MAPS/MPBC advances equity and inclusion in the workplace by providing equal employment opportunity to support a work environment free from discrimination on the basis of race, religious creed, color, national origin, ancestry, physical disability, mental disability, medical condition, genetic information, marital status, sex, gender, gender identity, gender expression, age, sexual orientation, military and veteran status, arrest or conviction record, and any other basis prohibited by law. The organization also provides reasonable accommodations for qualified applicants and employees with disabilities. This equal employment opportunity policy applies to all aspects of employment, including recruitment, selection, advancement, training, problem resolution, and separation from employment. Through this policy, MAPS/MPBC strives to establish and maintain an equitable and accessible work environment that is supportive and free from discrimination.

Clinical Research Associate

Location: Remote

Hours: Full-time, 40 hours per week

Exemption Status: Exempt

Position Duties:

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 Associate Director of Clinical Operations Manager.

Minimum Requirements:

A bio-medical related scientific degree or relevant experience with a strong interest in clinical research. Minimum of Bachelor degree preferred. The amount of experience and years of experience will determine the amount of responsibility of the CRA. A minimum of 1 years CRA experience or 2 years CRA experience is required. Knowledge of medical practice/techniques and terminology. Knowledge of U.S. regulations governing clinical trials.

Additional Competencies:

  • Interest in gaining experience working on a FDA approved clinical trial following ICH/GCP standards.
  • 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 General CRA Responsibilities:

  • Provide assistance, where directed by management, in tasks relating to preparation and review of protocol and protocol related documents. 
  • Assist in design of Protocols, ICFs, CRFs, Source Records  
  • 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, 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).  
  • Regularly 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 
    • Participant 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, MPBC SOPs, guidelines and ICH Good Clinical Practice.
  • Write visit reports, meeting timelines outlined in the Monitoring Plan.
  • 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 upon completion of the trial

Application Instructions

If you are interested and qualified for this position, please email This email address is being protected from spambots. You need JavaScript enabled to view it.. Include your resume or CV as an attachment. Include a cover letter or a statement of interest in the body of your email. Applications will be reviewed on a rolling basis.

Clinical Data Specialist (CDS)

Location: Remote

Hours: Full-time, 40 hours per week

Exemption Status: Non-Exempt

Salary Range: Upon Request

Position Duties:

Reporting directly to the Clinical Data Manager and indirectly to the Clinical Systems and Quality Manager, the Clinical Data Specialist (CDS) will participate in all phases of data acquisition, data cleaning and analysis working with an electronic data capture (EDC) system. The CDS should possess familiarity in working with electronic filing systems, preferably in a clinical trial setting, experience with Clinical Trial Management Systems (CTMS) configurations and reports is desirable The CDS will assist in tasks including designing, implementing, testing, maintaining, and supporting the processes to maintain, develop, and test EDC, eTMF, CTMS, and other Informatics Systems supporting clinical trials. The individual must have the ability to exercise good judgment in a variety of situations, with strong written and verbal communication, organizational skills, and the ability to maintain a realistic balance among multiple priorities. The CDS must be creative and enjoy working within a small, entrepreneurial environment that is mission-driven, results-driven and research-oriented.

Requirements:

Experience with quantitative research methodology and a Bachelor’s degree with a major in a quantitative or scientific field is required.

A Master’s degree is preferred. At least two years of relevant experience in one or more database technologies and cloud-based methodologies is preferred. The ideal candidate will possess technical proficiency in working with regional databases, understanding a variety of programming and coding languages, and working with reporting/query tools. The candidate should be willing to stay abreast of the development in the area of professional competence, the ability to understand requirements in whole and in detail and the ability to utilize technical problem-solving skills to investigate, debug, and effectively report issues.

Additional Competencies:

  • Interest in gaining experience working on a FDA approved clinical trial following ICH/GCP standards.
  • Self-driven with the ability to work independently and within a team. 
  • Open and clear communicator. 
  • Excellent written and verbal communication skills, especially in communicating business technical information and statistical information and specifications. 
  • Capable of preparing and delivering requirements and test plan documents. 
  • Strong interpersonal skills that can be used to effectively collaborate on work with other  professionals. 
  • Ability to present to small groups.
  • Demonstrates a results-orientation, determination, ownership of responsibility, reliability, and accountability, while functioning as a team member and following direction as part of a team under general supervision. 
  • Experience working with clinical trial documents and data. 
  • 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.

