Urwah Admin

DM Clinical Research

<div>The Clinical Research Coordinator II will ensure that quality research is conducted at the 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. The CRC II will also ensure study enrollment meets or exceeds Sponsors' expectations. To ensure company goals are achieved on a timely basis. 
 
DUTIES &amp; RESPONSIBILITIES 
1. Completing all the DMCR-required training, including but not limited to ICH-GCP Certification and IATA Certification on a timely basis. 
2. 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>
a. Sponsor-provided and IRB-approved Protocol Training</li><li>
b. All relevant Protocol Amendments Training</li><li>
c. Any study-specific Manuals Training, as applicable</li><li>
d. Sponsor-specified EDC and/or IVRS and any other relevant Electronic Systems training.</li></ul>
3. Conducting study subject visits, and all other relevant protocol-required procedures and documenting these in a timely manner. 
4. Adherence to ALCOA-C Standards with all the relevant clinical trial documentation. 
5. Completing data entry and query resolution in a timely manner as per internal company guidelines and as per sponsor expectations. 
6. Demonstration of appropriate and timely follow-up on the action items, at their respective sites. 
7. Demonstrated understanding and implementation of Laboratory Manuals and protocol-specified laboratory procedures, storage, temperature monitoring, equipment calibration, and laboratory kit inventory, under the direction of the Site/Study Management Team, for assigned protocols. 
8. Liaising with the Laboratory team, Data team, Administrative staff, Clinical Investigators, Research Participants and Sponsor/CRO representatives, under the direction of the Site/Study Management Team, for assigned protocols. 
9. Demonstrating adherence and compliance to the assigned protocols at their respective site(s). 
10. Maintaining a working knowledge of current FDA regulations, ICH-GCP guidelines, all the organizational SOPs, all the guidance documents, and assigned study protocol(s) 
11. Maintaining a working knowledge of the recruitment and retention process for their assigned protocol(s) at their respective site(s). 
12. Demonstrating visit preparedness for all the relevant sponsor and CRO visits for their assigned protocol(s) 
13. 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). 
14. 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. 
15. Completing data entry and query resolution in a timely manner as per internal company guidelines and as per sponsor expectations. 
16. Striving to meet Sponsor subject enrollment goals for their assigned protocols at their respective site(s). 
17. Being prepared for and available at all required company meetings. 
18. Submitting required administrative paperwork per company timelines. 
19. Occasionally attending out-of-town Investigator Meetings 
20. Conduct patient consent discussions and ensure comprehension of medical procedures, risks, benefits, and alternatives 
21. Provide clear explanations of study protocols and ensure patients' understanding before obtaining their consent 
22. Facilitate effective communication between patients, healthcare providers, and research staff 
23. Any other matters as assigned by management. 
KNOWLEDGE &amp; EXPERIENCE 
Education:<ul><li>
High School Diploma or equivalent required; Bachelor's degree preferred</li><li>
Foreign Medical Graduates preferred</li></ul>
Experience:<ul><li>
At least 2 years of experience as a CRC, preferably with practice coordinating industry-sponsored vaccines in a private setting.</li></ul>
Credentials:<ul><li>
ACRP or equivalent certification is preferred</li></ul>
Knowledge and Skills:<ul><li>
Be an energetic, go-getter who is detail-oriented and can multi-task.</li><li>
Be goals-driven while continuously maintaining quality.</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 II

<div>The Senior Supervisor of Clinical Research Trials job is to ensure that quality research is conducted at assigned investigative sites. To ensure study enrollment meets or exceeds Sponsors' expectations and company goals are achieved on a timely basis.
DUTIES &amp; RESPONSIBILITIES<ul><li>
Responsible for immediate supervision and performance of the assigned site staff under the supervision of the Site Director or Director of Site Operations.</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:</li><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><li>
It is the responsibility of the Site Manager to make sure all the relevant training is completed prior to performing any applicable tasks on the assigned study.</li><li>
Ensuring visit preparedness for all the relevant sponsor and CRO visits for their assigned protocol(s) and appropriate as well as timely follow-up on the action items, at their respective sites.</li><li>
Make sure that the most recent versions of the Protocol, Informed Consents, Study Manuals and all the other relevant study-related documents are utilized and implemented at all times for the assigned protocol(s) at their respective site(s).</li><li>
Ensuring clinical trial management from FPFV to study close out with strict adherence to study protocol, adherence to all other relevant study manuals, study documents, ICH-GCP Guidelines, FDA Regulations, and ALCOA-C standards, organizational SOPs, and guidance documents.</li><li>
Ensuring data quality, subject retention, and compliance, timely and adequate study data reporting on the assigned protocol(s) being conducted at their respective site(s).</li><li>
Accomplishing site objectives by managing staff; facilitating staff training as applicable; communicating job expectations</li><li>
Coaching, counseling, and disciplining the employees as applicable.</li><li>
To develop, coordinate, and enforce site-specific systems, policies, procedures, and productivity standards.</li><li>
Communicating and effective implementation of strategic goals from senior management to the site team.</li><li>
Striving to meet Sponsor subject enrollment goals for their assigned protocols at their respective site(s).</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>
Bachelor&rsquo;s degree preferred</li><li>
Advanced degree preferred</li></ul>
Experience:<ul><li>
At least 4 years of clinical research coordinator experience, including 2 years of management experience at a clinical research organization.</li></ul>
Credentials:<ul><li>
Certified Clinical Research Coordinator (CCRC) or equivalent certification preferred.</li></ul>
Knowledge and Skills:<ul><li>
Solid teamwork, organizational, interpersonal, and problem-solving skills and attention to detail.</li><li>
Critical Thinking</li><li>
Active Listening</li><li>
Reading Comprehension &mdash; Understanding written sentences and paragraphs in work-related documents.</li><li>
Speaking and Writing to communicate effectively as appropriate for the needs of the audience.</li><li>
Ability to multitask, adhere to deadlines, and work both independently and cooperatively with interdisciplinary teams.</li><li>
Strong computer skills in relevant software and related clinical systems are required.</li><li>
Comprehensive knowledge of FDA regulations, ICH-Good Clinical Practices (GCP) and ISOs.</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>

