Sub-Investigator

About Syneos Health

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 we do. We continuously look for ways to simplify and streamline our work to make Syneos Health easier to collaborate with and easier to work for.

• 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 and where we take care of our people.
• We continuously build a company that all of us want to work for and our customers want to work with by fostering diversity of thoughts, backgrounds, cultures, and perspectives so everyone feels they belong.

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.

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 volunteers who meet study eligibility criteria and are enrolled in the trial.

• 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 effectively perform the duties and tasks outlined in the study protocol.
• Assist in recruitment of appropriate participant populations with adherence to Good Clinical Practice (GCP) guidelines.
• Assist in explaining, reviewing, and obtaining signed and dated currently approved informed consent forms.
• Review screening documents and perform screening procedures according to study protocol.
• Evaluate and determine volunteer eligibility based on inclusion/exclusion criteria as outlined in the protocol.
• Upon participant enrollment, perform all clinical exams and evaluate laboratory work, ECGs and other study data.
• Communicate with laboratory, P.I., and sponsor regarding laboratory findings.
• Monitor study participant status daily according to protocol guidelines.
• Document and review adverse event (AE) information and assist the P.I. in determining the relationship/severity of the study drug(s) to the AEs; follow up to determine resolution specifics.
• In case of serious adverse events (SAE), contact the P.I. and manage emergency situations.
• Capture and record AE data, 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 devise alternative solutions to address business and operational challenges.

• Medical Doctor (MD), Doctor of Osteopathic Medicine (DO), Nurse Practitioner (NP), or Physician Assistant (PA) from an accredited school.
• Must have and maintain appropriate licenses/permits.
• 2-5 years of applicable work experience in clinical research.
• Good computer skills, especially Microsoft Word and Excel.
• Extensive knowledge of GCP/ICH or GLP/EMA guidelines and other applicable regulatory requirements.
• Excellent communication, presentation, interpersonal skills, both written and spoken, with the ability to inform, influence, convince, and persuade.
• Ability to travel as necessary (approximately 10%).
• Bilingual in English and Spanish.

• Company car or car allowance.
• Health benefits including medical, dental, and vision.
• Company match 401(k).
• Eligibility to participate in Employee Stock Purchase Plan.
• Eligibility to earn commissions/bonus based on company and individual performance.
• Flexible paid time off (PTO) and sick time, with eligibility varying by state and municipality.

$67,700.00 - $

Mid-Senior level

Full-time

Other, Information Technology, and Management

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