Clinical Research Associate jobs at PRA Health Sciences - 25 jobs

Artech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets, refresh existing skill base, allow for flexibility in project planning and execution phases, and provide budgeting/financial flexibility by offering contingent labor as a variable cost. Job Description • The Study Specialist will augment activities performed by existing study team members whether from client or client's preferred CROs by providing support to CRA activities to ensure adherence to study timelines and deliverables. • This position will provide site level problem solving expertise for complex rare disease clinical studies in early and late phase development. • Position will support all site management activities, which may include operational activities related to site evaluation, initiation, monitoring and close out for assigned clinical study sites to ensure compliance with ICH/Good Clinical Practices (GCP), client SOPs, protocol and patient safety. Organizational Relationships: • Oversight by client Clinical Operations Study Team Lead • Role will lease with client Compliance Oversight Lead for monitoring related activities if they occur • Interfaces with cross-functional study team members in a matrix environment (e.g., CRO Project Lead) Primary Duties: • Removing site obstacles to site start-up, maintenance and close-out while maintaining awareness of site dynamics with ability to motivate and educate site staff • Exhibits ability to independently and proactively identify and interpret problems, recommend creative solutions, drive resolution, and influence appropriate changes • Liaise with site, sponsor and CRO to provide site issue identification and resolution bringing sites to initiation, readiness to enroll and recruitment for assigned clinical research sites • Point of escalation for clinically identified site related issues • Problem solves identified issues (monitoring and/or regulatory) with appropriate escalation to Project Manager and/or designee • Supports the management of multiple academic sites (e.g., clinical research naive requiring in depth coordination and support) • Assures protection of the rights, safety, and wellbeing of subjects, study integrity and data quality • Supports inspection readiness including for example the facilitation of the collection and maintenance of regulatory and site documentation for the Trial Master File and site file • Supports local IRB workflow, submission through approval and reporting of safety information and may prepare answers, as required, to the IRB in conjunction with study team/Client • Completes assigned training as necessary, including general training requirements, SOPs, system and process related training, and protocol specific training. • Complies with all departmental objectives and metrics related to study execution • Attend/lead/facilitate meetings as requested (i.e. investigator, project) to gain and/or share project/site knowledge Secondary Duties • As needed, performs site development and training (supporting and coaching site personnel), site monitoring, and site close-out activities for assigned clinical research sites with designated project SOPs, Client expectations, study specific protocol and GCPs • As needed, supports activities such as but not limited to source data verification, case report form review, AE/SAE review and reconciliation, IP accountability, questionnaire reconciliation, equipment maintenance, supplies tracking and query resolution • Complies with the Clinical Monitoring Plan (CMP) and becomes knowledgeable of the protocol to guide assigned sites in the proper conduct of the study • Potential to complete monitoring reports in compliance with requirements in the Clinical Monitoring Plan Training and Education Preferred: • Bachelor's Degree in Life Science, RN preferred • Minimum 5 years of study management experience with preferred focus in Rare Diseases (for example Sickle Cell Disease and/or other genetic hematological diseases) and experience in on-site monitoring • Expertise in study start up and site management (experience in complex hospital-based Phase 3 clinical trials highly desirable) • Demonstrated ability to problem solve and to prioritize site related activities • Demonstrates solid understanding of drug development and clinical practices • Understands and is able to comprehend study protocols • Has knowledge of FDA regulations • Possesses working knowledge of GCPs and other regulations governing clinical research • Demonstrates technical expertise in computer skills • Demonstrates diligent and self-motivated approach to working in an independent environment • Demonstrates effective oral and written communication skills • Travel anticipated at 25% but could up to 50% at times. Qualifications BS/MS Additional Information For more information, please contact Akriti Gupta ************** Morristown, NJ 07960

Artech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets, refresh existing skill base, allow for flexibility in project planning and execution phases, and provide budgeting/financial flexibility by offering contingent labor as a variable cost. Job Description • The Study Specialist will augment activities performed by existing study team members whether from client or client's preferred CROs by providing support to CRA activities to ensure adherence to study timelines and deliverables. • This position will provide site level problem solving expertise for complex rare disease clinical studies in early and late phase development. • Position will support all site management activities, which may include operational activities related to site evaluation, initiation, monitoring and close out for assigned clinical study sites to ensure compliance with ICH/Good Clinical Practices (GCP), client SOPs, protocol and patient safety. Organizational Relationships: • Oversight by client Clinical Operations Study Team Lead • Role will lease with client Compliance Oversight Lead for monitoring related activities if they occur • Interfaces with cross-functional study team members in a matrix environment (e.g., CRO Project Lead) Primary Duties: • Removing site obstacles to site start-up, maintenance and close-out while maintaining awareness of site dynamics with ability to motivate and educate site staff • Exhibits ability to independently and proactively identify and interpret problems, recommend creative solutions, drive resolution, and influence appropriate changes • Liaise with site, sponsor and CRO to provide site issue identification and resolution bringing sites to initiation, readiness to enroll and recruitment for assigned clinical research sites • Point of escalation for clinically identified site related issues • Problem solves identified issues (monitoring and/or regulatory) with appropriate escalation to Project Manager and/or designee • Supports the management of multiple academic sites (e.g., clinical research naive requiring in depth coordination and support) • Assures protection of the rights, safety, and wellbeing of subjects, study integrity and data quality • Supports inspection readiness including for example the facilitation of the collection and maintenance of regulatory and site documentation for the Trial Master File and site file • Supports local IRB workflow, submission through approval and reporting of safety information and may prepare answers, as required, to the IRB in conjunction with study team/Client • Completes assigned training as necessary, including general training requirements, SOPs, system and process related training, and protocol specific training. • Complies with all departmental objectives and metrics related to study execution • Attend/lead/facilitate meetings as requested (i.e. investigator, project) to gain and/or share project/site knowledge Secondary Duties • As needed, performs site development and training (supporting and coaching site personnel), site monitoring, and site close-out activities for assigned clinical research sites with designated project SOPs, Client expectations, study specific protocol and GCPs • As needed, supports activities such as but not limited to source data verification, case report form review, AE/SAE review and reconciliation, IP accountability, questionnaire reconciliation, equipment maintenance, supplies tracking and query resolution • Complies with the Clinical Monitoring Plan (CMP) and becomes knowledgeable of the protocol to guide assigned sites in the proper conduct of the study • Potential to complete monitoring reports in compliance with requirements in the Clinical Monitoring Plan Training and Education Preferred: • Bachelor's Degree in Life Science, RN preferred • Minimum 5 years of study management experience with preferred focus in Rare Diseases (for example Sickle Cell Disease and/or other genetic hematological diseases) and experience in on-site monitoring • Expertise in study start up and site management (experience in complex hospital-based Phase 3 clinical trials highly desirable) • Demonstrated ability to problem solve and to prioritize site related activities • Demonstrates solid understanding of drug development and clinical practices • Understands and is able to comprehend study protocols • Has knowledge of FDA regulations • Possesses working knowledge of GCPs and other regulations governing clinical research • Demonstrates technical expertise in computer skills • Demonstrates diligent and self-motivated approach to working in an independent environment • Demonstrates effective oral and written communication skills • Travel anticipated at 25% but could up to 50% at times. Qualifications BS/MS Additional Information For more information, please contact Akriti Gupta ************** Morristown, NJ 07960

