Qureos Mentor

CenExel Clinical Research

<div>About Us: 

Each of CenExel&rsquo;s research sites specialize in Phase I to Phase IV clinical trials. Our Centers of Excellence comprise some of the most well respected and long-standing research facilities in the country. Specialty areas of research across our sites include Psychiatry, Acute Post Op Pain, Asian Bridging, Dermatology, GI, and Neurology. Each of our Centers of Excellence has tremendous experience and expertise in complex early phase trials, and all our sites have in-patient capability. We focus on quality people, teamwork, and highly experienced clinical research managers with a history of success. 


Along with an exceptional work environment that promotes teamwork, positive leadership, and optimal work-life balance, CenExel Clinical Research also provides highly competitive compensation and a generous benefits package to full time employees after 30 days of employment including Health Insurance, Dental, Vision, LTD, STD, Life Ins, and 401k. 


Job Summary:
The Research Assistant Sr. independently provides direct support to Clinical Research Coordinators in the completion of protocol-specific study goals while observing strict adherence to ICH, GCP, protocol, and site guidelines and policies. 


Essential Responsibilities and Duties:
<ul>
<li>Creating and maintaining patient charts for all assigned studies.</li>
<li>Preparing participant visits based on CRCs schedule, ensuring all source documents, assessments, lab kits and other visit materials are available and accurate. Filing of lab results, EKG results, and other communication in designated patient charts.</li>
<li>Maintaining inventory of study specific supplies including lab kits, assessments and participant facing materials.</li>
<li>Timely completion of data entry and query resolution for all CRFs, based on sponsor specific timelines and deadlines established in contract or other communication.</li>
<li>Conducts assessments, including but not limited to, blood pressure, urine collection.</li>
<li>Communicating with study participants, caregivers, third party vendors and laboratories as needed.</li>
<li>Assisting Coordinators with scheduling, copying, faxing, and other clerical tasks.</li>
<li>Aiding Coordinators in the facilitation of study monitoring visits.</li>
<li>Completion of daily responsibilities delegated by CRC as they pertain to the study and/or participants.</li>
<li>Assumes other duties and responsibilities as assigned. The above responsibilities are a general description of the level and nature of the work assigned to this classification and are not to be considered as all inclusive.</li></ul> 


Education/Experience/Skills:
<ul>
<li>Must have proper experience and demonstrate mastery of current position.</li>
<li>High school graduate or equivalent.</li>
<li>Excellent computer skills and advanced knowledge of electronic equipment (i.e., e-mail, computer, fax machine, copier, etc.).</li>
<li>Skilled in organization and record maintenance.</li>
<li>Skilled in developing and maintaining effective working relationships with supervisors and co- workers.</li>
<li>Strong personal initiative and attention to detail.</li>
<li>Ability to react calmly and effectively in emergency situations.</li>
<li>Ability to interpret, adapt and apply guidelines and procedures.</li>
<li>Must be able to effectively communicate verbally and in writing.</li>
<li>May require phlebotomy, pharmacy tech., or medical asst. certificate depending on site.</li></ul> 


Working Conditions
<div><ul><li>Indoor, Office environment.</li></ul>
<ul><li>Essential physical requirements include sitting, typing, standing, and walking.</li></ul>
<ul><li>Lightly active position, occasional lifting of up to 20 pounds and/or pushing carts up to 50 lbs.</li></ul>
<ul><li>Reporting to work, as scheduled, is essential.</li></ul>
<ul><li>On site work arrangement.</li></ul></div> 


CenExel Clinical Research is an Equal Opportunity Employer. All applicants will be considered for employment without regards to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or status.
Equal Opportunity Employer 
This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.</div>

Research Assistant Sr.

<div>About Us: 

Each of CenExel&rsquo;s research sites specialize in Phase I to Phase IV clinical trials. Our Centers of Excellence comprise some of the most well respected and long-standing research facilities in the country. Specialty areas of research across our sites include Psychiatry, Acute Post Op Pain, Asian Bridging, Dermatology, GI, and Neurology. Each of our Centers of Excellence has tremendous experience and expertise in complex early phase trials, and all our sites have in-patient capability. We focus on quality people, teamwork, and highly experienced clinical research managers with a history of success. 


