clinical research monitor

AbbVie

<div>
 
 Company Description
 
 
 
 
 About AbbVie
 
 
 
 AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.
 
 
 
 Job Description
 
 
 
 
 We are hiring in Pittsburg &amp; Michigan
 
 
 
 Advance AbbVie's pipeline by striving for excellence in clinical research, turning science into medicine for our patients and leveraging new advanced capabilities to drive industry leading performance.
 
 
 Partners with the investigator and site staff for meaningful and effective engagements positioning AbbVie as the choice in clinical trials.
 
 
 Focus on site clinical research that ensures appropriate conduct of the trial while driving improvement in data integrity, compliance, overall study performance and customer experience.
 
 
 
 Responsibilities
 
 
 
 <ul>
 <li>
 Considered as the primary point of contact for the investigative site. High level of competency or experience in providing contextual information on the clinical trials, connects stakeholder to the investigative sites and strengthens AbbVie&rsquo;s positioning.
 </li>
 <li>
 Aligns, trains and motivates the site staff and principal investigator on the goals of the clinical trial program, protocol and patient treatment principles for the trial ensuring a trusted partnership.
 </li>
 <li>
 Conducts site evaluation, site training, routine, and site closure monitoring activities with compliance to the protocol and monitoring plans, in accordance with applicable regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), and quality standards, ensuring safety and protection of study subjects.
 </li>
 <li>
 Advanced understanding of site engagement and ability to customize site engagement strategy for assigned study (ies). Gather local/site insights and utilize site engagement tools such as the Customer Relationship Management (CRM) tool, to report/track progress and measure impact of that strategy.
 </li>
 <li>
 Advanced level of competency connecting the study protocol, scientific principles and clinical trial requirements to the day-to-day clinical trial execution activities. Evaluate and ensure effective recruitment and retention techniques/plans based on the patient disease journey. Develop solid knowledge of therapeutic area, asset and clinical landscape / patient journey to enable successful patient recruitment and overall protocol compliance.
 </li>
 <li>
 Possesses experienced level of competency to mentor and train less experienced CRAs on various aspects of work and provides input into their development. May participate in global/local task forces and initiatives. Responsible for activities as assigned by manager.
 </li>
 <li>
 Responsible for continuous risk-assessment proactively, and in collaboration with Central Monitoring team, monitor activities conducted by clinical sites to detect early overall study performance or patient safety issues.
 </li>
 <li>
 Advanced ability to think critically to resolve site risk signals while having robust understanding of site processes to drive study execution. Ensures preventative and corrective action plans are put into place, as needed, to mitigate risk and promote compliance using a customer centric approach.
 </li>
 <li>
 Identifies, evaluates and recommends new/potential investigators/sites on an on going basis. Potential sites may be identified through networking or internal AbbVie requests to assist in the placement of planned clinical studies with qualified investigators.
 </li>
 <li>
 Ensures quality of data submitted from study sites and assures timely submission of data, including appropriate reporting and follow-up for all safety events by site personnel. Ensures audit and regulatory inspection readiness at assigned clinical site at all times. Manages investigator payments as per executed contract obligations, as applicable.
 
 
 </li>
 </ul>
 
 Qualifications
 
 
 
 <ul>
 <li>
 Appropriate tertiary qualification in health related disciplines (Medical, Scientific, Nursing) preferred.
 </li>
 <li>
 Minimum of 1 year of clinically related experience, of which a period of 6 months is required in clinical research monitoring of investigational drug or device trials. Familiar with risk&hyphen;based monitoring approach, onsite and offsite monitoring.
 </li>
 <li>
 Knowledge of appropriate therapeutic area indications is preferred with the ability to understand and apply scientific concepts as they relate to the conduct of clinical trials.
 </li>
 <li>
 Advanced knowledge on existing and emerging local regulatory and legal requirements, ICH/GCP Guidelines and applicable policies.
 </li>
 <li>
 Demonstrate strong cross-functional collaboration skills among internal and external stakeholders.
 </li>
 <li>
 Demonstrate strong planning and organizational skills and the ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines.
 </li>
 <li>
 Advanced ability to leverage technology, tools and resources to provide customer centric support based on the health of the site.
 </li>
 <li>
 Strong interpersonal skills with excellent written, verbal, active listening and presentation skills, with ability to establish and leverage site relationships and trusted partnerships through engagement, motivation, and training.
 </li>
 <li>
 Ability to use functional expertise with appropriate guidance, leverage critical thinking skills and apply good judgement to address clinical site issues.
 </li>
 <li>
 Acts with integrity in accordance with AbbVie code of business conduct and leadership values. Self-motivated individual focused on delivering timely and quality outcomes in a fast-paced environment.
 
