When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. Key Accountabilities: Site Management Responsibilities - Contributes to the selection of potential investigators. - In some countries, as required, SrCRAs are accountable for study start-up and regulatory maintenance. Tasks may include Site Qualification Visits, collection, preparation, review and tracking of documents for the application process; submission of proper application/documents to EC/IRB and to Regulatory Authorities for start-up and for the duration of the study. - Trains, supports, and advises Investigators and site staff in study related matters, including Risk Based Quality Management (RbQM) principles. - Confirms that site staff have completed and documented the required training appropriately, including ICH-GCP training, prior to and for the duration of the study. Ensures the sites are always inspection ready. - Actively participates in Local Study Team (LST) meetings. - Contributes to National Investigators meetings, as applicable. - Initiates, monitors, and closes study sites in compliance with Client Procedural Documents. Shares information on patient recruitment and study site progress (site quality/performance) within the LST. - Drives performance at the sites. Proactively identifies and ensures timely resolution to study-related issues and escalates them as appropriate. - Updates CTMS and other systems with data from study sites as per required timelines. - Manages study supplies (Investigator Site File (ISF), etc.), drug supplies and drug accountability at study site. Prepares study drug for destruction, if applicable. - Performs monitoring visits (remote and onsite), as well as remote data checks, in accordance with the timelines specified in the study specific Monitoring Plan. If required, determines and discusses with LSAD the correct timing and type of visits. - Performs Source Data Review (SDR), Case Report Form (CRF) review and Source Data Verification (SDV), in accordance with the Monitoring Plan. - Performs regular Site Quality Risk Assessments and adapts monitoring intensity accordingly during the study. - Ensures data query resolution in a timely manner. - Works with data management to ensure robust quality of the collected study data. - Ensures accurate and timely reporting of Serious Adverse Events and their follow ups. - Prepares and finalizes monitoring visit reports in CTMS and provides timely feedback to the Principal Investigator, including follow-up letter, within required timelines and in line with Client SOP. - Follows up on outstanding actions with study sites to ensure resolution in a timely manner. - Follows quality issue processes by escalating systematic or serious quality issues, data privacy breaches, Clinical Study Protocol (CSP) or ICH-GCP compliance issues to Local Management and/or Clinical Quality Management (CQM) as required. - Assists site in maintaining inspection ready ISF. - Prepares for and collaborates with the activities associated with audits and regulatory inspections in liaison with LSAD and Clinical Quality Associate Director (CQAD). - Ensures timely collection/uploading of essential documents into the eTMF in accordance with ICHGCP, Client SOPs and local requirements. Supports/participates in regular QC checks performed by LSAD or delegate. - Ensures that all study documents under their responsibility (i.e., site documents, relevant communications, etc.) are available and ready for final archiving and completion of local part of the eTMF. - Provides feedback on any research related information including sites/investigators/competing studies that might be useful for the local market. - Collaborates with local Medical Scientific Liaisons (MSLs) as directed by LSAD or line manager Compliance with Sponsor Standards - Ensures compliance with the Client’s Code of Ethics and company policies and procedures relating to people, finance, technology, security, and SHE (Safety, Health and Environment). - Ensures compliance with local, national, and regional legislation, as applicable. - Completes timesheets accurately as required Skills (Essential): - Excellent attention to detail. - Good written and verbal communication skills. - Good collaboration and interpersonal skills. - Good negotiation skills. - Proficient in written and spoken English language required. - Fluency in local language(s) required. Skills (Desirable): - Ability to work in an environment of remote collaborators. Manages change with a positive approach for self, team and the business. Sees change as an opportunity to improve performance and add value to the business. - Ability to look for and champion more efficient and effective methods/processes of delivering quality clinical trials with reduced budget and in less time. - Good analytical and problem-solving skills. - Demonstrates ability to prioritize and manage multiple tasks with conflicting deadlines. - Ability to understand the impact of technology on projects and to use and develop computer skills while making appropriate use of systems/software in an e-enabled environment. - Team oriented and flexible; ability to respond quickly to shifting demands and opportunities Knowledge and Experience (Essential): - Excellent knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDP. • Good knowledge of relevant local regulations. - Good medical knowledge and ability to learn relevant Client Therapeutic Areas. - Basic understanding of the drug development process. - Good understanding of Clinical Study Management including monitoring, study drug handling and data management. Knowledge and Experience (Desirable): - Familiar with risk-based monitoring approach including remote monitoring. - Good cultural awareness. Education: - Bachelor’s degree in related discipline, preferably in life science, (or equivalent adapted to local country market needs), that supports skills and capabilities of the position and ensures successful conduct of responsibilities and appropriate interactions with internal and or external customers. Other: - Ability to travel nationally/internationally as required. - Valid driving license per country requirements, as applicable

