Clinical Research Associate jobs at Precision For Medicine

Be Seen and Heard at EyePoint At EyePoint, leadership trusts our employees to get the job done. The patient-centric and award-winning approach we're taking in business fuels our success for: preventing blindness through vision-saving medications delivering best-in-class proprietary pharmaceutical technologies transforming ocular drug delivery We See You. Your wellbeing Your professional worth Your future at EyePoint EyePoint offers robust total rewards in a science-based entrepreneurial culture that empowers curiosity and innovation to help catapult your career. There's space for every voice and perspective to be heard in our on-site and remote environments where a variety of strengths and diverse backgrounds are connected. This position is reporting to the VP, Clinical Development and is remote. Responsibilities Primary responsibilities include, but are not limited to, the following: Individual Responsibilities Contribute in collaboration with a cross-functional team the implementation of Clinical Development Plans and Registrational Strategies for the assigned products within the portfolio. Collaborate within Clinical Development and partnered Clinical Research Organizations (CROs) all clinical trial documents including, Clinical Research Protocol Synopses, Clinical Research Protocols, Investigator Brochures, Informed Consent Templates, Study Case Report Forms/Electronic Data Capture Systems, Procedure Manuals, Clinical Study Reports ensuring high caliber of all documents in compliance with International Conference on Harmonization (ICH)/Good Clinical Practice (GCP) standards/Federal and local regulations and company specific SOPs. Assist in management of the collection, review, and analysis of clinical trial data in compliance with interim analysis and overall statistical analysis plans. Ensure ongoing active review clinical data for trends in safety, effectiveness and adherence to protocol across clinical trials. Assist with the preparation of clinical documents for submission to global health authorities including briefing books/materials supporting EMA Scientific Advice, Pre-IND, IND, End-of-Phase II, NDAs, MAAs and other regulatory meetings and regulatory filings as required. Assist with authorship of meeting abstracts and posters and the publication of clinical trial data in accord with the publication strategy for the clinical program. Assist with all site initiation activities including site initiation visits, investigator meetings, development and implementation of monitoring plans and annotated monitoring visit report templates and completion and submission of all required clinical trial documents prior to site initiation. Actively assist with clinical trial recruitment strategies with evaluation of actual enrollment against assigned targets and working with investigational sites to meet, and whenever feasible, exceed enrollment targets in collaboration with clinical operations. Assist with study milestones and study metrics in collaboration with clinical operations. Ensure proper conduct of global clinical trials in compliance with global regulatory authority, ICH and GCP guidelines. Qualifications Primary skills and knowledge required include, but are not limited to the following: A complete understanding and application of principles, concepts and practices of clinical research procedures and Good Clinical Practice (GCP) is required. Experience in ophthalmology and familiarity with drug/device combination products Experience with all phases of clinical drug development including regulatory submissions Ability to survey and interpret scientific literature related to the assigned portfolio of products Strong communication, organizational and interpersonal skills are required. Successful work experience in a matrix team environment with cross functional teams is required. Independent decision-making and analytical skills are required. Level of Education Required: Advanced degree in life science/clinical/medical field, PhD or PharmD Number of Years of Experience in the Function and in the Industry: Minimum of 5+ years of clinical development/research and R&D experience preferred for an Associate Director Level Minimum of 10 years of clinical development/research and R&D experience preferred at Director Level Envision Your Future With the exciting energy of a winning culture and an exhilarating pace, we are an ophthalmology company committed to preventing blindness by developing and commercializing innovative therapeutics. The collective power of our values influences everything we do, and everything we do for you. Transformational Innovation We exist to change our patients' lives through the power of sight. We are forward looking, embrace challenges with curiosity, and continuously seek to improve our products and ourselves by learning, problem-solving and pushing the limits of science and technology. Unwavering Integrity We recognize our responsibility to our patients, employees, and our community, and value the trust they put in us. We set a high ethical bar and expect responsible leadership at every level to ensure we serve those who matter most to us. Compassionate Excellence We believe that fun and excellence can coexist. We foster a culture where enjoying the work we do and caring for each other are as important as delivering exceptional outcomes. Inclusive Collaboration We strive to see through the eyes of others and work as one team. We appreciate one another's differences and perspectives, and ensure everyone feels valued, respected and encouraged to bring their ideas forward. EyePoint is proud to be an equal opportunity employer. We believe that diversity and inclusion among our colleagues is critical to our success as a company, and we seek to recruit, develop, and retain the most talented people from a diverse candidate pool. All applicants will be considered for employment without attention to age, race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or disability status. EyePoint is committed to fair and equitable compensation practices. The salary offer is commensurate with EyePoint's compensation philosophy and considers factors including but not limited to education, training, experience, market conditions, criticality of the role and internal equity. The target salary range for this position is listed below. #LI-Remote Min USD $154,500.00/Yr. Max USD $249,947.00/Yr.

More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks. With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives. Summary:In this (Senior) CRA role (depending on the candidate), you will be responsible for monitoring the progress of clinical studies, either at investigative sites or remotely, and ensure clinical trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), ICH-GCP, and all applicable regulatory requirements. You can be based anywhere in the U.S., although east coast is preferred. Travel expected: ~1+ site visit per week, for sites that do not permit virtual monitoring. The role may be engaged as contractor or full-time employee , depending on business needs. Responsibilities: May serve as the primary monitor and main point of contact for assigned clinical sites Conduct interim monitoring visits (IMVs) and ISF review Review electronic medical records (EMR)/patient data Source documentation verification (SDV) against case report form data, including informing the site staff of any entry errors, ensuring good documentation practices are being adhered to and communicating protocol deviations appropriately per SOPs, GCP and applicable regulatory requirements Verification and review of adverse events, serious adverse events, concomitant medications and corresponding illnesses to confirm accurate data reporting in accordance with the protocol Provide support to site staff including research coordinators and physicians Assist in the development of trial materials as needed (e.g., case report forms, monitoring guidelines, site tools and training guides) Contribute to the development of Clinical Operations SOPs, best practices, work instructions, tools and templates Author and submit high-quality monitoring visit reports within required timelines Ensure completeness and accuracy of monitoring documentation in the eTMF Desired Qualifications: BA/BS or equivalent with a minimum of 2+ years of CRA experience (for CRA role) or 5+ years with lead monitor responsibilities (Senior) Therapeutic experience in oncology/hematology and cell and gene therapy preferred Prior CRA experience working directly for sponsor, ideally a start-up/or small company, with primary site ownership and independent monitoring responsibility Strong working knowledge of FDA and ICH/GCP regulations and guidelines and thorough knowledge of clinical monitoring procedures Experience with Trial Master File management according to the DIA reference model Experience operating within various site EMR/EHR systems Experience using eTMF, EDC (IBM Zelta experience ideal), CTMS, and other vendors systems/portals Personal Qualities: Highly detail oriented with special attention to quality and quality control Ability to multitask and handle multiple responsibilities simultaneously; able to prioritize Well organized and able to work under tight deadlines Demonstrated strong work ethic, curiosity to learn and contribute in a fast-paced collaborative environment Strong interpersonal skills, including verbal and written communication, are essential Ability to work in a collegial and collaborative manner; independently and as part of a team Ability to work in a fast-paced and informal startup environment Highly tolerant and respectful of all members of our team Strong problem-solving skills with desire to improve upon established processes Sense of humor Who we are We are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all who need them. We live by our core values of passion, courage, and integrity. Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility. We innovate on a path that hasn't been paved. We embrace an entrepreneurial spirit and take calculated risks to achieve our mission. We aren't afraid to ask “why not” and challenge the status quo. We maintain a start-up culture of camaraderie and leadership by example, regardless of title. We're proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers. Notice to staffing firms Orca Bio does not accept resumes from staffing agencies with which we do not have a written agreement and specific engagement for a particular opening. Our employment activities, inquiries and offers are managed through our HR/Talent team, and all candidates are presented through this channel only. We do not accept unsolicited resumes, and we rarely outsource recruitment.