 
 </li>
 </ul>
 Additional Information
 
 
 Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
 
 
 <ul>
 <li>
 The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this roleat the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on manyfactors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
 </li>
 <li>
 We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
 </li>
 <li>
 This job is eligible to participate in our short-term incentive programs.
 
 
 </li>
 </ul>
 Note: No amount of pay is considered to be wages or compensation until such amount isearned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that areallocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company&rsquo;s sole and absolutediscretion, consistent with applicable law.
 
 
 AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer/Veterans/Disabled.
 
 
 US &amp; Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
 
 
 US &amp; Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
 
 
 https://www.abbvie.com/join-us/reasonable-accommodations.html
</div>

Clinical Research Associate II - Oncology (Remote US - Multiple Openings)

Sarah Cannon Research Institute

<div>
 
 It&rsquo;s More Than a Career, It&rsquo;s a Mission.
 
 
 
 Our people are the foundation of our success. By joining our growing team at Sarah Cannon Research Institute (SCRI), a subsidiary of McKesson, you will have the opportunity to become part of one of the largest community-based cancer programs to advance oncology treatments and improve outcomes for cancer patients across the globe. We look for mission-driven candidates who have a desire to advance the fight against cancer and make a difference in the lives of patients diagnosed with cancer every day.
 
 
 
 Our Mission
 
 
 
 People who live with cancer &ndash; those who work to prevent it, fight it, and survive it &ndash; are at the heart of every decision we make. Bringing the most innovative medical minds together with the most passionate caregivers in their communities, we are transforming care and personalizing treatment. Through clinical excellence and cutting-edge research, SCRI is redefining cancer care around the world.
 
 
 The Clinical Trial Central Screener (CTCS) will be responsible for centralized clinical support for patient screening at SCRIs network of community-based medical oncology practices. The CTCS will partner with various SCRI departments (including but not limited to Personalized Medicine, Genospace, Therapeutic Development, Research Operations) for central screening services. The services will include 1) clinical trial patient identification 2) remote chart review for clinical appropriateness 3) communication with site personnel when appropriate clinical trial candidates are found.
 
 
 
 Duties include but are not limited to:
 
 
 
 <ul>
 <li>
 Clinical support for clinical trial central screening process
 </li>
 <li>
 Serve as a liaison between SCRI network sites and Personalized Medicine Operations team to provide feedback and make adjustments to processes and technology tools
 </li>
 <li>
 Aid in the enhancement of SCRI&rsquo;s precision medicine software platform, Genospace, to more efficiently match patients to clinical trials
 </li>
 <li>
 Escalate appropriate issues to supervisor to enable timely resolution of any issues during the central screening process
 </li>
 <li>
 Support the deployment, training, and utilization of Genospace at SCRI network sites
 </li>
 <li>
 Lead and facilite routine internal and external cross-functional meetings
 </li>
 <li>
 Build and maintain strategic relationships across the organization
 </li>
 <li>
 Other duties as assigned
 
 
 </li>
 </ul>
 
 Mandatory:
 
 
 The following are mandatory expectations of all SCRI employees.
 
 
 
 <ul>
 <li>
 Practices and adheres to the &ldquo;Code of Conduct&rdquo; philosophy and &ldquo;Mission and Value Statement.&rdquo;
 </li>
 <li>
 During your employment with SCRI, you will be routinely assigned training requirements. You are expected to complete any training assignments by the due date.
 
 
 </li>
 </ul>
 
 Knowledge:
 
 
 A body of information needed to perform tasks; May be obtained through education, training or experience.
 
 
 
 <ul>
 <li>
 Knowledge of pharmaceutical industry, regulatory process, clinical trials and medical terminology
 </li>
 <li>
 Business Experience &ndash; Experience working in a clinical research environment (within a SMO, CRO, sponsor, site) and a deep understanding of the oncology clinical research setting is strongly preferred.
 </li>
 <li>
 Knowledge and interpretation of clinical research protocols, and experience in a clinical setting analyzing patient charts is required.
 
