Site Medical Director
Location: Phoenix, AZ
Reports to: Dr. Suzanne Sisley, Site Principal Investigator
Employment Dates: Immediate. Study is expected to last until Spring 2019.Hours: 0.50 FTE
Under the direction of the Site Principal Investigator, the Site Medical Director will provide ongoing study oversight for a clinical trial investigating the use of marijuana for treatment of PTSD symptoms in military veterans. The Site Medical Director will assist in the conduct of the clinical trial, scheduling of study staff personnel, and representing the Scottsdale Research Institute to trial participants, the community and other external parties as required. The Site Medical Director will provide leadership for the clinical staff, guide problem solving for clinical trial operations, and add clinical insight to strategic vision/activities. This position will specifically coordinate the medical care of study participants and provide medical supervision for study participants.
- Become acquainted with MPBC’s standard clinical trial procedures and timelines.
- Perform medical eligibility assessments for potential study participants, including conducting physical exams and reviewing inclusion and exclusion criteria.
- Review, assess and maintain safety data for clinical trial, including serious adverse event reporting.
- Provide medical oversight for acute self-administration of marijuana in the laboratory.
- Maintain familiarity with study protocol and clinical trial design.
- Oversee all procedures, protocols and standards regarding the efficiency and quality of care delivered to study participants at Scottsdale Research Institute.
- Exercise professional and administrative supervision of the Scottsdale Research Institute study team.
- Able to lead, motivate and understand the needs of others.
- Responsible for verification that the rights and well-being of human subjects are protected and that the reported trial data are accurate, complete, and verifiable from source documents, and that the conduct of the trial is in compliance with the currently approved protocol/amendment(s).
- Assure the integrity and quality of data.
- Serve as a mentor and role model for study staff.
- Possess sound judgment, providing appropriate escalation of site issues.
- Participate in ongoing recruitment, evaluation, and retention of a study participants.
- Maintain compliance standards in accordance with ICH/GCP and all applicable regulations governing the conduct of clinical trials.
- Foster a positive image and an excellent reputation for Scottsdale Research Institute and the study program.
- Conduct and attend study staff meetings.
- As part of the management team, meet frequently with the Site Principal Investigator, Study Coordinator and Research Assistant regarding study issues.
- Respond to requests and questions for medical information.
- Provide medical consultation on medical issues as requested by the Site Principal Investigator.
- Willingness to work in-person on site.
- Other duties as assigned within scope of job.
- Perform aspects of clinical study visits associated with subject participation including consent process, screening, enrollment and physical exams, study visits.
- Perform phlebotomy.
- Willingness to work with a flexible schedule to meet the needs of study participant scheduling.
- Medical Degree or Advanced Practice Nursing License with appropriate licensure to practice in Arizona Experience:
- Research experience required, clinical research experience highly preferred
- Knowledge of ICH/GCP guidelines and FDA CFR regulations as they apply to clinical research.
- Skills/Job Requirement:
- Strong organizational and time management skills
- Proven computer and database management skills
- Cultural sensitivity
- Leadership and organizational skills essential
- Excellent interpersonal and communication skills
- Public health or delivery of care to medically underserved populations desired
This clinical investigation is sponsored by the Multidisciplinary Association for Psychedelic Studies (MAPS). Investigators are conducting a triple-blind, placebo-controlled study investigating the use of marijuana in treating the symptoms of Posttraumatic Stress Disorder (PTSD) in military veterans. Marijuana is a Schedule I controlled substance. This study is funded by the Colorado Department of Public Health and Environment and MAPS, a non-profit research and educational organization and is being conducted as a pharmaceutical trial under the jurisdiction of the U.S. Food and Drug Administration (FDA). MAPS' mission is 1) to treat conditions for which traditional medicines provide limited relief—such as posttraumatic stress disorder (PTSD), pain, drug dependence, and anxiety and depression associated with end-of-life issues—by developing psychedelics and marijuana into prescription medicines; 2) to cure people by building a network of clinics where treatments can be provided; and 3) to educate the public honestly about the risks and benefits of these substances.
Clinical Research Associate - Site Monitor
We are seeking a Clinical Research Associate/Site Monitor to support the MAPS Public Benefit Corp (MPBC) and work from our office in Santa Cruz, CA or from home in the greater Bay Area.