Along with an exceptional work environment that promotes teamwork, positive leadership, and optimal work-life balance, CenExel Clinical Research also provides highly competitive compensation and a generous benefits package to full time employees after 30 days of employment including Health Insurance, Dental, Vision, LTD, STD, Life Ins, and 401k. 


Job Summary:
With moderate oversight the Regulatory Coordinator I is responsible for the preparation, organization and implementation of regulatory research documents such as pre-study activities, initiation, execution, and reporting on the various status of research tasks in accordance with FDA guidelines, ICH GCP and SOPs. Maintain regulatory documents in accordance with applicable regulations and coordinate required investigator and study staff training. 


Essential Responsibilities and Duties:
<ul>
<li>Collects, prepares, and submits documentation to various sponsors/CROs during study start-up, including:</li>
<li>o Submission documents/approvals</li>
<li>o Protocol amendments with respective signature pages</li>
<li>o Informed consent documents</li>
<li>o FDA form 1572</li>
<li>o Lab normal result documents</li>
<li>o financial disclosure forms</li>
<li>o Delegation of authority logs</li>
<li>o Licenses</li>
<li>o Reports</li>
<li>o Logs (e.g., temperature logs, drug accountability logs, master subject logs, screening and enrollment logs, specimen logs, etc.)</li>
<li>Collects, prepares, and submits documentation to institutional review boards for all ongoing and new trials.</li>
<li>Serve as a liaison between the IRB, site, and investigator.</li>
<li>Obtain necessary signatures from investigators and staff.</li>
<li>Maintains and tracks current staff credentials (i.e., CV, certifications, etc.)</li>
<li>Maintains and distributes new and revised regulatory documents to applicable site staff and applicable corporate teams.</li>
<li>Refers necessary regulatory questions to Sr. Regulatory Coordinator, Regulatory Manager or Regional Regulatory Manager.</li>
<li>Maintains regulatory documents for ongoing trials, and ensures all appropriate regulatory documents are archived at the conclusion of the study.</li>
<li>Submits applicable subject facing documents for translations.</li>
<li>Maintains current Clinical Conductor Regulatory information.</li>
<li>Prepares appropriate reports for submission as required to the IRB including Serious Adverse Events (SAE&rsquo;s), protocol deviations and other required reports.</li>
<li>Completes onboarding of new Investigators, including CV creation, obtaining medical license, and training documents.</li>
<li>Ensures the regulatory binder is ready for monitor review during monitor visits. Meets with monitor, as necessary.</li>
<li>Assists with regulatory inspections and sponsor audits as necessary.</li>
<li>Performs close-out duties including preparing the final report to the IRB and ensuring all original documents are filed in the regulatory binder. Ensures all appropriate regulatory documents are archived at the conclusion of the study.</li>
<li>Supports and ensures strictest adherence to best practices, FDA Code of Federal Regulations, ICH (International Conference on Harmonization), GCP (Good Clinical Practices), CenExel standard operating procedures, site working Practices, protocol, and company guidelines and policies.</li>
<li>Assumes other duties and responsibilities as assigned. The above responsibilities are a general description of the level and nature of the work assigned to this classification and are not to be considered as all inclusive.</li></ul> 


Education/Experience/Skills:
<ul>
<li>Must be a high school graduate or have GED equivalency.</li>
<li>0-2 years of experience in clinical research regulatory affairs.</li>
<li>Demonstrated prioritization and organizational skills to efficiently and effectively, providing accurate information in a timely manner.</li>
<li>Ability to prioritize workload to meet demands of PI, coordinators, sponsors, and IRBs.</li>
<li>Demonstrated interpersonal skills to work with physicians, administrators, work colleagues, representatives from sponsors and others to achieve maximum efficiency in reaching and maintaining workplace goals in a professional manner.</li>
<li>Ability to understand work may be delegated by more than one person, depending on the individual needs of the clinical study and to carry out job responsibilities as assigned in a timely manner.</li>
<li>Computer skills using PC platform computers with proficiency in Excel and Word to enter data and generate correspondence accurately.</li>
<li>Ability to learn and become proficient in eRegulatory systems, IRB portals, vendor portals and sponsor portals.</li>
<li>A critical thinker with strong attention to detail and superb problem-solving abilities.</li>
<li>Must be able to effectively communicate verbally and in writing.</li></ul> 


