Role Description The Contractor CRA will perform various responsibilities including: - Site qualification, initiation, interim monitoring, management, and close-out visits (on-site or remotely). - Ensuring compliance with regulatory, ICH-GCP, GPP, and protocol standards. - Evaluating site performance and providing recommendations for site-specific actions. - Maintaining knowledge of ICH/GCP Guidelines, relevant regulations, and company SOPs. - Verifying informed consent processes for each subject/patient. - Protecting subject/patient confidentiality and assessing safety factors affecting clinical data integrity. - Conducting Source Document Reviews and verifying clinical data accuracy. - Applying query resolution techniques and providing guidance to site staff. - Verifying compliance with electronic data capture requirements. - Performing investigational product inventory and ensuring proper dispensing and administration. - Reviewing the Investigator Site File for accuracy and completeness. - Documenting activities via confirmation letters, trip reports, and other required documents. - Supporting subject/patient recruitment and retention strategies. - Managing site-level activities to meet project objectives and timelines. - Acting as a primary liaison with study site personnel. - Preparing for and attending Investigator Meetings and sponsor meetings. - Providing guidance towards audit readiness standards. - May supervise, train, and mentor junior CRAs. - For Real World Late Phase (RWLP), additional responsibilities include: - Site support throughout the study lifecycle. - Chart abstraction activities and data collection. - Collaborating with Sponsor and local staff. - Training junior staff as needed. - Identifying operational efficiencies and process improvements. - Participating in bid defense meetings and providing input into RFPs. Qualifications - Bachelor’s degree or RN in a related field or equivalent combination of education, training, and experience. - Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements. - Good computer skills and ability to embrace new technologies. - Excellent communication, presentation, and interpersonal skills. - Moderate level of critical thinking skills expected. - Ability to manage required travel of up to 75% on a regular basis. Benefits - Company car or car allowance. - Health benefits including Medical, Dental, and Vision. - Company match 401k. - Eligibility to participate in Employee Stock Purchase Plan. - Eligibility to earn commissions/bonus based on performance. - Flexible paid time off (PTO) and sick time. Company Description Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities. Over the past 5 years, we have worked with: - 94% of all Novel FDA Approved Drugs. - 95% of EMA Authorized Products. - Over 200 Studies across 73,000 Sites and 675,000+ Trial patients. At Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop, and advance.

Role Description Experienced Clinical Research Associate - Full-Service - Ophthalmology - Performs site qualification, site initiation, interim monitoring, site management activities, and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance. - Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and develops action plans. - Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes. - Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate. - Demonstrates diligence in protecting the confidentiality of each subject/patient. - Assesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues. - Per the Clinical Monitoring/Site Management Plan (CMP/SMP): Assesses site processes. - Conducts Source Document Review of appropriate site source documents and medical records. - Verifies required clinical data entered in the case report form (CRF) is accurate and complete. - Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines. - Utilizes available hardware and software to support the effective conduct of the clinical study data review and capture. - Verifies site compliance with electronic data capture requirements. - May perform investigational product (IP) inventory, reconciliation and reviews storage and security. - Verifies the IP has been dispensed and administered to subjects/patients according to the protocol. - Verifies issues or risks associated with blinded or randomized information related to IP. - Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned. - Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. - Reconciles contents of the ISF with the Trial Master File (TMF). - Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations. - Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan. - Supports subject/patient recruitment, retention and awareness strategies. - Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution. - For assigned activities, understands project scope, budgets, and timelines; manages site-level activities/communication to ensure project objectives, deliverables and timelines are met. - Must be able to quickly adapt to changing priorities to achieve goals/targets. - May act as primary liaison with study site personnel, or in collaboration with Central Monitoring Associate. - Ensures all assigned sites and project-specific site team members are trained and compliant with applicable requirements. - Prepares for and attends Investigator Meetings and/or sponsor face-to-face meetings. - Participates in global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements. - Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions. - Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes; completes assigned training as required. - For Real World Late Phase, the CRA II will use the business card title of Site Management Associate II. - Additional responsibilities include: Site support throughout the study lifecycle from site identification through close-out. - Knowledge of local requirements for real world late phase study designs. - Chart abstraction activities and data collection. - Collaboration with Sponsor affiliates, medical science liaisons and local country staff. - The SMA II may be requested to train junior staff. - Identify and communicate out of scope activities to Lead CRA/Project Manager. - Proactively suggest potential sites based on local knowledge of treatment patterns, patient advocacy and Health Care Provider (HCP) associations. Qualifications - Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience. - Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements. - Must demonstrate good computer skills and be able to embrace new technologies. - Excellent communication, presentation and interpersonal skills. - Ability to manage required travel of up to 75% on a regular basis. Requirements - As part of your employment with Syneos Health, you may be deployed to Sites that require certain medical and other personal information to gain facility access. - Pursuant to our Employee Privacy Notice, Syneos Health can provide the Sites with the information necessary for you to gain such access. - Further, a Site may ask you for additional information beyond that which Syneos Health has in its possession. - You are required to comply with any such Site requests as a condition of your employment with Syneos Health. - Please note that failure to provide requested information may result in a Site barring you from entry, which could put your ongoing employment at risk. Benefits - Company car or car allowance. - Health benefits to include Medical, Dental and Vision. - Company match 401k. - Eligibility to participate in Employee Stock Purchase Plan. - Eligibility to earn commissions/bonus based on company and individual performance. - Flexible paid time off (PTO) and sick time.

