Clinical research associate jobs in Bangor, ME - 16 jobs

**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 \#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 University of New England College of Dental Medicine (UNE CDM) invites applications for an Assistant Clinical Professor/Associate Clinical Professor/Clinical Professor in Public Health and Research Coordinator. This is a full-time (1.0 FTE) 12-month non-tenure, clinical track position with an administrative appointment. Located on UNE's Portland Campus for the Health Sciences, UNE CDM is the only dental school in a region where access to quality oral healthcare is a persistent challenge, especially in rural areas. Grounded in our mission to "improve the health of Northern New England as well as rural and underserved areas while shaping the future of dentistry through excellence in education, discovery, and service," our college continues to mature into one of the most innovative and exciting dental education programs available. UNE CDM with its dedicated and talented faculty and professional staff, exemplifies an environment of learning and discovery that is creative, humanistic, promotes professionalism, and cultivates diversity. The College maintains a strong commitment to providing excellent education and oral health care in a patient-centered, comprehensive care clinical learning environment. UNE is a great place to work and we offer a generous comprehensive benefits package to eligible employees and their dependents. The package includes varied health and dental plans; a retirement plan that includes up to an 8% match; extensive paid leave including holidays, vacation, sick and personal time; and educational benefits for both employees and dependent children. Please visit the Human Resources Benefits site ******************************* for additional information regarding UNE's fantastic benefits package. Responsibilities The Research Coordinator for the College of Dental Medicine will oversee research activities within the college and will serve as the liaison to UNE's Office of Research and Scholarship. The Research Coordinator will also be responsible for identifying research opportunities for faculty members and exploring funding mechanisms to support research initiatives to grow the research program at UNE CDM. The Research Coordinator will report to the Dean of the College of Dental Medicine. Core responsibilities as a Public Health faculty member will include didactic, pre-clinical, and clinical instruction and curriculum development in the general dentistry and public health disciplines; mentoring pre-doctoral students; faculty oversight during off-campus student service learning and community outreach activities; after-hours emergency call coverage (by rotation); and participation in college, university, and community service. The faculty member will serve in the Department of Preventative, Pediatric, & Community Dentistry. Academic rank and salary will be commensurate with qualifications and experience. Interviews of qualified candidates will begin immediately and continue until the position is filled. Qualifications Qualified candidates must possess a D.D.S./D.M.D. degree, or international equivalent and have successfully completed the NBDE Parts I & II or the INBDE. By the position start date, the candidate must have completed public health training at the master or doctorate level and must have active Maine Board of Dental Practice licensure (full). Completion of a CODA-accredited graduate program in Dental Public Health and Board Certification, or eligibility for Board Certification, as a Diplomate of the American Board of Dental Public Health is preferred, but not required. The successful candidate for the Research Coordinator role will have demonstrated accomplishments in research and scholarship. A track record of research funding is preferred. The candidate must demonstrate the skills necessary to successfully lead a research program including strong communication skills and experience collaborating with colleagues to develop research initiatives. EEO Statement Summary Consistent with federal and state law and University policy, the University of New England is committed to the fundamental concept of equal opportunity for all of the members of the University community. The University prohibits, and will not tolerate, discrimination in employment, the provision of academic services or in any other area of University life based on race, color, sex, physical or mental disability, religion, age, ancestry, national origin, sexual orientation, gender identity and/or expression, ethnicity, genetic information, HIV status, or status as a veteran. Prohibited bias factors should not motivate decisions regarding students, employees, applicants for admission, applicants for employment, contractors, volunteers or participants in and/or users of institutional programs, services, and activities. COVID Vaccination Statement (PLEASE NOTE) Employees in clinical settings must meet the State of Maine's immunization requirements for clinical activity and be medically cleared, fit tested, and trained on proper respirator (N95, Powered Air Purifying Respirator (PAPR)) use.

Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn. The Trial Master File (TMF) Specialist will be responsible for ensuring that SMPA studies have comprehensive and quality Trial Master Files (TMFs) ready for audits and inspections. Partnering with the Associate Director, Clinical Business Operations, the specialist ensures accountable functions follow the requirements of the TMF SOP and system work instructions. Provide support and guidance to study team members during the full lifecycle of the study, including planning, set-up, maintenance, QC and closure of the study TMF. **Key Responsibilities** + Responsible for overall quality, maintenance, and completeness of Trial Master Files. + Working closely with the TMF Process Owner, identify trends or quality concerns and oversee resolution of issues. + Develop project specific TMF plan and structure and update the plan as needed. + Participate in system UAT as needed and collaborate with Information Technology to ensure system validation is maintained. + Work closely with Clinical Operations and Regulatory Affairs to ensure compliance with regulatory requirements. + Act as a liaison between the Site IRBs and study team to resolve queries and concerns. + Provide study team reports or updates regarding status of TMF on a regular basis. + Participate in audits and provide documents as requested. + Perform investigation of deviations and monitoring of Corrective actions & preventive actions (CAPA) relating to non-compliance issues and findings. + Oversee TMF maintenance done by CROs and ensure final transfer of TMF is sufficient to support any potential regulatory filings. + Champion best practices for building and maintaining TMF health. **Professional Experience / Qualifications** + BA/BS with minimum of 3 year of clinical research experience in academic and/or industry settings + Knowledge of and direct experience with Trial Master Files. + Prior eTMF (e.g. Veeva) administration required. + Strong Microsoft Office skills required. + Demonstrate a comprehensive knowledge of Good Clinical Practice, Good Documentation Practice, and International Council for Harmonization E6(R2). + Fundamental knowledge of the conduct of clinical trials is preferred. + Strong focus on teamwork, attention to detail, excellent organizational skills. Must have ability to prioritize, and the ability to work in a multi-task environment. The base salary range for this role is $72,500 to $90,600. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law. Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. **Confidential Data** : All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential. **Compliance** : Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. **Mental/Physical Requirements** : Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time. **Sumitomo Pharma America (SMPA)** **is an Equal Employment Opportunity (EEO) employer** Qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn. Sumitomo Pharma America (SMPA) endeavors to make its application process accessible to all. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact SMPA at ********************************************** This contact information is for accommodation requests only and cannot be used to inquire about the status of applications. At Sumitomo Pharma America, our work is guided by the Sumitomo Pharma mission, vision and values, which tie closely to our company's cultural pillars. **Our** **Mission** _To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people_ _worldwide_ **Our** **Vision** _For Longer and Healthier Lives, we unlock the future with cutting edge technology and_ _ideas_

Clinical CoordinatorOcean Street adult residential program Pay rate: $31/hour with conditional license $32-$33/hour with full licensure . The Opportunity Alliance is seeking a full-time Clinical Coordinator to jump in and support our Ocean Street residential program. The Ocean Street Residential Program, with a capacity of eight residents, provides trauma-informed treatment and support services to adults living with mental illness complicated by co-occurring chronic health conditions as well as a potential substance use disorder. The Clinical Coordinator is a professional social work position that is responsible for providing quality treatment and service planning for the program. This position contributes to the accomplishment of the Agency mission through the provision of direct clinical services to residential clients and serving as a clinical consultant to the residential staff or through the provision of home-based and community-based case management services to youth, adults, and families with a mental health diagnosis. Work is performed, reviewed, and evaluated under the supervision of the Program Director. Schedule: This is a Full-Time, salaried role. Location: Onsite in South Portland, ME with flexibility for some remote work. Qualifications: Masters of Social Work degree or Masters of Counseling from an accredited graduate school required. LCSW or LCPC preferred or related clinical graduate degree required; with clinical conditional license required. (CADC Strongly Recommended for Co-Occurring Treatment Programs). Minimum of 1 or more years of direct experience with Co-Occurring Disorders preferred. Must be able to successfully pass a criminal background, child protective service check & sex offender check. Must not be on the state or federal suspension and disbarment list. If MHRT is required for position you must pass CNA registry check Must be able to pass pre-employment physical and TB screen. Must be able to exert moderate physical effort with occasional standing, walking, reaching, stooping, bending, kneeling, crouching, typing and frequently lift and carry small children or material weighing up to 25 pounds. Normal office conditions such as sitting, with occasional standing, walking, reaching, stooping, bending, kneeling, crouching, typing and lifting up to 10 pounds. Driving may be necessary to attend meetings and trainings and for the occasional need to meet with clients offsite and within the program service area. This may include transportation of clients or driving to agency location to complete work. A good driving record is required. Benefits: Our benefits include but are not limited to: (offered to full-time and part-time employees) Generous paid time off accrual 9 paid holidays per calendar year and up to 3 floating holidays per calendar year Excellent medical benefits at very reasonable cost Dental and Vision insurance options Agency paid basic life insurance and STD & LTD disability insurances 403(b) retirement with a generous agency match (all employees are eligible) Tuition Reimbursement - offered once per year through an application process The Opportunity Alliance (TOA) is a qualified employer under the Public Service Loan Forgiveness (PSLF) program. To learn more about our benefits please visit, ******************************************************** Who we are… The Opportunity Alliance is “Helping People Reach for a Brighter Future”. Mission: The Opportunity Alliance works with people to build better lives and stronger communities. We provide advocacy, leadership, and support to identify the goals and address the needs of individuals, families, and communities. The Opportunity Alliance (TOA) is a dynamic, results-focused Community Action Agency providing approximately 50 integrated community-based and clinical programs serving more than 20,000 people annually throughout the state of Maine. With over 50 years of experience, TOA draws from a comprehensive set of programs which address issues such as mental health, substance use, homelessness, lack of basic needs, and access to community supports. Through an extensive array of services, TOA provides opportunities for individuals to stabilize fragile situations and then works with them to achieve self-sufficiency. TOA is client-focused with extensive experience working with diverse client populations. TOA programming includes four key sectors of service: Mental Health & Wellness Community Building Family & Early Childhood Education Economic Resources ____________________________________________________________ If you are viewing this posting on a third-party site, please visit our website at ********************************************************* to apply . Please submit a cover letter and resume along with your application. Thank you!