Artech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets, refresh existing skill base, allow for flexibility in project planning and execution phases, and provide budgeting/financial flexibility by offering contingent labor as a variable cost. Job Title: Clinical Study Manager-Remote Location: Collegeville, PA Duration: 36 months Job Description: This position is needed to assist with Inspection Readiness Prepartion. The candidate will need to assist in leading diverse CRO teams through the Inspection Readiness process. Strong pTMF experience is also desired. A large component of the position will be to search for documents in pTMF and work with 2 different CRO to ensure that all documents are present in pTMF. Strong understanding of clinical trial documents is needed as well as a thorough understanding of a sponsor Inspection. The candidate should be flexible and able to positvely influence CRO staff while meeting the needs of the business. The candidate will also be asked to assist with filing protocol amendments in pTMF, ICD updates, and helping the COSTL and Clinican with tasks on an ad hoc basis. The candidate will lead 2 CROs through Inspection Readiness Activities for a large, high visibility, global oncology protocol that is in submission. The candidate needs to be able to influence and lead the 2 CROs through the Inspection Readiness checklist (~500 items). All items on the checklist will need to be reviewed, the location of the documents will need to be identified and entered onto the checklist. The candidate will need to be able to navigate through pTMF to ensure all documents are in pTMF in the correct cabinet and folder. The candidate will need to be proficient at searching for documents such as Monitoring Visit Reports, Financial Disclosure Documents, SOPs, vendor oversight plans. The candidate will need to compile a listing of relevant SOPs used on the study both past and present and download those SOPs into folders on a sharepoint space. The candidate will need to be comfortable leading 2 CROs in document retrieval and ensuring all Inspection Readiness Documents are up to date with the correct versions. The candidate will need to work with the 2 CROs for any corrections or updates needed. Additional Skills: pTMF, Inspection Readiness activities, Study conduct activities. Qualifications BS Additional Information For More information, Contact Best Regards, Akriti Gupta ************** Morristown, NJ 07960

Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing. 70% of an average work week, so about 28 hours/week. Preferably working from New Haven, CT. Contractor will need to train onsite and then be able to work remote Job description: Provide product training and support to clinical sites for the pill cam procedure. Support the randomization process and act as the IWRS PRIMARY Administrator Arranging and participating in the organization of study team meetings Taking minutes and distributing Managing and maintaining study documents and trial supplies, colonoscopy forceps, FedEx envelop, IWRS User information. Administer, Maintain and coordinate the logistic aspects of clinical trials according to GCP and Sop's Ensure That any clinical trial databases/tracking tools are set up and maintained throughout the trial Assist with collating, tracking & shipping CRFs & Data queries to data management Maintaining study data control table Review and approve monitoring reports in Siebel CTM SW update Coordinating archiving of study documentation Perform and support study site qualification, Initiation interim monitoring and closeout visits according to SOP's GCP's, FDA regulation and ICH guidelines at multiple investigational sites Ensure safety and welfare of Patient enrolled in clinical study Site management to ensure Compliance Ensure integrity of data reported Helping in setting up the Study centers, Which includes ensuring each center has the trial materials and training site staff to trial-specific standards Administrative support for CA and date management team including: shipment training records and inventory control. Qualifications Bachelor's degree Engineering/ (B.A./B.S.C./Other) Experience required: 0-2 years Additional Information Feel free to forward my email to your friends/colleagues who might be available. We do offer referral bonus Thank you for your time and consideration. I look forward to hearing from you! Warm Regards, Nisha Integrated Resources, Inc. IT REHAB CLINICAL NURSING Inc. 5000 - 2007, 2008, 2009, 2010, 2011, 2012 ,2013 and 2014 (8th Year) Certified MBE I GSA - Schedule 66 I GSA - Schedule 621I I GSA - Schedule 70 Direct: (732)-429-1649 Tel: (732) 549 2030 x 230 Fax: (732) 549 5549

Integrated Resources, Inc., is led by a seasoned team with combined decades in the industry. We deliver strategic workforce solutions that help you manage your talent and business more efficiently and effectively. Since launching in 1996, IRI has attracted, assembled and retained key employees who are experts in their fields. This has helped us expand into new sectors and steadily grow. Job Description Contractor will need to train onsite for 3 months and then be able to work remote. · Provide product training and support to clinical sites for the pill cam procedure. · Support the randomization process and act as the IWRS PRIMARY Administrator · Arranging and participating in the organization of study team meetings Taking minutes and distributing · Managing and maintaining study documents and trial supplies, colonoscopy forceps, FedEx envelop, IWRS User information. · Administer, Maintain and coordinate the logistic aspects of clinical trials according to GCP and Sop's · Ensure That any clinical trial databases/tracking tools are set up and maintained throughout the trial · Assist with collating, tracking & shipping CRFs & Data queries to data management · Maintaining study data control table · Review and approve monitoring reports in Siebel · CTM SW update · Coordinating archiving of study documentation · Perform and support study site qualification, Initiation interim monitoring and closeout visits according to SOP's GCP's, FDA regulation and ICH guidelines at multiple investigational sites · Ensure safety and welfare of Patient enrolled in clinical study · Site management to ensure Compliance · Ensure integrity of data reported · Helping in setting up the Study centers, Which includes ensuring each center has the trial materials and training site staff to trial-specific standards · Administrative support for CA and date management team including: shipment training records and inventory control. Qualifications Bachelor's degree Engineering/ (B.A./B.S.C./Other) Experience required: 0-2 years Additional Information Kind Regards, Sasha Sharma Clinical Recruiter Integrated Resources, Inc. IT Life Sciences Allied Healthcare CRO DIRECT # - 732-662-7964

Huron helps its clients drive growth, enhance performance and sustain leadership in the markets they serve. We collaborate with education organizations to develop strategies and implement solutions that enable the transformative change our clients need to own their future. Together, we empower clients to drive innovation, create sustainable funding streams and deliver better student outcomes. Today, leaders of higher education institutions and academic medical centers are spending too much time reacting to market forces, rather than focusing on the essential priorities that help students, faculty and staff thrive. The most productive path forward requires an intentional approach and innovative thinking, whereby stakeholders across the entire institution rally around a shared vision and embrace the hard work of effecting change. You'll help our clients to achieve organizational effectiveness, improve student outcomes, implement new technologies and align resources and investments to ensure long-term sustainability. Join our team as the expert you are now and create your future. Your passion and expertise in clinical research will make you a key member of Huron's Research Office Team. As a Clinical Research Administrative Specialist II, you'll assist Huron's Research Office team in developing coverage analysis reports, study budgets, study calendars, charge segregation, and other trial documentation required for clinical research studies, including industry, federally sponsored, and locally (investigator) sponsored research. You will also assist in review and feedback for Clinical Research Administrative Specialist I projects and will begin to support client contacts for client specific needs. You'll have the opportunity to expand upon your working knowledge and experience with clinical trial regulation, and to develop strong skills in the variety of service lines Huron's Research Office offers **Essential Duties:** + Calendar development for multiple clients including the creation of arms, segments, procedures, and visit assignments in accordance with Huron and industry standards in Clinical Trial Management Systems ("CTMS"). + Financial console build including adding protocol related elements, parameters, specifications, subject related items, and milestones for both new and legacy clinical trials in CTMS. + Coverage Analysis development for multiple clients in accordance with Huron and industry standards both in Excel and in client CTMS. + Other research administrative back-office deliverable development including by not limited to, budget development and negotiation, sponsor invoicing, account receivable management and reconciliation, and regulatory administrative support. **Required Qualifications:** + U.S. work authorization is required. + Bachelor's degree required in a health/science related discipline (biology, public health, healthcare administration, nursing, etc.) or equivalent professional experience. + A minimum of 3 years of clinical research administration related experience including exposure to coverage analysis, clinical trial budgeting, and/or CTMS calendar or financial console development. + Ability to interpret and apply clinical guidelines including Centers for Medicare and Medicaid, Federal Drug Administration, National Comprehensive Cancer Network. + Highly detail oriented with the ability to provide quality assurance or develop back-office research related deliverables with minimal to no errors. + Intermediate Excel competency + This is a full time US-REMOTE role. This salaried position may require working additional hours at times, depending on business needs. **Preferred Qualifications:** + Experience with at least one of the following CTMS / CRMS is preferable: **Forte Research System's OnCore** , Study Manager's Reveal, Velos's eResearch and Patient Protocol Manager. + Experience with conducting Quality Assurance reviews. + Experience developing others including providing training for new skills. + Experience drafting standard operating procedures or other process documents. The estimated base salary range for this job is $65,000 - $95,000. The range represents a good faith estimate of the range that Huron reasonably expects to pay for this job at the time of the job posting. The actual salary paid to an individual will vary based on multiple factors, including but not limited to specific skills or certifications, years of experience, market changes, and required travel. This job is also eligible to participate in Huron's annual incentive compensation program, which reflects Huron's pay for performance philosophy. Inclusive of annual incentive compensation opportunity, the total estimated compensation range for this job is $70,200 - $112,100. The job is also eligible to participate in Huron's benefit plans which include medical, dental and vision coverage and other wellness programs. The salary range information provided is in accordance with applicable state and local laws regarding salary transparency that are currently in effect and may be implemented in the future. **Position Level** Senior Analyst **Country** United States of America At Huron, we're redefining what a consulting organization can be. We go beyond advice to deliver results that last. We inherit our client's challenges as if they were our own. We help them transform for the future. We advocate. We make a difference. And we intelligently, passionately, relentlessly do great work...together. Are you the kind of person who stands ready to jump in, roll up your sleeves and transform ideas into action? Then come discover Huron. Whether you have years of experience or come right out of college, we invite you to explore our many opportunities. Find out how you can use your talents and develop your skills to make an impact immediately. Learn about how our culture and values provide you with the kind of environment that invites new ideas and innovation. Come see how we collaborate with each other in a culture of learning, coaching, diversity and inclusion. And hear about our unwavering commitment to make a difference in partnership with our clients, shareholders, communities and colleagues. Huron Consulting Group offers a competitive compensation and benefits package including medical, dental, and vision coverage to employees and dependents; a 401(k) plan with a generous employer match; an employee stock purchase plan; a generous Paid Time Off policy; and paid parental leave and adoption assistance. Our Wellness Program supports employee total well-being by providing free annual health screenings and coaching, bank at work, and on-site workshops, as well as ongoing programs recognizing major events in the lives of our employees throughout the year. All benefits and programs are subject to applicable eligibility requirements. Huron is fully committed to providing equal employment opportunity to job applicants and employees in recruitment, hiring, employment, compensation, benefits, promotions, transfers, training, and all other terms and conditions of employment. Huron will not discriminate on the basis of age, race, color, gender, marital status, sexual orientation, gender identity, pregnancy, national origin, religion, veteran status, physical or mental disability, genetic information, creed, citizenship or any other status protected by laws or regulations in the locations where we do business. We endeavor to maintain a drug-free workplace.

