Clinical research coordinator jobs near me

Piper Companies is seeking Clinical Research Associates to join a highly accredited CRO. This position is fully remote but does require on-site monitoring in Canada. The Clinical Research Associate will take part in assisting the process of creating lifesaving drugs and treatments. Responsibilities of the Clinical Research Associate * Conduct monitoring and close-out visits that align with GCP and ICH guidelines. * Support subject recruitment plans and provide study-specific training to site staff. * Manage regulatory submissions, enrollment, data collection, and documentation in TMF/ISF. * Work with study teams, mentor staff, and generate visit reports and follow-ups. Qualifications of the Clinical Research Associate: * Bachelor's degree in healthcare or science concentration. * Strong experience in onsite oncology monitoring. * Phase 1 oncology required. * Bilingual in French and English. * Skilled in clinical research protocols, technology, and communication. Compensation for the Clinical Research Associate: * Salary Range: $90,000-$120,000 CAD * Comprehensive Benefits: Vacation, PTO, Medical, Dental, Vision, 401k, and sick leave if required by law This job opens for applications on 10/31/2025. Applications for this job will be accepted for at least 30 days from the posting date. Keywords: Clinical Research Associate, CRA, oncology, recruitment, training, communication, quality, documentation, reporting, mentorship, collaboration, GCP, ICH, protocols, submissions, enrollment, CRF, data, TMF, ISF, site-management, initiation, close-out, resolution, scientific, healthcare, experience, Phase1 #LI-HL1 #LI-REMOTE

Scholar Rock is a biopharmaceutical company that discovers, develops, and delivers life-changing therapies for people with serious diseases that have high unmet need. As a global leader in the biology of the transforming growth factor beta (TGFβ) superfamily of cell proteins and named for the visual resemblance of a scholar rock to protein structures, the clinical-stage company is focused on advancing innovative treatments where protein growth factors are fundamental. Over the past decade, the company has created a pipeline with the potential to advance the standard of care for neuromuscular disease, cardiometabolic disorders, cancer, and other conditions where growth factor-targeted drugs can play a transformational role. Scholar Rock is the only company to show clinical proof of concept for a muscle-targeted treatment in spinal muscular atrophy (SMA). This commitment to unlocking fundamentally different therapeutic approaches is powered by broad application of a proprietary platform, which has developed novel monoclonal antibodies to modulate protein growth factors with extraordinary selectivity. By harnessing cutting-edge science in disease spaces that are historically under-addressed through traditional therapies, Scholar Rock works every day to create new possibilities for patients. Learn more about the company's approach at ScholarRock.com and follow @ScholarRock and on LinkedIn . Summary of Position: The in-house Lead Clinical Research Associate (LCRA) will provide support for study management tasks in collaboration with the Clinical Trial Manager and Director with an emphasis on leading monitoring oversight activities for our clinical CROs. The LCRA works with clinical to assure that protocol requirements, laboratory collections, regulatory guidelines and timelines are met. Position Responsibilities: Serves as a representative of Scholar Rock to CRO, study vendors, and site staff Create CRA training materials and ensure the CRO CRAs are adequately trained and are prepared to train the study site staff Review Monitoring Visit Reports from the CRO Monitor studies or perform co-monitoring visits as required per the Sponsor Oversight Plan or as needed Develop and monitor metrics to evaluate the CRO CRAs and site performance and ensure compliance with ICH-GCP, SOPs, Local Laws & Regulations, Protocol, Monitoring Plan and associated documents Ensure the Trial Master File is maintained in an inspection-ready state at the CRO. Review for compliance and address findings as needed Oversee the setup activities and activation at the study sites Assist the Clinical Trial Manager in the review of ICFs and essential documents Participate in investigator meetings and assist with planning Collaborate with the CRO counterpart Travel, including international travel, required Candidate Requirements: BS/BA degree in a scientific discipline; advanced degree preferred Minimum of 3 years demonstrated site monitoring experience in a biotechnology, pharmaceutical and/ or CRO company Highly organized, outcome oriented, self-motivated performance Ability to adapt to change in a growth environment Excellent interpersonal skills, ability to develop important relationships with key stakeholders across a variety of disciplines, good conflict management and negotiation skills Knowledgeable of Electronic Data Capture and other IT systems (CTMS, Microsoft Office, etc.) Ability to analyze complex issues to develop relevant and realistic plans, programs and recommendations Good understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines Good understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines Strong written and oral communication skills Certification as a Clinical Research Associate or Clinical Research Professional is highly desirable Scholar Rock is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees .

