Clinical Research Investigator – ASD – Greenwich CT

Kelly Science and Clinical is currently recruiting for a qualified, temporary, part-time Clinical Research Investigator in the Greenwich, CT area.
Pay: flexible based on experience – this position will be primarily remote with ability to travel as required for site visits, meetings, and other related activities/events. This position prefers EST candidates but open to CST candidates also.

Hours: Around 10+hrs/week – may increase or decrease based on business needs – flexibility may be needed for travel/meetings, etc.
Overview:

• This client is launching a multi-specialty Clinical Trials Site Network, with a primary focus on Phase 2-3 studies across a number of therapeutic areas including autism spectrum disorder (ASD), dermatology, and obesity. As expansion occurs, the client will also cover areas such as diabetes, asthma, hypertension, and neurodegenerative diseases. The focus of this client involves partnering with private physicians to serve as principal investigators on research studies, while it secures studies and provide clinical operations services to drug sponsors and contract research organizations (CROs).

Summary:

• The ASD Clinical Research Investigator will work with designated clinical practice sites as a principal investigator, co-investigator, or sub-investigator to conduct clinical research studies focused on autism spectrum disorder.
  

• The Investigator will collaborate with our Clinical Operations team on the direction and oversight of clinical research studies to ensure adherence to regulatory requirements, ethical guidelines, and study protocols to deliver high-quality research output

Responsibilities:

• Ensure that the welfare and health of all study participants are prioritized at all times during every aspect of the study.
  

• Allocate sufficient time to thoroughly examine and evaluate study participants as required by FDA regulations.
  

• Ensure timely assessments and evaluations to meet study timelines and standards. Adverse Event Reporting:
  

• Promptly inform the company of any adverse events or reactions in study participants.
  

• Collaborate with the company to perform appropriate reporting procedures and generate necessary documentation.
  

• Follow up on adverse events or reactions in accordance with sponsor and company requirements
  

• Adhere strictly to all study protocols, following Good Clinical Practice (GCP) guidelines.
  

• Implement and comply with the company’s instructions, procedures, and policies as directed.
  

• Abide by the terms and conditions of study-specific contracts with sponsors.
  

• Help ensure that records related to the studies, equipment and the study drugs.
  

• Meet with representatives from the company, sponsors, or the FDA to discuss or review studies upon reasonable notice.
  

• Permit onsite visits from company or sponsor representatives to evaluate compliance with procedures and study protocols.
  

• Cooperate with periodic study-specific evaluations of your performance conducted by the company or sponsors.
  

• Participate in company or sponsor-developed systems for data collection, monitoring, and compilation to ensure the efficient and timely delivery of quality services.

Qualifications/Education/Skills:

• MD, DO, PhD, or an equivalent advanced degree in a relevant field.
  

• Must have ASD experience, which is experience with studies around autism
  

• Must have clinical PI experience
  

• Extensive clinical research experience, including as a principal investigator or sub-investigator.
  

• Proven track record of successful study management and completion.
  

• Strong leadership and organizational skills.
  

• Excellent communication and interpersonal abilities.
  

• Proficient in data management and analysis tools.
  

• Knowledge of regulatory requirements and ethical guidelines.
  

• Certification in Good Clinical Practice (GCP).
  

• Ability to travel as required by study protocols

For more information or to be considered, please contact me directly at Tierra.Barbour@kellyscientific.com or at 804-991-0745!
 

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