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. CRA and Sr CRA positions- Remote - Need for SE Region - FL ONCOLOGY preferred Job Purpose: The Clinical Research Associate (CRA) has local responsibility for the delivery of the studies at allocated sites and is an active participant in the local study team(s). The CRA works in close collaboration with other CRAs and the Local Study Team/ Local Study Associate Director (LSAD) to ensure that study commitments are achieved in a timely and efficient manner. The CRA acts as the main contact with the study site and has the responsibility for monitoring the study conduct to ensure proper delivery of the study. The CRA is responsible for the preparation, initiation, monitoring, and closure of assigned sites in clinical studies, in compliance with Client Procedural Documents, international guidelines such as ICH-GCP, and relevant local regulations and that the sites deliver according to their respective commitment in the individual studies. Key Accountabilities: Site Management Responsibilities Contributes to the selection of potential investigators. In some countries, as required, CRAs 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 inspection ready at all times. 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 ICH-GCP, 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 Science 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. Compliance with Parexel Standards Complies with required training curriculum. Completes timesheets accurately as required. Submits expense reports as required. Updates CV as required. Maintains working knowledge of and complies with Parexel/Client processes, ICH-GCPs and other applicable requirements. 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 (Desired): 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 qualification (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. LI-LG4 EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

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. The Senior Clinical Research Associate (SrCRA) has local responsibility for the delivery of the studies at allocated sites and is an active participant in the local study team(s). The SrCRA works in close collaboration with other CRAs and the Local Study Team/ Local Study Associate Director (LSAD) to ensure that study commitments are achieved in a timely and efficient manner. The SrCRA acts as the main contact with the study site and has the responsibility for monitoring the study conduct to ensure proper delivery of the study. The SrCRA is responsible for the preparation, initiation, monitoring, and closure of assigned sites in clinical studies, in compliance with Client Procedural Documents, international guidelines such as ICHGCP, and relevant local regulations and that the sites deliver according to their respective commitment in the individual studies. The SrCSA performs all the duties of the CRA with higher proficiency, independency, accountability, and ability to take on additional tasks or tutor more junior personnel. A SrCRA with longer tenure and experience may take on additional responsibilities that include additional tasks associated with LSAD. 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 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 #LI-LO1 EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

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. The Senior Clinical Research Associate (Sr. CRA) is responsible for the site management, site monitoring and close-out of assigned clinical trials investigator sites to ensure patient safety and quality study execution in accordance with applicable prevailing laws, Good Clinical Practices (GCP), and the Sponsor's standards. The Sr. CRA is accountable for site management and monitoring, managing investigator site relationships to ensure effective delivery of clinical trials (e.g. enrollment, database release), to safeguard the quality of investigator sites (e.g. patient safety, site quality and compliance with GCP), to maintain investigator and site staff engagement and satisfaction, and to enhance the company's image with its external stakeholders. The Sr. CRA is responsible for the resolution of all protocol-related issues for assigned investigator sites and will work closely with the Site Care Partner (SCP), and other members of the study team, as required, in activities associated with the set-up, running and close-out of sites in a clinical trial. Monitoring Responsibilities and Study Conduct: Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan (SMP) and applicable prevailing laws, GCP, and the Sponsor's standards to achieve project goals, timelines and quality Manage assigned operational aspects for implementation of clinical trial activities at assigned investigator sites from site activation through to database lock, ensuring relevant timelines and quality deliverables are met During study conduct, serve as the primary point of contact for assigned investigator sites. Work in partnership with and/or escalate to the SCP to ensure quality of site delivery Interface with the study team as needed, facilitate information flow between members of the study team, vendors and assigned investigator sites Partner with Site Care Partner to perform investigator site development, coaching and training of site personnel to ensure ongoing compliance with protocol and the safeguarding of patients; provide protocol training to, and address protocol related questions from the investigator site staff when required, including discussions on known/anticipated operational and clinical trial risks Attend investigator meeting when required (virtual or F2F). Provide enrollment support and ensure progress by responding to site activation and recruitment issues from investigators. Partner with Site Care Partner and the study team to define and support recruitment initiatives at site level Conduct onsite, remote/electronic monitoring as needed for study site initiation, routine monitoring and study site closure activities and ensure these are conducted accordance to the SMP, Standard Operating Procedures (SOPs) and commensurate with emerging issues and technologies Monitor site level adverse events (AEs) and serious adverse events (SAEs) and collaborate with the Drug Safety Unit and follow-up with investigators sites, as needed, to bring SAE reports required information to resolution Submit all required reports, documentation, updates and tracking within required timeframes, including but not limited to Trial Master File (TMF) documentation, site reports, site follow up letters, protocol deviations, patient recruitment, clinical supply management, study progress and metrics Identify and resolve investigator site issues within required timeframes; agree and develop corrective and preventative actions with investigator and site personnel to close open issues and to prevent recurrence/persistence of issues Resolve data queries within required timelines, prepare investigator site close-out plan and conduct close-out activities within required timelines Ensures adequate oversight of the investigational product at the investigator site, including receipt, handling, accounting, storage conditions, and destruction activities Support database release as needed May undertake the responsibilities of an unblinded monitor where appropriate Clinical/Scientific and Site Monitoring Risk: Maintain thorough understanding of the product, protocol and therapy area in sufficient details to have appropriate discussions with the investigator and site team Interact with investigator site heath care professionals in a manner which enhances the Sponsor's credibility, scientific leadership and in order to facilitate their clinical development goals Support the study clinician in ensuring patient safety, eligibility and providing clinical guidance to investigators Drive Quality Event (QE) remediation, when applicable Serve as a point of contact for audit conduct, and drive Audit Observation corrective action/preventive action (CAPA) development and checks, when applicable Skills: Extensive knowledge of clinical trial methodologies, ICH/GCP, Food and Drug Administration (FDA) and local country regulations Monitoring Experience: Minimum 3 years relevant experience in clinical research site monitoring (preferably 2 years in Oncology) Preferred therapeutic experience in Oncology, Vaccines, Internal Medicine or Infectious Diseases Must be fluent in English and in the native language(s) of the country they will work in Ability to travel 60-80% Valid driver's license and passport required Education: Bachelor's degree in life sciences or professional degree in life sciences such as nursing, pharmacy, medical background or equivalent #LI-LO1 EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