🔗Are you being referred to one of our roles by a connection in Alira Health? If so, please apply using the referral link emailed to you. Join our global team dedicated to innovation and initiative, where physical walls and different time zones don't limit, but encourage, collaboration. Where all contributions and new ideas are explored with an open mind and work is driven by our shared values: be courageous, be accountable, be honest, be inclusive and elevate others. Summary The CRA is an important member of the Alira Health Clinical team. The CRA is highly motivated and functions independently to conduct site monitoring responsibilities for clinical trials; as well as providing oversight, leadership, and guidance in the management and execution of clinical trials to ensure compliance and quality. The CRA works closely with Lead CRAs, Sr CRAs, in-house CRAs, Associate Director of Clinical Monitoring and Project Managers to ensure protocol compliance, address site questions, and assist with study recruitment, site training, and other site-related issues. Job Description 2+ years oncology monitoring is a requirement for this position.KEY RESPONSABILITIES Provides guidance, oversight, and feedback to the CRA team to ensure adherence to project scope, SOPs, timelines, and budget requirements. Reviews monitoring visit reports, conducts co-monitoring and evaluation visits as needed. Ensures appropriate and timely investigator site visits. Coordinates with appropriate cross-functional departments to facilitate negotiation/issue resolution for clinical trial monitoring related issues. Assists in development of study-specific Monitoring Plans and training presentations as required. Assists in set up/collection of site specific ethics documents and site contract negotiation as required. Provides monthly billing information to finance team as required. For monitoring stand-alone projects, manages study budget and acts as referent for the sponsor. Performs qualification, initiation, interim, and close-out visits both remotely and onsite, ensuring proper documentation of monitoring visits. Prepares consistently accurate and timely monitoring visit reports documenting site-related problems, resolutions, actions taken, protocol deviations, study progress, and enrollment status. Ensures integrity of CRF data through meticulous and thorough source document review and verification. Performs quality control and verification of documents collected at sites for eTMF/TMF. Conducts investigational product accountability. Reviews site regulatory binder for required documents. Maintains regular contact with study sites to ensure protocol/GCP compliance, assesses patient accrual rates, and responds to sponsor requests. Complies with and ensures team compliance with ICH GCP guidelines, FDA regulations, and company/Sponsor SOPs. Participates in internal, client/sponsor, scientific, and other meetings as required. Facilitates adverse event reporting and ensures the reconciliation of SAE reports with source documentation and CRFs. Works closely with in-house CRAs/CTC and data management to resolve queries on discrepant data. Proactively identifies site issues and develops problem-solving strategies for sites. Conducts audit preparation at study sites as needed. Works with other CRAs to maintain consistency and promote a collaborative team atmosphere. Participates in internal, client/sponsor, scientific, and other meetings as required. Assists in CRA new hire training and onboarding. Performs CRA mentoring. Collaborates with development and maintenance of Clinical Trial Management System (CTMS). Manages and resolves conflicting priorities to deliver on commitments. Performs additional duties as assigned. DESIRED QUALIFICATION & EXPERIENCE EU: Graduation in a scientific health field EU (Italy): Certified Monitor in compliance with Italian CRO decree dated 15Nov2011 Ability to establish and maintain positive relationships with Sponsor, Site and Project Team members Ability to autonomously manage monitoring activities TECHNICAL COMPETENCES & SOFT SKILLS Quality focused; Proven ability to be careful, thorough, and detail-oriented Strong organizational skills and the ability to multi-task and work effectively in a fast-paced environment Able to manage priorities, organize time and solve problems Strong analytical, negotiation, meeting management, cross-functional team, and leadership skills Ability to travel Ability to manage stress Professional, trustworthy and disciplined Ability to problem-solve unstructured or ambiguous challenges Strong command of Local language, both written and verbal, in the country where monitoring activities are performed Excellent communication and interpersonal skills with customer service orientation Good computer skills, with ability to use clinical trial management systems, clinical trial databases and electronic data capture Self-starter who thrives in a collaborative, yet less structured team environment Knowledge of clinical research, ICH GCP and local regulations Knowledge of Regulatory and Ethical requirements EU: Adequate English Languages English Education Bachelor of Science (BS): Biology, Bachelor of Science (BS): Life Sciences Contract Type Regular

