Clinical Trial Leader - Remote Position

Clinical Operations · Any City, Any State, California
Department Clinical Operations
Employment Type Full-Time
Minimum Experience Experienced

About MAPS Public Benefit Corporation (MAPS PBC)

MAPS Public Benefit Corporation (MAPS PBC) catalyzes healing and well-being through psychedelic drug development, therapist training programs, and sales of prescription psychedelics while 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) non-profit organization.

 

More information about the organization is available at https://mapspublicbenefit.com.

 

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, arrest or conviction record, 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. MAPS PBC strives to continually improve upon the supportive, equitable, and accessible work environment.

 

Why work for MAPS Public Benefit Corporation (MAPS PBC)?

MAPS PBC is a dispersed workforce that offers full-time employment in a dynamic remote work environment. This means our employees enjoy competitive salaries and benefits packages, as well as the comfort of working from their own homes. Through the conscious use of technology, we stay connected to our team members and professional community while, at the same time, enjoying the freedom of a remote environment.

 

We are committed to conscious leadership and an inclusive team dynamic. Our culture is one of mutual respect, responsibility, and trust. Our employees’ health and happiness are priorities, and we treat our staff like people, not numbers on a spreadsheet.

 

MAPS PBC is at the forefront of changing the way mental health issues are treated and is committed to bringing dignity and access to overcoming mental health challenges through the conscious use of psychedelics. We believe we are changing the world, and we want you to be a part of it.


Position Summary

To 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. The CTL is responsible for managing, implementing and maintaining oversite of clinical studies in a team setting over multiple protocols. CTL responsibilities include: managing assigned clinical study protocols from conception through database lock and clinical study reporting, mentoring CRAs/CSAs; contributing to protocol development, including amendments, task management of assigned clinical trial sites, CRAs/CSAs, communicating clinical program timelines, coordinating clinical supplies and budgets.


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.

  

Hours

Full-time, 40 hours per week. We are a West Coast-based company and applicants must be available during normal business hours (9:00 AM - 6:00 PM Pacific Time, Monday through Friday). 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’s degree preferred. A minimum 8 years CRA experience or equivalent experience. 

 

Knowledge of medical practice/techniques and terminology. Proficient knowledge of clinical research study design and process. Knowledge of U.S. regulations governing clinical trials, demonstrated ability to adhere to GCP and regulatory standards. Demonstrated experience preparing, gaining approval and managing clinical protocols.


General Responsibilities:

  • Preparation and finalization of protocol and protocol related documents. Coordinate input form the Medical Monitor and team reviewers, taking an active part in study design, internal discussion and site discussion
  • Coordinate creation of and review of ICF, CRFs, Source Records, Study Reference Manual, Quality Plans, Risk Assessment (RACT) etc. working cross functionally amongst teams to maintain consistency
  • Coordinate IMP supply planning and logistics of importing and ordering
  • Contribute to planning budgets and budget tracking
  • Ensure preparation of regulatory submissions on time in coordination with the Regulatory Department
  • Ensure and coordinate 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
  • Mentor and help manage CRAs and CSAs, providing honest and effective feedback to team members
  • Ensure SOPs and Training Plans/Quality Plans/Data Safety Monitoring Plans are adhered to, including monitoring report timelines and review
  • Provides internal and external education related to clinical trials
  • Think critically to problem solve and improve upon processes
  • Locate and assess the suitability of facilities
  • Liaise with doctors/consultants/investigators on conducting the trial, as appropriate
  • Oversee set up of the study clinics, including ensuring each clinic is prepared for success
  • Manage CRA monitoring and, if needed, monitoring of the trial throughout its duration according to the data safety monitoring plan (SQV/SIV/IMV/COV)
  • Oversee or as needed complete verification of data, plan data audits and oversee database lock activities according to SOPs
  • Provide input to Clinical Systems as requested by Clinical Systems Dept.
  • Travel as project needs require

 

Specific Responsibilities:

  • Leads activities on multiple clinical protocols and assists in managing CRAs and CSAs supporting regional monitors, Investigators and Site Staff
  • Lead team meetings with sites and MPBC as appropriate
  • Facilitates the exchange of information within the Clinical Operations Department as well as other Departments at MPBC and external groups including CRAs, Medical Monitors, Department Heads, CRA’s, Site Staff, Data Management, Finance, Logistics, Adherence Raters, Independent Raters and other collaborators
  • Provide leadership in the creation of study training or other formal training at site and at the study team level, providing ongoing training as needed
  • Attends, makes presentations and provides training in GCP/ICH/FDA/SOP at Initiation/investigators/site meetings, as appropriate
  • Create and carry out CAPAs as appropriate
  • Guide clinical trial sites in obtaining schedule I license, coordinating DEA submission process for sites, ensuring licenses are kept current
  • Coordinate with CRAs and sites through the drug storage, packaging and import logistics
  • Leads the preparation of study related documents through finalization
  • Assist with responding to regulatory or ethics committee comments to gain approval
  • Ensure successful study recruitment thought creative trouble shooting using tools at MPBC reporting back to leadership
  • Ensures the quality of study data by reviewing data listings and findings, managing data entry, ensuring MM and site review of data, completing data base lock tasks
  • Facilitates data analysis and identifies study data trends
  • Ensure data cleaning timelines are communicated to staff and sites to meet data deadlines for Annual Reports, IBs, DSMB meetings, etc.
  • Organizing audits according to SOPs and Quality Plans
  • Escalates and leads resolution of compliance issues at assigned centers
  • Assist in the review of trends in monitoring findings – taking the lead on resolution of compliance issues at study sites with CRAs
  • Ensure monitoring visits occur on time, reports are completed, reviewed, signed off and filed on time
  • Ensure protocol deviations are collected and assessed for compliance issues, providing or ensuring re-training and escalation where needed
  • Maintain oversight of eTMF
  • Maintains accurate and up-to-date information of project management and tracking systems
  • After study conclusion ensures central archiving of the Trial Master File and all study related documents according to SOPs, national law and GCP-ICH requirements
  • Assist as needed in developing timelines and action items for realization of the analysis plan and preparation of the study report
  • Participates in the management of resources, timelines, CDPs and budgets
  • Participates in the identification and selection of CROs, new hires or contractors, as needed
  • Assist in writing SOPs, policies and procedures, as needed

 

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
  • Ability to make public presentations and represent MAPS at conferences


FLSA Status

Exempt


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  • Location
    Any City, Any State, California
  • Department
    Clinical Operations
  • Employment Type
    Full-Time
  • Minimum Experience
    Experienced