Qureos Mentor

University of Massachusetts

University Sergeant (2 positions)

<div>Overview:
<div>
Under the general supervision of Lab Management, the Lab Analyst II NENSP Molecular performs laboratory assays for the timely detection of newborn disorders. Maintains competency in high complexity testing (as defined by CLIA) in all molecular methodologies used in the section. Performs other related laboratory tasks in support of laboratory management. Responsibilities include careful adherence to established laboratory protocols, or specific directives of appropriate laboratory managers. This is an intermediate level laboratory position that requires previous relevant laboratory experience and will work under a moderate level of direction and supervision to perform assigned work.</div>
Responsibilities:
<div>
Responsibilities</div><ul><li>Performs laboratory assays (clinical or research) with appropriate documentation, as an integral member of the section&rsquo;s laboratory analysts, following validated protocols.</li><li>Follows established safety and privacy protocols.</li><li>Performs bench work to assist management in the performance and documentation of laboratory activities for the technical development, validation, performance and troubleshooting of laboratory assays (both laboratory-developed tests as well as kit assays) used in the screening procedures.</li><li>Performs bench work to assist management in laboratory activities for validation, troubleshooting the performance of and management of instrumentation used in the screening procedures.</li><li>Performs bench work to assist management in laboratory activities for validation, troubleshooting and monitoring of the instrumentation relationships with Laboratory Information Management System.</li><li>Works as an integral team member as needed in the preparation and validation of reagents, materials and kits used in the laboratory.</li><li>Contributes data for laboratory documentation of quality assurance, quality control, and competency data in accordance with Program policies and CLIA requirements.</li><li>Perform other duties as required.</li></ul>
Qualifications:
<div>
REQUIRED EDUCATION<br>
Bachelor&rsquo;s degree or equivalent in chemical, life or clinical sciences<br>
College-level coursework or equivalent yielding a solid understanding of the theory of molecular biology<br>
<br>
REQUIRED WORK EXPERIENCE<br>
1 &ndash; 5 years of relevant experience including some previous clinical laboratory experience<br>
2 &ndash; 5 years of Assay Implementation and Troubleshooting experience<br>
Experience with several of the following: Primer Design, Probe Design, LNA design, Multiplex RealTime PCR design, Nested PCR design, copy-number assay design in relation to<br>
Experience in the clinical application of PCR-based assays, inclusive of the prevention and containment of amplicon contaminants<br>
Experience in the implementation of clinical detection systems for the generation of human genotypic data using a variety of techniques (Luminex Lab developed tests, Real-Time lab developed tests)<br>
Experience in the implementation of clinical assays for the evaluation of the presence/absence and quantification of molecular markers (RealTime and Digital Droplet PCR or equivalent).
<br>
2 &ndash; 5 years of Implementation of High-throughput Clinical Molecular Assays experience<br>
Practical experience in the isolation of nucleic acids from small-volume (3 &micro;L) dried blood spots or other similar human specimens.
<br>
Expertise in high-throughput processing of clinical specimens<br>
Experience with robotics applications for high-throughput processing of clinical specimens<br>
1 &ndash; 3 years of experience with specialized assays such as sequencing or human identity testing<br>
1 &ndash; 3 years of experience in database and spreadsheet applications for quality monitoring<br>
Must satisfy CLIA requirements for high complexity testing<br>
Experience with standard concepts, practices, and procedures within the clinical laboratory<br>
Good communication and organizational skills, with focus on detail and orderliness<br>
Ability to perform laboratory procedures independently once trained, with great care and attention<br>
Strong interpersonal skills<br>
Experience with productivity software (Excel, Word, Access)<br>
Flexibility in work schedule as required by laboratory section (i.e., weekend and holiday rotations).<br>
<br>
PREFERRED WORK EXPERIENCE<br>
Experience<br>
Experience with standard concepts, practices, and procedures within the field of emerging technologic analyses<br>
Experience in the development of PCR-based assays, inclusive of the prevention and containment of amplicon contaminants<br>
Experience in the development of clinical detection systems for the generation of human genotypic data using a variety of techniques (Luminex Lab developed tests, Real-Time lab developed tests)<br>
Experience in the development of clinical assays for the evaluation of the presence/absence and quantification of molecular markers (RealTime and Digital Droplet PCR or equivalent).
<br>
Experience with Sanger sequencing and related informatics</div></div>