Remote Clinical Research Associate III needs 2 years of site management and field monitoring experience Remote Clinical Research Associate III requires: Work Schedule: M-F 7:00 am -3:30 pm or 8:00 am to 4:30 pm EST Qualifications: BS/BA Minimum of 2 years of site management and field monitoring experience Knowledge of applicable standards and regulations for clinical trials Proven oral and written communication skills Proven planning skills; ability to create and track detailed project plans Proven interpersonal, leadership, organizational and effective time management skills Demonstrated experience in computer skills to include Microsoft Word, Excel and basic templates Ability to work independently and within a cross-functional team environment to identify and escalate site/monitoring related activities issues to the management team in a timely fashion Preferred: Experience in womens fertility VD Study Experience Medidata RAVE system Remote Clinical Research Associate III duties: Performs Site initiation, interim & close out monitoring visits Verifies required clinical data entered in the electronic case report form (eCRF) is accurate and complete Manages site communication and escalates to leadership in a timely fashion when needed Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations. Documents activities via confirmation letters, follow-up letters, trip reports Site support throughout the study lifecycle from site identification through close-out Attends and participates in internal meetings

Work Schedule Standard (Mon-Fri) Environmental Conditions Laboratory Setting, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.) Job Description At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future. Discover Impactful Work: We are seeking a Clinical Research Coordinator III (Registered Nurse) to support our government customer on-site in Silver Spring, Maryland . This is a per diem, non benefited position. Availability needed (6:00 am - 10: 00 am). Relocation assistance is NOT provided for this role. Must be a U.S. citizen. Must be able to pass a comprehensive background check, which includes a drug screening and a physical. Required to be a Registered Nurse licensed to practice in the state of Maryland. A day in the Life: Organizes and prioritizes all activities associated with conducting phase 1, 2, and 3 clinical and operational research studies within a military clinic setting. Reviews and understands research protocols, ensuring applicable regulations and guidelines are followed. Organizes research information for clinical projects Selects and observes subjects and assists with data analysis and reporting. Oversees experiment scheduling and collection of data. Participates in source document and study document design, writing SSP, materials planning, visit schedule creation, etc. Enters required data routinely on CRFs and audit records for accuracy, resolve discrepancies, and correct as necessary. Maintains study/test article or investigational product accountability and administration. Monitors study data collection procedures to ensure uniformly high levels of compliance with GCP, GLP, FDA and other government- or locally required guidance. Relies on experience and judgment to plan and accomplish goals. Works under general supervision and performs a variety of tasks. Keys to Success: Required Education Required to be a Registered Nurse licensed to practice in the state of Maryland, who is skilled and qualified in nursing procedures to include, but not limited to the administration of experimental vaccines and other parenteral therapeutics as per specific protocol guidance in accordance with the 21 Code of Federal Regulation (CFR) 11, 50, 54, 56, 312, and 314. Basic Life Support (BLS -CPR/AED) certification. Required Experience and Skills: Five (5) years of experience in clinical research coordination, with expertise in FDA-regulated trials. Experience utilizing clinical trial management systems and databases (e.g., REDcap and Inform). Must be able to work both independently and in a team setting following a brief period of specific technical training. Must have excellent communication, organization, and prioritization skills. Ability to establish and maintain effective working relationships with coworkers, managers and customers. Maintenance of Certification in Clinical Research Coordination by Association of Clinical Research Professionals (ACRP) or Society of Clinical Research Associates (SoCRA). Desired Experience and Skills Advanced Cardiac Life Support (ACLS) certification encouraged. Certification in clinical research (e.g., CCRP or CCRA) is preferred. Commission for Case Manager Certification (CCMC) certification preferred. Compensation and Benefits The salary pay range estimated for this position CRA (Level II) based in Maryland is $38.46-$44.23. This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes: A choice of national medical and dental plans, and a national vision plan, including health incentive programs Employee assistance and family support programs, including commuter benefits and tuition reimbursement At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan Employees' Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount For more information on our benefits, please visit: *****************************************************

HistoSonics is a medical device company, founded in 2009, that has developed a non-invasive, sonic beam therapy platform that uses histotripsy, which is capable of destroying targeted liver tumors. Our mission and passion are to advance the novel science of histotripsy and its powerful benefits, bringing meaningful and transformational change to physicians and their patients. Location: Remote position, ideally candidates will live in a major metro area with an international airport in the Northeast, Southeast or West Coast. Travel Expectation: Travel (by automobile or air, day trips and overnight stays) up to 30% of the time. Position Summary: The Clinical Research Associate will play a key role in proactively helping the conduct of pre-market and post-market global clinical studies to ensure compliance with all the regulatory requirements and company strategic initiatives. As a member of the Clinical Affairs team, this role will work with key stakeholders to execute clinical studies. This role will be responsible for study site management, including site qualification, training, activation, and monitoring. Key Responsibilities: * Works on assigned studies to