Role Description Experienced Clinical Research Associate - Full-Service - Oncology - Performs site qualification, site initiation, interim monitoring, site management activities, and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance. - Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and develops action plans. - Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes. - Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate. - Demonstrates diligence in protecting the confidentiality of each subject/patient. - Assesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues. - Per the Clinical Monitoring/Site Management Plan (CMP/SMP): Assesses site processes. - Conducts Source Document Review of appropriate site source documents and medical records. - Verifies required clinical data entered in the case report form (CRF) is accurate and complete. - Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines. - Utilizes available hardware and software to support the effective conduct of the clinical study data review and capture. - Verifies site compliance with electronic data capture requirements. - May perform investigational product (IP) inventory, reconciliation and reviews storage and security. - Verifies the IP has been dispensed and administered to subjects/patients according to the protocol. - Verifies issues or risks associated with blinded or randomized information related to IP. - Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned. - Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. - Reconciles contents of the ISF with the Trial Master File (TMF). - Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations. - Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan. - Supports subject/patient recruitment, retention and awareness strategies. - Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution. - For assigned activities, understands project scope, budgets, and timelines; manages site-level activities/communication to ensure project objectives, deliverables and timelines are met. - Must be able to quickly adapt to changing priorities to achieve goals/targets. - May act as primary liaison with study site personnel, or in collaboration with Central Monitoring Associate. - Ensures all assigned sites and project-specific site team members are trained and compliant with applicable requirements. - Prepares for and attends Investigator Meetings and/or sponsor face-to-face meetings. - Participates in global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project-specific requirements. - Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions. - Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes; completes assigned training as required. - For Real World Late Phase, the CRA II will use the business card title of Site Management Associate II. - Additional responsibilities include site support throughout the study lifecycle from site identification through close-out. - Knowledge of local requirements for real world late phase study designs. - Chart abstraction activities and data collection. - Collaboration with Sponsor affiliates, medical science liaisons and local country staff. - The SMA II may be requested to train junior staff. - Identify and communicate out of scope activities to Lead CRA/Project Manager. - Proactively suggest potential sites based on local knowledge of treatment patterns, patient advocacy and Health Care Provider (HCP) associations. Qualifications - Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience. - Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements. - Must demonstrate good computer skills and be able to embrace new technologies. - Excellent communication, presentation and interpersonal skills. - Ability to manage required travel of up to 75% on a regular basis. Requirements - As part of your employment with Syneos Health, you may be deployed to Sites that require certain medical and other personal information to gain facility access. - Pursuant to our Employee Privacy Notice, Syneos Health can provide the Sites with the information necessary for you to gain such access. - A Site may ask you for additional information beyond that which Syneos Health has in its possession. - You are required to comply with any such Site requests as a condition of your employment with Syneos Health. - Failure to provide requested information may result in a Site barring you from entry, which could put your ongoing employment at risk. Benefits - Company car or car allowance. - Health benefits to include Medical, Dental and Vision. - Company match 401k. - Eligibility to participate in Employee Stock Purchase Plan. - Eligibility to earn commissions/bonus based on company and individual performance. - Flexible paid time off (PTO) and sick time. - Compliance with all applicable federal, state, and municipal paid sick time requirements. Company Description Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health: Syneos Health