CRA Level: I and II
Hours: 40 per week
Exemption status: Exempt
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 CRA is responsible for managing, implementing and monitoring clinical studies in a team setting. The CRA has the responsibility to verify that the rights and well-being of human subjects are protected and that the reported trial data are accurate, complete, and verifiable from source documents, and that the conduct of the trial is in compliance with the currently approved protocol/amendment(s). CRA Monitor responsibilities include: manage assigned clinical study protocols and amendments; track deviations; manage clinical trial sites and assure timely initiation and completion of clinical studies. The focus of the CRA monitor role is acting as the point of contact for assigned clinical site(s) and monitoring the assigned site(s) under direction of the Clinical Operations Manager.
A bio-medical related scientific degree or relevant experience with a strong interest in clinical research. Minimum of Bachelor degree preferred. The CRA monitor role applies to both level I and II CRAs, the amount of experience and years of experience will determine the amount of responsibility and the CRA level. A minimum of 2 years CRA experience (CRA I) or 1 years CRA experience (CRA II). Knowledge of medical practice/techniques and terminology. Knowledge of U.S. regulations governing clinical trials.
- 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
Description of Responsibilities: General CRA I-II Responsibilities
- Provide assistance, where directed by the Clinical Operations Manager, in tasks relating to preparation and review of protocol and protocol related documents
- Assist in design of ICFs, CRFs, Source Records
- Assist in study supply planning
- Assist in tracking budgets
- 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, as required, of the status assigned studies, and make any necessary recommendations for contingency planning.
- Ensuring each centre 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).
- Review study data and assist with cleaning and locking clinical trial databases.
- Archive study documentation and correspondence.
- Assist the team in preparing final reports.
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 it is adequately maintained throughout the study. 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
- Patient Information Sheets and Informed Consent
- Ethical Committee requirements
- Supplies, storage and drug accountability
- Video equipment and handling of recordings
- Good Clinical Practice
- 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.
- Lead meetings with sites as needed 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, MAPS SOPs, guidelines and ICH Good Clinical Practice.
- Verify that source data and other trial records are accurate, complete, and maintained.
- Collect completed CRFs, track them and deliver them to the Sponsor.
- Write visit reports.
- File, collate and track documentation for the Trial Master File.
- Review, track and resolve any data queries/protocol deviations prior to database lock.
- Ensure AEs, SAEs, reactions, concomitant medications, and inter current illnesses are reported in accordance with the protocol on the CRFs and the SAE Database.
- Ensure timely reporting of important AEs and SAEs
- Track study progress using tracking tools, ensuring timely and quality updates.
- Communicate deviations from the protocol, SOPs, GCP, and the applicable regulatory requirements.
- Ensure all unused trial supplies are accounted for.
- Close down study centers on completion of the trial.
The Clinical Intern will assist the clinical research group with general administrative duties necessary to execute clinical research trials. The intern's responsibilities will include, but are not limited to, filing, document tracking, file migration, document development, and IT Support duties. The Clinical Intern will have the opportunity to learn about Good Clinical Practices (GCP) and standard clinical trial procedures and timelines. This position will offer the chosen applicant a chance to learn a wide array of clinical research terminology and use a variety of different systems.
Salary Range: TBD
Hours: 20 hours per week between 9:00AM-5:00PM PST
Location: Santa Cruz, CA
- Become acquainted with MPBC’s standard clinical trial procedures and timelines.
- Become acquainted with MPBC’s ongoing clinical studies.
- Assist in maintenance and integration of Montrium electronic trial master file (eTMF) system.
- Scan, file, and retrieve relevant clinical study documentation.
- Assist with ongoing clinical systems maintenance and projects.
- Order, package, and ship study materials to various study sites.
- Help track regulatory submissions and maintain regulatory correspondence with the FDA.
- Assist in study document drafting and tracking for various ongoing clinical studies.
- Provide general assistance to members of the clinical group.
- Provide internal and external IT support on projects, tasks, and support requests.
- Comfortable using PC and Mac platforms.
- Experience using Microsoft Office Applications (Word, Excel, Outlook).
- Previous or current college/research experience in a related biological, life, or social science is strongly preferred.
- Able to navigate through folder structures and files.
- Excellent communication skills (spoken and written) and the ability to ask coherent questions.
- Interest in clinical, psychedelic, trauma, and/or harm reduction research.
- Ability to multi-task and thrive in a fast-paced environment.
- Have excellent attention to detail and problem-solving skills.
- Willingness to dedicate time during regular business hours (9:00 AM - 5:00 PM PST), Monday through Friday, at the MAPS office in Santa Cruz, CA.
- May require carrying packages, up to 30 pounds, up and down stairs.
- Will require traveling up one set of stairs.
- The Clinical Intern will mainly be reporting to the Clinical Operations Manager.