Join us as we work to create a thriving ecosystem that delivers accessible, high-quality, and sustainable healthcare for all. We are seeking an experienced and proactive Research Coordinator Associate to join our Research Operations team in the Product division at athenahealth. In this role, you will support product development by recruiting research participants for a variety of user research studies. Working closely with product teams, User Experience designers, and researchers, you will help teams connect with end-users and develop innovative ways to improve how we support research. About the Team Our Research Operations team helps designers and product teams at athenahealth connect quickly and easily with users for quality research. Research Coordinators play an essential role in speeding innovation by managing participant recruitment and supporting research studies. We welcome candidates passionate about making a difference in healthcare and who enjoy working in a fast-moving, collaborative team environment. Who you are You are an effective communicator and collaborator who remains calm and approachable even under tight deadlines and shifting priorities. You skillfully balance the needs of multiple stakeholders and build strong relationships across teams and external partners, including clients and customer success leaders. You communicate clearly, concisely, and accurately, helping to keep everyone aligned. You take full ownership of your work and projects, demonstrating accountability and follow-through. You are naturally curious and innovative, always looking for ways to improve processes and solve challenges creatively. As a dependable team player, you support your colleagues and share knowledge generously. You approach your work with empathy and professionalism, representing athenahealth with integrity and care. You serve as a trusted partner to researchers, designers, product teams, and clients alike. You thrive in fast-paced environments where you adapt to change, anticipate needs, and contribute to athenahealth's mission to transform healthcare through effective user research. Job Responsibilities Build and maintain engaged, diverse participant panels for qualitative and quantitative research activities. Build and maintain relationships with internal teams and external professional groups to connect with more end-users and establish more effective recruitment channels. Anticipate and balance the needs of different teams, communicating clearly and managing details to keep research activities running smoothly. Manage research participant scheduling, communication, and incentives-using our research and scheduling tools. Create and maintain screener surveys and participant lists to recruit eligible research participants quickly. Lead efforts to improve recruitment by testing new ideas, such as pre-scheduling participants and refining outreach campaigns. Serve as a role model in collaboration, communication, and accountability by supporting team goals and sharing best practices with peers and junior members. Track recruitment progress and adjust plans to meet deadlines and participant needs. Typical Qualifications Bachelor's degree or equivalent professional experience. 2-3 years of experience managing research participant recruitment, scheduling, or complex coordination projects in research, product development, or related areas. Strong oral and written communication skills, fluent in English, with proven ability to communicate effectively with diverse stakeholders. Reliable and accountable for completing tasks and delivering quality work. Experience building and managing relationships with clients, stakeholders, or user groups. Familiarity with research recruitment tools, survey platforms, or participant management systems is preferred. Knowledge or experience with user research, user-centered design, or product development is preferred. Able to thrive in a fast-paced, collaborative environment that values innovation, empathy, and teamwork. Comfortable adopting new technologies and tools to improve recruitment and research processes. Expected Compensation The base salary range shown reflects the full range for this role from minimum to maximum. At athenahealth, base pay depends on multiple factors, including job-related experience, relevant knowledge and skills, how your qualifications compare to others in similar roles, and geographical market rates. Base pay is only one part of our competitive Total Rewards package - depending on role eligibility, we offer both short and long-term incentives by way of an annual discretionary bonus plan, variable compensation plan, and equity plans. About athenahealth Our vision: In an industry that becomes more complex by the day, we stand for simplicity. We offer IT solutions and expert services that eliminate the daily hurdles preventing healthcare providers from focusing entirely on their patients - powered by our vision to create a thriving ecosystem that delivers accessible, high-quality, and sustainable healthcare for all. Our company culture: Our talented employees - or athenistas, as we call ourselves - spark the innovation and passion needed to accomplish our vision. We are a diverse group of dreamers and do-ers with unique knowledge, expertise, backgrounds, and perspectives. We unite as mission-driven problem-solvers with a deep desire to achieve our vision and make our time here count. Our award-winning culture is built around shared values of inclusiveness, accountability, and support. Our DEI commitment: Our vision of accessible, high-quality, and sustainable healthcare for all requires addressing the inequities that stand in the way. That's one reason we prioritize diversity, equity, and inclusion in every aspect of our business, from attracting and sustaining a diverse workforce to maintaining an inclusive environment for athenistas, our partners, customers and the communities where we work and serve. What we can do for you: Along with health and financial benefits, athenistas enjoy perks specific to each location, including commuter support, employee assistance programs, tuition assistance, employee resource groups, and collaborative workspaces - some offices even welcome dogs. We also encourage a better work-life balance for athenistas with our flexibility. While we know in-office collaboration is critical to our vision, we recognize that not all work needs to be done within an office environment, full-time. With consistent communication and digital collaboration tools, athenahealth enables employees to find a balance that feels fulfilling and productive for each individual situation. In addition to our traditional benefits and perks, we sponsor events throughout the year, including book clubs, external speakers, and hackathons. We provide athenistas with a company culture based on learning, the support of an engaged team, and an inclusive environment where all employees are valued. Learn more about our culture and benefits here: athenahealth.com/careers ******************************************************

