Clinical Research Associate

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MAPS Public Benefit Corporation (MAPS PBC) catalyzes healing and well-being through psychedelic drug development, therapist training programs, and sales of prescription psychedelics prioritizing public benefit above profit. Founded in 2014, MAPS PBC is a wholly-owned subsidiary of the Multidisciplinary Association for Psychedelic Studies (MAPS) a 501(c)(3) nonprofit. 

MAPS PBC is committed to the evolution of psychedelic healing modalities. We are building a diverse and inclusive workplace where we learn from each other.  We value transparency, autonomy, experimentation, and kind, direct feedback. We welcome applicants who thrive in the midst of a growing organization that values science and healing.

We believe in diversity and inclusion of people of all backgrounds, genders, races, ethnicities, sexual orientations, educational backgrounds, military and veteran status, religions, abilities, and perspectives. MAPS PBC values and seeks applicants who are people of color, queer, transgender, gender non-conforming, and gender fluid people. MAPS PBC strives to establish a supportive, equitable and accessible work environment.

Call for Candidates

MAPS PBC is seeking an enthusiastic, focused, and organized person to join our Clinical Operations Department. The CRA role will report to the Associate Director of Clinical Operations and will ensure that clinical trials are conducted in a timely manner and in accordance with Standard Operating Procedures (SOPs), the principles of ICH/Good Clinical Practice and all applicable regulations governing the conduct of clinical trials. Suitable candidates are able to work well in a fast environment and adept at organizing and managing lots of information virtually. Interested and qualified candidates are encouraged to apply online at: https://tinyurl.com/applyMPBC

Location

This is a remote position from a suitable home office with a private and quiet area to work. Secure internet and reliable phone reception are required. This position requires frequent phone and internet meetings. Certain home office expenses may be reimbursed. A work computer will be provided. Priority is placed on applicants based in the Pacific Time Zone. The MAPS PBC headquarters office is located in Santa Cruz, CA. Travel will be required.

 

Hours

Full time, 40 hours per week. Applicants must be available 40 hours a week, during normal business hours (9:00 AM – 6:00 PM Monday-Friday PST). The exact schedule may be arranged upon hire. Occasional weekend hours may be required with advance arrangement.

 

Minimum Requirements

A bio-medical related scientific degree or relevant experience with a strong interest in clinical research. Minimum of Bachelor degree preferred. A minimum of 2 years CRA site management, monitoring or other relevant experience is required as well as knowledge of U.S. regulations governing clinical trials.

 

Additional Competencies

  • Ability to work independently and within a team
  • Open and clear communicator
  • Excellent written and verbal communication skills
  • Confident and influential approach
  • Self-motivating, able to prioritize and take initiative
  • Make informed decisions based on guidance from manager and take responsibility for actions
  • Possess sound judgment, discretion and be detail orientated
  • Able to lead, motivate and understand the needs of others
  • Strong organizational skills with attention to details and timelines
  • Able to work quickly in a remote virtual setting
  • Computer skills, facility with word-processing and spreadsheet applications.
  • Coordination and planning of tasks and time management
  • Recognize potential obstacles and work within set timelines
  • Conscientious and precise delivery of work even when under pressure
  • Be proactive in problem solving
  • Ability to use the following tools with some training (previous experience a plus): Microsoft Office Applications (Word, Excel, Powerpoint, Outlook, Sharepoint), Smartsheet, Zoom and Asana.

 

General CRA Responsibilities

  • Communicate and collaborate with key players, internal and external staff.
  • Check in regularly with Department Director and complete assignments by agreed deadline.
  • Document process and provide regular updates.
  • Proactively seek methods of improvement, of individual work and project outcomes.
  • Proactively work to streamline work flows, build efficiency, security and user interface of various platforms.
  • Provide assistance, where directed by management, in tasks relating to preparation and review of protocol and protocol related documents.
  • Assist in study supply planning
  • Assist with preparation of regulatory submissions
  • Assist clinical sites with IRB/IEC submissions and ensure collection of required essential documents for study start-up and throughout conduct of study.
  • Maintain effective communication with other members of the clinical team and management.
  • Assist in identifying sites, conduct pre-study meetings and advise the team of suitability of sites.
  • Conduct study initiation, monitoring and close-out visits as specified in the monitoring plan and protocol to ensure subject safety. Prepare training material as appropriate.
  • Liaise with investigators on conducting the trial under the guidance of the clinical team.
  • Provide a report, of the status assigned studies, and make any necessary recommendations for contingency planning.
  • Ensuring each site has the trial materials and training the site staff to trial-specific industry standards.
  • Verify that data entered into the electronic CRFs is consistent with participant source documents, known as Source Document Verification (SDV) according to the monitoring plans and SOPs.
  • Regularly review study data and assist with cleaning and locking clinical trial databases.
  • Collect, manage, file and archive all study documentation and correspondence.
  • Assist the team in preparing final reports.

