Sub-Investigator
Listed on 2025-12-07
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Science
Clinical Research
Sub-Investigator
Syneos Health is a leading biopharmaceutical solutions organization. The Sub-Investigator assists the Medical Director by managing the day‑to‑day responsibilities for clinical conduct and assessment of the clinical trial, and provides treatment and care to all volunteers who meet study eligibility criteria and are enrolled in the trial.
Job SummaryThe Sub-Investigator will support the principal investigator and study team in ensuring compliance with the study protocol and regulatory requirements, maintain participant safety, and facilitate the successful completion of the clinical trial.
Job Responsibilities- Acquire and maintain an in‑depth knowledge of the study protocol and related documents.
- Interpret and apply clinical techniques and procedures, performing duties outlined in the protocol.
- Assist the recruitment of appropriate participant populations, adhering to Good Clinical Practice (GCP) guidelines.
- Explain, review, and obtain signed, dated, and currently approved informed consent forms.
- Perform screening procedures and review screening documents according to protocol.
- Determine volunteer eligibility based on inclusion and exclusion criteria.
- Conduct all clinical examinations and evaluate laboratory work, ECGs, and other study data upon participant enrollment.
- Communicate laboratory findings with the laboratory, sponsor and other stakeholders as needed.
- Monitor study participant status daily according to protocol guidelines.
- Document and review adverse event (AE) information, assisting the PI in assessing relatedness and severity; follow up AE to determine resolution.
- In the event of serious adverse events (SAE), contact the PI and manage emergency situations.
- Capture and record AE data, and prepare AE reports for regulatory agencies.
- Perform other duties as required by the PI/Study Director.
- Supervise, coach, and mentor staff members.
- Set priorities, schedule departmental activities, implement company objectives, and develop alternative solutions to business and operational challenges.
- Medical Doctor (MD), Doctor of Osteopathic Medicine (DO), Nurse Practitioner (NP), or Physician Assistant (PA) from an accredited school.
- Must hold and maintain appropriate licenses/permits.
- 2‑5 years of applicable work experience in clinical research.
- Strong computer skills, particularly Microsoft Word and Excel.
- Extensive knowledge of GCP/ICH, GLP/EMA guidelines and other relevant regulations.
- Excellent communication, presentation, and interpersonal skills, both written and spoken.
- Ability to travel as necessary (approximately 10%).
- Bilingual in English and Spanish preferred.
$67,700.00 – $ (Actual salary will vary based on qualifications, experience, and other factors).
BenefitsCompany car or car allowance, health benefits (medical, dental, vision), 401(k) match, Employee Stock Purchase Plan eligibility, performance‑based commissions/bonuses, flexible paid time off (PTO) and sick time.
Additional InformationTasks, duties, and responsibilities in this job description are not exhaustive. The Company may assign other tasks or duties at its discretion. Equivalent experience, skills, and/or education may be considered. The Company is committed to compliance with the Americans with Disabilities Act and the EU Equality Directive, and provides reasonable accommodations when appropriate. No prior notice is required for changes in duties or compensation.
The Company complies with all applicable federal, state, and municipal paid sick time requirements. The Company holds no intent to create an employment contract.
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