Description of Responsibilities:

  • Provide assistance, where directed by management, in tasks relating to preparation and review of protocol and protocol related documents. 
  • Support completion of user acceptance and quality assurance testing of EDC databases. 
  • Assist with review and mapping of source records to study databases. 
  • Support in analytical investigations around database issues, requests, and pending updates. 
  • Support management in tracking and storage of regulatory documentation and submissions.
  • Hands-on training support as required. 
  • Support technical team as needed to support system enhancement and roll out of changes/enhancements. 
  • Support the development of training material/user manuals/learning solutions and end user training for clinical systems. 
  • When applicable, participates in implementation, validation, user acceptance testing (UAT), configuration, systems integration, and generation and maintenance of auditable documentation.
  • Works with vendors and programmers on systems upgrades, licenses, and maintenance, and communicates to wider MPBC team as necessary.

Application Instructions

If you are interested and qualified for this position, please email This email address is being protected from spambots. You need JavaScript enabled to view it.. Include your resume or CV as an attachment. Include a cover letter or a statement of interest in the body of your email. Applications will be reviewed on a rolling basis.

IT Program Manager

Location: TBA

Salary Range: Available upon request

Hours: TBA

Exemption Status: Exempt

Position Duties:

The ideal individual will have the ability to exercise good judgment in a variety of situations, with strong written and verbal communication and organizational skills, as well as the ability to effectively manage competing and overlapping priorities. The IT Program Manager must be solution-oriented, creative, and enjoy working within a small, entrepreneurial environment that is mission-driven, results-driven, and research-oriented. The focus of the role will be to develop and enforce IT policy. This will include but not be limited to oversight of the full suite of IT systems essential for protection of MPBC’s interests including physical and intellectual property, which maintains compliance with the relevant SOPs covering data security.

Minimum Requirements:

A bachelor’s degree is preferred, with 5 or more years of relevant experience. Relevant validated or regulated environment experience, as well as familiarity with a clinical research work environment preferred.

Additional Competencies:

  • Ability to lead, work independently, and liaise with related individuals/functions
  • Experience with MS work environment, cloud based clinical systems, Sharepoint, correspondence tracking
  • Strong technical skills as an individual contributor, with evidence of overseeing large development projects or multiple smaller projects that are timeline oriented and require careful management
  • Open and clear communicator with excellent written and verbal communication skills
  • Efficient, pragmatic, and organized in approach

Job Responsibilities:

  • Responsible for strategic planning around IT infrastructure projects
  • Contribute and play lead role in the definition of programmatic objectives, as well as the ability to lead efforts to implement these objectives
  • Evaluate new IT contractors as needed
  • Research and implement system solutions (such as cloud-based backup, anti-virus protection, and remote access solutions)
  • Determine technical standards for scalability
  • Pursue standardization of approaches to streamline and simplify
  • Manage the development lifecycle for key software and hardware systems
  • Help to define associated budgets and to manage the related expenditures effectively

Programmatic Objectives IT Policy and Strategy Must Address:

  • Establish robust IT plan and infrastructure to support business operations
  • Establish robust and scalable Support structure to support a growing team
  • Serve as default Administrator for globally based Clinical Systems
  • Develop, implement, and maintain IT infrastructure for system-wide use 
  • Coordinate with institutional IT Departments
  • Provide employees and contacting entities the means to securely connect to company network
  • Oversee permission management and documentation thereof according to necessary requirements
  • Manage internal file sharing platform(s)
  • Develop IT SOPs including, but not limited to: Data Security and Privacy Policies (Acceptable Use Policy, Confidential Data Policy, Email Policy, Mobile Device Policy, Incident Response Policy, Network Policy, Password Policy, Physical Security Policy, Wireless Network Policy
  • Lead initiatives to evaluate current infrastructure and migration to next generation approach
  • Develop a centralized monitoring platform for all Clinical Systems
  • Develop an internal support ticketing system
  • Ensure company compliance with relevant SOPs, HIPAA, GDPR, and other applicable data protection laws and regulations
  • Manage a small team of developers, consultants, and IT support personnel
  • IT infrastructure to support internal staff on PC and Mac platforms
  • IT infrastructure to support study sites as appropriate
  • IT infrastructure to support clinical data collection

Application Instructions

If you are interested and qualified for this position, please email This email address is being protected from spambots. You need JavaScript enabled to view it.. Include your resume or CV as an attachment. Include a cover letter or a statement of interest in the body of your email. Applications will be reviewed on a rolling basis.