Senior Clinical Research Associate, Dermatology & Rheumatology (North Central Regions: Illinois, Indiana, Michigan, Ohio, and/or Wisconsin or East coast ) The senior clinical research associate (CRA) will monitor the progress of clinical studies 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. This role will be perfect for you if: You are a seasoned Clinical Research Associate (CRA) who thrives in autonomous environments and consistently meets high-quality standards and deadlines. You bring experience in dermatology and rheumatology, and you're eager to deepen your expertise in these therapeutic areas. You value working within a mid-sized CRO where your contributions are visible, appreciated, and have a direct impact. RESPONSIBILITIES The senior clinical research associate (CRA): Conducts site qualification, initiation, monitoring, and close-out visits for research sites according to the monitoring plan, Innovaderm and sponsor SOPs, ICH/CGP guidelines and applicable regulations Participates in investigators' meetings Prepares site visit reports and follow-up letters to the investigator Builds productive relationships with investigators and site staff to achieve study objectives, including patient recruitment targets Performs source data verification, ensures on-site study drug storage, dispensing, and accountability, data collection, and regulatory document collection is adequate The Sr CRA may also assume the following Lead CRA responsibilities: Reviews and approves site visit reports. Tracks site visit and trip report metrics and escalates issues to project teams. Recommends potential solutions to identified issues and work with the project managers to find resolution. Supports the development of annotated site visit reports, clinical monitoring plans, and monitoring tools. Supports the preparation and development of materials related to the training of CRAs. Mentors CRAs. Conducts on-site quality control visits with CRAs. Education B.Sc. in a field relevant to clinical research, nursing degree and/or equivalent experience Experience At least 5 years experience in conducting on-site clinical monitoring in the biotechnology, pharmaceutical, and/or contract research organization (CRO) industry Rheumatology exposure Knowledge and skills Good knowledge of ICH/GCP standards and applicable regulatory requirements Strong verbal and written communication skills in English Ability to prioritize different assignments and work under pressure while maintaining attention to detail and meeting timelines Excellent judgement and problem-solving skills Travel to research sites approximately 65% of the time Excellent knowledge of Microsoft Office (i.e., Word, Excel, PowerPoint) Experience in dermatology is an asset The work environment At Indero, you will work with brilliant and driven colleagues. Our values are collaboration, innovation, reliability and responsiveness. We offer a stimulating work environment and attractive advancement opportunities. Recruitment process: what to expect As part of the recruitment process for this position you will meet various team members at Indero The first interview will be conducted by Teams (30 minutes) and the second via video conference (1 hour) About Indero A Global Clinical Leader In Dermatology and Rheumatology! Formerly known as Innovaderm, Indero is a world-renowned expert and clinical research leader in dermatology. We have more than two decades of experience serving a broad range of indications, patient populations, administration routes, and drug classes, and a global footprint. Indero is a dual-focus CRO for dermatology and rheumatology, with 25+ years' experience in clinical research and trial delivery. Our full-service approach - which includes everything from protocol design and patient recruitment to trial monitoring and biometrics - provides biotech and pharmaceutical sponsors with the rigorous scientific foundation and tailored expertise their studies need to reach the finish line efficiently and effectively. With capabilities in North America, Europe, Asia Pacific and Latin America; vast, continuously growing relationships with investigators and patients; and a dedicated research clinic through which we design and execute our own studies, Indero is the ideal CRO partner for clinical needs at global scale. Indero is committed to providing equitable treatment and equal opportunity to all individuals. As such, Indero will provide accommodations throughout the recruitment and selection process to applicants with disabilities, upon request. Indero only accepts applicants who can legally work in United States.

Job Description Join Our Team as a Clinical Coordinator in the Joints Department! Are you a compassionate, detail-oriented healthcare professional looking for a fulfilling role in a dynamic and supportive environment? We are seeking a Clinical Coordinator to join our dedicated orthopaedic team within the Joints Department! In this role, you'll work closely with physicians, advanced practice providers (APPs), and clinic staff to ensure seamless, high-quality patient care. From coordinating pre- and post-operative care to serving as a key resource for patients and staff, you'll play a crucial part in improving patient experiences and outcomes. Why Join Us? ✅ Make a Difference Every Day - Be the bridge between patients and providers, helping to deliver outstanding care. ✅ Supportive Team Culture - Work in a collaborative and positive environment where your contributions are valued. ✅ Growth & Development - Expand your knowledge and skills in orthopaedics while working alongside experienced professionals. What You'll Do: ???? Act as a key liaison between patients and providers, ensuring clear communication and exceptional care. ???? Assist with pre-appointment chart checks, wound care, medication documentation, and post-surgical follow-ups. ???? Manage scheduling, patient education, and medical records to keep operations running smoothly. ???? Work closely with the clinic team to problem-solve and enhance patient experiences. What We're Looking For: ✔ LPN (Maine license eligible), Certified Medical Assistant (CMA/RMA), or other relevant healthcare credentials ✔ 2+ years of experience in a healthcare setting (orthopaedics experience is a plus!) ✔ Excellent communication, problem-solving, and organizational skills ✔ Proficiency in electronic medical records (EMR) systems ✔ A compassionate, patient-first mindset with a passion for healthcare Ready to Make an Impact? If you're excited about providing exceptional patient care in a team-oriented environment, we'd love to hear from you! Apply today and take the next step in your healthcare career.

