Urwah Admin

DM Clinical Research

<div>The Research Assistant (Lab) will be responsible for assisting the clinical research staff in conducting clinical research trials.
DUTIES &amp; RESPONSIBILITIES<ul><li>
Completing DMCR-required training, including GCP and IATA.</li><li>
Maintaining a working knowledge of current FDA regulations, GCP/ICH guidelines, organizational SOPs, guidance documents, and study protocols.</li><li>
Assisting in the collection and recording of patient data per Sponsor requirements via the respective EDC system.</li><li>
Timely and accurately assist in collection, management, and shipment of subjects' samples, and/or specimens</li><li>
Completing Sponsor-required training prior to study-start, including, but not limited to<ul><li>
Sponsor-provided and IRB-approved protocol</li><li>
All amendments</li><li>
Investigator Brochure</li><li>
Sponsor-specified EDC and/or IVRS</li></ul></li><li>
This includes completing the above-mentioned training prior to any study-related procedures being conducted on that said protocol should the RA be added to a protocol post-study start.</li><li>
Maintaining clear, concise, accurate, and legible records.</li><li>
Being prepared for and available at all required company meetings and monitoring visits for their assigned protocols at their respective site(s).</li><li>
Utilizing the most recent version of the Protocol, Informed Consent, and Investigator Brochures at their respective site(s).</li><li>
Assisting in the compilation and organization of all regulatory and administrative binders for their assigned protocols at their respective site(s) upon initial receipt of and wherever applicable.</li><li>
Assisting in the creation of source documents for their assigned protocols at their respective site(s).</li><li>
Conducting patient visits.</li><li>
Assisting in reporting Adverse and Serious Adverse Events to the appropriate authorities per Sponsor.</li><li>
Assisting in addressing and resolving issues from internal/external audits and monitoring letters for all assigned protocols at their respective site(s) in a timely manner.</li><li>
Assists with all other aspects of the study and conducts as needed.</li><li>
Any other matters as assigned by management.</li></ul>
KNOWLEDGE &amp; EXPERIENCE
Education:<ul><li>
High school diploma or equivalent required</li></ul>
Experience:<ul><li>
Prior experience in clinical research is not required but preferred</li></ul>
Credentials:<ul><li>
Phlebotomist certificate preferred</li><li>
Medical Assistant Certification preferred</li></ul>
Knowledge &amp; Skills:<ul><li>
Knowledge of medical terminology required</li><li>
Must be detail-oriented and demonstrate attention to detail</li><li>
Excellent customer service skills</li><li>
Excellent computer skills</li></ul></div>

Research Assistant I (Lab)

<div>Patient Engagement Training Specialists are responsible for creating and executing training for onboarding new talents, patient enrollment teams based on study awarding, maintaining teaching materials, ensuring trainee readiness, and conducting feedback surveys to assess the effectiveness of learning and development programs within the Patient Engagement department.
DUTIES &amp; RESPONSIBILITIES<ul><li>
Assess the training needs of individual employees, department teams, and the department as a whole in collaboration with other department leadership.</li><li>
Develop and maintain onboarding / new hire training within the Patient Engagement department</li><li>
Deliver engaging and informative training programs to onboard new hires on company culture, product knowledge, and essential tools.</li><li>
Develop and deliver training materials and presentations that comply with IRB/FDA regulations, departmental needs, and business needs.</li><li>
Maintain good knowledge of GCP, HIPAA regulations, and train team members on the same.</li><li>
Create study protocol cheat sheets, phone screens, and all other relevant materials used for training the enrollment and site teams.</li><li>
Conduct Study Protocol training sessions for all clinical research studies assigned to the organization</li><li>
Utilizes internal and external resources to achieve goals.</li><li>
Develops and implements a learning curriculum that is consistent with current trends and best practices.</li><li>
Researching training strategies and best practices in the industry and bringing them to the forefront.</li><li>
Recommend training materials and methods.</li><li>
Order and maintain in-house training materials.</li><li>
Write and maintain department SOPs and handbook.</li><li>
Designing and delivering training materials and evaluating their effectiveness.</li><li>
Conduct feedback sessions with individual employees, department teams, and the department as a whole based on applicable opportunities for improvement and/or changes in information, policy, or processes.</li><li>
Evaluate the skills of new and existing employees and identify where further training is needed.</li><li>
Team members work under the guidance of the Team Leader and alongside other team members to ensure that organizational goals are met.</li><li>
Executing all tasks assigned by the Team Lead or Manager diligently, on schedule, and to the highest standard.</li><li>
Expanding your skills by attending workshops and training sessions.</li><li>
Create, conduct, and deliver knowledge and feedback checks/surveys to ensure and measure the efficacy of training materials and presentations.</li><li>
Collaborate with experienced trainers to develop and improve the curriculum.</li><li>
Perform other tasks as assigned by the management.</li></ul>
KNOWLEDGE &amp; EXPERIENCE
Education:<ul><li>
A healthcare-related bachelor&rsquo;s degree preferred, with equivalent years of experience in clinical research.</li></ul>
Experience:<ul><li>
2 Years of experience working in Clinical Research or Customer Service-related roles</li><li>
1+ Year(s) of experience in training/coaching within Sales/Customer Service</li></ul>
Credentials:<ul><li>
N/A</li></ul>
Knowledge and Skills:<ul><li>
Medical knowledge on clinical protocols and clinical trial processes</li><li>
Computer proficiency, especially in Word, Excel, Outlook, and Google Docs</li><li>
Excellent written and oral communication and customer service skills</li><li>
High typing speed (WPM) 50+ preferred</li><li>
Outgoing personality</li><li>
Well-organized with attention to detail</li><li>
Must be able to multitask and speak well in front of a large audience</li><li>
Be fluent in English and be able to conduct interactive training sessions</li></ul></div>