 
 </li>
 </ul>
 
 Skills:
 
 
 The proficiency to perform a certain task.
 
 
 
 <ul>
 <li>
 Attention to detail, solid execution, meeting aggressive timelines, strong interpersonal skills and team player. Excellent verbal and written communication skills.
 </li>
 <li>
 Documented training, knowledge and application of current FDA Regulations, GCP and ICH guidelines in clinical trials.
 </li>
 <li>
 Ability to collaborate effectively with the study team, cross functional team members and external partners (including investigators and site staff) using collaborative negotiation skills.
 </li>
 <li>
 Excellent organizational and priority management skills.
 </li>
 <li>
 Strong computer skills including knowledge of Microsoft Excel, Word, PowerPoint and Outlook.
 </li>
 <li>
 Ability to work within established timelines, in a fast-paced environment.
 
 
 </li>
 </ul>
 
 Abilities:
 
 
 An underlying, enduring trait useful for performing duties.
 
 
 
 <ul>
 <li>
 Problem solving skills in fast-paced environment
 </li>
 <li>
 Interpersonal skills and detailed-oriented
 </li>
 <li>
 Detail-oriented and meticulous
 </li>
 <li>
 Demonstrate ability to positively influence others in a team environment
 
 
 </li>
 </ul>
 
 Minimum Qualifications:
 
 
 
 <ul>
 <li>
 Bachelor's Degree in Nursing or Licensed Registered Nurse
 </li>
 <li>
 3+ years of experience as a research nurse, preferably within clinical research
 </li>
 <li>
 Experience in clinical trials required
 </li>
 <li>
 Must be able to read a protocol and match patients with a protocol
 
 
 </li>
 </ul>
 
 About Sarah Cannon Research Institute
 
 
 
 Sarah Cannon Research Institute (SCRI) is one of the world&rsquo;s leading oncology research organizations conducting community-based clinical trials. Focused on advancing therapies for patients over the last three decades, SCRI is a leader in drug development. In 2022, SCRI formed a joint venture with former US Oncology Research to expand clinical trial access across the country. It has conducted more than 850 first-in-human clinical trials since its inception and contributed to pivotal research that has led to the majority of new cancer therapies approved by the FDA in the past decade. SCRI&rsquo;s research network brings together more than 1,300 physicians who are enrolling patients into clinical trials at more than 200 locations in 20+ states across the U.S. Please click here to learn more about our research offerings.
 
 
 We care about the well-being of the patients and communities we serve, and that starts with caring for our people. That&rsquo;s why we have a Total Rewards package that includes comprehensive benefits to support physical, mental, and financial well-being. Our Total Rewards offerings serve the different needs of our diverse colleague population and ensure they are the healthiest versions of themselves. For more information regarding benefits through our parent company, McKesson, please click here.
 
 
 As part of Total Rewards, we are proud to offer a competitive compensation package. This is determined by several factors, including performance, experience and skills, equity, regular job market evaluations, and geographical markets. In addition to base pay, other compensation, such as an annual bonus or long-term incentive opportunities may be offered.
 
 
 McKesson has become aware of online recruiting-related scams in which individuals who are not affiliated with or authorized by McKesson are using McKesson&rsquo;s (or affiliated entities, like CoverMyMeds or RxCrossroads) name in fraudulent emails, job postings or social media messages. In light of these scams, please bear the following in mind:
 
 
 McKesson Talent Advisors will never solicit money or credit card information in connection with a McKesson job application.
 
 
 McKesson Talent Advisors do not communicate with candidates via online chatrooms or using email accounts such as Gmail or Hotmail. Note that McKesson does rely on a virtual assistant (Gia) for certain recruiting-related communications with candidates.
 
 
 McKesson job postings are posted on our career site: careers.mckesson.com.
 