Management/Leadership This position is for someone interested in joining a hands-on team at the MaineHealth Institute for Research. This Research Coordinator Supervisor will work at the direction of the Manager, Clinical Trials Office, and will be responsible for research coordination: including but not limited to supervising staff, overseeing training and serving as an educational resource for research studies. A hybrid work schedule from our Scarborough, Maine location is available for this position. The MaineHealth application, a cover letter and a resume or CV are all required elements for application to this position. Required Minimum Knowledge, Skills, and Abilities (KSAs) * Education: Bachelor's degree, or equivalent combination of education and experience is required. * License/Certifications: Certification by the Association of Clinical Research Professionals or Society of Clinical Research Associates preferred. * Experience: 3-4 years of research experience required. Experience in a clinical setting preferred. * Additional Skills/Requirements Required: Experience as a leader or a mentor required. * Additional Skills/Requirements Required: Ability to function independently and as part of a team. Additional Information With a career at any of the MaineHealth locations across Maine and New Hampshire, you'll be working with health care professionals that truly value the people around them - both within the walls of the organization and the communities that surround it. We offer benefits that support an individual's needs for today and flexibility to plan for tomorrow - programs such as paid parental leave, a flexible work policy, student loan assistance, training and education, along with well-being resources for you and your family.

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 Description New England Cancer Specialists (NECS) is seeking a fulltime Clinical Research Assistant in our Westbrook Clinic. The Research Assistant will work within a dedicated Research Department in an outpatient setting, providing professional research and study support for assigned clinical research protocols. Responsibilities include assisting with patient recruitment and the management of volunteer subjects in compliance with study protocols, FDA regulations, and sponsor and practice requirements. The Research Assistant will also support the regulatory management of research projects from study start-up through close-out, under the guidance of the Regulatory Specialist. NECS is a private medical practice composed of 18 oncologists and hematologists serving the region from four separate locations in Maine and New Hampshire. Our mission is to make life better for people with cancer and blood disorders. Kindness, compassion, and respect are part of everything that we do - from our phone operators to our physicians, every person on our team is important, and everyone makes a difference every day. We are proud to be the first Dana Farber Affiliate practice in the country, striving to provide the highest quality care and unmatched, holistic support for every patient, every day. Job Duties: Provide departmental support activities as necessary. Examples include: ordering/shipping/receiving of study materials, inventory management, data entry, regulatory, etc. Assist in the maintenance of regulatory files (financial disclosures, FDA forms, NCI forms, CVs, medical license, etc.) for clinical trials within an eRegulatory platform Assist in providing sponsor access to electronic systems (OncoEMR, Florence, Assist in preparation for institutional, pharmaceutical and internal audits Facilitate PI and study staff protocol and industry level training Assist in screening, enrollment and retention of volunteer patients Develop, facilitate, and maintain medication dispensation and usage records during study activation Assist in managing the archiving process and organization of legacy study documents Track and manage equipment calibration and temperature logs across all sites including monthly and annual calibration Maintain database/spreadsheets/files as necessary to facilitate tracking/documentation of departmental activities Stay up-to-date with new and revised standard operating procedures and regulations Maintain compliance with good clinical practice (GCP) guidelines, patient confidentiality (HIPAA) and any other applicable laws Ensure confidentiality of patient records and data: HIPAA compliance Performs miscellaneous, job-related activities as assigned Associate's degree in related field or equivalent work experience in the clinical setting. A minimum of 1-2 years of work experience with clinical trials, or a combination of clinical trials and relevant work experience preferred. CITI certification preferred. Must be able to complete CITI program upon hire. Oncology experience preferred. Benefits: New England Cancer Specialists offers competitive pay and a comprehensive benefits package to our employees. Our benefits include medical, prescription, dental, and vision insurances. Company-paid Life Insurance, Short Term, and Long-Term disability insurances. Other benefits include a retirement program, voluntary benefits, and a generous Paid Time Off in addition to 10 Company-paid holidays. NECS supports continuing education and offers a tuition reimbursement program as well as covering expenses associated with obtaining and maintaining national certification.

Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn. **Job Duties and Responsibilities** + Collaborate effectively with key internal and external stakeholders at the departmental and cross-department levels leading the creation and execution of Confidential Disclosure Agreements (CDA). + Assist with the entry of Contractual Agreements into an electronic document repository. + Ensure all outsourcing decisions are properly documented, compliant, and audit-ready. + Manage and/or facilitate issue escalations at the operational level and ensure timely escalation to senior leadership when appropriate. + Work cross-functionally with clinical teams, Finance and Legal, towards solutions; process, and communication improvements. + Perform other duties as requested. **Key Core Competencies** + Strong strategic and analytical reasoning and problem-solving ability. Able to deliver at high quality, in a fast-paced, dynamic environment and able to manage competing priorities + Ability to proactively identify and act on opportunities for operational efficiencies + Ability to work within a team as well as independently on specifically assigned tasks. The individual will be organized, detail-oriented, and will possess a financial aptitude + Proficient with MS Office Suite (Excel, Word and PowerPoint), Smartsheet and Contract Repository Solution + Excellent written and oral communication skills **Education and Experience** + BA/BS preferred with at least 2 years experience, or 5 years equivalent experience + Clinical Operations, Project Management, Clinical Outsourcing, and/or CRO relevant industry provider Outline the relevant work experience required, including any specific industries or roles. The base salary range for this role is $72,500 to $90,600. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law. Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. **Confidential Data** : All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential. **Compliance** : Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. **Mental/Physical Requirements** : Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time. **Sumitomo Pharma America (SMPA)** **is an Equal Employment Opportunity (EEO) employer** Qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn. Sumitomo Pharma America (SMPA) endeavors to make its application process accessible to all. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact SMPA at ********************************************** This contact information is for accommodation requests only and cannot be used to inquire about the status of applications. At Sumitomo Pharma America, our work is guided by the Sumitomo Pharma mission, vision and values, which tie closely to our company's cultural pillars. **Our** **Mission** _To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people_ _worldwide_ **Our** **Vision** _For Longer and Healthier Lives, we unlock the future with cutting edge technology and_ _ideas_

The School of Food and Agriculture (SFA) at the University of Maine seeks applicants for a full-time, 12-month, non-tenure-track Lecturer of Food Science and Coordinator of Food Science Teaching & Research Facilities and Programs. This is a 70% teaching and 30% administrative appointment. Responsibilities include teaching in SFA's Food Science & Human Nutrition program and coordinating operations and activities within the Food Science Teaching & Research Facilities. The successful candidate will teach undergraduate courses in the Food Science and Human Nutrition (FSN) program within SFA. Initial teaching responsibilities could include the Science of Food Preparation, Introduction to Food and Nutrition, Food Processing Lab, Research Learning Experiences, Foodservice Management, Field Experience, and Contemporary Issues in the Food Industry. Courses and teaching expectations may change based on School needs and faculty expertise. Additional teaching-related activities to be performed include preparation for lab courses that take place in the food science facilities, supervision of students to ensure safety and sanitation procedures are met, supervision of teaching assistants working within the facilities, and support of additional classes in SFA that involve food preparation, facility safety, and sanitation. This position includes an expectation to mentor students working on honors or capstone projects within the facilities and to participate in faculty meetings, curriculum committee meetings, and program assessments. The successful candidate will contribute to undergraduate recruiting efforts, attend open houses, and collaborate on youth summer educational programs for students interested in food science and human nutrition. In addition to teaching responsibilities, the successful candidate will coordinate operations in the Dr. Matthew Highlands Pilot Plant, Commercial Kitchen, and related teaching and research facilities in Hitchner Hall. Responsibilities include coordinating use of the space by students, faculty, and staff, and providing safety and sanitation training; hiring and supervising student workers in the facilities; communicating with Facilities Management and external contractors for scheduled maintenance and repairs; purchasing supplies and equipment for the facilities, including writing specs and obtaining bids; becoming proficient at operating and maintaining equipment in the facilities and establishing standard operating procedures; acting as the safety officer to train or facilitate training of all relevant facilities users on proper use and safety in the pilot plant, kitchen, and teaching and research labs; acting as point of contact for risk and safety management, maintaining safety records, and anticipating and responding to safety needs; working effectively, proactively, and cooperatively with members of SFA and other users of the facilities and managing agreements for facilities usage; and performing other reasonably related duties as assigned. SFA offers a B.S. degree program in Food Science and Human Nutrition with three concentrations, of which the Human Nutrition and Dietetics option is accredited by the Accreditation Council for Education in Nutrition and Dietetics (ACEND) and the Food Science concentration is approved by the Institute of Food Technologists. SFA also offers an M.S. degree in Food Science and Human Nutrition and a Ph.D. in Food and Nutrition Sciences. The University of Maine provides many resources to support the instructional needs of university faculty in 21st-century learning. About the University: The University of Maine is a community of more than 11,900 undergraduate and graduate students, and 2,500 employees located on the Orono campus, the regional campus in Machias, and throughout the state. UMaine is a land, sea and space grant university, and maintains a leadership role as the University of Maine System's flagship institution. UMaine is the state's public research university and a Carnegie R1 top-tier research institution, dedicated to providing excellent teaching, research and service for Maine, the nation and the world. More information about