Lab Analyst II NENSP Molecular

<div>Overview:
<div><b>
POSITION SUMMARY:</b></div><div>
Under the direction of the Principal Investigator (PI) or designee, the Clinical Research Coordinator is responsible for independently performing delegated tasks and procedures involving human subject research. This work includes coordination of regulatory activities and aspects of collection and management of data for research protocols related to treatment, ancillary services, and prevention practices.</div><div></div><div><br>
This is an open-rank posting (there are 4 levels of Clinical Research Coordinator) - candidates will be hired into the level commensurate with their experience.</div><div></div><div><b><i><br>
We are seeking a dedicated and compassionate professional to join us, working directly with adult oncology patients enrolled in clinical trials. In this role, you will be part of a collaborative and supportive team conducting exciting, FDA-regulated interventional clinical trials that advance cancer treatment. This is an opportunity to make a meaningful impact by contributing to cutting-edge research while providing exceptional care to patients. The ideal candidate will have prior experience in at least one of these areas: oncology or clinical research. If you thrive in a team-oriented environment, are assertive, motivated and are passionate about oncology, clinical research could be the right place for you.</i></b></div><br>
<div></div>
Responsibilities:
<div><b>
ESSENTIAL FUNCTIONS:</b></div><div><b>
Clinical Research Coord I:</b></div><ul><li>
Obtain consent of research participants in accordance with the IRB approved protocols and all applicable regulations including HIPAA</li><li>
Identify, schedule and/or conduct participant study visits, tests and/or interviews/telephone follow up calls</li><li>
Coordinate participant remuneration/compensation per protocol</li><li>
Maintain all regulatory documentation, including local or central IRB and study data. Provide data/support to study Investigators, sponsors and/or external monitors/auditors</li><li>
Identify issues with protocol compliance. Keep principal investigator and manager aware of any issues regarding compliance</li><li>
Document and collect data and/or samples for research related procedures performed during participant study visits.</li><li>
Ensure clinicians and/or PI accurately document their study activities according to protocol</li><li>
Track and maintain study enrollment and completion of milestones</li><li>
Assist with financial /operational aspects of grant and contracts. May be responsible for clinical research billing review within the required timeframe.</li><li>
Track and maintain study related information in the data management system within the required timeframe</li><li>
Responsible for monitoring the inventory of research related supplies</li><li>
Participate in grant preparation, manuscript writing, data presentations and Institutional Review Board (IRB) processes</li><li>
Provide detailed written summaries from literature searches and related sources to serve as a resource for the study team and clinicians/PIs</li><li>
Present study status reports related to assigned research projects</li><li>
Participate in the design, development, and documentation of study related data and collection tools, (e.g. questionnaires, treatment data and/or therapeutic checklists)</li><li>
Maintain strict adherence to all study protocols, including all regulatory requirements adhering to appropriate federal, local and institutional guidelines.</li><li>
Comply with all safety and infection control standards appropriate to this position</li><li>
Adhere with established policies, health and safety regulations and requirements, procedures, and department objectives</li><li>
Adhere to Good Clinical Practice (GCP) guidelines and all human subject protection practices</li><li>
Must practice discretion and adhere to school and hospital confidentiality at all times</li><li>
Perform other duties as required.</li></ul><div><b>
Clinical Research Coord II</b></div><div>
Duties noted above plus:</div><ul><li>