 
 
 We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
 
</div>

Clinical Trial Central Screener

<div>Company Description 
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube. 
Job Description 
This position will be field based in Central Florida
Advance AbbVie's pipeline by striving for excellence in clinical research, turning science into medicine for our patients and leveraging new advanced capabilities to drive industry leading performance. 
Partners with the investigator and site staff for meaningful and effective engagements positioning AbbVie as the choice in clinical trials. 
Focus on site clinical research that ensures appropriate conduct of the trial while driving improvement in data integrity, compliance, overall study performance and customer experience.
Responsibilities<ul><li>
Considered as the primary point of contact for the investigative site. High level of competency or experience in providing contextual information on the clinical trials, connects stakeholder to the investigative sites and strengthens AbbVie&rsquo;s positioning.</li><li>
Aligns, trains and motivates the site staff and principal investigator on the goals of the clinical trial program, protocol and patient treatment principles for the trial ensuring a trusted partnership.</li><li>
Conducts site evaluation, site training, routine, and site closure monitoring activities with compliance to the protocol and monitoring plans, in accordance with applicable regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), and quality standards, ensuring safety and protection of study subjects.</li><li>
Advanced understanding of site engagement and ability to customize site engagement strategy for assigned study (ies). Gather local/site insights and utilize site engagement tools such as the Customer Relationship Management (CRM) tool, to report/track progress and measure impact of that strategy.</li><li>
Advanced level of competency connecting the study protocol, scientific principles and clinical trial requirements to the day-to-day clinical trial execution activities. Evaluate and ensure effective recruitment and retention techniques/plans based on the patient disease journey. 
Develop solid knowledge of therapeutic area, asset and clinical landscape / patient journey to enable successful patient recruitment and overall protocol compliance.</li><li>
Possesses experienced level of competency to mentor and train less experienced CRAs on various aspects of work and provides input into their development. 
May participate in global/local task forces and initiatives. Responsible for activities as assigned by manager.</li><li>
Responsible for continuous risk-assessment proactively, and in collaboration with Central Monitoring team, monitor activities conducted by clinical sites to detect early overall study performance or patient safety issues.</li><li>
Advanced ability to think critically to resolve site risk signals while having robust understanding of site processes to drive study execution. Ensures preventative and corrective action plans are put into place, as needed, to mitigate risk and promote compliance using a customer centric approach.</li><li>
Identifies, evaluates and recommends new/potential investigators/sites on an on going basis. Potential sites may be identified through networking or internal AbbVie requests to assist in the placement of planned clinical studies with qualified investigators.</li><li>
Ensures quality of data submitted from study sites and assures timely submission of data, including appropriate reporting and follow-up for all safety events by site personnel. 
Ensures audit and regulatory inspection readiness at assigned clinical site at all times. 
Manages investigator payments as per executed contract obligations, as applicable.</li></ul> 

Qualifications 
<ul><li>
Appropriate tertiary qualification in health related disciplines (Medical, Scientific, Nursing) preferred.</li><li>
Minimum of 1 year of clinically related experience, of which a period of 6 months is required in clinical research monitoring of investigational drug or device trials. Familiar with risk‐based monitoring approach, onsite and offsite monitoring.</li><li>
Knowledge of appropriate therapeutic area indications is preferred with the ability to understand and apply scientific concepts as they relate to the conduct of clinical trials.</li><li>
Advanced knowledge on existing and emerging local regulatory and legal requirements, ICH/GCP Guidelines and applicable policies.</li><li>
Demonstrate strong cross-functional collaboration skills among internal and external stakeholders.</li><li>
Demonstrate strong planning and organizational skills and the ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines.</li><li>
Advanced ability to leverage technology, tools and resources to provide customer centric support based on the health of the site.</li><li>
Strong interpersonal skills with excellent written, verbal, active listening and presentation skills, with ability to establish and leverage site relationships and trusted partnerships through engagement, motivation, and training.</li><li>
Ability to use functional expertise with appropriate guidance, leverage critical thinking skills and apply good judgement to address clinical site issues.</li><li>
Acts with integrity in accordance with AbbVie code of business conduct and leadership values. Self-motivated individual focused on delivering timely and quality outcomes in a fast-paced environment.</li></ul> 

Additional Information 
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
<ul><li>The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this roleat the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on manyfactors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
</li><li>We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
</li><li>This job is eligible to participate in our short-term incentive programs.
</li></ul>Note: No amount of pay is considered to be wages or compensation until such amount isearned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that areallocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company&rsquo;s sole and absolutediscretion, consistent with applicable law.<div></div>
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US &amp; Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US &amp; Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
https://www.abbvie.com/join-us/reasonable-accommodations.html</div>

Clinical Research Associate II

Thermo Fisher Scientific

<div>Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
Join Us as a Clinical Research Associate (Level II) &ndash; Make an Impact at the Forefront of Innovation 
We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years.<div>
Must have at least 1 year of travel monitoring experience in Neurology!
 