Senior Supervisor of Clinical Research Trials

<div>The Lab Technician III will conduct the collection of blood samples from subjects while working closely with our Clinical Research staff to provide excellent customer care to patients and their parents participating in our clinical
trials. 
DUTIES &amp; RESPONSIBILITIES<ul><li>
Prepares, processes, and ships laboratory samples to outside laboratories following IATA regulations.</li><li>
Conducts venipuncture and phlebotomy on study subjects.</li><li>
Provides quality service by enforcing quality and customer service standards.</li><li>
Contributes to team effort by accomplishing related results as needed.</li><li>
Verifies subject by reading subject identification.</li><li>
Maintains specimen integrity by using an aseptic technique, following protocol procedures; observing protocol specific procedures.</li><li>
Tracks collected specimens by initialing, dating, and noting times of collection; maintaining daily tallies of collections performed as applicable.</li><li>
Maintains a safe, secure, and healthy work environment by following standards and procedures; complying with legal regulations.</li><li>
Enhances laboratory department by accepting ownership for accomplishing new and different requests; exploring opportunities to add value to job accomplishments.</li><li>
Monitors inventory of laboratory supplies and laboratory kits and order as needed.</li><li>
Organizes laboratory layout and facilitates laboratory operations.</li><li>
Conducts clinical studies according to FDA regulations and guidelines.</li><li>
Protects the safety and welfare of the study subjects by ensuring that the study is conducted properly and in compliance with ICH/GCP and Optimal Research Standing Operating Procedures.</li><li>
Manages equipment and storage conditions of samples and reagents within the laboratory.</li><li>
Manages vendors per DM and protocol procedure with regard to samples, dry-ice, liquid nitrogen (if applicable), and biohazard waste pick-up.</li><li>
Knowledgeable of the Sponsor&rsquo;s protocol so all study activities are completed correctly.</li><li>
Ability to train and mentor new staff, as needed.</li><li>
Demonstration of appropriate and timely follow-up on the action items, at their respective sites.</li><li>
Other tasks and duties as assigned by the supervisor.</li></ul>
KNOWLEDGE &amp; EXPERIENCE
Education:<ul><li>
High school diploma or equivalent required</li></ul>
Experience:<ul><li>
4+ years of phlebotomy and lab processing experience.</li></ul>
Credentials:<ul><li>
Phlebotomy certification required</li><li>
Medical Assistant certification preferred</li></ul>
Knowledge and Skills:<ul><li>
Meticulous attention to details and deadlines.</li><li>
Knowledge of basic use of scientific methods, procedures, and techniques</li><li>
Good communication skills are required, both written and verbal</li><li>
Fluent English is a must, Spanish is preferred.</li></ul></div>

Lab Technician III

<div>DM Clinical Research, the largest privately-owned Research Management Organization in the Houston area and one of the top fifty in the country, is looking for a Patient Engagement Specialist for their Patient Marketing Department. Please note this position will be paid on an hourly basis.
Responsibilities: 
A Patient Engagement Coordinator for DM Clinical Research (DMCR) will be responsible for but 
not limited to:<ul><li>
Completing DMCR-required training, including GCP and NIH.</li><li>
Engaging diverse populations to volunteer as participants in diverse research studies.Capturing required metrics in company databases while adhering to IRB and HIPAA 
guidelines for data collection, to drive ongoing evaluation of program operations</li><li>
Analyzing daily metrics in all databases to assess individual and team performance</li><li>
Initiating data-driven improvements for engagement, enrollment, and retention 
processes</li><li>
Learning process of engagement and enrollment after training and observation by 
Clinical Research Coordinator and Principal Investigators (PIs).</li><li>
Communicating closely with patients, providers, clinical team, outreach workers, and other staff to promote participation and achieve patient engagement metrics established management team.</li><li>
Utilizing electronic medical records and health center workflow to maximize patient 
engagement and minimize interruptions to clinical processes.</li><li>
Assist with creation and execution of patient marketing collateral
</li><li>Social media management for patient marketing</li></ul>
Experience and Skills Required:<ul><li>
Beginning follow-up process to maintain contact with participants already enrolled in the program.</li><li>
Flexibility to work evenings and weekends.</li><li>
Bachelor&rsquo;s Degree required
</li><li>Some social media/marketing experience preferred</li><li>
Graphic design experience is a plus but not required</li></ul></div>

Patient Engagement Specialist

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

Clinical Research Coordinator II

Senior Supervisor of Clinical Research Trials

Lab Technician III

Patient Engagement Specialist