Huron helps its clients drive growth, enhance performance and sustain leadership in the markets they serve. We collaborate with education organizations to develop strategies and implement solutions that enable the transformative change our clients need to own their future. Together, we empower clients to drive innovation, create sustainable funding streams and deliver better student outcomes. Today, leaders of higher education institutions and academic medical centers are spending too much time reacting to market forces, rather than focusing on the essential priorities that help students, faculty and staff thrive. The most productive path forward requires an intentional approach and innovative thinking, whereby stakeholders across the entire institution rally around a shared vision and embrace the hard work of effecting change. You'll help our clients to achieve organizational effectiveness, improve student outcomes, implement new technologies and align resources and investments to ensure long-term sustainability. Join our team as the expert you are now and create your future. Your passion and expertise in clinical research will make you a key member of Huron's Research Office Team. As a Clinical Research Administrative Specialist II, you'll assist Huron's Research Office team in developing coverage analysis reports, study budgets, study calendars, charge segregation, and other trial documentation required for clinical research studies, including industry, federally sponsored, and locally (investigator) sponsored research. You will also assist in review and feedback for Clinical Research Administrative Specialist I projects and will begin to support client contacts for client specific needs. You'll have the opportunity to expand upon your working knowledge and experience with clinical trial regulation, and to develop strong skills in the variety of service lines Huron's Research Office offers Essential Duties: Calendar development for multiple clients including the creation of arms, segments, procedures, and visit assignments in accordance with Huron and industry standards in Clinical Trial Management Systems (“CTMS”). Financial console build including adding protocol related elements, parameters, specifications, subject related items, and milestones for both new and legacy clinical trials in CTMS. Coverage Analysis development for multiple clients in accordance with Huron and industry standards both in Excel and in client CTMS. Other research administrative back-office deliverable development including by not limited to, budget development and negotiation, sponsor invoicing, account receivable management and reconciliation, and regulatory administrative support. Required Qualifications: U.S. work authorization is required. Bachelor's degree required in a health/science related discipline (biology, public health, healthcare administration, nursing, etc.) or equivalent professional experience. A minimum of 3 years of clinical research administration related experience including exposure to coverage analysis, clinical trial budgeting, and/or CTMS calendar or financial console development. Ability to interpret and apply clinical guidelines including Centers for Medicare and Medicaid, Federal Drug Administration, National Comprehensive Cancer Network. Highly detail oriented with the ability to provide quality assurance or develop back-office research related deliverables with minimal to no errors. Intermediate Excel competency This is a full time US-REMOTE role. This salaried position may require working additional hours at times, depending on business needs. Preferred Qualifications: Experience with at least one of the following CTMS / CRMS is preferable: Forte Research System's OnCore™, Study Manager's Reveal, Velos's eResearch and Patient Protocol Manager. Experience with conducting Quality Assurance reviews. Experience developing others including providing training for new skills. Experience drafting standard operating procedures or other process documents. The estimated base salary range for this job is $65,000 - $95,000. The range represents a good faith estimate of the range that Huron reasonably expects to pay for this job at the time of the job posting. The actual salary paid to an individual will vary based on multiple factors, including but not limited to specific skills or certifications, years of experience, market changes, and required travel. This job is also eligible to participate in Huron's annual incentive compensation program, which reflects Huron's pay for performance philosophy. Inclusive of annual incentive compensation opportunity, the total estimated compensation range for this job is $70,200 - $112,100. The job is also eligible to participate in Huron's benefit plans which include medical, dental and vision coverage and other wellness programs. The salary range information provided is in accordance with applicable state and local laws regarding salary transparency that are currently in effect and may be implemented in the future. Position LevelSenior AnalystCountryUnited States of America