ensure that human subject protection is maintained in accordance with Good Clinical Practice (GCP), SOPs, and applicable regulations * Conducts on-site and remote site qualification, initiation, interim, and close-out monitoring visits * Serve as primary point of contact for site questions relating to study enrollment and conduct; collaborate with appropriate study team members as needed * Assists with the development and execution of clinical study documents including protocols, informed consents, case report forms, and study plans * Communicates through verbal and written communication with site investigator and the project team on the overall site performance, trends, deficiencies, and concerns * Ensures quality and completeness of central and site master files * Oversees site investigational product requirements and device accountability * Supports the planning and coordination of Investigator Meetings * Other duties as assigned Qualifications and Skills: * 2+ years clinical research study monitoring for medical device or related experience * BS degree in relevant area of study * Knowledge of federal and local regulations and policies pertinent to research involving human subjects * Knowledge of ICH, GCP and Declaration of Helsinki * Excellent communication, interpersonal and organizational skills * Ability to collaborate in a team environment and work independently * Self-starter with the ability to manage projects and effectively prioritize tasks in a dynamic, start-up environment * Must be willing and able to travel (by automobile or air, day trips and overnight stays) up to 30% of the time HistoSonics will not offer sponsorship or take over sponsorship of an employment visa for this position at this time. Benefits: We offer a comprehensive benefits package for full-time employees. This includes health, dental, and vision insurance, life, short-term and long-term disability insurance, 401(k), paid time off, and more. We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status. #LI-Remote

Current Employees: If you are currently employed at any of the Universities of Wisconsin, log in to Workday to apply through the internal application process. Job Category:Academic StaffEmployment Type:Terminal (Fixed Term) Job Profile:Clin Res Coord IIJob Summary: The Department of Orthopedics and Rehabilitation at the University of Wisconsin School of Medicine and Public Health (SMPH) is seeking a skilled and motivated Clinical Research Coordinator II to support innovative research efforts in sports medicine. In this role, you will work closely with a faculty researcher with extensive clinical research experience, gaining mentorship while contributing to the advancement of patient care and outcomes. This position will be a great opportunity for those looking to gain patient population experience while primarily working in a clinic healthcare setting. Additionally, the Clinical Research Coordinator role offers the opportunity to coordinate both internally and externally funded clinical studies, including participation in multi-center research collaborations. Through these partnerships, you will develop a professional network that extends across leading research institutions beyond UW-Madison. The coordinator will interact directly with patients in the sports medicine clinic, supporting recruitment, screening, enrollment, and protocol adherence while also ensuring a positive participant experience. You will play an active role in study design, protocol development, and the ongoing refinement of how clinical outcomes are measured in orthopedics sports medicine research. Terminal, [24] month appointment This position has the possibility to be extended or converted to an ongoing appointment based on need and/or funding. This position may require some work to be performed in-person, onsite, at a designated campus work location. Some work may be performed remotely, at an offsite, non-campus work location. Contact with vulnerable populations that are non-minors (does not pertain to physicians/providers who work with minors): This position has been identified as a position of trust with access to vulnerable populations. The selected candidate will be required to pass an initial caregiver check to be eligible for employment under the Wisconsin Caregiver Law and every four years. Key Job Responsibilities: May assist with training of staff Coordinates multi-site clinical study activities, including activation, maintenance, and closure processes. Serves as a liaison among the Principal Investigator/research team, participating sites, study sponsors, and collaborators to administer protocols and ensure study goals and timelines are met. Recruits, screens, selects, determines eligibility and enrolls trial participants, collects more complex information, performs medical assessments, and answers varied questions under supervision of a medically licensed professional. Performs medical assessments after completion of required training/certification, such as collecting vital signs, obtaining weight, and performing phlebotomy Schedules logistics, determines workflows, and secures resources for clinical research trials Manages research workflow components, collects, prepares, processes, and submits participant data and samples to appropriate entities, adhering to research protocols Performs quality checks Supports Principal Investigators with manuscript preparation, authorship contributions, and grant preparation Serves as a main point of contact for clinical research participants, providing information regarding research procedures, expectations, and informational inquiries. Ensures participants follow the research protocol and alerts Principal Investigator of issues Identifies work unit resources needs and manages supply and equipment inventory levels Department: School of Medicine and Public Health, Department of