 
As part of our global team, you&rsquo;ll have the opportunity to perform and coordinate all aspects of the clinical monitoring and site management process. As a Clinical Research Associate (Level II), you'll conduct remote or on-site visits to assess protocol and regulatory compliance and manage required documentation. You will manage procedures and guidelines from different sponsors and/or monitoring environments (i.e., FSO, FSP, Government, etc.). Acting as a site processes specialist, you will ensure that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations, and SOPs to guarantee subjects' rights, well-being, and data reliability. You will ensure audit readiness and develop collaborative relationships with investigational sites. Detailed tasks and responsibilities assigned to your role are outlined in the task matrix. 
 
What You&rsquo;ll Do: 
<ul><li>Monitors investigator sites with a risk-based monitoring approach: applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks. Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities. Assess investigational product through physical inventory and records review. Documents observations in reports and letters in a timely manner using approved business writing standards. Escalates observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution. May need to maintain regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, that previously identified issues are being resolved and that the data is being recorded in a timely manner. Conducts monitoring tasks in accordance with the approved monitoring plan. Participates in the investigator payment process. Ensures a shared responsibility with other project team members on issues/findings resolution. Investigates and follows-up on findings as applicable.</li><li>Participates in investigator meetings as necessary. Identifies potential</li><li>investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites. Initiates clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted. Performs trial close out and retrieval of trial materials.</li><li>Ensures that required essential documents are complete and in place, according to ICH-GCP and applicable regulations. Conducts on-site file reviews as per project specifications.</li><li>Provides trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required. Ensures study systems are updated per agreed study conventions (e.g. Clinical Trial Management System).</li><li>Facilitates effective communication between investigative sites, the client company and the PPD project team through written, oral and/or electronic contacts.</li><li>Responds to company, client and applicable regulatory requirements/audits/inspections.</li><li>Maintains &amp; completes administrative tasks such as expense reports and timesheets in a timely manner.</li><li>Contributes to the project team by assisting in preparation of project publications/tools, and sharing ideas/suggestions with team members.</li><li>Contributes to other project work and initiatives for process improvement, as required.</li></ul> 
Education and Experience Requirements: 
<ul><li>Bachelor's degree in a life sciences related fieldor a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification.</li><li>Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 1 years as a clinical research monitor) or completion of PPD Drug Development Fellowship.</li><li>Valid driver's license where applicable.</li></ul>
In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role. 
 
Knowledge, Skills and Abilities: 
<ul><li>Proven clinical monitoring skills</li><li>Demonstrated understanding of medical/therapeutic area knowledge and medical terminology</li><li>Demonstrated ability to attain and maintain a working knowledge of ICH GCPs, applicable regulations and procedural documents</li><li>Well-developed critical thinking skills, including but not limited to: critical mindset, in-depthinvestigation for appropriate root cause analysis and problem solving</li><li>Ability to manage Risk Based Monitoring concepts and processes</li><li>Good oral and written communication skills, with the ability to communicate effectively with medical personnel</li><li>Ability to maintain customer focus through the utilization of good listening skills, attention to detail and the ability to perceive customers&rsquo; underlying issues</li><li>Good organizational and time management skills</li><li>Effective interpersonal skills</li><li>Attention to detail</li><li>Ability to remain flexibile and adaptable in a wide range of scenarios</li><li>Ability to work in a team or independently as required</li><li>Good computer skills: solid knowledge of Microsoft Office and the ability to learn appropriate software</li><li>Good English language and grammar skills</li><li>Good presentation skills</li></ul> 
Working Conditions and Environment: 
<ul><li>Work is performed in an office/ laboratory/clinical/and/or home office environment with exposure to electrical office equipment.</li><li>Frequent drives to site locations. Frequent travel, generally 60-80% but more for some individuals. May also include extended overnight stays.</li><li>Exposure to biological fluids with potential exposure to infectious organisms.</li><li>Personal protective equipment required such as protective eyewear, garments and gloves.</li><li>Exposure to fluctuating and/or extreme temperatures on rare occasions</li></ul></div></div>

Clinical Research Associate II/ Neurology/ Eastern region of the US!

