PPD Clinical Research Principal Investigator - Licensed MD in Denver, Colorado

We are seeking a Principal Investigator to oversee and assist with research functions in Denver, CO.

The Physician functions as Principal Investigator (PI) on clinical trials, performing tasks such as physical and medical history assessment, rating scales, and the overall medical management of subjects on a trial. Additionally, this role seeks to improve the sites operations by providing management with support in change management and process improvement. The Principal Investigator must also be able to perform clinical tasks and will participate at Pre-study visits, Site Initiation visits and other customer facing meetings.

  1. Ensure and protect the patient’s welfare and rights as a research subject;

  2. Maintain strict confidentiality of patients, employees and company information at all times and adheres to HIPAA Guidelines;

  3. Be thoroughly familiar with the protocol, case report form, informed consent, source documentation, patient diary (when applicable), and study medication(s) for the assigned research study;

  4. Adhere to GCP, ICH, HIPAA, NIH, FDA Regulations and SOPs and maintain ongoing regulatory documents;

  5. Establish rapport with sponsor representatives and maintain frequent face-to-face, written and telephone contact with various persons involved in the study, including but not limited to the patients, relatives/friends of the patients, doctors, pharmaceutical sponsors and all levels of the company;

  6. Serve as Principal Investigator for a number of clinical trials;

  7. Assist and participate in study recruitment to ensure enrollment goals are met or exceeded;

  8. Direct and guide Research Staff on study specific tasks;

  9. Utilizes and ensures the appropriate equipment is on-site for Universal Precautions for themselves and others in and around areas that may contain potential biohazards;

  10. Perform appropriate research protocol procedures which may include, but are not limited to: physical exams, medical history review and assessment, assessment of; vital signs, laboratory results and adverse events;

  11. Work with the Site Director and Sub Investigator(s) to maintain high quality and patient safety;

  12. May dispense investigational product and instruct subjects on usage and potential drug interactions;

  13. Practical knowledge of document processes and reporting of SAEs, 1572s, CRFs, ICFs, etc.;

  14. Prepare presentations to schedule training for physicians, nurses and staff on research protocol;

  15. Provide patient education regarding disease process and involve patient and family in decision-making processes;

  16. Maintain accountability of own ongoing professional growth and development;

  17. Perform necessary functions as approved by the organization, for the conduct of clinical research;

  18. Attend investigator meetings; and

  19. May perform other duties not specifically listed in this job description.

  • A Medical degree (MD or DO) and a minimum of 1 year of experience as a licensed physician is required. Current license (in good standing) to practice as a physician in the state of practice and prescriptive authority, including a DEA registration, is 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) and Web 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 HIPAA guidelines, patient matters and other sensitive information.

Synexus is an Affirmative Action and Equal Opportunity Employer.

Synexus is an Affirmative Action and Equal Opportunity Employer.

Salary Competitive Pay

Job Reference synexus/TP/13884/1343

Job Category Operations - Clinical

Closing Date 2019-01-30

Business Unit Synexus US

Location Denver, CO, United States