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. Job Purpose: The Senior Clinical Research Associate (Sr. CRA) is responsible for the site management, site monitoring and close-out of assigned clinical trials investigator sites to ensure patient safety and quality study execution in accordance with applicable prevailing laws, Good Clinical Practices (GCP), and sponsor standards. The Sr. CRA is accountable for site management and monitoring, managing investigator site relationships to ensure effective delivery of clinical trials (e.g. enrollment, database release), to safeguard the quality of investigator sites (e.g. patient safety, site quality and compliance with GCP), to maintain investigator and site staff engagement and satisfaction, and to enhance the company's image with its external stakeholders. The Sr. CRA is responsible for the resolution of all protocol-related issues for assigned investigator sites and will work closely with the Site Care Partner (SCP), and other members of the study team, as required, in activities associated with the set-up, running and close-out of sites in a clinical trial. Key Accountabilities: Oversight of Monitoring Responsibilities and Study Conduct Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan (SMP) and applicable prevailing laws, GCP, and sponsor standards to achieve project goals, timelines and quality Manage assigned operational aspects for implementation of clinical trial activities at assigned investigator sites from site activation through to database lock, ensuring relevant timelines and quality deliverables are met During study conduct, serve as the primary point of contact for assigned investigator sites. Work in partnership with and/or escalate to the SCP to ensure quality of site delivery Interface with the study team as needed, facilitate information flow between members of the study team, vendors and assigned investigator sites Partner with SCP to perform investigator site development, coaching and training of site personnel to ensure ongoing compliance with protocol and the safeguarding of patients; provide protocol training to, and address protocol related questions from the investigator site staff when required, including discussions on known/anticipated operational and clinical trial risks Attend investigator meeting when required (virtual or F2F). Provide enrollment support and ensure progress by responding to site activation and recruitment issues from investigators. Partner with SCP and the study team to define and support recruitment initiatives at site level Conduct onsite, remote/electronic monitoring as needed for study site initiation, routine monitoring and study site closure activities and ensure these are conducted accordance to the SMP, Standard Operating Procedures (SOPs) and commensurate with emerging issues and technologies Monitor site level adverse events (AEs) and serious adverse events (SAEs) and collaborate with the Drug Safety Unit and follow-up with investigators sites, as needed, to bring SAE reports required information to resolution Submit all required reports, documentation, updates and tracking within required timeframes, including but not limited to Trial Master File (TMF) documentation, site reports, site follow up letters, protocol deviations, patient recruitment, clinical supply management, study progress and metrics Identify and resolve investigator site issues within required timeframes; agree and develop corrective and preventative actions with investigator and site personnel to close open issues and to prevent recurrence/persistence of issues Resolve data queries within required timelines, prepare investigator site close-out plan and conduct close-out activities within required timelines Ensures adequate oversight of the investigational product at the investigator site, including receipt, handling, accounting, storage conditions, and destruction activities Support database release as needed May undertake the responsibilities of an unblinded monitor where appropriate Clinical/Scientific and Site Monitoring Risk Maintain thorough understanding of the product, protocol and therapy area in sufficient details to have appropriate discussions with the investigator and site team Interact with investigator site heath care professionals in a manner which enhances sponsor's credibility, scientific leadership and in order to facilitate sponsor's clinical development goals Support the study clinician in ensuring patient safety, eligibility and providing clinical guidance to investigators Drive Quality Event (QE) remediation, when applicable Serve as a point of contact for audit conduct, and drive Audit Observation corrective action/preventive action (CAPA) development and checks, when applicable Collaboration Reports to Director of Clinical Site Operations (DCSO) or Director of Site Management and Monitoring (DSMM) Partners with SCP and Country Study Operations Manager (SOM) When required Partners with other Study Team members (e.g. Clinician, Recruitment Specialist, Clinical Data Scientist) May act as a Mentor for Clinical Research Associates Skills: Monitoring Experience: Minimum 3 years relevant experience in clinical research site monitoring (preferably 2 years in Oncology) in a CRO or pharma organization Preferred therapeutic experience in Oncology Global clinical trial experience preferred Extensive knowledge of clinical trial methodologies, ICH/GCP, Food and Drug Administration (FDA) and local country regulations Must be fluent in English and in the native language(s) of the country they will work in Travel (60-80%) within area is required Valid driver's license and passport required Knowledge and Experience: Demonstrated knowledge of clinical research and development processes and ability to gain command of process details Demonstrated knowledge of global and local regulatory requirements Demonstrated understanding of key operational elements of clinical research (e.g., monitoring, data acquisition and cleaning, reporting, etc.) Demonstrated knowledge in disease and technical areas pertaining to clinical studies, including knowledge of company direction, investigational product(s), and associated development plan(s) Demonstrated ability to support sponsor regulatory interactions/inspections Demonstrated knowledge of the processes around protocol design and feasibility assessment Demonstrated understanding of region/country, culture, and medical practice and how they affect clinical trial delivery Proven ability to work in a matrix team environment with the ability to influence, drive / lead and work through others for successful delivery of clinical trial Ability to evaluate, interpret and present complex issues and data to support risk management and mitigation Effective verbal and written communication skills in relating to colleagues and associates both inside and outside of the organization Education: Bachelor's degree in life sciences or professional degree in life sciences such as nursing, pharmacy, medical is required #LI-CF1 EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

Crinetics is a pharmaceutical company based in San Diego, California, developing much-needed therapies for people with endocrine diseases and endocrine-related tumors. We were founded by a dedicated team of scientists with the simple belief that better therapies developed from rigorous innovation can lead to better lives. Our work continues to make a real difference in the lives of patients. We have a prolific discovery engine and a robust preclinical and clinical development pipeline. We are driven by science with a patient-centric and team-oriented culture. Crinetics is known for its inclusive workplace culture. We are also a dog-friendly workplace. This is an exciting time to join Crinetics as we shape our organization into the world's premier fully-integrated endocrine company from discovery to patients. Join our team as we transform the lives of others. Position Summary: The Clinical Scientist will be working within a multi-disciplinary team focusing on a Clinical Development Program. This individual will provide clinical expertise and scientific insights to help elaborate a protocol for phase 1 - 3 studies then monitor, track, and analyze subjects' data in these studies. The incumbent will collaborate with all the groups involved in Clinical Development e.g., Clinical Pharmacology (CP), Clinical Operations, Medical Writing, Biometrics, Pharmacovigilance, Regulatory Affairs, HEOR and Medical Affairs. Essential Job Functions and Responsibilities: These may include but are not limited to: Conduct data analyses before and during clinical studies to support medical decision making, create presentation slides, and prepare for development division discussion meetings. Perform high quality clinical data review to identify events of special interest from data within the EDC system for further investigations. Collaborate with biometrics and pharmacovigilance to review periodic data listings (e.g. adverse events, protocol deviations, concomitant medications) to discussion with clinical team. Perform regular trend analysis in ongoing clinical trials. Lead periodic Medical Review meetings. Use the findings and other analyses to contribute to trial-related advisory boards, lead investigator meetings, protocol training meetings. Contribute to the development of relevant sections of regulatory documents such as protocols, amendments to protocols, informed consent forms, briefing books, safety updates, responses to Health Authorities questions. Contribute to the development of study documents such as feasibility questionnaires, study plans, electronic Case Report Forms (eCRFs), eCRF guidelines and other essential trial specific documents. Collaborate in cross-functional meetings (with internal stakeholders and/or external consultants) to develop clinical development plans. Support Clinical Operations, CROs, and site staff on study protocol related questions Support preparation for safety review committees, DSMBs/DMC incl. data review and development of presentations Collaborate with Medical Affairs and Patient Advocacy to support effective working relationships with key investigators, key opinion leaders and patient advocates. Participate in research site identification and relationship building with CROs in this space. Track progress, take notes and plan meetings for the protocol discussion group (Biometrics and Clinical Research, plus ad hoc functions). Other duties as assigned. Education and Experience: Required: MD, Ph.D., Pharm. D., MPH (Master of Public Health), MSN or RN with 8 years of industry related experience with a minimum of 2 years clinical research experience in clinical development within a biopharmaceutical company. Working knowledge of FDA and EMA regulations and expectations, Good Clinical Practice, ICH guidelines, and clinical drug development. Practical knowledge of the day-to-day medical monitoring of clinical trials required (e.g., review of safety parameters, etc.). Great analytical skills and a passion for “search and find” among complex data generated in clinical studies. Collaborative, effective writing skills, with the ability to build and maintain strong interpersonal relationships, gaining trust and confidence from all levels within the organization. Ability to thrive and flourish in a fast-paced, dynamic, entrepreneurial small company environment; ability to prioritize and parallel process multiple workstreams, comfortable “changing gears” and remaining flexible, as well as making definitive decisions. Ability to inspire and earn respect from the leadership team, colleagues, and staff. Respectful of the ideas and experience of all members of the Crinetics team Ethical, with the highest standards of integrity recognizing that we are the creators of hope for our patients and the health care professionals who serve them as well as stewards of the investments of all our shareholders. Desire to develop personal and communication skills through several complex tasks and challenges. Physical Demands and Work Environment: Physical Activities: On a continuous basis, sit at desk for a long period of time; intermittently answer telephone and write or use a keyboard to communicate through written means. Some walking and lifting up to 25 lbs. may be required. The noise level in the work environment is typically low to moderate. The physical demands described above are representative of those that must be met by an employee to successfully perform the essential functions and responsibilities of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions and responsibilities. Laboratory Activities (if applicable): Biology and chemical laboratory environment experience needed. Environmental health and safety requirements also apply. Travel: You may be required to travel for up to 5% of your time. The Anticipated Base Salary Range: In addition to your base pay, our total rewards program consists of a discretionary annual target bonus, stock options, ESPP, and 401k match. We also provide top-notch health insurance plans for employees (and their families) to include medical, dental, vision and basic life insurance, 20 days of PTO, 10 paid holidays, and a winter company shutdown. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience and education. Crinetics Pharmaceuticals is a multi-state employer, and this salary range may not reflect positions that work in other states. Your recruiter can share more about the specific salary range during the hiring process. Equal Opportunity Employer: Crinetics is proud to be an Equal Opportunity Employer. We provide equal employment opportunities to all employees and employment applicants without regard to unlawful considerations of sex, sexual orientation, gender (including gender identity and/or expression), pregnancy, race, color, creed, national or ethnic origin, citizenship status, religion or similar philosophical beliefs, disability, marital and civil union status, age, genetic information, veteran status or any personal attribute or characteristic that is protected by applicable local, state or federal laws. Salary Range The salary range for this position is: $144,000 - $180,000. In addition to your base pay, our total rewards program consists of a discretionary annual target bonus, stock options, ESPP, and 401k match. We also provide top-notch health insurance plans for employees (and their families) to include medical, dental, vision and basic life insurance, 20 days of PTO, 10 paid holidays, and a winter company shutdown.

