Clinical Research Physician (Sub-Investigator)

Lexington, United States
14 Aug 2019
13 Sep 2019
Part Time
Contract Type
Experience Level
Experienced (non-manager)
Job Summary

We are seeking a Sub-Investigator toassist with research functions atourLexington, KY site.

Sub-The Investigator will have responsibilities for the conduct of studies at the site in compliance with the standards and regulations of the United States Food and Drug Administration and other relevant governmental agencies. The Sub-Investigator assists the Site Director in the on-going profitability and efficient operation of the site. In addition to administrative duties, the Sub-Investigator acts as the co-investigator on selected new and on-going studies conducted at the siteand will devote such time and effort as are required to fulfill his/her duties with respect to such studies.

Role Responsibility

  • Assist in managing the activities and performance of the clinical staff affiliated with the site.
  • Assist in managing the implementation of and ensuring adherence to policies, documents and procedures.
  • Serve as the co-investigator or sub-investigator, as determined by each study protocol.
  • Read GCP guidelines and be familiar with them, and comply with the terms of FDA Forms
  • 1572, applicable requirements of the US Investigational New Drug regulations (Title 21, Part
  • 312 et seq.), the Code of Federal Regulations (Title 21, Parts 50 and 56), the provisions of the Generic Drug Enforcement Act of 1992, and any successor laws or regulations.
  • Comply with all applicable legal and regulatory requirements of any federal, state or local agency, department, commission, association or other governing or advisory body having authority to set standards governing the practice of medicine, the operation or use of any services or facilities which may be subject to such regulation, and the conduct of clinical research.
  • Read the study protocol and the Investigator Brochure for each study, and follow all study protocols using GCP guidelines.
  • Abide by the terms and conditions of any study-specific contracts with sponsors, or with the terms of any other service contracts which affect, directly or indirectly, the conduct of a study.
  • Observe and inform any adverse events or reactions in study participants.
  • Cooperate with sponsor-developed system of data collection, monitoring, and compilation to promote the efficient and timely delivery of quality services to sponsors.
  • Ensure that the welfare and/or health of all study participants receive the highest priority at all times during any aspect of any study.
  • Attend investigator meetings as necessary for study participation.
  • Maintain strict confidentiality of patients, employees and company information at all times and adheres to HIPAA Guidelines;
  • Review of laboratory data and adverse events
  • Provide patient education regarding disease process and involve patient and family in
  • decision-making processes;
  • Perform other duties as are assigned.

Ideal Candidate

  • A Medical degree (MD or DO) and a minimum of 2years' of experience as a licensed physician is required.Current license (in good standing) in to practice as a physician in the state of Kentucky and prescriptive authorityis required. Unrestricted ability to participate in federal programs. Previous clinical research experience is preferred.
  • High degree of clinical experience, skill and assessment to ensure subject safety;
  • Exceptional diagnosis and treatment proficiency;
  • Adequate understanding and ability to comply with GCP/ICH and the applicable federal regulations;
  • Proficiency with Microsoft Office (Outlook, Word) andWeb applications;
  • Exceptional organizational skills, attention to detail and follow through
  • Excellent verbal and written communication skills;
  • Well-developed interpersonal skills and the ability to work well independently as well as with co-workers, peers, supervisors and external customers;
  • Ability to effectively and efficiently handle multiple tasks simultaneously with precision and adapt to changes in responsibilities and workloads;
  • Must be professional, possess a high degree of urgency and self-motivation, and have a strong work ethic;
  • Must possess a high degree of integrity and ability to maintain confidentiality with HIPAAguidelines, patient matters and other sensitive information.

Package Description

We offera comprehensive benefits package that includes medical, dental, and vision insurance offerings, life and disability insurance offerings, 401K, paid time off, and various other benefits and discount programs!

We are an Affirmative Action and Equal Opportunity Employer.

About Synexus

Accelerated Enrollment Solutions (AES) is a business unit of PPD that offers both sponsors and contract research organizations best-in-class site and enrollment solutions, with tiered offerings combining the expertise, as needed, of industry leaders PPD, Synexus, Acurian and Optimal Research.

The array of AES services include strategic enrollment solutions that offer speed, certainty and commercial value to our clients. Acurian and Synexus have proven track records for enrolling patients and study conduct through proprietary, direct-to-patient recruitment methodologies and a global site network. When combined, these services provide a new standard of clinical trial productivity that delivers more patients from fewer sites in less time.