Conduct preliminary quality assurance reviews of study data</li><li>
Contribute to data presentations and Institutional Review Board (IRB) processes</li><li>
Track and maintain study related information in the data management system within the required timeframe
</li><li>Contribute to the design, development, and documentation of study related data and collection tools, (e.g. questionnaires, treatment data and/or therapeutic checklists)</li><li>
Document and collect data/ samples for research related procedures performed during participant study visits. Ensure clinicians and/or PI accurately document their study activities according to protocol.</li><li>
Monitor strict adherence to all study protocols, including all regulatory requirements adhering to appropriate federal, local and institutional guidelines. Identify and resolve issues with protocol compliance. Keep principal investigator and manager aware of any issues regarding compliance</li></ul><div><b>
Clinical Research Coord III</b></div><div>
Duties noted above plus:</div><ul><li>
Assist with recruiting, screening, selecting, maintaining and terminating study subjects for multiple protocols</li><li>
Ensure accuracy and completion of all regulatory documentation, including local or central IRB and study data. Provide data/support to study Investigators, sponsors and/or external monitors/auditors</li><li>
Direct the activities of research support staff. Assist with the training of staff</li><li>
Develop preliminary designs for study related documentation of data and collection tools, (e.g. questionnaires, treatment data and/or therapeutic checklists)</li><li>
Contribute to grant preparation, assessment of protocol feasibility, manuscript writing, data presentations and Institutional Review Board (IRB) processes</li></ul><div><b>
Sr Clinical Research Coord</b></div><div>
Duties noted above plus:</div><ul><li>
Responsible for internal review/monitoring of clinical data for quality assurance purposes. Reports findings</li><li>
Responsible for the smooth operation of all assigned studies on a day-to-day basis, interacting with investigators, staff members, clinicians, sponsors, etc. to ensure project timelines and goals are met</li><li>
Contribute independently to the development of preliminary designs for study related documentation of data and collection tools, (e.g. questionnaires, treatment data and/or therapeutic checklists)</li><li>
May Supervise the activities of research support staff. Assist with the selection, training, and supervision of staff</li><li>
Prepare ongoing summary reports from various data sources, and collaborate with investigators on data presentation, interpretation, and the writing of manuscripts for publication and grant proposals</li><li>
Identify and resolve issues with protocol compliance. Keep principal investigator and manager aware of any issues regarding compliance</li><li>
Accountable for quality assurance reviews of study data</li><li>
Assist with financial /operational aspects of grant and contracts. Responsible for clinical research billing review within the required timeframe.</li><li>
Contribute independently to grant preparation, assessment of protocol feasibility, manuscript writing, data presentations and Institutional Review Board (IRB) processes</li></ul><br>
<div></div>
Qualifications:
<div><b>
REQUIRED QUALIFICATIONS:</b></div><div><b>
Clinical Research Coord I:</b></div><ul><li>
Bachelor&rsquo;s degree in a scientific or health related field, or equivalent experience</li><li>
0-1 year of related experience</li><li>
Ability to travel off site locations</li></ul><div><b>
Clinical Research Coord II:</b></div><ul><li>
Requirements noted for CRC I plus:</li><li>
1-3 years of related experience</li></ul><div><b>
Clinical Research Coord III:</b></div><ul><li>
Requirements noted for CRC I plus:</li><li>
3-5 years of related experience</li></ul><div><b>
Sr Clinical Research Coord:</b></div><ul><li>
Requirements noted for CRC I plus:</li><li>
5-7 years of related experience</li><li>
Demonstrated knowledge of quality management principles in a scientific or hospital setting</li></ul>
Additional Information:
<div>
#LI-KR1</div></div>

