CRA II

ComplianceComplianceFull TimeRemoteMid LevelTeam 10,001+H1B No SponsorCompany SiteLinkedIn

Location

Argentina

Posted

40 days ago

Salary

0

Seniority

Mid Level

No structured requirement data.

Job Description

CRA II

Fortrea

Summary of Responsibilities: - Site management responsibility for clinical studies according to Fortrea’s Standard Operating Procedures, ICH GCP Guidelines, applicable project plans and Sponsor requirements, including verification of study training records. - Conducts site monitoring responsibilities for clinical trials according to Fortrea’s Standard Operating Procedures (SOPs), ICH guidelines and GCP; including Pre-study, Site Initiation, Process Monitoring, Routine Monitoring, and Close-out Visits. - Prepares and implements project plans related to Clinical Monitoring responsibilities. - Ensures the protection of subjects by verifying that informed consent procedures and protocol requirements are adhered to alongside applicable regulatory requirements. - Safeguards data integrity by careful source document review, source document verification, query generation, and resolution against established data review guidelines on Fortrea or client data management systems. - Confirms Site Regulatory documents and applicable eTMF/Sponsor Documents are complete and current throughout the duration of the trial. - Guarantees that the study Investigational Product inventory and accountability is accurate and that study materials are stored securely and per protocol requirements. - Ensures adherence to global quality control and CRA performance metrics. - Ensures audit readiness at site level. - Acts in the project role of a Lead CRA as assigned. - General On-Site Monitoring Responsibilities: - Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter subjects/patients into the study. Ensure the protection of study subjects or patients by performing eligibility review, verifying that screening, informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements. - Ensure the integrity of the source data reported by careful source document review. Monitor data for missing or implausible data. - Ensure study data completeness, accuracy, consistency, and compliance; identify deficiencies, deviations and discrepancies, and initiate corrective action as required. - Ensure the resources of the Sponsor and Fortrea are spent wisely by performing the required monitoring tasks in an efficient manner, according to SOPs and established guidelines, including managing travel expenses in an economical fashion according to Fortrea travel policy. - Travel, including air travel, may be required and is an essential function of the job. - Prepare and submit accurate and timely trip reports. - Independently perform eCRF review, 100% source data verification, query generation and resolution against established data review guideline with or without direct supervision, on Fortrea or client data management systems, as assigned by management. - Assist with the administration of clinical research projects, recruiting investigators (if applicable), collecting investigator documentation and site management. - Update, navigate, and maintain Fortrea or study/Sponsor-specific trial management tools/eClinical systems. - Track IP shipments and supplies, as needed. - Track and follow-up on serious adverse events as assigned. - Work closely with the study team, align monitoring to critical study timelines ensuring study deliverables are met. - Prepare and implement study-specific monitoring plans and site Initiation slides, as assigned. - Attend investigators’ meetings (if applicable), project team meetings and teleconferences, and others as needed. - Present training content for site initiation. - Assist with training of new employees (e.g., co-monitoring). - All other duties as needed or assigned. Qualifications (Minimum Required): - University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure). An equivalent amount of experience can be substituted as appropriate. - Thorough understanding of ICH GCP Guidelines and understanding of local regulatory requirements. - Thorough knowledge of monitoring procedures. - Basic understanding of the clinical trial process. - Fluent in local office language and in English, both written and verbal. - Fortrea may consider relevant and equivalent experience in lieu of educational requirements. Experience (Minimum Required): - External Candidates: - University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure). AND - A minimum of 2 years of Clinical Monitoring experience. - Internal Candidates: - Internal candidates with a minimum of 2 years of Clinical Monitoring experience. - Ability to monitor study sites independently according to monitoring plan, project requirements, SOPs, and ICH GCP guidelines. - Ability to work with minimal supervision. - Have an understanding of the Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs. - Good planning, organization, and problem-solving abilities. - Works efficiently and effectively in a matrix environment. Preferred Qualifications Include: - Thorough working knowledge of Fortrea SOPs for site monitoring. - One (1) or more additional years of experience in a related field (i.e., medical, clinical, pharmaceutical, laboratory, research, data analysis, data management or technical writing) is preferred. - Phase I monitoring experience. - Life Science or Nursing qualification. - Specific skills, systems, certifications, and/or licenses preferred. - Personal characteristics (leadership, problem solving, interpersonal skills). - Good attention to detail. - Methodical approach to work. - Good understanding of medical and clinical research terminology and clinical research processes. - An understanding of the basics of physiology, pharmacology, and medical devices (when applicable). - Good understanding of the principles of ICH GCP, ISO 14155 (if applicable) and local regulatory requirements. - Good computer literacy with working knowledge of PCs, Windows and Microsoft Office applications. - Good oral and written internal and external communication. Strong interpersonal team and organizational skills, personal presentation. The ability to communicate effectively in English. - Focus on Customer. - Innovate and Change. - Pursue Scientific and Process Excellence. - Work with Others. - Achieve Results. - Ability to maintain confidentiality of data and information during interactions with staff at all levels and across studies and sponsors. - Demonstrated ability to conduct clinical operations activities most effectively and efficiently. - Good analytical and negotiation skills. - Experience using e-clinical systems [e.g., clinical trial management system (CTMS)]. - For medical device positions, experience in providing customer service to device end users. Physical Demands/Work Environment: - Must be able to sit at a computer for long periods of time. - Must be able to use hands to finger, handle or touch objects, tools or controls, including a computer keyboard, for up to 8 hours per day. - Standard office and/or home working environment. - Clinical Research Unit and hospital environment (administrative only). - Risk of eye strain. - Will involve outside of normal office hours as required by the role. - Travel Requirement is 60% of the time (traveling to study sites). Learn more about our EEO & Accommodations request here.