Huron helps its clients drive growth, enhance performance and sustain leadership in the markets they serve. We collaborate with education organizations to develop strategies and implement solutions that enable the transformative change our clients need to own their future. Together, we empower clients to drive innovation, create sustainable funding streams and deliver better student outcomes. Today, leaders of higher education institutions and academic medical centers are spending too much time reacting to market forces, rather than focusing on the essential priorities that help students, faculty and staff thrive. The most productive path forward requires an intentional approach and innovative thinking, whereby stakeholders across the entire institution rally around a shared vision and embrace the hard work of effecting change. You'll help our clients to achieve organizational effectiveness, improve student outcomes, implement new technologies and align resources and investments to ensure long-term sustainability. Join our team as the expert you are now and create your future. Your passion and expertise in clinical research will make you a key member of Huron's Research Office Team. As a Clinical Research Administrative Specialist II, you'll assist Huron's Research Office team in developing coverage analysis reports, study budgets, study calendars, charge segregation, and other trial documentation required for clinical research studies, including industry, federally sponsored, and locally (investigator) sponsored research. You will also assist in review and feedback for Clinical Research Administrative Specialist I projects and will begin to support client contacts for client specific needs. You'll have the opportunity to expand upon your working knowledge and experience with clinical trial regulation, and to develop strong skills in the variety of service lines Huron's Research Office offers **Required:** + U.S. work authorization is required + Huron requires a bachelor's degree in a field related to this position or equivalent work experience + A minimum of 3 years of clinical research administration related experience + Experience developing clinical research budgets + Experience in coverage analysis **This is a full time US-REMOTE role. This salaried position may require working additional hours at times, depending on business needs. **Preferred:** *****Coverage Analysis experience is highly desired***** + Clinical Trials Policy and Research Billing Rules Knowledge: Experience in clinical trials policy and other applicable research billing rules. Experience applying the policy to clinical trial protocols for coverage determination. + Quality Assurance Expertise: Experience with conducting Quality Assurance reviews, aiming to significantly reduce the QA burden. + Medical Coding/Billing Experience: Background in medical coding or billing or degree in Health Information Management. + Professional Communication Proficiency: Demonstrated experience interacting with individuals at various levels in an organization and providing timely updates both from an internal and external standpoint. + Innovative Problem Solving: Ability to contribute to innovative solutions and process improvements in clinical trial coverage analysis and budgeting. + Training and Mentorship: Experience in providing guidance and training to junior staff, fostering a culture of continuous improvement and skill development. + Industry Knowledge: Staying abreast of industry trends and regulatory changes to maintain expertise. The estimated base salary range for this job is $72,000 - $88,000. The range represents a good faith estimate of the range that Huron reasonably expects to pay for this job at the time of the job posting. The actual salary paid to an individual will vary based on multiple factors, including but not limited to specific skills or certifications, years of experience, market changes, and required travel. This job is also eligible to participate in Huron's annual incentive compensation program, which reflects Huron's pay for performance philosophy. Inclusive of annual incentive compensation opportunity, the total estimated compensation range for this job is $77,760 - $98,60. The job is also eligible to participate in Huron's benefit plans which include medical, dental and vision coverage and other wellness programs. The salary range information provided is in accordance with applicable state and local laws regarding salary transparency that are currently in effect and may be implemented in the future. **Position Level** Senior Analyst **Country** United States of America At Huron, we're redefining what a consulting organization can be. We go beyond advice to deliver results that last. We inherit our client's challenges as if they were our own. We help them transform for the future. We advocate. We make a difference. And we intelligently, passionately, relentlessly do great work...together. Are you the kind of person who stands ready to jump in, roll up your sleeves and transform ideas into action? Then come discover Huron. Whether you have years of experience or come right out of college, we invite you to explore our many opportunities. Find out how you can use your talents and develop your skills to make an impact immediately. Learn about how our culture and values provide you with the kind of environment that invites new ideas and innovation. Come see how we collaborate with each other in a culture of learning, coaching, diversity and inclusion. And hear about our unwavering commitment to make a difference in partnership with our clients, shareholders, communities and colleagues. Huron Consulting Group offers a competitive compensation and benefits package including medical, dental, and vision coverage to employees and dependents; a 401(k) plan with a generous employer match; an employee stock purchase plan; a generous Paid Time Off policy; and paid parental leave and adoption assistance. Our Wellness Program supports employee total well-being by providing free annual health screenings and coaching, bank at work, and on-site workshops, as well as ongoing programs recognizing major events in the lives of our employees throughout the year. All benefits and programs are subject to applicable eligibility requirements. Huron is fully committed to providing equal employment opportunity to job applicants and employees in recruitment, hiring, employment, compensation, benefits, promotions, transfers, training, and all other terms and conditions of employment. Huron will not discriminate on the basis of age, race, color, gender, marital status, sexual orientation, gender identity, pregnancy, national origin, religion, veteran status, physical or mental disability, genetic information, creed, citizenship or any other status protected by laws or regulations in the locations where we do business. We endeavor to maintain a drug-free workplace.

Sr. CRA , Midwest, Remote ( Michigan, Ohio, Illinois, Wisconsin, Indiana ) ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. We are currently seeking a Senior Clinical Research Associate (CRA) in the Midwest Region to join our diverse and dynamic team. As a Senior CRA at ICON Plc, you will play a critical role in overseeing and managing clinical trial activities to ensure they are conducted according to protocol, regulatory requirements, and industry standards. You will contribute to the success of clinical trials by ensuring data integrity, participant safety, and compliance throughout the study lifecycle. Ideal locations would be: * Kansas City, MO * St. Louis, MO * Des Moines, IA * Wichita, KS, * Chicago, IL * Omaha, NE What You Will Be Doing: * Perform site management activities to support Oncology site success and maintain a continuous state of inspection readiness * Act as the primary contact and facilitate efficient communications between the clinical trial team and the sites * Perform remote and on-site monitoring/co-monitoring visits (Site Qualification Visits, Site Initiation Visits, Interim Monitoring Visits and Close-Out Visits) to ensure data integrity and subject safety in trials * May perform oversight activities to assess monitoring quality and train/mentor less experienced CRAs * Promptly document monitoring activities and submit/approve visit reports * Manage site essential document collection and TMF reconciliation with site files * Support sites with local Institutional Review Board (IRB)/Ethics Committee (EC) submissions and confirm approvals * Regularly review site Key Risk Indicator (KRI) metrics, issues and action items to detect trends and ensure prompt resolution * Independently determine root causes and develop/implement site Corrective Action and Preventive Action (CAPA) plans * Deliver training to ensure sites comply with the protocol, Standard Operating Procedures (SOPs), Good Clinical Practices (GCPs) and regulations * Support sites during regulatory inspections * Contribute to site identification; drive site feasibility and qualification progress; and support site activation activities * Lead site engagement initiatives and foster relationships with key Oncology sites and networks Your Profile: * Bachelor's degree (scientific field preferred) * 5+ years monitoring Oncology trials independently conducting on-site and remote monitoring visits * 1+ years early development trial experience preferred * Solid tumor clinical trial experience is preferred * Experience utilizing Veeva CTMS for report writing is required * Demonstrated experience developing/maintaining site relationships and securing compliance * Expertise in GCPs and Oncology monitoring techniques (including Risk-Based Monitoring) and terminology * Experience collaborating with sites from initial engagement through close-out phases * Experience activating sites * Experience training site staff * Experience supporting sites and/or sponsors in regulatory inspections * Experience working within an FSP (or in-house) monitoring model is preferred * Willing to travel up to 50% domestically * Reside in Midwest Region USA What ICON can offer you: Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: * Various annual leave entitlements * A range of health insurance offerings to suit you and your family's needs. * Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. * Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family's well-being. * Life assurance * Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others. Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles. Are you a current ICON Employee? Please click here to apply