NEL & SHEY MEDICAL CENTER AND RESEARCH

Job Summary We are seeking a highly motivated and detail-oriented Clinical Research Coordinator to join our dynamic research team. In this vital role, you will oversee the planning, execution, and management of clinical trials, ensuring compliance with regulatory standards and maintaining the integrity of data collection. Your energetic approach will help drive innovative research forward, contributing to advancements in healthcare and patient outcomes. This paid position offers an exciting opportunity to work closely with multidisciplinary teams, coordinate complex studies, and make a meaningful impact in the clinical research field.Responsibilities<ul><li>Coordinate all aspects of clinical trials from start-up through closeout, including participant recruitment, scheduling, and follow-up.</li><li>Review and verify study documentation for accuracy, completeness, and regulatory compliance.</li><li>Monitor patient progress by conducting vital signs assessments, blood sampling (phlebotomy), and recording clinical data accurately.</li><li>Manage data collection and entry using electronic medical record (EMR) systems while ensuring adherence to CDISC standards for data formatting.</li><li>Ensure compliance with FDA regulations, ICH GCP guidelines, HIPAA privacy rules, and other applicable protocols.</li><li>Supervise research staff and collaborate with investigators to facilitate smooth trial operations.</li><li>Conduct clinical laboratory procedures and analyze results to support study objectives.</li><li>Maintain detailed documentation review processes, prepare reports, and support audits or inspections as needed.</li><li>Oversee patient safety by monitoring adverse events and ensuring proper reporting procedures are followed.</li><li>Utilize statistical software tools for data analysis to interpret research findings effectively.</li></ul>Requirements<ul><li>Proven supervising experience in a clinical research or healthcare setting.</li><li>Strong knowledge of clinical trials management, including FDA regulations and ICH GCP standards.</li><li>Excellent understanding of medical terminology, clinical laboratory procedures, and blood sampling techniques.</li><li>Experience with EMR systems, data management practices, and adherence to CDISC standards.</li><li>Ability to review complex documentation thoroughly while maintaining attention to detail.</li><li>Familiarity with clinical development processes and research methodologies.</li><li>Certification in Good Clinical Practice (GCP) from a recognized issuer for California or equivalent certification is preferred.</li><li>Knowledge of HIPAA compliance requirements related to patient privacy and data security.</li><li>Skills in analysis using statistical software packages are advantageous.</li><li>Effective communication skills for coordinating with multidisciplinary teams and ensuring protocol adherence. Join us as a Clinical Research Coordinator to be at the forefront of groundbreaking healthcare research! Your dedication will help shape the future of medicine while gaining invaluable experience in a fast-paced, rewarding environment dedicated to excellence in clinical trials management.</li></ul>Pay: $16.00 - $18.00 per hourWork Location: In person

Clinical Research Coordinator

OC PAin and Wellness

Responsibilities:- Coordinate clinical research studies from start to finish- Recruit and screen potential participants for eligibility- Obtain informed consent from participants and ensure compliance with ethical standards- Collect and analyze data, including blood samples, using appropriate clinical laboratory techniques- Monitor participants' progress throughout the study and address any concerns or adverse events- Collaborate with healthcare professionals, including nurses and physicians, to ensure proper care and treatment of participants- Maintain accurate and up-to-date documentation of study activities and participant records- Adhere to regulatory standards and guidelines for clinical research, including Good Clinical Practice (GCP) standardsSkills:- Strong knowledge of clinical research principles, practices, and regulations- Proficiency in statistical software for data analysis- Experience in clinical development and conducting clinical trials- Ability to perform blood sampling and other clinical procedures as required- Excellent organizational skills with attention to detail- Strong analytical skills to research, analyze, and interpret complex data sets- Effective communication skills to collaborate with multidisciplinary teams and communicate study findingsPlease note that this job description is not exhaustive and additional responsibilities may be assigned as needed.Job Type: Full-timePay: $23.00 - $25.00 per hourBenefits:<ul><li>Dental insurance</li><li>Health insurance</li><li>Paid time off</li><li>Vision insurance</li></ul>Location:<ul><li>Newport Beach, CA 92660 (Required)</li></ul>Ability to Relocate:<ul><li>Newport Beach, CA 92660: Relocate before starting work (Required)</li></ul>Work Location: In person

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7886 clinical research monitor jobs Near Me

Clinical Research Associate II - Oncology (Remote US - Multiple Openings)

Clinical Trial Central Screener

Clinical Research Associate II

Clinical Research Associate II/ Neurology/ Eastern region of the US!

Clinical Research Associate II/ Neurology/ Eastern region of the US!

Clinical Research Coordinator

Clinical Research Coordinator