Related Categories

Related Job Pages

More Compliance Jobs

Supervisor, Compliance

Delta Dental

Established in 1957, Delta Dental of Michigan is a prominent division of the Delta Dental Plans Association, providing dental benefits to millions across the United States. The org

Compliance40 days ago

Location: DDMI - Okemos Job Description: Job Title: Supervisor, Compliance Number of Positions: 1 Location: Okemos, MI Location Specifics: Hybrid Position Job Summary: At Delta Dental of Michigan, Ohio, and Indiana we work to improve oral health through benefit plans, advocacy and community support, and we amplify this mission by investing in initiatives that build healthy, smart, vibrant communities. We are one of the largest dental plan administrators in the country, and are part of the Delta Dental Plans Association, which operates two of the largest dental networks in the nation. At Delta Dental, we celebrate our All In culture. It’s a mindset, feeling and attitude we wrap around all that we do – from taking charge of our careers, to helping colleagues and lending a hand in the community. Position Description Supervises and supports the implementation and day-to-day operation of the Compliance Program and activities while ensuring the company and its affiliates, and/or subsidiaries, comply with relevant industry standards and regulations, contractual requirements, and internal policies. - Provides guidance, coaching, and day-to-day support to Compliance team. - Serves as an escalation point for routine compliance questions and operational issues, resolving matters and elevating higher-risk issues as appropriate. - Coordinates and leads assigned compliance initiatives. - Identifies and leads the development, maintenance, and implementation of compliance policies, procedures, job aids, and tools. - Supports leadership in monitoring program effectiveness, audits and regulatory inquiries, and advancing compliance awareness throughout the organization. - Leads auditing and monitoring activities, including data collection, analysis, documentation, and follow-up remediation tracking. - Maintains ongoing monitoring of compliance risks and controls, identifying trends and potential gaps and recommending corrective actions. - Partners with management to support the annual compliance risk assessment and the implementation of related work plans. - Builds and maintains effective working relationships with internal stakeholders. - Plans and leads the activities of the team to ensure completion of assigned matters. - Participates in regulatory exams and market conduct examinations, as necessary. - Coordinates requests for compliance and ethics investigations. - Responds to alleged violations of rules, regulations, policies, procedures, and Code of Ethics and Conduct by evaluating or recommending the initiation of investigative procedures. - Updates compliance training materials as needed, and monitors ongoing completion and effectiveness of compliance training programs Performs other related assigned duties as necessary to complete the Primary Job Responsibilities as described above. #LI-Hybrid Minimum Requirements: Position requires a bachelor’s degree in business administration, health administration, public health/public policy, or a related field and five years of compliance or regulatory experience in the health or insurance industry, with leadership experience preferred. Medicare and/or Medicaid compliance experience preferred. Compliance professional certification preferred. Will accept any suitable combination of education, training, or experience. Position requires working knowledge of applicable laws and regulations; the ability to provide guidance to others; strong organizational, analytical, verbal, and written communication skills; attention to detail; ability to manage multiple priorities; and the ability to work collaboratively across the organization. The company will provide equal employment and advancement opportunity within the context of its unique business environment without regard to race, color, religion, gender, gender identity, gender expression, age, national origin, familial status, citizenship, genetic information, disability, sex, sexual orientation, marital status, pregnancy, height, weight, military status, or any other status protected under federal, state, or local law or ordinance.