Patient Engagement Training Specialist

<div>The Infrastructure and Cybersecurity Engineer holds a pivotal role in the efficient operation, maintenance, and security of the company's IT systems. This position requires a blend of hands-on technical expertise and strategic security implementation. The engineer will be responsible for designing, implementing, and managing the company's network, servers, and software, with a strong emphasis on cybersecurity measures to protect sensitive information and ensure regulatory compliance. This role involves contributing to IT projects, managing hardware and software, and safeguarding the network against threats and vulnerabilities
DUTIES &amp; RESPONSIBILITIES<ul><li>
Lead the secure design and deployment of IT projects from inception to completion.</li><li>
Monitor network traffic to optimize performance, reliability, and security.</li><li>
Implement and manage security tools, including firewalls and intrusion detection systems, to defend against</li><li>
cyber threats.</li><li>
Manage software and application lifecycle, including installation, patching, and updates.</li><li>
Administer Google Workspace and Office 365 environments, managing user accounts and configurations.</li><li>
Perform maintenance, troubleshooting, and upgrades on hardware such as servers, switches, and storage.</li><li>
Evaluate vendor security and develop test strategies for new hardware and software.</li><li>
Provide advanced support for complex hardware and software issues through in-depth research and</li><li>
resolution.</li><li>
Manage SSL certificate installation and renewal to ensure secure communication.</li><li>
Document network configurations, IT procedures, and troubleshooting steps.</li><li>
Prioritize tasks effectively while working independently in a hybrid environment.</li><li>
Contribute to developing IT security policies and incident response plans to ensure compliance and address</li><li>
emerging threats.</li><li>
Manage the IT infrastructure and cybersecurity budget for optimal resource allocation.</li><li>
Develop and implement employee cybersecurity awareness and training programs.</li><li>
Perform other duties as assigned.</li></ul>
KNOWLEDGE &amp; EXPERIENCE
Education:<ul><li>
Bachelor's degree in Information Technology, Computer Science, Information Systems, or a related field, or equivalent experience.</li></ul>
Experience:<ul><li>
5+ years of progressive experience in IT operations, including system and network administration.</li><li>
Demonstrated, hands-on experience with a strong focus on cybersecurity, including implementing security protocols, firewalls, and measures to safeguard against cyber threats.</li><li>
Proven experience leading or playing a key role in IT infrastructure projects, from design and inception to the deployment of new systems and services.</li><li>
Minimum of 2 years in a role requiring project leadership, team lead responsibilities, or mentorship of technical staff</li></ul>
Credentials:<ul><li>
Relevant industry certifications are a plus, such as CompTIA Security+, CompTIA Network+, Cisco</li><li>
Certified Network Associate (CCNA), or Microsoft/Google certifications.</li></ul>
Knowledge and Skills:<ul><li>
Lead and manage large IT projects, overseeing the rollout of IT infrastructures across various technologies.</li><li>
Excellent working knowledge of computer systems, security, network and systems administration, databases, and data storage systems.</li><li>
Proven ability to lead and manage IT projects and the rollout of IT infrastructures.</li><li>
Proficiency in software and hardware troubleshooting.</li><li>
Extensive experience with network monitoring tools and Google Workspace/O365 administration.</li><li>
Thorough understanding of network security best practices and emerging cybersecurity threats.</li><li>
Strong communication, interpersonal, and project management skills with the ability to prioritize effectively.</li><li>
Proven ability to adapt to new technologies and implement solutions effectively.</li></ul></div>

Infrastructure and Cybersecurity Engineer

<div>A CRC III will ensure that quality research is conducted at assigned investigative sites in accordance with the sponsor protocol, FDA Regulations, and ICH/GCP guidelines and to provide the best quality data to the sponsor. To ensure study enrollment meets or exceeds Sponsors' expectations. To ensure company goals are achieved on a timely basis. 
 