UMaine is at umaine.edu. The University of Maine offers a wide range of benefits for employees including, but not limited to, tuition benefits (employee and dependent), comprehensive insurance coverage including medical, dental, vision, life insurance, and short and long term disability as well as retirement plan options. UMaine is located in beautiful Central Maine. Many employees report that a primary reason for choosing to come to UMaine is quality of life. Numerous cultural activities, excellent public schools, safe neighborhoods, high quality medical care, little traffic, and a reasonable cost of living make the greater Bangor area a wonderful place to live. Visit the Maine Office of Tourism to learn more about what the Bangor region has to offer. Qualifications: Required: An M.S. degree in food science or a closely related field. Knowledge and experience in food science and/or food safety. Demonstrated ability or potential to teach food science at the undergraduate level. Demonstrated ability to mentor students. Strong written and oral communication skills. Preferred: A Ph.D., or an M.S. degree plus at least 2 years of relevant experience. Record or promise of high professional service and leadership capacity. Record of supervising programmatic activities in food science or a related field. Other Information: To be considered for this position you will need to “Apply” and upload the documentation listed below: 1.) a cover letter which describes your experience, interests, and suitability for the position 2.) a resume/curriculum vitae Candidates selected to proceed to the final stages of the search process will be requested to provide a list of names and contact information for references. Incomplete application materials cannot be considered. Materials received after the initial review date will be reviewed at the discretion of the University. For full consideration, materials must be submitted by 4:30 p.m. EST on July 15, 2025. For questions about the search, please contact search committee chair, Jennifer Perry, at ************************ or ************. The successful applicant is subject to appropriate background screening. In complying with the letter and spirit of applicable laws and pursuing its own goals of diversity, the University of Maine System does not discriminate on the grounds of race, color, religion, sex, sexual orientation, transgender status, gender, gender identity or expression, ethnicity, national origin, citizenship status, familial status, ancestry, age, disability physical or mental, genetic information, or veterans or military status in employment, education, and all other programs and activities. The University provides reasonable accommodations to qualified individuals with disabilities upon request. The following person has been designated to handle inquiries regarding non-discrimination policies: Director of Equal Opportunity and Title IX Services, 5713 Chadbourne Hall, Room 412, University of Maine, Orono, ME 04469-5713, ************, TTY 711 (Maine Relay System). Clery Act The Jeanne Clery Disclosure of Campus Security Policy and Campus Crime Statistics Act, or Clery Act, mandates that all Title IV institutions, such as the University, prepare, publish and distribute an Annual Security Report, (ASR) and provide notice of the availability of the ASR to all prospective employees. This report consists of two basic parts: disclosure of the University's crime statistics for the past three calendar years; and disclosures regarding the University's current campus security policies. You may view the University's Annual Security Report. If you wish to have a paper copy of the ASR or you need to have a copy of the ASR in an accessible format, the University will provide such a copy upon request. Please contact: UMaine Police Department, 81 Rangeley Rd., The University of Maine, Orono, ME 04469-5794, or call ************.

**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.

The School of Food and Agriculture (SFA) at the University of Maine seeks applicants for a full-time, 12-month, non-tenure-track Lecturer of Food Science and Coordinator of Food Science Teaching & Research Facilities and Programs. This is a 70% teaching and 30% administrative appointment. Responsibilities include teaching in SFA's Food Science & Human Nutrition program and coordinating operations and activities within the Food Science Teaching & Research Facilities. The successful candidate will teach undergraduate courses in the Food Science and Human Nutrition (FSN) program within SFA. Initial teaching responsibilities could include the Science of Food Preparation, Introduction to Food and Nutrition, Food Processing Lab, Research Learning Experiences, Foodservice Management, Field Experience, and Contemporary Issues in the Food Industry. Courses and teaching expectations may change based on School needs and faculty expertise. Additional teaching-related activities to be performed include preparation for lab courses that take place in the food science facilities, supervision of students to ensure safety and sanitation procedures are met, supervision of teaching assistants working within the facilities, and support of additional classes in SFA that involve food preparation, facility safety, and sanitation. This position includes an expectation to mentor students working on honors or capstone projects within the facilities and to participate in faculty meetings, curriculum committee meetings, and program assessments. The successful candidate will contribute to undergraduate recruiting efforts, attend open houses, and collaborate on youth summer educational programs for students interested in food science and human nutrition. In addition to teaching responsibilities, the successful candidate will coordinate operations in the Dr. Matthew Highlands Pilot Plant, Commercial Kitchen, and related teaching and research facilities in Hitchner Hall. Responsibilities include coordinating use of the space by students, faculty, and staff, and providing safety and sanitation training; hiring and supervising student workers in the facilities; communicating with Facilities Management and external contractors for scheduled maintenance and repairs; purchasing supplies and equipment for the facilities, including writing specs and obtaining bids; becoming proficient at operating and maintaining equipment in the facilities and establishing standard operating procedures; acting as the safety officer to train or facilitate training of all relevant facilities users on proper use and safety in the pilot plant, kitchen, and teaching and research labs; acting as point of contact for risk and safety management, maintaining safety records, and anticipating and responding to safety needs; working effectively, proactively, and cooperatively with members of SFA and other users of the facilities and managing agreements for facilities usage; and performing other reasonably related duties as assigned. SFA offers a B.S. degree program in Food Science and Human Nutrition with three concentrations, of which the Human Nutrition and Dietetics option