Working Conditions
<div><ul><li>Indoor, Office environment.</li></ul>
<ul><li>Essential physical requirements include sitting, typing, standing, and walking.</li></ul>
<ul><li>Lightly active position, occasional lifting of up to 20 pounds.</li></ul>
<ul><li>Reporting to work, as scheduled, is essential.</li></ul>
<ul><li>Ability to work overtime, weekends, and/or holidays as needed.</li></ul>
<ul><li>Ability to travel as needed.</li></ul>
<ul><li>Remote work arrangement depending on location.</li></ul></div> 


CenExel Clinical Research is an Equal Opportunity Employer. All applicants will be considered for employment without regards to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or status.
Equal Opportunity Employer 
This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.</div>

Regulatory Coordinator

<div>About Us: 

Each of CenExel&rsquo;s research sites specialize in Phase I to Phase IV clinical trials. Our Centers of Excellence comprise some of the most well respected and long-standing research facilities in the country. Specialty areas of research across our sites include Psychiatry, Acute Post Op Pain, Asian Bridging, Dermatology, GI, and Neurology. Each of our Centers of Excellence has tremendous experience and expertise in complex early phase trials, and all our sites have in-patient capability. We focus on quality people, teamwork, and highly experienced clinical research managers with a history of success. 


Along with an exceptional work environment that promotes teamwork, positive leadership, and optimal work-life balance, CenExel Clinical Research also provides highly competitive compensation and a generous benefits package to full time employees after 30 days of employment including Health Insurance, Dental, Vision, LTD, STD, Life Ins, and 401k. 


Job Summary:
Responsible for the management of clinical research studies and the personnel assigned to those studies, under the direction of the Clinical Director. 


Essential Responsibilities and Duties:
<ul>
<li>Manages all assigned clinical staff.</li>
<li>Reads and understands assigned protocols and leads and interfaces on such protocols with the study staff to achieve successful execution within appropriate timeframes.</li>
<li>Conducts Site Qualification Visits, as assigned. Schedules and oversees Investigator Meeting arrangements, conducts initiation, study start-up, and team meetings. Oversees scheduling and conduct of monitor visits. Represents the clinical team during site visits.</li>
<li>Oversees preparation of, or personally prepares study-specific source documents for new protocols. Reviews and modifies sponsor-provided source documents, when necessary. Assists Study Coordinators in duties, as necessary.</li>
<li>On assigned protocols, assists to oversee delivery, shipment, inventory, storage, calibration and accountability of investigational products, supplies and equipment required to conduct clinical investigations.</li>
<li>Ensures optimum team function by assisting Clinical Research Coordinators with site start up, enrollment and study execution. Is present for first patient randomized on each study.</li>
<li>Fields protocol questions from Clinical Research Coordinators.</li>
<li>Acts as the project lead, liaising between sites, investigators, monitors, clinical research coordinators, physicians, laboratory, pharmacy staff, and other study team members. Assists with study in-services and other training needs as needed.</li>
<li>Oversees the following aspect of trials but is not limited to: Vendors, Client Satisfaction, Recruitment, Quality, Study Start-up and Trial Outcomes.</li>
<li>Monitoring the progress and completion of routine action items and ensuring timely follow-up.</li>
<li>Ensuring proper internal procedures are followed and documentation is obtained from coordinators for approval of retest, unscheduled visits, admits, AE treatments, etc.</li>
<li>Hires, trains, supervises, and evaluates personnel. Champions and enforces the strictest adherence to best practices, FDA Code of Federal Regulations, ICH (International Conference on Harmonization), GCP (Good Clinical Practices), CenExel standard operating procedures, site Working Practices, protocol, and company guidelines and policies. Retrains and implements corrective and preventative actions, as needed.</li>
<li>Assumes other duties and responsibilities as assigned. The above responsibilities are a general description of the level and nature of the work assigned to this classification and are not to be considered as all inclusive.</li></ul> 