Clinical Research Coordinator - Open Rank

<div>Overview:
<div><b>
General Summary</b></div><div></div><div><br>
Under the direction of the Principal Investigator or designee, the Research Coordinator I is responsible for carrying out multiple complex research protocols.</div><div></div><div><br>
At the Lifeline for Families Center, we develop and scale practical approaches to integrating mental healthcare into perinatal, infant, and child healthcare. We develop, implement, and test scalable models of care, trainings, and tools that support families, regardless of what professional or setting they present to. Lifeline for Families is a mission-based, women-led organization which supports parents (all child caregivers) and their children in their relationship with one another in traditionally adult- or child-centric settings. We promote mental health for parents and/or children through social connections, trust, and nurturing. Lifeline for Families has two programs: Lifeline for Moms, which drives innovative solutions to addressing multi-level barriers (patient, clinician, practice, population, and policy levels) to perinatal mental health care, and Lifeline for Kids, which addresses the impact of trauma on children and families while simultaneously promoting protective factors, operating under the principle of &ldquo;you don&rsquo;t have to be a therapist to be therapeutic.&rdquo; These programs are synergistic with each other; together, we work to create a holistic landscape of trauma-informed family care with an equity lens.</div><div></div><div><br>
The Research Coordinator I will work primarily on a project funded by the Patient-Centered Outcomes (PCORI). This project, Pathways for Perinatal Mental Health Equity (Pathways), is a clinical trial that is being conducted at Lifeline for Families. The Research Coordinator may also work on an innovative research program focused on improving perinatal mental health beginning in the preconception period by developing and evaluating a novel Community Health Worker-facilitated digital intervention that integrates preventative mental health support into primary care settings before pregnancy. By combining scalable digital health technology with community-informed expertise, this work seeks to improve engagement, accessibility, and early intervention for women at risk of perinatal mental health conditions.</div><div><br>
</div><div>For these projects, the Research Coordinator will:</div><br>
<div></div><ul><li>
Participate in qualitative and quantitative data collection and storage.
</li><li>Assist the study team with the creation and dissemination of materials for project team meetings and activities.</li><li>
Work closely with investigators to coordinate project activities and adhere to project work plans.
</li><li>Coordinate communication with all collaborators on the project, including participants, research staff, and project personnel, and support these relationships via active communication.</li></ul>
Responsibilities:
<div><b>
Responsibilities</b></div><ul><li>
Collaborate with investigators in the design, development, and documentation of data forms, questionnaires, and other survey materials</li><li>
Responsible for aspects of the development of research recommendations and the design of research projects</li><li>
Participate in the grant, manuscript, and Institutional Review Board process</li><li>
Develop overall research plan for conducting surveys in the community</li><li>
Conduct in-person or telephonic field research</li><li>
Monitor selection and randomization process of study participants</li><li>
Coordinate data collection of study participants, complete case report forms, and develop and maintain spreadsheets</li><li>
Collect and maintain questionnaires and other data forms from study participants</li><li>
Perform literature searches and write detailed written summaries of the findings</li><li>
Collaborate with other project leaders on data presentation, interpretation and writing of scientific reports</li><li>
Develop and maintain computerized data files for all data to be collected</li><li>
May assist with budget /operational aspect of grant and contract proposals</li><li>
Prepare summary reports and ongoing project evaluations for investigators</li><li>
May help recruit, select, supervise and direct the activities of data collection employees and Research Technicians</li><li>
Conduct quality control check on field data collection system</li><li>
Collaborate with other research sites to insure consistency between research sites and accuracy of documentation</li><li>
Perform other duties as required.</li></ul>
Qualifications:
<div><b>
Qualifications</b></div><ul><li>
Bachelor&rsquo;s degree in the sciences, health care, or equivalent experience</li><li>
1 year of related experience</li><li>
Experience in using computer-based tools (Word, Excel, Access, Outlook, PowerPoint, etc.)</li><li>
Oral and written communication skills</li><li>
Excellent organization, analytical, and interpersonal skills required</li><li>
Ability to travel to off-site locations.</li></ul>
Additional Information:
<div><b>
Additional Responsibilities:</b></div><br>
<div></div><ul><li>
Collect and disseminate questions from the data collection teams for discussion to ensure consistent data collection practices</li><li>
Create and maintain standard operating procedure (SOP) documents for quantitative and qualitative data collection</li><li>
Assist with running analytics, compiling data, and drafting reports</li><li>
Assist with drafting content, formatting and releasing e-newsletters</li><li>
Request and collect data required for reports to funders</li><li>
Attend local and/or national conference</li></ul><p></p><div><b><br>
Preferred Qualifications:</b></div><br>
<div></div><ul><li>
Previous experience with REDCap databases</li><li>
An interest in healthcare research</li><li>
Previous experience with qualitative research</li><li>
An interest in digital health interventions</li></ul></div>

Research Coordinator I

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University of Massachusetts

About Company

University Sergeant (2 positions)

Lab Analyst II NENSP Molecular

Clinical Research Coordinator - Open Rank

Research Coordinator I