Michigan
Advocate Aurora Health logo

Compliance Reimbursement Consultant

Advocate Aurora Health

We help people live well. We’re proud to be part of Advocate Health.

Compliance40 days ago
Full TimeRemoteTeam 10,001+H1B No Sponsor

• Assist with hotline triage and response for Medical Group/Clinic compliance questions and concerns • Navigation/connection to other support departments and collaboration within compliance team, as needed • Assist with risk assessment process and remediation for Medical Group risks • Assist with physician compensation analysis, as assigned • Research of regulatory topics related to physician/professional services, reimbursement, and program requirements • Prepare and present compliance reviews, regulatory, and educational information to audiences across the organization • Assist with monthly review of regulatory updates at federal and state levels • Prepare reports of reviews and investigations and delivers the results to Operational Leaders • Completes special compliance related projects as needed

United States
$41 - $61 / hour
Job Closed
GE HEALTHCARE logo

Lead Clinical Applications Specialist

GE HEALTHCARE

GE HealthCare is a leading global medical technology and digital solutions innovator. Our purpose is to create a world where healthcare has no limits. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world.

Compliance40 days ago
Full TimeRemoteTeam 10,001

Job Description Summary The Lead Clinical Applications Specialist provides industry leading applications support for the development of Ultrasound Enhancing agents in Echocardiography exams. The primary responsibility of this specialist is to act as clinical “voice of the customer”. Deliver in-service education presentations to customers in large and small group settings and provide product demonstrations to customers. Cross-functionally, you will work closely with sales, marketing, and other internal stakeholders. You will stay on-label in all discussions, education, and training, both internal and external customers. Job Description Responsibilities: - Provide clinical support for the development of Ultrasound Enhancing Agents. - Apply knowledge of clinical Echocardiography to guide definition and development of new imaging and post-processing techniques. - Assist with trials, implementation, training, and Echocardiography Ultrasound Enhancing Agents. - Develop (clinical) competitive intelligence to support the field with counter arguments and selling advantages. - Represent and assist at local, regional, or National trade shows and meetings, as required - Demonstrate effective sales and presentation skills in diverse settings from one-on-one to formal large group situations, in-person and virtually Qualifications: - Preferred ARDMS, CCI certified or global equivalent - Experienced in Echocardiography including all clinical applications and performing procedures - At least 5 yrs. of experience in the medical industry - Ability to work independently, as well as within a team - Customer contact experience in various situations - Ability to travel 70% of the time - Demonstrate strong organizational, written, and verbal communication skills Preferred Knowledge/Skills: - Bachelors or 5 years equivalent experience - Ultrasound Enhancing Agent application experience - Echocardiography experience We will not sponsor individuals for employment visas, now or in the future, for this job opening. Additional Information GE HealthCare offers a great work environment, professional development, challenging careers, and competitive compensation. GE HealthCare is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law. GE HealthCare will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable). While GE HealthCare does not currently require U.S. employees to be vaccinated against COVID-19, some GE HealthCare customers have vaccination mandates that may apply to certain GE HealthCare employees. Relocation Assistance Provided: No