Ibis Reproductive Health is a global nonprofit driving change through bold, rigorous research, and principled partnerships that advance sexual and reproductive autonomy, choices, and health worldwide. We believe that research can catalyze change when the entire research process is viewed as an opportunity to shift power, is undertaken in partnership with the communities most affected, and includes a focus on how data can be most effectively used to make change. We focus on increasing access to quality abortion care, transforming access to abortion and contraception through technology and service innovations, and expanding comprehensive sexual and reproductive health information and services. Ibis works with partners in more than 30 countries on six continents, through our offices are located in Cambridge, MA and Oakland CA, USA; and Johannesburg, South Africa. For more information, visit: ******************************* We seek an individual with a commitment to sexual and reproductive health, rights, and justice who is keen to support rigorous research across our organization. The Research Coordinator will work on a randomized clinical trial comparing two medication abortion regimens, as well as a research project focused on supporting the needs and experiences of abortion seekers now and in the future. Tasks include, but are not limited to, data collection, entry, and management; implementation of data validation and quality assurance systems; support for complex survey response tracking and participant remuneration; data coding; implementation of data analysis and results creation tasks; protocol development; study team and meeting coordination; and overall project support. Additional administrative tasks may include assisting with scheduling, the management of technology systems, and logistical support for meetings. Ibis Reproductive Health is currently using a model of hybrid work where all staff (excluding permanently remote staff) work in-person at an Ibis office at least two days/week. Our preference is for this position to be physically based out of either the Oakland or Cambridge office, with the expectation of at least two days of in-office time per week. Qualifications and Requirements: Minimum: Exposure to quantitative and qualitative research Excellent computer skills (e.g. MS Outlook, Word, Excel, and PowerPoint) Experience working in teams with individuals of varying work styles Ability to manage multiple responsibilities on a range of projects Ability to work independently Self-starter, detail-oriented, highly organized, hardworking, and able to meet deadlines Excellent writing and proofreading skills Have a willingness to travel up to 20 % I n addition, to help ensure needed perspectives and expertise on our research team we particularly welcome: Applicants who have experience: working on projects related to sexual and reproductive health, rights, and justice using quantitative software (R or Stata) and qualitative software (e.g. MAXQDA, Dedoose) searching for and identifying scientific literature, especially in public health Salary: This role will be hired as a band 1, level 2 position, and the starting salary for this position will be $61,390 Cambridge (Oakland adjusted rate: $68,640) Location: Preference for Cambridge, MA or Oakland, CA. A remote work location in the United States may be considered. Start date: Position starts as soon as it is filled. End date: This position is funded through a specific research project grant with an expected end date of October 31, 2028. This is a temporary position tied directly to the availability of project funds, and employment is expected to conclude when the project has completed/funding for the project comes to an end. Ibis is committed to supporting professional development and transition planning during the tenure of these roles. Benefits: Medical insurance, with most of the premium paid by Ibis; dental, disability, and life insurances; paid sick leave; a 403(b) retirement savings plan with employer contributions after the first year; paid holidays; four weeks of vacation per year; transit benefits; and professional development opportunities. Deadline for applications: Interested applicants should submit their CV and responses to a short questionnaire (in lieu of a cover of letter) on BambooHR. Priority consideration will be given to applications received by January 5. Ibis is an equal opportunity employer. Ibis seeks to build and maintain a diverse and inclusive workplace; we encourage applications from people of color, people with disabilities, LGBTQ+ people, first-generation college graduates, and people from other underrepresented communities.

Clinical Project Manager - Remote (Must Have commit to east coast hours ) Duration : 9 Months Total Hours/week : 40.00 1st Shift Client: Medical Device Company Job Category: Project Management Level Of Experience: Entry Level Employment Type: Contract on W2 (Need US Citizens or GC Holders Only) Job Description: Working within the Global Clinical Development (GCD) organization, the Clinical Project Manager is responsible for clinical trial management of multiple studies and may be subject matter expert for group or platform of assigned clinical studies including the planning, implementation, oversight, project management and completion of clinical trials conducted by GCD or Contract Research Organizations (CRO). This role serves as the project lead for studies of moderate to high complexity from protocol development through study conduct and closeout in compliance with Good Clinical Practices, and all Global, National and Local Regulations. Reports to and collaborates with Clinical Portfolio Management to review business requests and evaluate or develop early plans and concepts for optimal study execution. Responsibilities Prepares and/or reviews study-related or essential study start-up documents as they relate to the assigned clinical trials (e.g., Clinical Protocols, Informed Consent forms, Investigator Brochures, Monitoring Plan, Laboratory Manual, Patient Diary, Clinical Site Procedures Manual, Case Report Form (CRFs), CRF Completion Guidelines and other relevant study plans and charters). Serves as a Clinical Project Manager ensuring that the Study Management team meets or exceeds the timelines and deliverables assigned to the study team Oversees/leads study-specific study management resources Develops and manages group of studies for an entire business unit or large development program Provides critical thinking and leadership when issues arise during execution of clinical studies. Leads or contributes to continuous improvement activities/initiatives. Manages relationships with sites/PIs. other study related vendors, including CRO's. Intermediate knowledge, of established project management standards used to develop and maintain integrated project plans (scope/work packages, time/schedule, cost/material and human resource, quality, communication/escalation, risk, value) and organizes/facilitates meetings and discussions as needed. Defines, tracks and reports schedule attributes such as durations, interdependencies, milestones, critical path, and other key deliverables including efficiency and effectiveness of plans and staff. Adapts work package deliverables based on study scale and complexity. Creates aggressive but achievable resource and budget forecasts and timelines. Interacts with both Internal and External contacts, providing direction to the GCD cross functional team members and vendors (if applicable) regarding the technical, protocol-specific, and operational aspects of assigned studies. Proactively identifies and manages risks and issues (including a log, mitigations, and contingencies) to ensure cost effective timely delivery of the project including escalation if needed Plans and maintains high quality standards to meet compliance requirements. Ability to travel approximately 30% of the time, US and Internationally. All other duties as assigned Requirements: BS Degree in Medical Technology or regional equivalent, or in the Life or Medical Sciences such as: Microbiology, Biology, Biochemistry, Chemistry, Immunology, or Clinical Microbiology research experience. A minimum of 3- 5 years in human clinical research. Experience/Knowledge in IVD products, and Clinical Laboratory processes Clinical laboratory or clinical research experience, experience in a medical device/lVD company a plus Familiarity with CLSI guidelines and other standards Background in Infectious Diseases and/or Cancer Demonstrated experience in: Microbiology, Virology, Immunology, Biochemistry, Molecular Biology, Haematology, Chemistry or any other aspect of clinical laboratory medicine, In Vitro Diagnostics, Specimen collection and processing Biospecimen acquisition and prospective sample collection protocols Project management experience desirable using MS Project and/or recent proven success within a client product development core/extended team. PMP Certification a plus Knowledge of clinical trial concepts and practices, including international clinical research guidelines. Strong client and vendor relationship management skills. Ability to work effectively, independently with multi-level teams, manage multiple projects and work in a fast paced and changing environment. Demonstrated and effective interpersonal, communications and negotiation skills for a wide variety of audiences. Ability to work effectively in a virtual environment.

Artech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets, refresh existing skill base, allow for flexibility in project planning and execution phases, and provide budgeting/financial flexibility by offering contingent labor as a variable cost. Job Description: Accountable for all aspects of assigned clinical trials. Lead the Clinical Trial Team, who is responsible for planning, conducting and reporting of clinical trials. Author robust protocols with scientific rigor and quality. Trial conduct must be efficient, with seamless execution and timely reporting. Lead and matrix manage the global multidisciplinary Clinical Trial Team who is responsible for planning, conducting and reporting on all clinical trials within Development, including trials for Proof-of-Concept and Registration. Each Clinical Manager leads 2 or more clinical trial teams for studies of medium to high complexity in support of one or more projects. Contribute medical/scientific/feasibility input for the development of the protocol synopsis. Collaborate with the Medical Advisors to ensure country feedback is adequately integrated into the protocol. Independently ensure quality and timely execution of a clinical trial within timeline and budget Forecast trial resource needs. Accountable for the development, management and tracking of trial budget. Obtains approval for trial budget. Accountable for accuracy of trial information in all trial databases and tracking systems. Manages ongoing study budget. Write scientifically rigorous protocols aligned with the approved protocol synopsis. Lead clinical trial team to select countries and sites. Ensure investigational product supply. Ensure Health Authority and IRB/IEC submission and approval. Ensure all auxiliary documents, including manual of procedures, informed consent template, investigator brochure, statistical analysis plan, data validation plan, etc. are written in high quality and available. Define clinical outsourcing specifications for clinical trial vendors (labs, reading centers, etc.). Work with Procurement to identify vendors. Define scope of work and contract requirements for clinical trial vendors. Oversees vendor conduct of tasks. Ensure implementation of standard data collection modules, where possible or obtains approval for deviation. Track trial progress and milestones. Resolve issues within the clinical trial team or elevates issue to appropriate teams and governance committee. Ensure ongoing data quality review (masked review). Ensure data cleaning and database lock. Ensure reporting of results to Management, Clinical Team and Core Team. Arrange and lead Clinical Trial Team Meetings and responsible for writing minutes Active participant of the Clinical Team under the leadership of the Clinical Lead (CL). Contribute to the development of clinical sections of regulatory documents like Investigators Brochures, briefing packets, safety updates, IND/NDA submission documents, responses to Health Authorities questions. Responsible for implementation of best practices and standards for trial management, including sharing lessons learned. Qualifications Skills: Ability to establish clear directions and set stretch objectives Aligns and energizes team members behind common objectives Excellent people and communication skills Organizational awareness to operate in a cross-functional team Builds support from others in situations with no direct authority Ability to embrace and communicate change Well organized / solid project management skills Customer/Quality Focus Scientific thinking allowing to identify bias and validity issues Establishes effective relationships with customers and gains their trust and respect Conduct of clinical studies Experience in running clinical studies independently without significant supervision Ability to proactively identify issues, respond appropriately and provide guidance for pro-active resolution Solid understanding of the clinical trial regulations (GCP, FDA, EMA, ICH, ISO etc.) Education: University degree in Medical Science or equivalent education required. Advanced degrees (e.g., MD, PhD, O.D., PharmD) are preferred. 9+ years in clinical research or relevant scientific, industry, therapeutic or geographic experience Relevant industry experience includes experience in planning and execution of clinical studies in various phases and geographies Solid understanding of the integrated development process of medical devices and/or pharmaceuticals Additional Information Warm Regards Neha Sharma Lead Recruiter Artech Information Systems LLC 360 Mt. Kemble Avenue, Suite 2000 | Morristown, NJ 07960 Office: ************ | Fax: ************