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. PXL FSP - Join an organization shaping smarter, faster clinical development PXL FSP is seeking a detail‑oriented and proactive Feasibility Study Manager to support the delivery of high‑quality global feasibility assessments. This role is ideal for someone who thrives in a fast‑paced, data‑driven environment and enjoys collaborating cross‑functionally to ensure clinical programs launch with the strongest foundation possible. Key ResponsibilitiesSurvey Design & Configuration Transform draft feasibility questionnaires into an electronic survey platform with clear, intuitive formatting. Apply branching logic, conditional pathways, and scoring algorithms in alignment with the Feasibility Lead's specifications. Build survey reporting templates directly within the platform or through external systems as needed. Site & Investigator Readiness Perform quality checks on potential investigators before survey deployment. Support verification of available CDAs prior to launch. Upload targeted site and investigator lists into the survey management system, ensuring accuracy and completeness. Survey Management & Execution Lead survey launch activities and oversee ongoing monitoring, including: Delegating surveys appropriately Tracking and reconciling survey status Ensuring thorough documentation of site notes and survey details Identifying and consolidating invalid contact information Conduct proactive research to update missing or incorrect contact details, ensuring seamless engagement and response tracking. Monitor country‑level response metrics to support early risk identification and mitigation planning. Site Identification Strategy Execute the agreed site‑identification strategy, including application of priority site designations. Implement the communication plan using approved study summaries, templates, and designated system email origins. Facilitate timely revisions to survey content, scoring, and site/country lists as needed throughout survey duration. Track CDA negotiation status for participating sites and communicate internal updates. Close‑Out Activities Oversee survey closure, including final site notifications and completion of assigned wrap‑up tasks. Minimum Qualifications Education: Bachelor's degree or equivalent. Experience: 3-5 years of relevant industry experience (clinical research, feasibility, site engagement, project coordination, or related areas). #LI-KW1 EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions. The Clinical Research Associate assists in the management of the clinical monitoring process to ensure site adherence to applicable regulatory requirements, ICH/GCP Guidelines, company SOPs, and study protocols. Ensures coordination of an accelerated study start-up including pre-study visits, initiation, interim, and closeout activities associated with clinical trials to ensure timelines and metrics are met and maintained throughout the study. **Primary responsibilities include:** + Tracking study specific tasks and progress of the trial. + Performing regulatory document review and approval for IP release. + Assisting in the coordination and planning of meetings (e.g. Investigator Meetings, Kick-off meetings). + Conducting monitor training. + Performing monitoring/co-monitoring activities for site initiation visits, interim site monitoring, and closeout visits, in conformance to all relevant laws, regulations, guidelines and internal SOPs/policies. + Understanding and implementing processes for distribution and tracking of SAE's, safety documentation, and pregnancies. Monitors compliance of these processes. + Collaborating with data management to resolve queries. + Facilitating investigator site payments, as applicable. + Reviews/creates/tracks trial newsletters, memos, mass correspondence, or other appropriate trial-related documentation. + Assisting in evaluation of vendor performance during conduct of the study. + Acquiring a basic knowledge of the therapeutic area and product. + Obtaining a complete understanding of all trial-related documents and operational procedures. + Gaining exposure/participates in CRF development, IVRS set-up, central lab set-up, and other vendor selection processes. + Maintaining clinical trial management system (CTMS) information pertaining to the study as applicable + Assisting with auditing of study files and retrieval of outstanding documents as needed (in-house and on-site document reconciliation). + Reviewing and tracking study documents, including: project files both electronically and in the Trial Master File and Project Status Reports. + Preparing accurate and complete meeting minutes for various meetings. + Communicating and interacting with relevant study personnel, including: develops and maintains collaborative relationships to manage study issues and support milestone achievement; conveys project information; answers study questions in a timely manner while using discretion when to escalate to study manage; troubleshoots and follows up on study progress; and, reviews report data for completeness and accuracy. + Assists with effective and timely audit/inspection responses. **For studies monitored in house by Grifols, additional responsibilities may include:** + Identifies/screens/qualifies investigators through feasibility questionnaires and pre-study visits. + Assists with expedited identification, retrieval, and review of study documents particularly those required for site activation/study start-up. + Conducts/oversees completion of Pre-Study Visits, Site Initiation Visits, Interim Monitoring Visits, and Close-Out Visits, to determine protocol and regulatory compliance. + Verifies study documents (e.g., case report forms, source documents, adverse events) are tracked and reviewed for completeness and accuracy to ensure data integrity. + Reconciles clinical supplies and drug accountability records at study sites. + Identifies and effectively documents site findings with an equal ability to re-train, place corrective action in place with the site, and follow-up as required. + Reviews, clarifies, and obtains, data changes via query resolutions with site personnel. + Prepares telephone contact reports, confirmation letters, site visit reports (PSV, SIV, IMV, and COV), and follow-up letters to accurately and completely document site status and activities. **Additional responsibilities:** Leads the activities of the CRA team to meet the study objectives. Identifies and addresses weaknesses in individual or team performance. Assists study manager in overall study management. Monitors and/or co-monitors as required with CRO and CRA staff to insure study integrity and compliance. Develops ICF templates and reviews study specific ICF(s). Participates in CRF development and completion. Reviews monitoring reports and QA reports from site visits. Manages clinical study set-up and follow-up study activities through tracking and review. Assists in the development of the clinical risk management plan. Develops, implements, and maintains monitoring plan for studies run internally. Coordinates and presents at investigator meetings, kick-off meetings, etc. Interacts as functional lead with data management, safety, regulatory personnel, and other functional groups. Leads team members in reviewing data listings in reviewing data listings and writing queries. Tracks and manages the distribution of study drug and clinical supplies. Contributes to development of site budget. **Knowledge, Skills, and Abilities:** Excellent knowledge of medical terminology, protocol, clinical trial process, regulatory requirements, and company SOPs. Excellent knowledge of therapeutic area assigned. Excellent knowledge of ICH/GCP Guidelines and EDC process. Strong verbal and written communication skills. Ability to train others in using MS Office Suite, Impact, and EDC systems. Ability to meet deadlines, multitask, and prioritize based on study needs. Ability to make sound decisions based on available information. Ability to establish rapport with site personnel/ colleagues. Ability to work both in a team and independently. Ability to facilitate team meetings and teleconferences. Ability to present at internal study team meeting(s). Ability to train and mentor junior CRAs. Ability to seek new learning opportunities within and outside of the assigned project. Ability and willingness to travel. **Requirements:** + Associate's degree in a life science field required. Bachelor's degree in a life science field preferred. + Typically requires 5 years of experience in clinical research, including a minimum of 2 years field monitoring experience and 3 years in lead CRA role. + Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements. Example: If a job level requires a Bachelor's degree plus 4 years of experience, an equivalency could include 8 years of experience, an Associate's degree with 6 years of experience, or a Master's degree with 2 years of experience. **Occupational Demands:** Work is performed in an office environment with exposure to electrical office equipment. Frequently sits for 6-8 hours per day. Frequent hand movement of both hands with the ability to make fast, simple, movements of the fingers, hands, and wrists. Occasionally walks and stands. Occasionally bends and twists neck. Light to moderate lifting and carrying objects with a maximum lift of 25lbs. Frequently drives to site locations with occasional travel within the United States. Able to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken and written words and sentences. Interacts with others, relates sensitive information to diverse groups. Must work with diverse groups to obtain consensus on issues. Third Party Agency and Recruiter Notice: Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate. **Grifols provides equal employment opportunities to applicants and employees without regard to race; color; sex; gender identity; sexual orientation; religious practices and observances; national origin; pregnancy, childbirth, or related medical conditions; status as a protected veteran or spouse/family member of a protected veteran; or disability. We will consider for employment all qualified applicants in a manner consistent with the requirements of all applicable laws.** Learn more about Grifols (************************************** **Req ID:** 536724 **Type:** Regular Full-Time **Job Category:** R & D