Education/Experience/Skills:
<ul>
<li>Bachelor's degree in related field or equivalent experience is preferred.</li>
<li>Minimum of three years of Clinical Research Coordinator or equivalent experience.</li>
<li>Ability to independently coordinate and manage complex protocols and to lead, motivate and train a clinical research team.</li>
<li>Experience managing and leading staff and implementing personnel procedures.</li>
<li>Professional image, upholding the company vision in actions, demeanor, and appearance.</li>
<li>Must be able to effectively communicate verbally and in writing.</li></ul> 


Working Conditions
<div><ul><li>Indoor, Clinic and Office environment.</li></ul>
<ul><li>Essential physical requirements include sitting, typing, standing, walking.</li></ul>
<ul><li>Lightly active position, occasional lifting of up to 20 pounds.</li></ul>
<ul><li>Reporting to work, as scheduled, is essential.</li></ul>
<ul><li>On site work arrangement.</li></ul></div> 


CenExel Clinical Research is an Equal Opportunity Employer. All applicants will be considered for employment without regards to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or status. 
Equal Opportunity Employer 
This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.</div>

Clinical Trial Manager

<div>About Us: 

Each of CenExel&rsquo;s research sites specialize in Phase I to Phase IV clinical trials. Our Centers of Excellence comprise some of the most well respected and long-standing research facilities in the country. Specialty areas of research across our sites include Psychiatry, Acute Post Op Pain, Asian Bridging, Dermatology, GI, and Neurology. Each of our Centers of Excellence has tremendous experience and expertise in complex early phase trials, and all our sites have in-patient capability. We focus on quality people, teamwork, and highly experienced clinical research managers with a history of success. 


Along with an exceptional work environment that promotes teamwork, positive leadership, and optimal work-life balance, CenExel Clinical Research also provides highly competitive compensation and a generous benefits package to full time employees after 30 days of employment including Health Insurance, Dental, Vision, LTD, STD, Life Ins, and 401k. 


Job Summary:
Responsible for assisting with coordinating clinical trials with the strictest adherence to ICH (International Conference on Harmonization), GCP (Good Clinical Practices), protocol, and company guidelines, regulations, and policies. 


Essential Responsibilities and Duties:
<ul>
<li>Assists with coordinating all aspects of patient involvement from study initiation until study completion.</li>
<li>Organizes research information for clinical trials.</li>
<li>Observes subjects and assists with data analysis and reporting.</li>
<li>Schedules the collection of data.</li>
<li>Documents adverse events, protocol deviations, and other unanticipated problems appropriately.</li>
<li>Reports research data to maintain quality and compliance.</li>
<li>Performs administrative and regulatory duties related to the study as appropriate.</li>
<li>Participates in other protocol development activities.</li>
<li>Ensures site receives accurate information and supplies from sponsors (i.e.: source, protocol, scales, supplies, approvals, contacts, etc.)</li>
<li>Educates potential participants and caregivers on protocol specific details and expectations.</li>
<li>Performs safety and efficacy assessments per protocol (vital signs, EKGs, blood draws and other assessments as assigned).</li>
<li>Assumes other duties and responsibilities as assigned. The above responsibilities are a general description of the level and nature of the work assigned to this classification and are not to be considered as all inclusive.</li></ul> 


Education/Experience/Skills:
<ul>
<li>High school graduate or equivalent; Bachelors Degree, preferred.</li>
<li>0-3 years of experience in the medical field.</li>
<li>Knowledge and understanding of Federal regulations protecting human subjects in research and that govern the conduct of clinical trials.</li>
<li>Strong leadership and mentorship skills.</li>
<li>Developing and maintaining effective working relationships at all levels of the organization, along with those at the sponsor and vendor level.</li>
<li>Crisis management and problem solving skills; ability to react calmly and effectively in emergent situations.</li>
<li>Works independently as well as functioning as part of a team.</li>
<li>Must be able to effectively communicate verbally and in writing in English and Spanish.</li></ul> 


Working Conditions
<div><ul><li>Indoor, Office environment.</li></ul>
<ul><li>Shift work, depending on location.</li></ul>
<ul><li>Essential physical requirements include sitting, typing, standing, and walking.</li></ul>
<ul><li>Lightly active position, occasional lifting of up to 20 pounds. Rarely lift over 20 pounds.</li></ul>
<ul><li>Reporting to work, as scheduled, is essential.</li></ul>
<ul><li>Overnight travel may be required for training and/or investigative meetings.</li></ul></div> 