DUTIES &amp; RESPONSIBILITIES<ul><li>
Completing all the DMCR-required training, including but not limited to ICH-GCP Certification and IATA Certification on a timely basis.</li><li>
Completing all the relevant training prior to study-start and on a continued basis in a timely manner. This will include but is not limited to:<ul><li>
Sponsor-provided and IRB-approved Protocol Training</li><li>
All relevant Protocol Amendments Training</li><li>
Any study-specific Manuals Training, as applicable</li><li>
Sponsor-specified EDC and/or IVRS and any other relevant Electronic Systems training.</li></ul></li><li>
Conducting and overseeing study subject visits, and all other relevant protocol-required procedures and documenting these in a timely manner.</li><li>
Adherence to ALCOA-C Standards with all the relevant clinical trial documentation.</li><li>
Completing and overseeing data entry and query resolution in a timely manner as per internal company guidelines and as per sponsor expectations.</li><li>
Demonstration of appropriate and timely follow-up on the action items, at their respective sites.</li><li>
Demonstrated understanding, implementation and supervision of protocol-specified laboratory procedures, storage, temperature monitoring, equipment calibration, and laboratory kit inventory for assigned protocols.</li><li>
Liaising with the Laboratory team, Data team, Administrative staff, Clinical Investigators, Research Participants and Sponsor/CRO representatives for assigned protocols.</li><li>
Maintaining a working knowledge of current FDA regulations, ICH-GCP guidelines, all the organizational SOPs, all the guidance documents, and assigned study protocol(s)</li><li>
Maintaining a working knowledge of the recruitment and retention process for their assigned protocol(s) at their respective site(s).</li><li>
Ability to train and mentor site staff, as needed</li><li>
Supervise visit preparedness for all the relevant sponsor and CRO visits for their assigned protocol(s)</li><li>
Demonstration of appropriate and timely follow-up on the action items, at their respective sites.</li><li>
Maintaining a working knowledge of the most recent versions of the Study Protocols, Informed consents, Study Manuals, and all the other relevant study-related documents that are utilized and implemented for the assigned protocols at their respective site(s).</li><li>
Maintaining a working knowledge of Study Participants&rsquo; Scheduling, Visit Tracking, Stipends and Transportation by liaising with the Administrative team.</li><li>
Maintaining a working knowledge of the Essential Clinical Trial Documents and maintenance of the Investigator Site Binders for their assigned protocol(s) at their respective site(s)</li><li>
Oversee reporting of all Adverse and Serious Adverse Events and any other relevant Safety Information to the appropriate authorities per internal company guidelines, Sponsor, IRB, and ICH-GCP Guidelines.</li><li>
Striving to meet Sponsor subject enrollment goals for their assigned protocols at their respective site(s).</li><li>
Being prepared for and available at all required company meetings.</li><li>
Submitting required administrative paperwork per company timelines.</li><li>
Occasionally attending out-of-town Investigator Meetings</li><li>
Conduct patient consent discussions and ensure comprehension of medical procedures, risks, benefits, and alternatives</li><li>
Provide clear explanations of study protocols and ensure patients' understanding before obtaining their consent</li><li>
Facilitate effective communication between patients, healthcare providers, and research staff</li><li>
Any other matters as assigned by management</li></ul> 
KNOWLEDGE &amp; EXPERIENCE 
Education:<ul><li>
High School Diploma or equivalent required</li><li>
Bachelor's degree preferred</li><li>
Foreign Medical Graduates preferred</li></ul>
Experience:<ul><li>
Minimum of 5 years experience in Clinical Research</li><li>
Supervisory experience preferred</li><li>
Wide therapeutic range of clinical trials experience preferred</li><li>
Regulatory research experience is a plus</li></ul>
Credentials:<ul><li>
ACRP or equivalent certification is preferred</li></ul>
Knowledge and Skills:<ul><li>
Goals-driven while continuously maintaining quality.</li><li>
Must be detailed-oriented, proactive, and able to take initiative.</li><li>
Must have strong written and communication skills.</li><li>
Must have excellent customer service skills.</li><li>
Proficient communication and comprehension skills both verbal and written in the English language are required.</li><li>
Proficient Bi-lingual (English/Spanish) communication and comprehension skills both in verbal and written are preferred.</li></ul></div>

Clinical Research Coordinator III

Join DM Clinical Research and explore 4   exciting career opportunities. They're hiring for various roles with options for remote or on-site work. Apply today and become part of their innovative team.

DM Clinical Research

ABOUT_COMPANY

Research Assistant I (Lab)

Patient Engagement Training Specialist

Infrastructure and Cybersecurity Engineer

Clinical Research Coordinator III