Artech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets, refresh existing skill base, allow for flexibility in project planning and execution phases, and provide budgeting/financial flexibility by offering contingent labor as a variable cost. Job Description: Accountable for all aspects of assigned clinical trials. Lead the Clinical Trial Team, who is responsible for planning, conducting and reporting of clinical trials. Author robust protocols with scientific rigor and quality. Trial conduct must be efficient, with seamless execution and timely reporting. Lead and matrix manage the global multidisciplinary Clinical Trial Team who is responsible for planning, conducting and reporting on all clinical trials within Development, including trials for Proof-of-Concept and Registration. Each Clinical Manager leads 2 or more clinical trial teams for studies of medium to high complexity in support of one or more projects. Contribute medical/scientific/feasibility input for the development of the protocol synopsis. Collaborate with the Medical Advisors to ensure country feedback is adequately integrated into the protocol. Independently ensure quality and timely execution of a clinical trial within timeline and budget Forecast trial resource needs. Accountable for the development, management and tracking of trial budget. Obtains approval for trial budget. Accountable for accuracy of trial information in all trial databases and tracking systems. Manages ongoing study budget. Write scientifically rigorous protocols aligned with the approved protocol synopsis. Lead clinical trial team to select countries and sites. Ensure investigational product supply. Ensure Health Authority and IRB/IEC submission and approval. Ensure all auxiliary documents, including manual of procedures, informed consent template, investigator brochure, statistical analysis plan, data validation plan, etc. are written in high quality and available. Define clinical outsourcing specifications for clinical trial vendors (labs, reading centers, etc.). Work with Procurement to identify vendors. Define scope of work and contract requirements for clinical trial vendors. Oversees vendor conduct of tasks. Ensure implementation of standard data collection modules, where possible or obtains approval for deviation. Track trial progress and milestones. Resolve issues within the clinical trial team or elevates issue to appropriate teams and governance committee. Ensure ongoing data quality review (masked review). Ensure data cleaning and database lock. Ensure reporting of results to Management, Clinical Team and Core Team. Arrange and lead Clinical Trial Team Meetings and responsible for writing minutes Active participant of the Clinical Team under the leadership of the Clinical Lead (CL). Contribute to the development of clinical sections of regulatory documents like Investigators Brochures, briefing packets, safety updates, IND/NDA submission documents, responses to Health Authorities questions. Responsible for implementation of best practices and standards for trial management, including sharing lessons learned. QualificationsSkills: Ability to establish clear directions and set stretch objectives Aligns and energizes team members behind common objectives Excellent people and communication skills Organizational awareness to operate in a cross-functional team Builds support from others in situations with no direct authority Ability to embrace and communicate change Well organized / solid project management skills Customer/Quality Focus Scientific thinking allowing to identify bias and validity issues Establishes effective relationships with customers and gains their trust and respect Conduct of clinical studies Experience in running clinical studies independently without significant supervision Ability to proactively identify issues, respond appropriately and provide guidance for pro-active resolution Solid understanding of the clinical trial regulations (GCP, FDA, EMA, ICH, ISO etc.) Education: University degree in Medical Science or equivalent education required. Advanced degrees (e.g., MD, PhD, O.D., PharmD) are preferred. 9+ years in clinical research or relevant scientific, industry, therapeutic or geographic experience Relevant industry experience includes experience in planning and execution of clinical studies in various phases and geographies Solid understanding of the integrated development process of medical devices and/or pharmaceuticals Additional InformationWarm Regards Neha Sharma Lead Recruiter Artech Information Systems LLC 360 Mt. Kemble Avenue, Suite 2000 | Morristown, NJ 07960 Office: ************ | Fax: ************

About Us: Each of CenExel'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. Hourly Rate: $20.00 - $22.00/hr (depending on education, experience, and skillset) Schedule: Monday - Friday 08:00 AM - 04:30 PM Job Summary: Assist the Regulatory Specialists/Manager in maintaining clinical trial documents for submission to regulatory agencies in accordance to site SOPs, ICH, GCP, and FDA guidelines. SOPs (Standard Operating Procedures) ICH (International Council for Harmonization) GCP (Good Clinical Practices) FDA (Food and Drug Administration) Essential Responsibilities and Duties: Complies with current protocols, site SOPs, GCPs, IRB (Institutional Review Board) and FDA guidelines. Uploads regulatory documents with RealTime eDOCs System and files is paper binders, as necessary. Prepares, obtains, organizes and maintains regulatory and training documents in various storage mediums. Tracks submissions and ensure timely filing of documents. Obtains CVs (Curriculum Vitae) of external Investigators and other contract personnel and their signatures for appropriate regulatory documents. Forwards revised copies of protocols, informed consents, and other pertinent study documents to appropriate staff. Assists in obtaining necessary signatures from investigators. Works closely with study sponsor/CRO and key clinical trial personnel on relevant regulatory document issues. Ensures Clinical Conductor regulatory information is current. Participates in team meetings and complies with training requirements. Assists sponsors/CRO's as needed. 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. 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. Education/Experience/Skills: Must be able to effectively communicate verbally and in writing. Minimum: High School graduate or equivalent. Minimum of 1 year of related experience in clinical research Must be self-directed and able to work with minimal supervision. Able to take a flexible approach to shifting priorities. Motivated to work consistently in a fast-paced and rapidly changing environment. Working Conditions Indoor, Office environment. Essential physical requirements include sitting, typing, standing, and walking. Lightly active position, occasional lifting of up to 20 pounds. Reporting to work, as scheduled, is essential. Ability to work overtime, weekends, and/or holidays as needed. Ability to travel as needed. Remote work arrangement depending on location. 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.