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. Job Title: Entry level Research Associate (per diem) Clinical/Data Entry Work Location: onsite in Baltimore, MD (some of the data entry work can be done remotely after training) Parexel Early Phase Clinical Unit supports the development of innovative new medicines which are vital for public health, improving outcomes, and saving lives. The early phase and “first in human” trials are the first step in testing these novel treatments in humans. At Parexel Baltimore, MD unit our highly trained and skilled Research Associates are crucial to ensuring the successful completion of Phase I trials. This is a great role for anyone that aspires to be an enrollment specialist, clinical research coordinator, or eventually manager. Parexel provides a great system of support to help you grow and advance your career internally. What you'll do after training is completed (including but not limited): Clinical: You will understand study protocols and be able to complete required medical procedures. Recruit study participants by calling the database, attending company sponsored community events, posting flyers in schools, senior centers, supermarkets, and other establishments. Enter study participants in the study participant tracking system Conduct screening visits and study protocol specific study participant visits, assist staff physicians in assessment of concomitant medications, adverse events, lab results, and other test results Prepare/monitor study supplies and stock levels in clinic/hospital. Ensure basic study participant safety is provided. Assist with Monitor visits (i.e., room set up, etc.). Maintain and update knowledge of Clinical Operating Guidelines and their proper application. Assume appropriate role with study participants and caregivers. Assure quality and accuracy of source and CRF documentation. Data Entry: Complete Case Report Forms/eCRF's according to sponsor expectations and set documentation standards for staff to follow. Review, monitor and address quality of data entry for accuracy and trends throughout the study. Maintain neat and legible documentation across all Case Report Forms. Review Case Report Forms to confirm capture of data according to protocol and amendments. Work closely with Investigators, Clinical Research Coordinators and Research Associates to document, resolve and integrate data clarification/queries. Edit, communicate/meet with Early Phase Management, Clinical Research Coordinator, Project Manager, Investigators to ensure clean data submissions. Organize track and report status of data entry to ensure that study data timelines are met. Check, review and ensure timely submission of data clarifications/queries. Your Profile: Proven customer service experience in a fast-paced environment Background working in a medical or clinical setting Comfortable with prolonged periods of standing and walking B.S.+ in related life science field OR HS diploma/GED with relevant experience CPT/Phlebotomy is highly preferred Hours/Shift - please note this is not a full-time opportunity we are currently seeking per diem candidates (this role is not eligible for full time benefits) Required Training: First 4 to 6 weeks required to work 30 to 40 hours a week for training (day shift M-F 6:50am to 3:20pm) Minimum availability requirements: 16 hours of availability per week AND two 12-hour weekend shifts in a 4-week month OR three 12-hour weekend shifts in a 5-week month The actual number of hours scheduled and confirmed can vary between 0-40 hours a week, depending on business needs (hours are not guaranteed) Shift Details: Seeking flexible candidate that can work any shift (day, evening, overnight, & weekend) Bi-monthly attendance may be required for training sessions, unless there are no mandatory trainings to complete Base Pay Range: $20.00 to $22.00 per hour (this role is eligible for shift differentials) Actual salaries may vary within the range based on several factors including, but not limited to education, training, experience, professional achievement, and location. In addition to base salary, some roles may be eligible for participation in Parexel's annual performance-based bonus plan, annual salary review and additional total rewards incentives. Our talent acquisition team will provide additional details on our bonus plan or incentive programs for those eligible roles. For all eligible employees, we offer market leading benefit programs including paid time off, 401k match, life insurance, health insurance, and other benefit offerings in accordance with the terms of applicable plans. EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

**PXL FSP - Join an organization shaping smarter, faster clinical development** PXL FSP is seeking a detail‑oriented and proactive **Feasibility Study Manager** to support the delivery of high‑quality global feasibility assessments. This role is ideal for someone who thrives in a fast‑paced, data‑driven environment and enjoys collaborating cross‑functionally to ensure clinical programs launch with the strongest foundation possible. **Key Responsibilities** **Survey Design & Configuration** + Transform draft feasibility questionnaires into an electronic survey platform with clear, intuitive formatting. + Apply branching logic, conditional pathways, and scoring algorithms in alignment with the Feasibility Lead's specifications. + Build survey reporting templates directly within the platform or through external systems as needed. **Site & Investigator Readiness** + Perform quality checks on potential investigators before survey deployment. + Support verification of available CDAs prior to launch. + Upload targeted site and investigator lists into the survey management system, ensuring accuracy and completeness. **Survey Management & Execution** + Lead survey launch activities and oversee ongoing monitoring, including: + Delegating surveys appropriately + Tracking and reconciling survey status + Ensuring thorough documentation of site notes and survey details + Identifying and consolidating invalid contact information + Conduct proactive research to update missing or incorrect contact details, ensuring seamless engagement and response tracking. + Monitor country‑level response metrics to support early risk identification and mitigation planning. **Site Identification Strategy** + Execute the agreed site‑identification strategy, including application of priority site designations. + Implement the communication plan using approved study summaries, templates, and designated system email origins. + Facilitate timely revisions to survey content, scoring, and site/country lists as needed throughout survey duration. + Track CDA negotiation status for participating sites and communicate internal updates. **Close‑Out Activities** + Oversee survey closure, including final site notifications and completion of assigned wrap‑up tasks. **Minimum Qualifications** + **Education:** Bachelor's degree or equivalent. + **Experience:** 3-5 years of relevant industry experience (clinical research, feasibility, site engagement, project coordination, or related areas). \#LI-KW1 \#LI-REMOTE EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