is accredited by the Accreditation Council for Education in Nutrition and Dietetics (ACEND) and the Food Science concentration is approved by the Institute of Food Technologists. SFA also offers an M.S. degree in Food Science and Human Nutrition and a Ph.D. in Food and Nutrition Sciences. The University of Maine provides many resources to support the instructional needs of university faculty in 21st-century learning. About the University: The University of Maine is a community of more than 11,900 undergraduate and graduate students, and 2,500 employees located on the Orono campus, the regional campus in Machias, and throughout the state. UMaine is a land, sea and space grant university, and maintains a leadership role as the University of Maine System's flagship institution. UMaine is the state's public research university and a Carnegie R1 top-tier research institution, dedicated to providing excellent teaching, research and service for Maine, the nation and the world. More information about UMaine is at umaine.edu. The University of Maine offers a wide range of benefits for employees including, but not limited to, tuition benefits (employee and dependent), comprehensive insurance coverage including medical, dental, vision, life insurance, and short and long term disability as well as retirement plan options. UMaine is located in beautiful Central Maine. Many employees report that a primary reason for choosing to come to UMaine is quality of life. Numerous cultural activities, excellent public schools, safe neighborhoods, high quality medical care, little traffic, and a reasonable cost of living make the greater Bangor area a wonderful place to live. Visit the Maine Office of Tourism to learn more about what the Bangor region has to offer. Qualifications: Required: An M.S. degree in food science or a closely related field. Knowledge and experience in food science and/or food safety. Demonstrated ability or potential to teach food science at the undergraduate level. Demonstrated ability to mentor students. Strong written and oral communication skills. Preferred: A Ph.D., or an M.S. degree plus at least 2 years of relevant experience. Record or promise of high professional service and leadership capacity. Record of supervising programmatic activities in food science or a related field. Other Information: To be considered for this position you will need to “Apply” and upload the documentation listed below: 1.) a cover letter which describes your experience, interests, and suitability for the position 2.) a resume/curriculum vitae Candidates selected to proceed to the final stages of the search process will be requested to provide a list of names and contact information for references. Incomplete application materials cannot be considered. Materials received after the initial review date will be reviewed at the discretion of the University. For full consideration, materials must be submitted by 4:30 p.m. EST on July 15, 2025. For questions about the search, please contact search committee chair, Jennifer Perry, at ************************ or ************. The successful applicant is subject to appropriate background screening. In complying with the letter and spirit of applicable laws and pursuing its own goals of diversity, the University of Maine System does not discriminate on the grounds of race, color, religion, sex, sexual orientation, transgender status, gender, gender identity or expression, ethnicity, national origin, citizenship status, familial status, ancestry, age, disability physical or mental, genetic information, or veterans or military status in employment, education, and all other programs and activities. The University provides reasonable accommodations to qualified individuals with disabilities upon request. The following person has been designated to handle inquiries regarding non-discrimination policies: Director of Equal Opportunity and Title IX Services, 5713 Chadbourne Hall, Room 412, University of Maine, Orono, ME 04469-5713, ************, TTY 711 (Maine Relay System). Clery Act The Jeanne Clery Disclosure of Campus Security Policy and Campus Crime Statistics Act, or Clery Act, mandates that all Title IV institutions, such as the University, prepare, publish and distribute an Annual Security Report, (ASR) and provide notice of the availability of the ASR to all prospective employees. This report consists of two basic parts: disclosure of the University's crime statistics for the past three calendar years; and disclosures regarding the University's current campus security policies. You may view the University's Annual Security Report. If you wish to have a paper copy of the ASR or you need to have a copy of the ASR in an accessible format, the University will provide such a copy upon request. Please contact: UMaine Police Department, 81 Rangeley Rd., The University of Maine, Orono, ME 04469-5794, or call ************.

Management/Leadership This position is for someone interested in joining a hands-on team at the MaineHealth Institute for Research. This Research Nurse Coordinator Supervisor will work at the direction of the Manager, Clinical Trials Office, playing a key role in the delivery of our Oncology therapeutic clinical trials mission to provide the highest quality research conduct and the best experience possible to our research participants. This role will serve as an educational resource to nurses conducting clinical research studies, supervising staff, overseeing training and ongoing operational support of Oncology Research Nurse Coordinators. A hybrid work schedule from our Scarborough, Maine location is available for this position. A resume or CV AND Cover Letter are required to be considered for this position. Learn more about the MaineHealth Institute for Research in this short video! Required Minimum Knowledge, Skills, and Abilities (KSAs) * Education: See "License/Certifications" * License/Certifications: Current license to practice as a Registered Nurse in the State of Maine. Current Clinical Research Coordinator Certification (ACRP or SOCRA) required. * Experience: 5+ years of research experience is required. MH research experience is preferred. Thorough knowledge of theory, practice, principles, processes and issues of nursing usually acquired through 2-3 years of clinical experience. * Additional Skills/Requirements Required: Demonstrated ability to serve in a role as a leader or a mentor. Ability to manage complex projects through all phases of development, implementation, and follow-up. * Additional Skills/Requirements Preferred: N/A Additional Information With a career at any of the MaineHealth locations across Maine and New Hampshire, you'll be working with health care professionals that truly value the people around them - both within the walls of the organization and the communities that surround it. We offer benefits that support an individual's needs for today and flexibility to plan for tomorrow - programs such as paid parental leave, a flexible work policy, student loan assistance, training and education, along with well-being resources for you and your family.