Be Part of an Extraordinary Team The MyCare Ohio Plan program is to deliver high‐quality, trauma informed, culturally competent, person‐centered coordination for all members that addresses physical health, behavioral health, long term services and supports, and psychosocial needs. Project Manager Location: This role requires associates to be in-office 1 - 2 days per week, fostering collaboration and connectivity, while providing flexibility to support productivity and work-life balance. This approach combines structured office engagement with the autonomy of virtual work, promoting a dynamic and adaptable workplace. When reporting to the office, the office assigned is OH-COLUMBUS, 8940 LYRA DR, STE 300. Alternate Office locations within Ohio may be considered if candidates reside within a commuting distance from an Ohio office. Travel within the state of Ohio as needed may be required. * Please note that per our policy on hybrid/virtual work, candidates not within a reasonable commuting distance from the posting location(s) will not be considered for employment, unless an accommodation is granted as required by law. Schedule: This position will work a first shift from 8:00 am- 5:00 pm EST Monday thru Friday. The Project Manager is responsible for working with business partners to identify and implement medium to large projects that support achievement of simple to complex non-clinical and clinical quality improvement activities/projects to improve the quality of care for members. Projects may be business and/or technical (software implementation or application updates) in nature. Works with moderate guidance and is responsible for applying project management knowledge, skills, tools and techniques to project deliverables, processes, and systems. Operates within defined parameters using project management methodology. Primary duties may include, but are not limited to: * Manages the development of a prescribed planning document. * Develops project charter. * Partners with sponsors to secure project approval. * Provides oversight to assure accurate and complete quantitative analysis of clinical data and presentation of data analysis results. * Leads interactions with regulators or oversight entities. * Develops communication management plan. * Defines project team roles and responsibilities, develops work plan structure and project schedule. * Develops deployment plan. * Maintains effective documentation of research programs to meet regulatory and Accreditation Standards. * Leads project meetings. * Identifies, documents and prioritizes scope changes and facilitates approval process. * Maintains and updates all project documents and maintains effective documentation of research programs to meet regulatory and Accreditation Standards. * Secures the appropriate skill sets for project. * Sets and manages expectations with resource managers and team members; * Provides performance feedback to team members and resource managers. * Maintains issue log and facilitates resolution of issues. * Executes communication plans and regularly reports status. * Manages and monitors ROI throughout the project lifecycle. * Tracks and manages time and budget against plan. * Develops testing strategy. * Conduct project close-out activities and prepares and participates in quality review checkpoints. * Obtain/secure and archive necessary approvals. * Manage and update project plan. Minimum Requirements: * Requires a BA/BS in a related field and minimum of 3 years professional project management experience, which at least 2 years are spent leading and directing project tasks; or any combination of education and experience, which would provide an equivalent background. Preferred Skills, Capabilities, and Experiences: * Demonstrated ability to create an effective team environment, build strong relationships, solving problems and issues in a matrix environment and communicating effectively at all levels of an organization is strongly preferred. * Project Management Professional (PMP) certification preferred. * Experience working in a lead role on one or more projects strongly preferred. * Medicaid Experience, IHI Model for Improvement experience strongly preferred. * HEDIS and CAHPS experience strongly preferred. * Certification in applicable field (CPHQ) preferred. Please be advised that Elevance Health only accepts resumes for compensation from agencies that have a signed agreement with Elevance Health. Any unsolicited resumes, including those submitted to hiring managers, are deemed to be the property of Elevance Health. Who We Are Elevance Health is a health company dedicated to improving lives and communities - and making healthcare simpler. We are a Fortune 25 company with a longstanding history in the healthcare industry, looking for leaders at all levels of the organization who are passionate about making an impact on our members and the communities we serve. How We Work At Elevance Health, we are creating a culture that is designed to advance our strategy but will also lead to personal and professional growth for our associates. Our values and behaviors are the root of our culture. They are how we achieve our strategy, power our business outcomes and drive our shared success - for our consumers, our associates, our communities and our business. We offer a range of market-competitive total rewards that include merit increases, paid holidays, Paid Time Off, and incentive bonus programs (unless covered by a collective bargaining agreement), medical, dental, vision, short and long term disability benefits, 401(k) +match, stock purchase plan, life insurance, wellness programs and financial education resources, to name a few. Elevance Health operates in a Hybrid Workforce Strategy. Unless specified as primarily virtual by the hiring manager, associates are required to work at an Elevance Health location at least once per week, and potentially several times per week. Specific requirements and expectations for time onsite will be discussed as part of the hiring process. The health of our associates and communities is a top priority for Elevance Health. We require all new candidates in certain patient/member-facing roles to become vaccinated against COVID-19 and Influenza. If you are not vaccinated, your offer will be rescinded unless you provide an acceptable explanation. Elevance Health will also follow all relevant federal, state and local laws. Elevance Health is an Equal Employment Opportunity employer and all qualified applicants will receive consideration for employment without regard to age, citizenship status, color, creed, disability, ethnicity, genetic information, gender (including gender identity and gender expression), marital status, national origin, race, religion, sex, sexual orientation, veteran status or any other status or condition protected by applicable federal, state, or local laws. Applicants who require accommodation to participate in the job application process may contact ******************************************** for assistance. Qualified applicants with arrest or conviction records will be considered for employment in accordance with all federal, state, and local laws, including, but not limited to, the Los Angeles County Fair Chance Ordinance and the California Fair Chance Act.

Job Description Want to make an impact? I Am Boundless is hiring for a Clinic Coordinator! Boundless is a non-profit organization specializing in assisting individuals with I/DD and has been serving Ohio for over 40 years. At I Am Boundless, we're on a mission to build a world that realizes the boundless potential of all people. Join our team, which shares a common passion and purpose in empowering our community. Benefits - Why Join Boundless? Financial & Retirement 401(k) Retirement Plan with 5% Employee Matching after Six Months of Employment - Immediately 100% Vested Annual Increases Paid Time Off 5 Weeks of Paid Time Off 8 Paid Holidays Health & Wellness Medical Insurance Free Dental & Vision Insurance Flexible Spending Account (FSA) Dependent Care Account (DCA) Life Insurance & Supplemental Life Insurance Disability Insurance Professional Support Tuition Discount Opportunities with Schools like Capella University & Franklin University A Qualified Employer for the Federal Public Service Loan Forgiveness (PSLF) Paid Training & Development Opportunities Perks & Discounts Employee Assistance Program (EAP) - Counseling, Therapy, Finance, Legal Discount Programs (Ex: Pet Insurance, Movie Tickets, Theme Parks, Costco Membership, etc.) Wellbeing Resources (Up to $50 off Health Insurance Premium Monthly) What You'll Do: As a Clinic Coordinator, you'll play a meaningful role in monitoring both behavioral health and educational goals, ensure goals are implemented with fidelity and documented accurately by educating and leading a team of Behavior Technicians. The Clinic Coordinator will also facilitate group instruction to individuals diagnosed with Autism Spectrum Disorders and related disorders using the principles of Applied Behavior Analysis. Clinic Coordinators will attend regular meetings with Intervention Specialists, Center-Based Clinicians, Behavior Analysts and Clinic Director. Minimum Qualifications: At least three years' experience working with individuals with behavioral health conditions, autism spectrum disorders, and/or developmental disabilities. Hold and maintain certification as a Registered Behavior Technician as outlined by the Behavior Analyst Certification Board or, actively working toward BCBA or BCBA certification (enrolled in fieldwork portion of pursuing the credential). Ability to obtain and maintain First Aid, CPR - adult, child and infant. Valid Ohio Driver's License with Ohio Bureau of Motor Vehicles; proof of auto insurance. No more than 5 points on license. Preferred Qualifications: College Degree in education, psychology, social work, or a related field. Ready to make a difference? Apply today and join a company where you can realize your Boundless potential! All candidates selected to undergo the pre-employment process will be required to complete a background check, drug screen, and health screen, as applicable for the role. We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, national origin, disability status, protected veteran status or any other characteristic protected by law. Monday - Friday, 7:00am - 3:00pm