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. PXL FSP - Join an organization shaping smarter, faster clinical development PXL FSP is seeking a detail‑oriented and proactive Feasibility Study Manager to support the delivery of high‑quality global feasibility assessments. This role is ideal for someone who thrives in a fast‑paced, data‑driven environment and enjoys collaborating cross‑functionally to ensure clinical programs launch with the strongest foundation possible. Key ResponsibilitiesSurvey Design & Configuration Transform draft feasibility questionnaires into an electronic survey platform with clear, intuitive formatting. Apply branching logic, conditional pathways, and scoring algorithms in alignment with the Feasibility Lead's specifications. Build survey reporting templates directly within the platform or through external systems as needed. Site & Investigator Readiness Perform quality checks on potential investigators before survey deployment. Support verification of available CDAs prior to launch. Upload targeted site and investigator lists into the survey management system, ensuring accuracy and completeness. Survey Management & Execution Lead survey launch activities and oversee ongoing monitoring, including: Delegating surveys appropriately Tracking and reconciling survey status Ensuring thorough documentation of site notes and survey details Identifying and consolidating invalid contact information Conduct proactive research to update missing or incorrect contact details, ensuring seamless engagement and response tracking. Monitor country‑level response metrics to support early risk identification and mitigation planning. Site Identification Strategy Execute the agreed site‑identification strategy, including application of priority site designations. Implement the communication plan using approved study summaries, templates, and designated system email origins. Facilitate timely revisions to survey content, scoring, and site/country lists as needed throughout survey duration. Track CDA negotiation status for participating sites and communicate internal updates. Close‑Out Activities Oversee survey closure, including final site notifications and completion of assigned wrap‑up tasks. Minimum Qualifications Education: Bachelor's degree or equivalent. Experience: 3-5 years of relevant industry experience (clinical research, feasibility, site engagement, project coordination, or related areas). #LI-KW1 EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

The Senior Clinical Research Associate (SrCRA) has local responsibility for the delivery of the studies at allocated sites and is an active participant in the local study team(s). The SrCRA works in close collaboration with other CRAs and the Local Study Team/ Local Study Associate Director (LSAD) to ensure that study commitments are achieved in a timely and efficient manner. The SrCRA acts as the main contact with the study site and has the responsibility for monitoring the study conduct to ensure proper delivery of the study. The SrCRA is responsible for the preparation, initiation, monitoring, and closure of assigned sites in clinical studies, in compliance with Client Procedural Documents, international guidelines such as ICHGCP, and relevant local regulations and that the sites deliver according to their respective commitment in the individual studies. The SrCSA performs all the duties of the CRA with higher proficiency, independency, accountability, and ability to take on additional tasks or tutor more junior personnel. A SrCRA with longer tenure and experience may take on additional responsibilities that include additional tasks associated with LSAD. **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 **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 \#LI-LO1 \#LI-REMOTE EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

The Senior Clinical Research Associate (Sr. CRA) is responsible for the site management, site monitoring and close-out of assigned clinical trials investigator sites to ensure patient safety and quality study execution in accordance with applicable prevailing laws, Good Clinical Practices (GCP), and the Sponsor's standards. The Sr. CRA is accountable for site management and monitoring, managing investigator site relationships to ensure effective delivery of clinical trials (e.g. enrollment, database release), to safeguard the quality of investigator sites (e.g. patient safety, site quality and compliance with GCP), to maintain investigator and site staff engagement and satisfaction, and to enhance the company's image with its external stakeholders. The Sr. CRA is responsible for the resolution of all protocol-related issues for assigned investigator sites and will work closely with the Site Care Partner (SCP), and other members of the study team, as required, in activities associated with the set-up, running and close-out of sites in a clinical trial. **Monitoring Responsibilities and Study Conduct:** + Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan (SMP) and applicable prevailing laws, GCP, and the Sponsor's standards to achieve project goals, timelines and quality + Manage assigned operational aspects for implementation of clinical trial activities at assigned investigator sites from site activation through to database lock, ensuring relevant timelines and quality deliverables are met + During study conduct, serve as the primary point of contact for assigned investigator sites. Work in partnership with and/or escalate to the SCP to ensure quality of site delivery + Interface with the study team as needed, facilitate information flow between members of the study team, vendors and assigned investigator sites + Partner with Site Care Partner to perform investigator site development, coaching and training of site personnel to ensure ongoing compliance with protocol and the safeguarding of patients; provide protocol training to, and address protocol related questions from the investigator site staff when required, including discussions on known/anticipated operational and clinical trial risks + Attend investigator meeting when required (virtual or F2F). Provide enrollment support and ensure progress by responding to site activation and recruitment issues from investigators. Partner with Site Care Partner and the study team to define and support recruitment initiatives at site level + Conduct onsite, remote/electronic monitoring as needed for study site initiation, routine monitoring and study site closure activities and ensure these are conducted accordance to the SMP, Standard Operating Procedures (SOPs) and commensurate with emerging issues and technologies + Monitor site level adverse events (AEs) and serious adverse events (SAEs) and collaborate with the Drug Safety Unit and follow-up with investigators sites, as needed, to bring SAE reports required information to resolution + Submit all required reports, documentation, updates and tracking within required timeframes, including but not limited to Trial Master File (TMF) documentation, site reports, site follow up letters, protocol deviations, patient recruitment, clinical supply management, study progress and metrics + Identify and resolve investigator site issues within required timeframes; agree and develop corrective and preventative actions with investigator and site personnel to close open issues and to prevent recurrence/persistence of issues + Resolve data queries within required timelines, prepare investigator site close-out plan and conduct close-out activities within required timelines + Ensures adequate oversight of the investigational product at the investigator site, including receipt, handling, accounting, storage conditions, and destruction activities + Support database release as needed + May undertake the responsibilities of an unblinded monitor where appropriate **Clinical/Scientific and Site Monitoring Risk:** + Maintain thorough understanding of the product, protocol and therapy area in sufficient details to have appropriate discussions with the investigator and site team + Interact with investigator site heath care professionals in a manner which enhances the Sponsor's credibility, scientific leadership and in order to facilitate their clinical development goals + Support the study clinician in ensuring patient safety, eligibility and providing clinical guidance to investigators + Drive Quality Event (QE) remediation, when applicable + Serve as a point of contact for audit conduct, and drive Audit Observation corrective action/preventive action (CAPA) development and checks, when applicable **Skills:** + Extensive knowledge of clinical trial methodologies, ICH/GCP, Food and Drug Administration (FDA) and local country regulations + Monitoring Experience: Minimum 3 years relevant experience in clinical research site monitoring (preferably 2 years in Oncology) + Preferred therapeutic experience in Oncology, Vaccines, Internal Medicine or Infectious Diseases + Must be fluent in English and in the native language(s) of the country they will work in + Ability to travel 60-80% + Valid driver's license and passport required **Education:** + Bachelor's degree in life sciences or professional degree in life sciences such as nursing, pharmacy, medical background or equivalent \#LI-LO1 \#LI-REMOTE EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

