Company

Headlands ResearchSee more

addressAddressOrlando, FL
type Form of workPer Diem
CategoryEducation/Training

Job description

Overview
At Headlands Research, we are building a best in class clinical trial network. We're an exceptional family of next-generation clinical trial sites, integrating cutting edge technology and high-quality support services, and significantly expanding participant engagement Founded in 2018, our company operates 15 clinical trial sites in the US and Canada with rapid plans for expansion.
The Role
We are seeking an experienced Neurologist or Psychiatrist provider to join our team on a PRN basis at our research site in Orlando, FL. We are flexible on our needs and are focused on finding the right fit.
Do you want to spend more time developing relationships with patients? Do you want to offer expansive and cutting-edge treatments to patients who might not be able to afford any treatment at all? Do you want to be at the forefront of medicine?
  • Schedule: Flexible, office hours are Mondays through Thursdays.
  • Hours: Flexible (up to 20 hours per week)
  • Team: large team of clinical research coordinators, research assistants, physicians and advanced providers, and patient recruitment specialists. Ample amount of support and excellent team culture provided.

Responsibilities
  • Possessing a thorough understanding of the requirements of each protocol
  • Determining that inclusion/exclusion criteria are applicable to the study population
  • Ensuring recruitment goals are reasonable and attainable
  • Assessing overall protocol feasibility
  • Following the trial's randomization procedures
  • Not implementing any protocol deviation or changes without agreement by the sponsor and prior review and approval by the IRB (except to eliminate immediate hazards to the subject)
  • Reviewing the inclusion /exclusion criteria, schedule of visits, end point criteria and investigational article use with the research team
  • Providing the IRB with adequate information to initially review the study (i.e., protocol, investigator's brochure, informed consent form, recruitment advertisements and any written information to be given to subject(s)
  • Providing the IRB with documents for ongoing review (i.e., amendments to the protocol, adverse events, deviations or new information)
  • Securing written IRB approval prior to initiating the study or instituting any changes to the protocol as approved
  • Providing written summaries of the trial status to the IRB annually, or as requested
  • Providing the IRB with all documents subject to their review
  • Ensuring that a qualified physician (PI or sub-investigator) is responsible for all trial-related medical decisions
  • Assessing subject compliance with the test article and follow-up visits
  • Assessing subject's response to therapy
  • Evaluating for adverse experiences
  • Ensuring that medical care is provided to a subject for any adverse event(s)
  • Informing a subject when medical care is needed to treat an intercurrent illness(es)
  • Informing the subject's primary physician about their participation in the trial
  • Reporting all serious adverse events immediately to the sponsor and IRB
  • Ensuring that the informed consent form contains all the elements required by CFG 56 and 45
  • Obtaining a signed and dated informed consent from the subject or subject's legal representative prior to initiating any study-related procedures
  • Informing the subject or legal representative about all aspects of the clinical trial
  • Providing new information about the study or rest article(s)
  • Communicating effectively with subjects, research team, IRB and sponsor
  • Meeting regularly with the research team to discuss subject participation and protocol progress
  • Ensuring that all research staff are informed about the protocol and investigational agents
  • Being knowledgeable about regulatory requirements and GCP standards
  • Preparing for and attending investigator and start-up meetings
  • Participating in monitoring visits and audits as appropriate
  • Permitting monitoring and auditing by the sponsor and appropriate regulatory authorities
  • Making available to monitors, auditors, IRB and regulatory authority(ies) all requested trail-related records
  • Ensuring that all research staff are informed about their trail-related duties and functions
  • Maintaining a list of qualified persons and their corresponding trial-related delegated duties

Qualifications
  • MD/DO required
  • Active and unencumbered license to practice within the state of FL required
  • Previous experience serving as a Principal Investigator (PI) preferred; experience serving as a Sub-Investigator required
  • Board-certified in Psychiatry or Neurology heavily preferred
Refer code: 7111152. Headlands Research - The previous day - 2023-12-16 11:29

Headlands Research

Orlando, FL
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