Want to make an impact? I Am Boundless is hiring for a Clinic Coordinator! Boundless is a non-profit organization specializing in assisting individuals with I/DD and has been serving Ohio for over 40 years. At I Am Boundless, we're on a mission to build a world that realizes the boundless potential of all people. Join our team, which shares a common passion and purpose in empowering our community. Benefits - Why Join Boundless? Financial & Retirement 401(k) Retirement Plan with 5% Employee Matching after Six Months of Employment - Immediately 100% Vested Annual Increases Paid Time Off 5 Weeks of Paid Time Off 8 Paid Holidays Health & Wellness Medical Insurance Free Dental & Vision Insurance Flexible Spending Account (FSA) Dependent Care Account (DCA) Life Insurance & Supplemental Life Insurance Disability Insurance Professional Support Tuition Discount Opportunities with Schools like Capella University & Franklin University A Qualified Employer for the Federal Public Service Loan Forgiveness (PSLF) Paid Training & Development Opportunities Perks & Discounts Employee Assistance Program (EAP) - Counseling, Therapy, Finance, Legal Discount Programs (Ex: Pet Insurance, Movie Tickets, Theme Parks, Costco Membership, etc.) Wellbeing Resources (Up to $50 off Health Insurance Premium Monthly) What You'll Do: As a Clinic Coordinator, you'll play a meaningful role in monitoring both behavioral health and educational goals, ensure goals are implemented with fidelity and documented accurately by educating and leading a team of Behavior Technicians. The Clinic Coordinator will also facilitate group instruction to individuals diagnosed with Autism Spectrum Disorders and related disorders using the principles of Applied Behavior Analysis. Clinic Coordinators will attend regular meetings with Intervention Specialists, Center-Based Clinicians, Behavior Analysts and Clinic Director. Minimum Qualifications: At least three years' experience working with individuals with behavioral health conditions, autism spectrum disorders, and/or developmental disabilities. Hold and maintain certification as a Registered Behavior Technician as outlined by the Behavior Analyst Certification Board or, actively working toward BCBA or BCBA certification (enrolled in fieldwork portion of pursuing the credential). Ability to obtain and maintain First Aid, CPR - adult, child and infant. Valid Ohio Driver's License with Ohio Bureau of Motor Vehicles; proof of auto insurance. No more than 5 points on license. Preferred Qualifications: College Degree in education, psychology, social work, or a related field. Ready to make a difference? Apply today and join a company where you can realize your Boundless potential! All candidates selected to undergo the pre-employment process will be required to complete a background check, drug screen, and health screen, as applicable for the role. We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, national origin, disability status, protected veteran status or any other characteristic protected by law. Monday - Friday, 7:00am - 3:00pm

Harbor is looking for a Clinical Coordinator who works in a highly collaborative manner with Physician Led Patient Centered team staff to ensure overall team success in patient centered service provision. Provides treatment services for individuals with behavioral health disorders based on assessment and treatment planning. Position is full-time. Education/Experience/Other Requirements Requires Master's degree in counseling, social work or a related behavioral/mental health field from an accredited college or university. Based on agency and team need, may consider Bachelor's degree with current LSW and 2 years of supervisory/administrative experience. Requires license to practice as a social worker/counselor in Ohio (LSW, LISW, LISW-S, LPC, LPCC, LPCC-S). Must be honest, dependable, self-disciplined, organized and be able to work well as a team member. Must have good documentation, treatment and assessment skills. Must be proficient and accurate in computer use, including Microsoft Word. Prefer licensure in chemical dependency in addition to mental health licensure or proven experience and training in treating substance use disorders. Required to obtain Health Officer certification within 6 months of employment. CPR/First Aid and NCI/CPI Certifications required within 90 days of employment. ESSENTIAL DUTIES AND RESPONSIBILITIES: Coordinates team coverage to ensure patient service needs are met including, but not limited to, reviewing and facilitating changes in staff schedules, arranging coverage for staff call offs and planned time off, crisis intervention and other unexpected patient needs that arise and need intervention/services. Provides oversight of clinical work, including documentation review and co-signing (based on licensure scope of practice) as assigned. Available to be the lead clinical consultant as needed. Ability to handle emergency situations in a prompt, clinical and professional manner and provides pre-screening services as needed. Works in highly collaborative manner with all members of the team to provide unified treatment approach and ensure overall team success in all areas of treatment, documentation, and compliance. Participates in the monitoring and managing the budget, when requested by supervisor. Demonstrates leadership skills that lead to acceptable/expected levels of productivity, efficiency, and effectiveness of team members in providing excellent care to clients. Provides counseling, CPST, MH Day Treatment, and/or SUD services based on licensure and provider team role in individual and group settings as part of a multi-disciplinary team to achieve treatment goals. Provides diagnostic assessments, treatment planning and completes necessary updates as required. Completes clinical documentation in the format appropriate and acceptable to Harbor and submits all documentation according to Harbor policy. May conduct home based diagnostic assessments, individual and group counseling in the home or other community setting, if clinically indicated. About Harbor: A leading provider of mental health and substance use treatment for over 100 years 350+ clinical staff serve over 24,000 clients across multiple locations and in the community each year Services ranging from counseling, pharmacological management, primary care, psychological testing, case management, substance use treatment, residential services, vocational program, and more! Why Work for Harbor? It is fast-paced and challenging, but you will have a lot of fun in the process. You will have the opportunity to meet other motivated individuals who are also making a positive impact at our company. Harbor is committed to investing our resources in you! Some benefits of working with Harbor include: Medical, dental, and vision coverage Retirement plan with company match Generous paid time off, sick time, and paid holidays Tuition and professional license reimbursement programs Clinical supervision hours offered Employee referral bonuses Ability to make a difference in your community!

Job Description Harbor is looking for a Clinical Coordinator who works in a highly collaborative manner with Physician Led Patient Centered team staff to ensure overall team success in patient centered service provision. Provides treatment services for individuals with behavioral health disorders based on assessment and treatment planning. Position is full-time. Education/Experience/Other Requirements Requires Master's degree in counseling, social work or a related behavioral/mental health field from an accredited college or university. Based on agency and team need, may consider Bachelor's degree with current LSW and 2 years of supervisory/administrative experience. Requires license to practice as a social worker/counselor in Ohio (LSW, LISW, LISW-S, LPC, LPCC, LPCC-S). Must be honest, dependable, self-disciplined, organized and be able to work well as a team member. Must have good documentation, treatment and assessment skills. Must be proficient and accurate in computer use, including Microsoft Word. Prefer licensure in chemical dependency in addition to mental health licensure or proven experience and training in treating substance use disorders. Required to obtain Health Officer certification within 6 months of employment. CPR/First Aid and NCI/CPI Certifications required within 90 days of employment. ESSENTIAL DUTIES AND RESPONSIBILITIES: Coordinates team coverage to ensure patient service needs are met including, but not limited to, reviewing and facilitating changes in staff schedules, arranging coverage for staff call offs and planned time off, crisis intervention and other unexpected patient needs that arise and need intervention/services. Provides oversight of clinical work, including documentation review and co-signing (based on licensure scope of practice) as assigned. Available to be the lead clinical consultant as needed. Ability to handle emergency situations in a prompt, clinical and professional manner and provides pre-screening services as needed. Works in highly collaborative manner with all members of the team to provide unified treatment approach and ensure overall team success in all areas of treatment, documentation, and compliance. Participates in the monitoring and managing the budget, when requested by supervisor. Demonstrates leadership skills that lead to acceptable/expected levels of productivity, efficiency, and effectiveness of team members in providing excellent care to clients. Provides counseling, CPST, MH Day Treatment, and/or SUD services based on licensure and provider team role in individual and group settings as part of a multi-disciplinary team to achieve treatment goals. Provides diagnostic assessments, treatment planning and completes necessary updates as required. Completes clinical documentation in the format appropriate and acceptable to Harbor and submits all documentation according to Harbor policy. May conduct home based diagnostic assessments, individual and group counseling in the home or other community setting, if clinically indicated. About Harbor: A leading provider of mental health and substance use treatment for over 100 years 350+ clinical staff serve over 24,000 clients across multiple locations and in the community each year Services ranging from counseling, pharmacological management, primary care, psychological testing, case management, substance use treatment, residential services, vocational program, and more! Why Work for Harbor? It is fast-paced and challenging, but you will have a lot of fun in the process. You will have the opportunity to meet other motivated individuals who are also making a positive impact at our company. Harbor is committed to investing our resources in you! Some benefits of working with Harbor include: Medical, dental, and vision coverage Retirement plan with company match Generous paid time off, sick time, and paid holidays Tuition and professional license reimbursement programs Clinical supervision hours offered Employee referral bonuses Ability to make a difference in your community!