**Job Purpose:** The Senior Clinical Research Associate (Sr. CRA) is responsible for the site management, site monitoring and close-out of assigned clinical trials investigator sites to ensure patient safety and quality study execution in accordance with applicable prevailing laws, Good Clinical Practices (GCP), and sponsor standards. The Sr. CRA is accountable for site management and monitoring, managing investigator site relationships to ensure effective delivery of clinical trials (e.g. enrollment, database release), to safeguard the quality of investigator sites (e.g. patient safety, site quality and compliance with GCP), to maintain investigator and site staff engagement and satisfaction, and to enhance the company's image with its external stakeholders. The Sr. CRA is responsible for the resolution of all protocol-related issues for assigned investigator sites and will work closely with the Site Care Partner (SCP), and other members of the study team, as required, in activities associated with the set-up, running and close-out of sites in a clinical trial. **Key Accountabilities:** **Oversight of Monitoring Responsibilities and Study Conduct** + Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan (SMP) and applicable prevailing laws, GCP, and sponsor standards to achieve project goals, timelines and quality + Manage assigned operational aspects for implementation of clinical trial activities at assigned investigator sites from site activation through to database lock, ensuring relevant timelines and quality deliverables are met + During study conduct, serve as the primary point of contact for assigned investigator sites. Work in partnership with and/or escalate to the SCP to ensure quality of site delivery + Interface with the study team as needed, facilitate information flow between members of the study team, vendors and assigned investigator sites + Partner with SCP to perform investigator site development, coaching and training of site personnel to ensure ongoing compliance with protocol and the safeguarding of patients; provide protocol training to, and address protocol related questions from the investigator site staff when required, including discussions on known/anticipated operational and clinical trial risks + Attend investigator meeting when required (virtual or F2F). Provide enrollment support and ensure progress by responding to site activation and + recruitment issues from investigators. Partner with SCP and the study team to define and support recruitment initiatives at site level + Conduct onsite, remote/electronic monitoring as needed for study site initiation, routine monitoring and study site closure activities and ensure these are conducted accordance to the SMP, Standard Operating Procedures (SOPs) and commensurate with emerging issues and technologies + Monitor site level adverse events (AEs) and serious adverse events (SAEs) and collaborate with the Drug Safety Unit and follow-up with investigators sites, as needed, to bring SAE reports required information to resolution + Submit all required reports, documentation, updates and tracking within required timeframes, including but not limited to Trial Master File (TMF) documentation, site reports, site follow up letters, protocol deviations, patient recruitment, clinical supply management, study progress and metrics + Identify and resolve investigator site issues within required timeframes; agree and develop corrective and preventative actions with investigator and site personnel to close open issues and to prevent recurrence/persistence of issues + Resolve data queries within required timelines, prepare investigator site close-out plan and conduct close-out activities within required timelines + Ensures adequate oversight of the investigational product at the investigator site, including receipt, handling, accounting, storage conditions, and destruction activities + Support database release as needed + May undertake the responsibilities of an unblinded monitor where appropriate **Clinical/Scientific and Site Monitoring Risk** + Maintain thorough understanding of the product, protocol and therapy area in sufficient details to have appropriate discussions with the investigator and site team + Interact with investigator site heath care professionals in a manner which enhances sponsor's credibility, scientific leadership and in order to facilitate sponsor's clinical development goals + Support the study clinician in ensuring patient safety, eligibility and providing clinical guidance to investigators + Drive Quality Event (QE) remediation, when applicable + Serve as a point of contact for audit conduct, and drive Audit Observation corrective action/preventive action (CAPA) development and checks, when applicable **Collaboration** + Reports to Director of Clinical Site Operations (DCSO) or Director of Site Management and Monitoring (DSMM) + Partners with SCP and Country Study Operations Manager (SOM) + When required Partners with other Study Team members (e.g. Clinician, Recruitment Specialist, Clinical Data Scientist) + May act as a Mentor for Clinical Research Associates **Skills:** + Monitoring Experience: Minimum 3 years relevant experience in clinical research site monitoring (preferably 2 years in Oncology) in a CRO or pharma organization + Preferred therapeutic experience in Oncology + Global clinical trial experience preferred + Extensive knowledge of clinical trial methodologies, ICH/GCP, Food and Drug Administration (FDA) and local country regulations + Must be fluent in English and in the native language(s) of the country they will work in + Travel (60-80%) within area is required + Valid driver's license and passport required **Knowledge and Experience:** + Demonstrated knowledge of clinical research and development processes and ability to gain command of process details + Demonstrated knowledge of global and local regulatory requirements + Demonstrated understanding of key operational elements of clinical research (e.g., monitoring, data acquisition and cleaning, reporting, etc.) + Demonstrated knowledge in disease and technical areas pertaining to clinical studies, including knowledge of company direction, investigational product(s), and associated development plan(s) + Demonstrated ability to support sponsor regulatory interactions/inspections + Demonstrated knowledge of the processes around protocol design and feasibility assessment + Demonstrated understanding of region/country, culture, and medical practice and how they affect clinical trial delivery + Proven ability to work in a matrix team environment with the ability to influence, drive / lead and work through others for successful delivery of clinical trial + Ability to evaluate, interpret and present complex issues and data to support risk management and mitigation + Effective verbal and written communication skills in relating to colleagues and associates both inside and outside of the organization **Education:** + Bachelor's degree in life sciences or professional degree in life sciences such as nursing, pharmacy, medical is required \#LI-CF1 \#LI-REMOTE EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

**PXL FSP - Join an organization shaping smarter, faster clinical development** PXL FSP is seeking a detail‑oriented and proactive **Feasibility Study Manager** to support the delivery of high‑quality global feasibility assessments. This role is ideal for someone who thrives in a fast‑paced, data‑driven environment and enjoys collaborating cross‑functionally to ensure clinical programs launch with the strongest foundation possible. **Key Responsibilities** **Survey Design & Configuration** + Transform draft feasibility questionnaires into an electronic survey platform with clear, intuitive formatting. + Apply branching logic, conditional pathways, and scoring algorithms in alignment with the Feasibility Lead's specifications. + Build survey reporting templates directly within the platform or through external systems as needed. **Site & Investigator Readiness** + Perform quality checks on potential investigators before survey deployment. + Support verification of available CDAs prior to launch. + Upload targeted site and investigator lists into the survey management system, ensuring accuracy and completeness. **Survey Management & Execution** + Lead survey launch activities and oversee ongoing monitoring, including: + Delegating surveys appropriately + Tracking and reconciling survey status + Ensuring thorough documentation of site notes and survey details + Identifying and consolidating invalid contact information + Conduct proactive research to update missing or incorrect contact details, ensuring seamless engagement and response tracking. + Monitor country‑level response metrics to support early risk identification and mitigation planning. **Site Identification Strategy** + Execute the agreed site‑identification strategy, including application of priority site designations. + Implement the communication plan using approved study summaries, templates, and designated system email origins. + Facilitate timely revisions to survey content, scoring, and site/country lists as needed throughout survey duration. + Track CDA negotiation status for participating sites and communicate internal updates. **Close‑Out Activities** + Oversee survey closure, including final site notifications and completion of assigned wrap‑up tasks. **Minimum Qualifications** + **Education:** Bachelor's degree or equivalent. + **Experience:** 3-5 years of relevant industry experience (clinical research, feasibility, site engagement, project coordination, or related areas). \#LI-KW1 \#LI-REMOTE EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

Department: Medical Immediate Supervisor Title: Coordinator Clinical Quality and Compliance General Summary: The Kidney Care Research Coordinator position at Goshen Medical Center, Inc. is responsible for performing a variety of duties related to an ongoing research study investigating the impact of coordinator intervention of the progression of chronic kidney disease. They may be involved in both the clinical and administrative areas. Provides information to patients so they may fully utilize and benefit from the coordinator's services offered through the study. Essential Job Responsibilities: 1. Facilitates engagement with research team, research study participants, and clinic partners. 2. Fulfills clerical responsibilities as assigned that may include preparing progress reports on research participants to include descriptions of barriers and facilitators of care. 3. Coordinates times and schedules for research testing process. 4. Effectively uses different platforms to link research study participants with community resources. 5. Participates with research team to troubleshoot and refine processes as needed. Education: High school diploma or general equivalency diploma (GED), medical assistant diploma preferred Experience: Minimum one year of recent experience working in a medical facility as a medical assistant and/or documented evidence of externship completed in a medical office. Performance Requirements: Knowledge: 5. Knowledge of health care field and medical office protocols/procedures. 6. Knowledge of kidney disease progression and treatment preferred. 7. Knowledge of information that must be conveyed to patients and research team. Skills: 8. Skill in performing medical assistance tasks appropriately. 9. Skill intact and diplomacy in interpersonal interactions. 10. Skill in understanding patient education needs by effectively sharing information with patients and families. Abilities: 11. Ability to learn and retain information regarding patient care. 12. Ability to project a pleasant and professional image. 13. Ability to plan, prioritize, and complete delegated tasks. 14. Ability to demonstrate compassion and caring in dealing with others. Equipment Operated: Standard medical exam/office equipment, which may include computerized health information management system for medical records, etc. Work Environment: Combination of medical office and exam/procedure room settings. Well-lighted, well-ventilated, adequate space. Mental/Physical Requirements: Must be able to use appropriate body mechanics techniques when making necessary patient transfers and helping patients with walking, dressing, etc. Must be able to lift 30 pounds of supplies. Occasional stress from dealing with many staff and patients.

