Sub-Investigator

Syneos Health•Miami, FL

About The Position

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 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.

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).

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.

Benefits

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.

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