United States

Compliance Specialist III *may underfill: Compliance Spec II range $23.75 - $35.65 Compliance Spec I range $16.39 - $24.60 FT / PT Status – FT Salary – $26.47-$39.74 Remote work / In-Office – Remote Recruiter – Christa Rowland|crowlan@utah.gov|801-538-4826 Application Deadline – 5-1-26 Job Description We are seeking a Compliance Specialist III to join our team. This is a working-level position that may be underfilled as a Compliance Specialist II or I, depending on qualifications. This pivotal role safeguards Utah's agricultural sector by ensuring adherence to state and federal laws concerning plant health, pest management, and agricultural product standards. Key responsibilities include conducting inspections, investigations, and audits to enforce regulatory compliance. The ideal candidate is a proactive individual with a strong foundation in plant science and regulatory frameworks, possessing exceptional communication and investigative abilities. This role requires an individual who works well independently and also has the ability to collaborate with others. The job requires excellent communication skills and a knowledge of agricultural practices. Key Responsibilities Reviewing product labels and collecting samples to ensure compliance. Conduct inspections at manufacturing facilities and retail establishments. Regulating agricultural products such as animal feed, fertilizers, nursery stock and seed products. Facilitate interstate and international commerce by conducting quarantine and phytosanitary inspections. Conduct seasonal trapping of invasive insect pests. Promote the control of invasive weed species through working with county and state weed control officials and issuing noxious weed free hay/straw certificates. Assist federal programs (FDA, USDA) on inspections and regulatory affairs. All other UDAF Programs as assigned. Qualifications Technical Skills & Knowledge Working knowledge of fertilizer, animal feed, or nursery production, control and identification of noxious weeds, organic certification, or other programs assigned to the Plant Industry Division. Strong understanding of state and federal agricultural laws, regulations, and policies and how to interpret and apply them. Proficiency in using computers and standard office software (e.g., Microsoft Office and Google Programs). Physical Requirements Ability to lift up to 50 pounds daily. Communication & Interpersonal Skills Exceptional written and verbal communication skills, including the ability to present complex information clearly and concisely to producers and consumers. Strong interpersonal skills and the ability to build rapport and work effectively with regulated industries, the public, and colleagues. Analytical & Problem-Solving Skills Excellent analytical, problem-solving, and critical thinking skills. Ability to conduct thorough investigations, collect evidence, and draw sound conclusions. Organizational & Management Skills Maintain accurate and thorough records of all activities, inspections, and investigations. The ability to work independently with minimal supervision and manage multiple priorities effectively. Licensing & Certification Valid Utah Driver's License or ability to obtain one within a specified timeframe. *Preference will be given to those with a bachelor’s degree in Agronomy, Biology, Botany, or related field or 5 years work experience related to agriculture inspection. Supplemental Information Risks which require the use of special safety precautions and/or equipment, e.g., working around operating machines, working with contagious diseases or hazardous chemicals, etc. Valid driver license required to drive a motor vehicle on a highway in this state per UCA53-3-202(1)(a) will be required. Work requires physical exertion. May require the ability to stand; walk over rough surfaces; bend, crouch, stoop, stretch, reach, lift moderately heavy items (up to 50 lbs.) in a recurring manner and/or for long periods of time. About the Role Location –4315 S 2700 W Background Check Required –No Drug Test Required – No Schedule Code – B Why You Should Join Our Team We offer a flexible schedule, daily variety, and a supportive team environment. Your essential role will be to conduct inspections and enforce regulations related to agricultural product safety, trade compliance (interstate/international), and biosecurity against harmful invasive pests and diseases. This is a highly rewarding job dedicated to consumer protection and agricultural health. If you are detail-oriented and enjoy working both in the office and the field, apply now! In Utah, we believe hard work is important, but balance is essential. Finding work/life balance is a vital element to our culture. To find out more about WHY Utah, click here. Other benefits may include: - Job Stability: Enjoy the security and reliability of employment within a well-established organization. - Career Growth: Develop valuable skills and gain opportunities for leadership within a large organization. - Meaningful Work: Contribute to an important service that benefits the community and supports organizational goals. - Supportive Work Environment: Be part of a team that values cooperation, strong work ethics, and mutual support. The Agency For more information about working for the Department of Agriculture and Food please click here. EEO Statement The State of Utah is committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity, or Veteran status. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements. For accommodations, please contact (801) 957-9390.

United States
$26 - $40 / hour