trial.
• Acquire and maintain an in-depth knowledge of the study protocol.
• Responsible for clinical conduct and assessment of the clinical trial.
• Maintain knowledge of clinical techniques and procedures and the ability to effectively perform the duties and tasks outlined in the study protocol.
• Assist in recruitment of appropriate volunteer populations for research studies with adherence to the guidelines of Good Clinical Practices (GCP) at all times.
• Assist as necessary in obtaining a signed and dated informed consent forms.
• Perform screening procedures according to study protocol.
• Determine volunteer eligibility based on inclusion / exclusion MAJOR criteria as outlined in the protocol.
• Upon volunteer enrollment into the study, perform all clinical exams and evaluate all laboratory work, ECGs and other study data.
• Communicate with laboratory, PI and sponsor, regarding laboratory findings.
• Responsible for close of daily monitoring of study volunteer status according to protocol guidelines.
• Review adverse event (AE) information and assist PI in making a determination regarding the relationship of the study drug to the AEs. Maintain follow-up to determine resolution of AE.
• In case of serious adverse events (SAE), responsible for contacting PI and managing emergency situations.
• Capture and record AE data and prepare AE reports for oversight agencies.
Perform other duties as assigned.
What we’re looking for
Medical Doctor (MD), Doctor of Osteopathic Medicine (DO), Nurse Practitioner (NP), or Physician Assistant (PA) from an Accredited School.
• Must have and maintain appropriate Licensures/Permits
• 2-5 years of applicable work experience in clinical research
• Must demonstrate good computer skills especially in the utilization of Microsoft Word and Excel
• Extensive knowledge of GCP/ICH or GLP/EMA guidelines and other applicable
• regulatory requirement
• Excellent communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince, and persuade
• Ability to travel as necessary (approximately 10%)
• Bilingual (English and Spanish)
Qualifications
Get to know Syneos Health
Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.
At Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements.
The annual base salary for this position ranges from $72,540 to $145,000. The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate’s qualifications, skills, competencies, and proficiency for the role.
Syneos Health has a voluntary COVID-19 vaccination policy. We strongly encourage all employees to be fully vaccinated. Additionally, certain local governments or Syneos Health customers may have vaccine requirements that apply to some of our employees. These employees are required to submit proof of vaccination to Syneos Health and maintain compliance with these requirements.
Why Syneos Health
- We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
- We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
- We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we’re able to create a place where everyone feels like they belong.
Job Responsibilities
The Sub-Investigator assists the Medical Director by managing the day-to-day responsibilities for clinical conduct and assessments of the clinical trial and provides treatment and care to all volunteers who meet study eligibility criteria and are enrolled in the clinical trial.
• Acquire and maintain an in-depth knowledge of the study protocol.
• Responsible for clinical conduct and assessment of the clinical trial.
• Maintain knowledge of clinical techniques and procedures and the ability to effectively perform the duties and tasks outlined in the study protocol.
• Assist in recruitment of appropriate volunteer populations for research studies with adherence to the guidelines of Good Clinical Practices (GCP) at all times.
• Assist as necessary in obtaining a signed and dated informed consent forms.
• Perform screening procedures according to study protocol.
• Determine volunteer eligibility based on inclusion / exclusion MAJOR criteria as outlined in the protocol.
• Upon volunteer enrollment into the study, perform all clinical exams and evaluate all laboratory work, ECGs and other study data.
• Communicate with laboratory, PI and sponsor, regarding laboratory findings.
• Responsible for close of daily monitoring of study volunteer status according to protocol guidelines.
• Review adverse event (AE) information and assist PI in making a determination regarding the relationship of the study drug to the AEs. Maintain follow-up to determine resolution of AE.
• In case of serious adverse events (SAE), responsible for contacting PI and managing emergency situations.
• Capture and record AE data and prepare AE reports for oversight agencies.
Perform other duties as assigned.
What we’re looking for
Medical Doctor (MD), Doctor of Osteopathic Medicine (DO), Nurse Practitioner (NP), or Physician Assistant (PA) from an Accredited School.
• Must have and maintain appropriate Licensures/Permits
• 2-5 years of applicable work experience in clinical research
• Must demonstrate good computer skills especially in the utilization of Microsoft Word and Excel
• Extensive knowledge of GCP/ICH or GLP/EMA guidelines and other applicable
• regulatory requirement
• Excellent communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince, and persuade
• Ability to travel as necessary (approximately 10%)
• Bilingual (English and Spanish)
Qualifications
Get to know Syneos Health
Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.
At Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements.
The annual base salary for this position ranges from $72,540 to $145,000. The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate’s qualifications, skills, competencies, and proficiency for the role.
Syneos Health has a voluntary COVID-19 vaccination policy. We strongly encourage all employees to be fully vaccinated. Additionally, certain local governments or Syneos Health customers may have vaccine requirements that apply to some of our employees. These employees are required to submit proof of vaccination to Syneos Health and maintain compliance with these requirements.
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