Job Summary: 

• Coordinates both investigator-initiated research studies and industry-sponsored clinical trials of new investigational drugs for children with musculoskeletal and neuromuscular disorders.
• Works collaboratively with investigators and clinical research staff to ethically recruit and consent patients.
• Responsible for tracking projects, including all study, investigator, and Institutional Review Board (IRB) information, and patient recruitment activity
• Coordinates the collection of data throughout a clinical study, including timely data collection, ensuring accurate data entry into secure research databases, verifying data quality through internal quality control measures to confirm reported study data is accurate, complete, and verifiable from source documents
• Confirms that appropriate training and education of study personnel are in place to safely perform study protocols

Skills on Resume: 

• Trial Coordination (Hard Skills)
• Ethical Recruitment (Soft Skills)
• Project Tracking (Hard Skills)
• Data Management (Hard Skills)
• Data Entry (Hard Skills)
• Quality Assurance (Hard Skills)
• Quality Control (Hard Skills)
• Teamwork (Soft Skills)

Job Summary: 

• Engage with eligible caregivers and patients to enroll them in the study and coordinate activities to collect baseline, 3- and 6-month follow-up surveys with enrolled participants
• Assist with all phases of study implementation, including participant recruitment and enrollment.
• Conduct virtual visits adhering to study procedures and training manuals.
• Assist participants in setting up the technology to engage in the different aspects of the project.
• Assist in the design and creation of project-related materials such as recruitment materials, publications, etc.
• Administer multiple self-reported study surveys for participant follow-up
• Maintain relationships with participants and recruitment sites (Penn Frontotemporal Degeneration Center)
• Adhere to protocol procedures to maintain participant safety and protection of human subjects' data.
• Assist with routine quality checks and cleaning of data.
• Perform data entry into REDCap.
• Assist with maintaining confidentiality of study participants (e.g., reporting adverse events).
• Assist with regulatory submissions
• Adhere to IRB IRB-approved protocol and assist with communication with IRB personnel.
• Comply with federal and state policies governing the protection of human subjects who participate in research.

Skills on Resume: 

• Participant Enrollment (Soft Skills)
• Survey Coordination (Hard Skills)
• Study Implementation (Hard Skills)
• Tech Support (Hard Skills)
• Material Creation (Hard Skills)
• Survey Administration (Hard Skills)
• Relationship Building (Soft Skills)
• Data Protection (Hard Skills)

Job Summary: 

• Identify and compile lists of potential research subjects following study objectives and parameters, contact potential subjects to introduce and explain study objectives and protocol, develop and implement diverse recruitment strategies, conduct, record, and evaluate face-to-face and/or telephone interviews with potential subjects
• Manage the day-to-day operation of clinical research studies, from IRB submissions, recruitment, scheduling research visits, conducting assessments and interviews, collecting data, data entry, subject reminder calls, remuneration and follow-up
• Administer and score cognitive tests, diagnostic and symptom assessments, clinical rating scales, and self-report measures
• Maintain Clinical Research Folders and Master Binders following IRB and HIPAA guidelines
• Schedule and conduct behavioral and MRI data collection procedures
• Coordinate with other study sites (Boston University) to enable smooth collection of data and follow-up of longitudinal visits.
• Perform quality assurance of all collected data to ensure completeness and accuracy of information, follow up with subjects to resolve problems, address queries or clarify data collected
• Contribute to database development and maintenance
• Prepare submissions to the IRB, including initial applications, continuing reviews, amendments and adverse events
• Maintain accurate study records and regulatory documentation, including source documents, case report forms, study logs, IRB correspondence, adverse event reports, progress reports and any other documentation that may be required to meet local or federal regulations
• Track and order study equipment, supplies, and materials
• Assist with the analysis of clinical, cognitive/behavioral and imaging data
• Prepare presentations of data and study findings for lab meetings, posters, grant submissions and publications

Skills on Resume: 

• Subject Recruitment (Soft Skills)
• Study Management (Hard Skills)
• Assessment Administration (Hard Skills)
• Data Collection (Hard Skills)
• Site Coordination (Soft Skills)
• Quality Assurance (Hard Skills)
• Database Maintenance (Hard Skills)
• Regulatory Documentation (Hard Skills)

Job Summary: 

• Responsible for evaluation, initiation, monitoring, close-out and other tasks associated with the management of clinical sites.
• Ensure the conduct of all clinical studies follows Good Clinical Practices, International Harmonization Guideline, and appropriate Standard Operating Procedures (SOP)
• Serve as primary contact for Clinical Research Organizations/vendors, Investigators, and study coordinators for study-related questions.
• In conjunction with the study team, support the feasibility and site selection process for clinical studies.
• Manage patient recruitment strategies to increase patient randomization into the trial
• Review all Adverse Events/Serious Adverse Events and ensure appropriate documentation is in place and any other safety issues are addressed and communicated.
• Order and coordinate study supplies for clinical studies
• Develop and maintain tracking tools to support the management of clinical studies

Skills on Resume: 

• Site Management (Hard Skills)
• GCP Compliance (Hard Skills)
• Stakeholder Communication (Soft Skills)
• Site Selection (Hard Skills)
• Recruitment Strategies (Hard Skills)
• Safety Monitoring (Hard Skills)
• Supply Coordination (Hard Skills)
• Tracking Tool Development (Hard Skills)

Job Summary: 

• Implement and manage clinical study activities for current and new IVDs and Medical Devices.
• Work with the team on all clinical study aspects, including CRO selection, site selection, PI selection, and protocol development
• Support with IRB activities, participate and monitor the studies, support with data analyses, and study close-out activities.
• Guide product development teams on GCP issues for the planning of clinical field investigations to generate the data necessary to support product claims or indications required for regulatory submissions (such as 510k and CLIA Waiver).
• Initiate and maintain contact with principal investigators, study coordinators and study participants.
• Prepare and perform evaluative studies/bench studies of current and new ARKRAY products.
• Travel to field sites to initiate, supervise, monitor and audit clinical studies.
• Provide technical support and lab training to other members of the Science department as well as to other departments, functioning in a team environment.
• Support with troubleshooting existing ARKRAY products, processes, and customer complaints, including performing laboratory or clinical studies.

Skills on Resume: 

• Study Management (Hard Skills)
• Site Selection (Hard Skills)
• IRB Support (Hard Skills)
• Regulatory Guidance (Hard Skills)
• Stakeholder Engagement (Soft Skills)
• Product Evaluation (Hard Skills)
• Field Monitoring (Hard Skills)
• Technical Training (Hard Skills)