M3 Wake Research, an M3USA Company, is an integrated network of premier investigational sites meeting the clinical research needs of global biopharmaceutical, biotechnology, medical device, pharmaceutical and clinical research organizations (CROs). With close to 30 owned and managed research sites across the country, M3 Wake Research is one of the largest independent, multi-site clinical research companies in the US. M3 Wake Research continues to grow through acquisitions and uncompromising commitment to careful planning and execution in accordance with regulatory compliance. Conducting studies since 1984, M3 Wake Research owns a proprietary patient database of potential clinical trial participants across the US. As of today, our board-certified physicians have completed more than 7,000+ successful clinical trials, while consistently exceeding sponsor expectations for integrity, timeliness, subject enrollment, human protection, and expeditious delivery of accurate evaluable data. Due to our continued growth, we are hiring for a Clinical Research Coordinator at Wake Research, an M3 company. This position is on-site and located in Raleigh, NC. The Clinical Research Coordinator (CRC) is a specialized research professional working with and under the guidance of the clinical research site management and Principal Investigator (PI). While the PI is primarily responsible for the overall conduct of the clinical trial, the CRC manages, supports, facilitates and coordinates the daily clinical trial activities and plays a critical role in the conduct of the study. Essential Duties and Responsibilities: Assisting trial Investigator in screening and review of potential study participants eligibility Maintaining case report forms, charts and documentation Mentoring, training, and high-level oversight of other clinical research coordinators and research assistants Ensuring that all clinical activities are carried out in accordance with established research protocol and standards in compliance with all applicable laws, regulations, policies, and procedural requirements Collecting and entering data as necessary Assist management with potential new hire selection and shadowing process Assist with study start-up, maintenance, and close-out of studies as needed for those on the team Ability to be flexible with study assignments Qualifications Clinical Research Coordinator with 1-2 years of experience Phlebotomy experience is highly preferred Previous experience as a medical assistant, LPN, or RN Excellent verbal & written communication skills Ability to learn quickly, read and understand complex protocols, follow very detailed directions, and multi-tasking Must be able to maintain strict confidentiality of patients, employees, and company information at all times and adhere to HIPAA Guidelines Extensive clinical trial knowledge through education and/or experience Successful completion of GCP Certification and Advanced CRC preferred Detail-oriented Familiarity with the Code of Federal Regulations as they pertain to human subject protection Strong interpersonal skills Additional Information About M3: M3 USA is at the forefront of healthcare innovation, offering digital solutions across healthcare, life sciences, pharmaceuticals, and more. Since our inception in 2000, we've seen remarkable growth, fueled by our mission to utilize the internet for a healthier world and more efficient healthcare systems. Our success is anchored in our trusted digital platforms that engage physician communities globally, facilitating impactful medical education, precise job placement, and insightful market research. M3 USA prides itself on a dynamic and innovative work environment where every team member contributes to global health advancements. Joining M3 USA means being part of a dedicated team striving to make a significant difference in healthcare. We provide a unique opportunity for you to be at the cutting edge of healthcare innovation, shaping the future in a meaningful career. Embrace the chance to drive change with M3 USA. Benefits: A career opportunity with M3 Wake Research offers competitive wages, and benefits such as: 401(k), 401(k) matching Dental insurance Disability insurance Employee assistance program Flexible spending account Health insurance Life insurance Paid time off Vision insurance *M3 reserves the right to change this job description to meet the business needs of the organization #LI-Onsite #LI-LB1

M3 Wake Research, an M3USA Company, is an integrated network of premier investigational sites meeting the clinical research needs of global biopharmaceutical, biotechnology, medical device, pharmaceutical and clinical research organizations (CROs). With close to 30 owned and managed research sites across the country, M3 Wake Research is one of the largest independent, multi-site clinical research companies in the US. M3 Wake Research continues to grow through acquisitions and uncompromising commitment to careful planning and execution in accordance with regulatory compliance. Conducting studies since 1984, M3 Wake Research owns a proprietary patient database of potential clinical trial participants across the US. As of today, our board-certified physicians have completed more than 7,000+ successful clinical trials, while consistently exceeding sponsor expectations for integrity, timeliness, subject enrollment, human protection, and expeditious delivery of accurate evaluable data. Due to our continued growth, we are hiring for a Clinical Research Coordinator at Wake Research, an M3 company. This position is on-site and located in Raleigh, NC. The Clinical Research Coordinator (CRC) is a specialized research professional working with and under the guidance of the clinical research site management and Principal Investigator (PI). While the PI is primarily responsible for the overall conduct of the clinical trial, the CRC manages, supports, facilitates and coordinates the daily clinical trial activities and plays a critical role in the conduct of the study. Essential Duties and Responsibilities: Assisting trial Investigator in screening and review of potential study participants eligibility Maintaining case report forms, charts and documentation Mentoring, training, and high-level oversight of other clinical research coordinators and research assistants Ensuring that all clinical activities are carried out in accordance with established research protocol and standards in compliance with all applicable laws, regulations, policies, and procedural requirements Collecting and entering data as necessary Assist management with potential new hire selection and shadowing process Assist with study start-up, maintenance, and close-out of studies as needed for those on the team Ability to be flexible with study assignments Qualifications Clinical Research Coordinator with 1-2 years of experience Phlebotomy experience is highly preferred Previous experience as a medical assistant, LPN, or RN Excellent verbal & written communication skills Ability to learn quickly, read and understand complex protocols, follow very detailed directions, and multi-tasking Must be able to maintain strict confidentiality of patients, employees, and company information at all times and adhere to HIPAA Guidelines Extensive clinical trial knowledge through education and/or experience Successful completion of GCP Certification and Advanced CRC preferred Detail-oriented Familiarity with the Code of Federal Regulations as they pertain to human subject protection Strong interpersonal skills Additional Information About M3: M3 USA is at the forefront of healthcare innovation, offering digital solutions across healthcare, life sciences, pharmaceuticals, and more. Since our inception in 2000, we've seen remarkable growth, fueled by our mission to utilize the internet for a healthier world and more efficient healthcare systems. Our success is anchored in our trusted digital platforms that engage physician communities globally, facilitating impactful medical education, precise job placement, and insightful market research. M3 USA prides itself on a dynamic and innovative work environment where every team member contributes to global health advancements. Joining M3 USA means being part of a dedicated team striving to make a significant difference in healthcare. We provide a unique opportunity for you to be at the cutting edge of healthcare innovation, shaping the future in a meaningful career. Embrace the chance to drive change with M3 USA. Benefits: A career opportunity with M3 Wake Research offers competitive wages, and benefits such as: 401(k), 401(k) matching Dental insurance Disability insurance Employee assistance program Flexible spending account Health insurance Life insurance Paid time off Vision insurance *M3 reserves the right to change this job description to meet the business needs of the organization #LI-Onsite #LI-LB1