Study Coordinator

4 days ago


Los Angeles, United States New School Research @ California Center for Psychedelic Therapy Full time

Study Coordinator

1.0 FTE exempt position- onsite, 5 day work week (M- F), 40 hours per week

New School Research is a small independent research company conducting clinical trials with psychedelic medicines since 2017. We have completed and published the results of multiple clinical trials and have had the privilege to be leaders within medical psychedelic research.

Our vision: Our vision is to be at the forefront of research in this growing field of medicine moving into the future.

Our mission: Our mission is to contribute to the safe and effective exploration of psychedelics as tools for health through research of new promising compounds while maintaining integrity in data collection and reporting.

Our Areas of Specialization include clinical trials focused on:

MDMA-Assisted Psychotherapy for PTSD

Psilocybin Therapy for TRD

LSD for General Anxiety

As a 1 FTE study coordinator, your responsibilities and duties will include:

  • Coordinating collection, processing & reporting of data
  • Assisting Principal Investigator (PI) in judging the validity of test data obtained in regard to biomedical &/or social-behavioral research study(ies) of limited complexity involving co-investigators, multiple sites &/or sponsors
  • Strictly following Good Clinical Practices (GCP), Health InformationPortability & Accountability Act (HIPAA), & all relevant current local, state, & federal laws, regulations, guidance, policy & procedures developed by the IRB, Food & Drug Administration (FDA), Code of Federal Regulations (CFR), & the International Conference on Harmonization (ICH) in all study related activities
  • Working with Principal Investigator to refine and finalize research protocols, draft source documents, study operating procedures, and data collection tools
  • Assisting throughout IRB approval and and continuing review processes
  • Implementing study protocols
  • Performing data collection and quality control of study data
  • Performing timely data entry and query resolution
  • Overseeing participant recruitment and pre-screening processes
  • Adherence to research protocols in obtaining informed consent, blood drawing and testing, data collection and management and participant confidentiality
  • Developing and implementing methods to track and follow up with study participants
  • Ensure availability of required equipment, supplies, and study team personnel in preparation for study visits
  • Corresponding with study participants to schedule study activities and provide education on study requirements
  • Coordinating data safety monitoring and producing quarterly reports
  • Overseeing questionnaires for completeness and accuracy
  • Creating study plans and establishing and managing contracting with 3rd party study partners/vendors
  • Arranging meetings of study partners, developing meeting agendas, and facilitating meetings
  • Implementing quality control procedures
  • May identify new research opportunities and assist in the preparation of budgets for future studies
  • In collaboration with the physician and other medical personnel, documenting thoroughly on Case Report Forms (CRFs) the following: changes in patient condition, adverse events, concomitant medication use, protocol compliance, response to study drug
  • Maintaining accurate source documents related to all research procedures while adhering to Good Documentation Practices (ALCOA-C)
  • Scheduling and participating in monitoring and auditing activities
  • Notifying direct supervisor about concerns regarding data quality and study conduct.
  • Working closely with regulatory partners or directly with the Institutional Review Board (IRB) to submit Adverse Events, Serious Adverse Events, protocol deviations, and Safety Letters in accordance with local and federal guidelines
  • May perform other regulatory / Institutional Review Board duties, budgeting duties, and assisting with patient research billing and reconciliation
  • May coordinate training and education of other personnel
  • May participate in centralized activities such as auditing, Standard Operating Procedure development, etc
  • May plan and coordinate strategies for increasing patient enrollment, and/or improving clinical research efficiency
  • May identify quality and performance improvement opportunities and collaborate with staff in the development of action plans to improve quality
  • Participation in required training and education programs

Technical

  • Participation in the planning & conduct of research study including participant recruitment and retention, adherence to all research protocols
  • Obtaining and/or monitoring informed consent processes
  • Ensure proper study execution on-site, incl. ensuring that the protocol is followed and document any deviations if applicable, and that all relevant ethical and government standards, Good Clinical Practices (GCPs) or Good Laboratory Practices, and company's procedures are respected
  • Ensure the overall equipment logistics, incl. coordinating equipment preparation, shipment, installation, de-installation and handling on-site
  • Extract & analyze data from medical charts
  • Complete basic clinical procedures such as drawing blood & obtaining blood pressure.
  • On site activity is expected 4-5 days per week

Administrative

  • Provides administrative support for basic clinical and research procedures, including blood drawing and testing, data collection, data management, appointment scheduling, participant confidentiality
  • Collects, records, reviews & summarizes research data
  • Prepares reports for investigators and sponsors on recruitment status and other pertinent study data
  • Writes portions of grant applications
  • May process reimbursements for research participants per study protocol
  • Completes documents associated with current local, state, & federal regulatory guidelines, requirements, laws & research protocols

Supervisory

  • Support training of study team members on all equipment and used for the study
  • May provide work direction &/or train other research staff to interview/test participants
  • May act as a mentor in regard to education, supervision and management of junior coordinators
  • Performs other duties as assigned

Preferred Qualifications:

  • Previous experience with psychedelic clinical trials is preferred
  • Ability to make decisions independently and yet must be team oriented
  • Ability to prioritize and multitask under deadline conditions
  • Ability to solve or suggest solutions for problems in a collaborative environment
  • Successful completion of a full 4-year course of study in an accredited college or university leading to a bachelor's or higher degree in a major such as social or health science or related; OR appropriate combination of education and experience and 2 years' research study or other relevant experience required; OR
  • Successful completion of a full course of study in an accredited college or university leading to a master's or higher degree in a major such as social or health science or related; OR appropriate combination of education and experience.
  • Must complete IRB CITI training before interacting with any participants & must re-certify every 3 years.

Minimum Competencies:

  • Excellent interpersonal, verbal, and written communication skills
  • Computer proficiency, especially Microsoft Word/ Excel and Google Drive equivalents
  • Familiarity with the research process and databases
  • Must be detail-oriented and highly organized

Details:

1.0 FTE, 5 day work week onsite

40 hours per week divided into 5 shifts: typically M-F 10a to 6p, requires occasional flex time to accommodate study activities that can start earlier in the morning

2 weeks of paid vacation annually

Compensation $45,000 to $55,000FTE per year, depending on experience.

New School Research is focused on building a diverse and inclusive workforce. We believe that businesses hold the responsibility of counteracting the disproportionate marginalization of people in society, including people of color, people from working class backgrounds, women, and LGBTQIA+ people. Because we believe that these communities must be centered in the work we do, we strongly encourage applications from people with these identities or who are members of other marginalized communities.

New School Research is an Equal Opportunity Employer and considers applicants for employment without regard to race, color, religion, gender identity, sex, sexual orientation, national origin, age, disability, genetics or any other basis forbidden under federal, state, or local law.


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