Elixia · 1 month ago
Part Time Psychiatric Clinical Research Sub-Investigator
Houston, TX, US
Full-time, Part-time
Onsite
Mid Level
3+ years expElixia is a company specializing in clinical research, and they are seeking a Part Time Psychiatric Clinical Research Sub-Investigator to support the Principal Investigator in conducting clinical trials. This role involves various responsibilities including attending training, performing study tasks, and evaluating patient eligibility for clinical trials.
EducationHealth CareHospitalTraining
Responsibilities
Attends Site Initiation Visits and/or training in-service for all current protocols
Completes required SOP training
Performs study tasks delegated by the Principal Investigator (PI) with full involvement and oversight in accordance with protocol and regulatory requirements
Provides guidance to the clinical team as needed
Assists in the training of support staff for the clinical trials under supervision
Assists in recruitment for clinical trials; refer to other site trials
Sets schedule to accommodate patients onsite and/or offsite as necessary. This may include weekends and holidays
Conducts proper informed consent process according to SOPs, ensuring the most current ICF version is used
Evaluates the eligibility of patients for inclusion into clinical trials
Collects medical and surgical history, concomitant medication use, and adverse event information
Documents source documents, inpatient activities, visit progress notes, and adverse events. Maintains accurate records throughout the study
Reviews lab results, provides clinical significance for any out-of-range or abnormal values, and signs off as appropriate
Evaluates appropriateness of patient inclusion into trials; order repeat labs if necessary, or screen-fail patients as needed. Counsels’ patients on seeking appropriate medical care when necessary
Reinforces study restrictions, diets, and study guidelines
Reviews and provides insight into impending CRFs, electronic CRFs, data clarification forms, and/or data queries
Reviews source documents, lab results, and procedures throughout the study
Assesses adverse events and drug reactions, thoroughly recording details, including the relationship to the study drug
Assists in reporting any serious adverse events (SAEs) to the PI
Participates in monthly staff meetings
Reads and understands the information in the Investigator's Brochure (IB), including the potential risks and side effects of the drug
Performs Clinical Research Coordinator duties
Occasional travel to Company sites, Investigator meetings, and/or Company meetings
Performs other miscellaneous job-related duties as assigned by your manager
Qualification
Required
Medical Degree (MD, DO)
Active US Medical License
In-depth knowledge of federal regulations regarding responsibilities of a Primary or Sub-Investigator
Demonstrated experience in conducting and scoring psychiatric rating scales and psychometric assessments
Proficiency in administering and interpreting clinical scales
Experience with a range of psychiatric disorders
Experience in clinical research or clinical trials required
Excellent communication skills
Problem-solving skills
Planning/organizational skills
Customer service skills
Attention to detail and ability to follow clinical research protocols
Ability to work collaboratively with a multidisciplinary research team
Strong analytical and critical thinking skills
Adaptability to a fast-paced research environment
In depth knowledge of FDA-GCP regulations pertaining to protecting human rights and safety, ethical issues and clinical assessments when dealing with clinical research and human volunteers
Preferred
Minimum of 3 years' experience in clinical research
Company
Elixia
Elixia conducts MDD clinical research and guides participants through eligibility screening, scheduling, and study visits.
Founded in 2022Chapel Hill, North Carolina, USA
51-200 employees
Funding
Current Stage
Growth StageLeadership Team
Sarah Petrucci
Chief Financial Officer
Recent News
2024-05-08
Company data provided by crunchbase