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Sub-InvestigatorSyneos Health/ inVentiv Health Commercial LLC • Miami, FL, United States
Sub-Investigator

Sub-Investigator

Syneos Health / inVentiv Health Commercial LLC • Miami, FL, United States
18 hours ago
Job type
  • Full-time
Job description

Sub-Investigator

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.

Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.

Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.

Discover what our 29,000 employees, across 110 countries already know :

WORK HERE MATTERS EVERYWHERE

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

  • 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 Summary :

    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.

    Job Responsibilities :

  • Acquire and maintain an in-depth knowledge of the study protocol and study documents.
  • Responsible for clinical conduct and assessment during the clinical trial.
  • Maintain knowledge of clinical techniques and procedures and ability to effectively perform the duties and tasks outlined in the study protocol.
  • Assist in recruitment of appropriate participant populations with adherence to the guidelines of Good Clinical Practices (GCP).
  • Assist, as necessary, in explaining, reviewing and obtaining a signed and dated currently approved informed consent forms.
  • Review Screening documents and Perform screening procedures according to study protocol.
  • Evaluate / Determine volunteer eligibility based on inclusion / exclusion criteria as outlined in the protocol.
  • Upon participant enrollment into the study, perform all clinical exams and evaluate all laboratory work, ECGs and other study data.
  • Communicate with laboratory, Pl and sponsor, as needed - regarding laboratory findings.
  • Responsible for close daily monitoring of study participant' status according to protocol guidelines.
  • Document and review adverse event (AE) information and assist PI in making a determination regarding the relationship / severity of the study drug(s) to the AEs. Maintain follow-up of the AE to determine resolution specifics.
  • 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 required.
  • Supervise, coach, and mentor staff.
  • Set priorities and schedule activities of departmental resources, implement company objectives, and create alternative solutions to address business and operational challenges.
  • Qualifications - External

    What we're looking for

    Qualifications Requirements :

  • 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).
  • 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.

    Salary Range :

    $67,700.00 - $115,100.00

    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.

    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.

    No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.

    http : / / www.syneoshealth.com

    Additional Information

    Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and / or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills / experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

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    Subinvestigator • Miami, FL, United States

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