Clinical Research Associate

Position Summary 

MAPS PBC is seeking an enthusiastic, focused, and organized person to join our Clinical Operations Department. The CRA role will report to the Clinical Program Manager 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.  

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.  

Occasional travel to the Santa Cruz or Oakland offices in California may be required. Travel to clinical study sites will be up to 50%. 

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 of 2 years CRA site management, monitoring, or other relevant experience is required as well as knowledge of U.S. regulations governing clinical trials.
• Ability to travel 45%-60%. 

Position Duties  

• Communicate and collaborate with key players, internal and external staff.  
• Check in regularly with managers as appropriate. 
• 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 workflows, build efficiency and user interface of various platforms. 
• Demonstrate thorough understanding of sponsor SOPs, protocols, monitoring plans, and other documents and processes required to manage clinical trial sites 
• Demonstrate ability to manage multiple protocols simultaneously 
• Provide assistance, where directed by managers, in tasks related to protocol and ICF related documents 
• 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.

Specific Monitoring Responsibilities 

• Prepare for and conduct qualification, initiation, monitoring, and closeout visits at clinical sites in compliance with the approved protocol and monitoring plan. 
• Completion of monitoring reports and follow-up letters, which includes providing summaries of the significant findings, deviations, deficiencies, and recommended actions to secure compliance. 
• Ensure quality of trial data through in-house review of electronic CRF data and on-site and remote source document verification. 
• Verify adequate investigator qualifications, training, and resources, including facilities, laboratories, equipment, and staff. Document and maintain training throughout trial. 
• Perform drug accountability.  
• Ensure clinical trial sites are audit ready and be prepared to assist actively in an inspection by FDA or another regulatory body at the clinical study site. 
• Effectively monitor and manage approximately 4-6 clinical study sites. 
• Act as the main line of communication between the sponsor and trial site personnel including, the investigator, physician, therapists, coordinator, and other site personnel. 
• 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 adheres to the protocol and complies with all regulatory standards including ICH GCP, FDA, IRB, and other pertinent regulatory agencies. Maintain familiarity of local regulatory requirements, MAPS PBC SOPs, guidelines and ICH GCP. 
• Review and manage the enrollment process at clinical trial sites. 
• Collate, file and track documentation for the Trial Master File using Montrium eTMF. 
• Identify, track, and resolve any data queries/protocol deviations throughout trial. 
• 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, Adverse Events of Special Interest, 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, ICH GCP, and the applicable regulatory requirements to management, as appropriate. 
• Ensure all unused trial supplies are accounted for. 
• Ensuring each site has the trial materials and training the site staff to trial-specific industry standards. 
• 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. 
• Travel is required 

Additional Competencies  

• Extensive knowledge of applicable clinical trial regulatory requirements in U.S. 
• Experience preparing sites for FDA or other regulatory audits 
• 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 minimal additional training: Microsoft Office Applications (Word, Excel, PowerPoint, Outlook, SharePoint) 
• Ability to learn new tools (previous experience a plus), including Smartsheet, Zoom and Asana 

FLSA Status: Exempt 

Compensation: Salary depends on experience. Includes excellent benefits package.