 

Qualifications

  • Assist with forecasting of IMP supply needs in collaboration with Senior Management and Clinical Operations
  • Assist coordinating and managing packaging/labelling requirements for US and non-US clinical trials
  • Assist with inventory management across multiple vendors and depots
  • Manage IMP shipments to domestic/international clinical sites and third-party investigators according to current processes and associated SOPs/WIs
  • Support SOP review, updates and formatting
  • Oversight and filling of all study related IMP essential documents within the respective eTMFs
  • Supports eCTD submissions to regulatory agencies using ARIM, Web Trader, Eudralink and EudraCT
  • Attendance at vendor project management calls and follow-up related to minutes, action items and decision logs, as applicable
  • Coordination of vendor documents review and approval with Senior Management and external consultants as needed
  • Assist with vendor contracts tracking and program/study budget/cost projections
  • Assist with vendor identification, SOW planning, review and development
  • Assist with creation of study specific IMP related plans, logs and processes according to established SOPs and templates
  • Assist with maintaining clinical team training documents
  • Assist in the creation of IMP related study training materials
  • Distribute IMP clinical trial related materials to sites or clinical team members as appropriate
  • Maintain effective communication with other members of the drug development and clinical teams
  • Participate in team meetings and assist in preparation, calendaring and management of meeting minutes
  • Perform administrative tasks to support the Drug Development Team members as needed

 

Specific Monitoring Responsibilities – Travel is required as needed by the study enrollment rate.

  • Ensure all personnel at study sites are appropriately informed and trained at study initiation and that training is adequately documented and maintained throughout the study through training records. This will include orientation, training and monitoring of:
    • Protocol details including any special efficiency or safety measurements
    • Source Document Verification requirements
    • Adverse Event (AE) and Serious Adverse Event (SAE) reporting
    • Case Record Form completion
    • Participant Information Sheets and Informed Consent
    • Ethics Committee requirements
    • Supplies, storage and drug accountability
    • Video equipment and handling of recordings
    • Good Clinical Practice
  • Ensure clinical trial sites are audit ready.
  • Effectively manage approximately 6 clinical trial sites.
  • Act as the main line of communication between the sponsor and the investigator. Make regular contact with investigators or site staff during the course of studies, to ensure protocols are proceeding in an appropriate manner.
  • Meticulously track study progress and offer solutions for issues that arise.
  • Escalation of site issues through the proper channels of communication.
  • Lead meetings with sites providing meeting notes and follow through on action items.
  • Verify that the investigator follows the approved protocol and all GCP procedures. Maintain familiarity of local regulatory requirements, MPBC SOPs, guidelines and ICH Good Clinical Practice.
  • Conduct routine monitoring visits with timely completion of monitoring visit reports, meeting timelines as defined in the Monitoring Plan.
  • Review and manage the enrollment process at clinical trial sites.
  • File, collate and track documentation for the Trial Master File using Montrium eTMF.
  • Review, track and resolve any data queries/protocol deviations prior to database lock.
  • Ensure AEs, SAEs, reactions, concomitant medications, and intercurrent illnesses are reported in accordance with the protocol in source, eCRFs and the SAE Database.
  • Ensure timely reporting of important AEs and SAEs.
  • Track study progress using tracking tools (deviations logs, decision logs, SmartSheet, etc.), ensuring timely and quality updates.
  • Communicate deviations from the protocol, SOPs, GCP, and the applicable regulatory requirements to management, as appropriate.
  • Ensure all unused trial supplies are accounted for.
  • Close out study centers upon completion of the trial.

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MAPS PBC is a wholly-owned subsidiary of the Multidisciplinary Association for Psychedelic Studies (MAPS). MAPS is a 501(c)(3) non-profit research and educational organization.