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com. As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. Job Function: MedTech Sales Job Sub Function: Clinical Sales – Hospital/Hospital Systems (Commission) Job Category: Professional All Job Posting Locations: Houston, Texas, United States of America Job Description: Johnson & Johnson is hiring for a Field Clinical Specialist for Shockwave Medical Inc. located in Houston Texas. At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity. Learn more at https://www.jnj.com/. Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Ready to join a team that’s pioneering the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. Our Shockwave Medical portfolio aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated and proprietary local delivery of sonic pressure waves for the treatment of calcified plaque. Position Overview The Field Clinical Specialist is a visible position that will provide case support to physicians within certain territories. Case support will be done on peripheral and coronary interventional procedures in the pre-market and post-market phases of product development with the Shockwave Medical Intravascular Lithotripsy (IVL) ® technology. The Field Clinical Specialist will also play a critical role in clinical studies including device training, case support and ensuring timely data collection for clinical programs. Case support may be required to support other territories at certain times. Essential Job Functions - Physician and hospital staff training, and procedural case coverage to ensure the safe and effective use of medical devices. - Effectively meet the needs of internal and external customers with a sense of urgency and drive. - Present clinical study training materials based on investigational plans to support the safe and effective use of medical devices, inclining study protocol, instructions for use, core lab manuals and case report forms. - Manage key study investigators; foster and maintain strong relationships through direct interactions with medical advisors and clinical leaders. - Partner with other clinical research colleagues to meet business needs in the field including site re-training, data collection for timely database locks and resolution of critical issues. - Administrative activities including training to procedures, manage territory travel and budgets. - Other duties as assigned. Qualifications - Minimum Bachelor’s Degree in business, science, nursing or related fields, or equivalent experience. - Minimum 2 years’ experience directly supporting interventional or surgical procedures within a hospital setting OR, 1 year of industry, hospital-based life sciences, sales support experience. Cardiovascular industry experience preferred but not required. - Working knowledge of clinical research, Good Clinical Practice (GCP) and regulatory compliance guidelines for clinical trials. - A history of effective collaboration with regulatory agencies through clinical studies and market releases. - Product knowledge including product vigilance and medical device reporting. - High attention to detail and accuracy. - Computer skills (MS Office products, word processing, spreadsheets, etc.). - Finance and budgeting knowledge. - Good prioritization and organizational skills. - Excellent critical thinking skills. - Excellent influencing and negotiation skills. - High energy and results-oriented individual who is mature and successful in a business environment and is skilled in motivating and inspiring people. - Entrepreneurial “hands-on” experience. Pro-active and “can do” attitude. - Ability to consider and accept feedback and suggestions for continuous improvement. - Works effectively on cross-functional teams. Demonstrated willingness to make decisions and to take responsibility for such. - Effective written, verbal and presentation skills with all levels of customers and management. - Ability to work in a fast-paced environment while managing multiple priorities - Operate as a team and/or independently while demonstrating flexibility to changing requirements. - There may be continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day) - Significant travel >50% of time requiring the employee to be effective in a remote manner. - Employee may be required to lift objects up to 40lbs or more. Employees will be required to work in an air conditioned office space and possibly perform some tasks in our non-temperature controlled warehouse space. Pay Transparency: Additional Information: - The base pay range for this position is $100,000. - The Company maintains a highly competitive sales incentive compensation program. Under current guidelines, this position is eligible for participation in this program in accordance with the terms of the applicable plan. - This position is eligible for a car allowance through the Company’s Fleet program - Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. - Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)). - Employees are eligible for the following time off benefits: - Vacation – up to 120 hours per calendar year - Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year - Holiday pay, including Floating Holidays – up to 13 days per calendar year - Work, Personal and Family Time - up to 40 hours per calendar year - Additional information can be found through the link below. https://www.careers.jnj.com/employee-benefits The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market. Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource. Required Skills: Preferred Skills: Business Behavior, Communication, Consulting, Cross-Selling, Customer Centricity, Customer Effort Score, Customer Retentions, Execution Focus, Goal Attainment, Hospital Operations, Innovation, Market Research, Medicines and Device Development and Regulation, Sales, Solutions Selling, Sustainable Procurement, Vendor Selection