Title: Associate Professor, Clinical Faculty Appointment (CFA) - Musculoskeletal Imaging - Requisition #:180133 - Department:Musculoskeletal Imaging Dept - Location:Houston, TX Job Description: The University of Texas MD Anderson Cancer Center is a world-renowned center for oncological care and research. The Department of Musculoskeletal Imaging, Division of Diagnostic Imaging at MD Anderson Cancer Center invites applications for a full-time, open rank clinical faculty appointment. The department prides itself on its balanced work-life and collegial culture. The Musculoskeletal Imaging Department consists of 11 musculoskeletal radiologists who provide diagnostic imaging services to diagnose, stage, and follow-up patients with known or suspected malignancy using conventional radiographs, computed tomography (CT), magnetic resonance imaging (MRI) and positron emission tomography (PET). Members of the department are responsible for the following: - Delivering excellent, comprehensive, and compassionate care for patients; - Providing multimodality approaches to musculoskeletal imaging including CT, MRI, whole body MRI, PET, and conventional radiography; - Educating medical students, residents, and fellows; - Developing academic and scholarly programs and projects; and - Fostering interdisciplinary and collaborative approaches to clinical care, research, and education. This position consists of a target base salary, various incentive/bonus compensation, and retirement benefits placing our remuneration package well in the 75th percentile nationally. Comprehensive health, wellness, time off, and various savings benefits are also included. The University of Texas MD Anderson Cancer Center offers excellent benefits, including medical, dental, paid time off, retirement, tuition benefits, educational opportunities, and individual and team recognition. This position may be responsible for maintaining the security and integrity of critical infrastructure, as defined in Section 113.001(2) of the Texas Business and Commerce Code and therefore may require routine reviews and screening. The ability to satisfy and maintain all requirements necessary to ensure the continued security and integrity of such infrastructure is a condition of hire and continued employment. It is the policy of The University of Texas MD Anderson Cancer Center to provide equal employment opportunity without regard to race, color, religion, age, national origin, sex, gender, sexual orientation, gender identity/expression, disability, protected veteran status, genetic information, or any other basis protected by institutional policy or by federal, state, or local laws unless such distinction is required by law.http://www.mdanderson.org/about-us/legal-and-policy/legal-statements/eeo-affirmative-action.html Additional Information - Requisition ID: 180133 - Employee Status: Regular - Minimum Salary: US Dollar (USD) 0 - Midpoint Salary: US Dollar (USD) 0 - Maximum Salary : US Dollar (USD) 0 - FLSA: exempt and not eligible for overtime pay - Work Location: Hybrid Onsite/Remote #LI-Hybrid

Please note: This is a limited appointment with 18 months duration. Senior Clinical Research Coordinators independently coordinate and are accountable for the overall administration of one or more clinical studies, typically requiring advanced-level knowledge and skills. They may provide leadership to lower-level clinical research coordinators and/or other support personnel. The position is responsible for, and critically important to the overall operational management of clinical research activities. It has direct responsibility for implementing a diverse portfolio of research activities for one or more studies which may include multicenter clinical trials (both NIH and industry-sponsored), local investigator-initiated clinical trials, and/or programmatic clinical research activities, such as a clinical database and biorepository. Required Qualifications - BS/BA degree in a related area and/or equivalent experience/training. Sufficient experience and demonstrated skills to perform the assigned duties and responsibilities. - Sufficient experience and demonstrated skills to successfully perform the assigned duties and responsibilities. - Demonstrated ability to develop recruitment strategies in complex environments and differing patient pools, independently identifying recruitment leads, implementing new strategies, and continually adjusting strategies to meet current recruitment goals. - In-depth knowledge of clinical research contracts and grants, clinical trials, protocols, FDA regulations, and complex visit structures. - Project management skills to oversee the administrative operations of the clinical trials program; knowledge of strategies for recruiting human subjects. - Exceptional analytical skills to evaluate the importance and urgency of problems; excellent demonstrated interpersonal, verbal and written communication skills. - Ability to analyze complex and non-routine issues requiring innovative solutions. - Ability to operate effectively in a changing organizational and technological environment. - Ability to assess and respond to audit risk; ability to develop project plans/schedules and motivate team to meet deadlines. - Ability to interpret and apply policies and regulations. - Financial analysis skills; demonstrated skills in preparing and presenting financial and quantitative analyses, including financial projections and budgets. - Significant project and clinical trial management experience or progressively responsible experience in a related position including regulatory and compliance responsibilities. - Experience using database software, such as REDCap or Medidata RAVE or other electronic data capture system. - Ability to obtain certification by the Society of Clinical Research Associates or the Association of Clinical Research Professionals within one year of date of hire. Preferred Qualifications - Fluency in spreadsheet software; ability to develop complex spreadsheets independently; demonstrated skills in audit preparation, execution, and follow-up. - Experience in risk management regarding study subjects, federal and non-federal sponsors and regulating bodies. - Experience with grant application procedures, personnel documentation, contract generation and subcontracting, preferably at UCSF. - Certification by the Society of Clinical Research Associates or the Association of Clinical Research Professionals.

The Clinical Research Coordinator (CRC) will execute, manage, and coordinate the routine duties of the Postmortem Investigation of Sudden Cardiac Death (POST SCD) research program alongside a team of CRCs under the guidance of the Principal Investigator (PI) and/or study team. Learn more about the lab here: https://ziantsenglab.ucsf.edu/. POST SCD is a clinical research laboratory with a multidisciplinary team and collaborations with local and federal agencies to comprehensively characterize the burden, underlying causes, and risk factors of sudden cardiac death (SCD) in a prototypic, diverse U.S. community. It is a first-of-its-kind partnership between cardiac electrophysiology specialists and the County Medical Examiner to perform comprehensive autopsies and antemortem medical history reviews for every incident out-of-hospital sudden death within the County of San Francisco.