CenExel Clinical Research is an Equal Opportunity Employer. All applicants will be considered for employment without regards to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or status.
Equal Opportunity Employer 
This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.</div>

Clinical Research Coordinator

<div>About Us: 

Each of CenExel&rsquo;s research sites specialize in Phase I to Phase IV clinical trials. Our Centers of Excellence comprise some of the most well respected and long-standing research facilities in the country. Specialty areas of research across our sites include Psychiatry, Acute Post Op Pain, Asian Bridging, Dermatology, GI, and Neurology. Each of our Centers of Excellence has tremendous experience and expertise in complex early phase trials, and all our sites have in-patient capability. We focus on quality people, teamwork, and highly experienced clinical research managers with a history of success. 


Along with an exceptional work environment that promotes teamwork, positive leadership, and optimal work-life balance, CenExel Clinical Research also provides highly competitive compensation and a generous benefits package to full time employees after 30 days of employment including Health Insurance, Dental, Vision, LTD, STD, Life Ins, and 401k. 


Job Summary:
Responsible for performing various clinical and neurocognitive test evaluations and interview/ratings on study participants specific to the study protocol. To administer and score assessments confirming diagnosis, assessing cognitive, neuropsychological, behavioral, and functional status. 


Essential Responsibilities and Duties:
<ul>
<li>Administers clinical rating scales on study participants to confirm diagnosis and determine current levels of psychopathology and function.</li>
<li>Responsible for completing organizational queries regarding clinical scales and neuropsych ratings.</li>
<li>Utilize interpersonal and clinical skills to assist in appropriate management of study participants across multiple therapeutic areas within neuroscience.</li>
<li>Actively participates in acquiring on-going knowledge and instruction.</li>
<li>Assists management in maintaining a positive, motivated work environment.</li>
<li>Responsible for assisting PI to maintain integrity of data derived from clinical ratings scale and neurocognitive testing for all studies.</li>
<li>Ensures data collection continuity during absences/sick leave/vacation of ratings staff including documentation of consensus between back-up and primary ratings.</li>
<li>Conducts clinical research consensus rounds concerning accurate signal detection with clinical subject ratings</li>
<li>Participates in assessment of prescreened and screening patients per PI discretion and as per protocol.</li>
<li>Complete required study specific trainings in a timely manner.</li>
<li>Supports and ensures strictest adherence to best practices, FDA Code of Federal Regulations, ICH (International Conference on Harmonization), GCP (Good Clinical Practices), CenExel standard operating procedures, site working Practices, protocol, and company guidelines and policies.</li>
<li>Assumes other duties and responsibilities as assigned. The above responsibilities are a general description of the level and nature of the work assigned to this classification and are not to be considered as all inclusive.</li></ul> 


Education/Experience/Skills:
<ul>
<li>Must be able to effectively communicate verbally and in writing in English and Spanish.</li>
<li>Master&rsquo;s Degree and/or Ph.D/Psy.D in Psychology required.</li>
<li>Minimum 2 years clinical experience with the mental health population.</li>
<li>Skill in organization and problem solving.</li>
<li>Skill in maintaining records.</li>
<li>Skill in developing and maintaining effective working relationships with study participants, families, staff and the public.</li>
<li>Ability to complete paperwork with precision and attention to detail.</li>
<li>Ability to interpret, adapt and apply guidelines and procedures.</li>
<li>Ability to work independently as well as functioning as part of a team.</li></ul> 


Working Conditions
<div><ul><li>Indoor, Clinic environment.</li></ul>
<ul><li>Essential physical requirements include sitting, typing, standing, walking.</li></ul>
<ul><li>Lightly active position, occasional lifting of up to 20 pounds.</li></ul>
<ul><li>Reporting to work, as scheduled, is essential.</li></ul>
<ul><li>On site work arrangement.</li></ul></div> 


CenExel Clinical Research is an Equal Opportunity Employer. All applicants will be considered for employment without regards to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or status.
Equal Opportunity Employer 
This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.</div>

Clinical Rater