Orthopedics and Rehabilitation, Clinical Research The Department of Orthopedics and Rehabilitation is committed to conducting cutting edge research, training the next generation of leaders and providing world-class patient care for both adults and pediatric patients. The Department embraces both independent and collaborative work-styles. Our general approach is to empower individuals to work independently through thorough and hands-on training and onboarding, while also having regular meetings with collaborators and support staff within the department to foster a strong team environment. Compensation: The starting salary for the position is $55,000; but is negotiable based on experience and qualifications. Employees in this position can expect to receive benefits such as generous vacation, holidays, and sick leave; competitive insurances and savings accounts; retirement benefits. For more information, refer to the campus benefits webpage and the SMPH Academic Staff Benefits Flyer Preferred Qualifications: Prior experience with human subject research Prior experience with data entry Prior experience with electronic data capturing (EDC) systems Prior experience with electronic medical/health records (EMR or EHR) systems Prior experience managing multiple projects simultaneously Schedule flexibility preferred Education: Bachelor's degree preferred How to Apply: To apply for this position, please click on the "I am a current employee" button or "I am not a current employee" button under Apply Now. You will be prompted to upload the following documents. Cover Letter Resume Please note, there is only one attachment field. You must upload all your documents in the attachment field. Applicants are to submit a cover letter and resume detailing their training and experience relating to the required and preferred qualifications referenced above. The application reviewers will be relying on written application materials to determine which qualified applicants will advance in the recruitment process. We will notify selected applicants to participate further in the selection process directly. References will be requested of final candidates. All applicants will be notified after the search is complete and a candidate has been selected. University sponsorship is not available for this position, including transfers of sponsorship and TN visas. The selected applicant will be responsible for ensuring their continuous eligibility to work in the United States (i.e. a citizen or national of the United States, a lawful permanent resident, a foreign national authorized to work in the United States without the need of an employer sponsorship) on or before the effective date of appointment. This position is currently scheduled to end 24 months from the start date and will require eligibility to work until that time. If you are selected for this position you must provide proof of work authorization and eligibility to work. Contact Information: Rachel Timbers, **************** Relay Access (WTRS): 7-1-1. See RELAY_SERVICE for further information. Institutional Statement on Diversity: Diversity is a source of strength, creativity, and innovation for UW-Madison. We value the contributions of each person and respect the profound ways their identity, culture, background, experience, status, abilities, and opinion enrich the university community. We commit ourselves to the pursuit of excellence in teaching, research, outreach, and diversity as inextricably linked goals. The University of Wisconsin-Madison fulfills its public mission by creating a welcoming and inclusive community for people from every background - people who as students, faculty, and staff serve Wisconsin and the world. The University of Wisconsin-Madison is an Equal Opportunity Employer. Qualified applicants will receive consideration for employment without regard to, including but not limited to, race, color, religion, sex, sexual orientation, national origin, age, pregnancy, disability, or status as a protected veteran and other bases as defined by federal regulations and UW System policies. We promote excellence by acknowledging skills and expertise from all backgrounds and encourage all qualified individuals to apply. For more information regarding applicant and employee rights and to view federal and state required postings, visit the Human Resources Workplace Poster website. To request a disability or pregnancy-related accommodation for any step in the hiring process (e.g., application, interview, pre-employment testing, etc.), please contact the Divisional Disability Representative (DDR) in the division you are applying to. Please make your request as soon as possible to help the university respond most effectively to you. Employment may require a criminal background check. It may also require your references to answer questions regarding misconduct, including sexual violence and sexual harassment. The University of Wisconsin System will not reveal the identities of applicants who request confidentiality in writing, except that the identity of the successful candidate will be released. See Wis. Stat. sec. 19.36(7). The Annual Security and Fire Safety Report contains current campus safety and disciplinary policies, crime statistics for the previous 3 calendar years, and on-campus student housing fire safety policies and fire statistics for the previous 3 calendar years. UW-Madison will provide a paper copy upon request; please contact the University of Wisconsin Police Department.

Department: MED-Pathology Salary/Grade: NEX/11 Target hiring range for this position will be between be Salary range is as be $19.89-$24.86 per hour. Offered salary will be determined by the applicant's education, experience, knowledge, skills and abilities, as well as internal equity and alignment with market data. Job Summary: Coordinates and performs collection, analysis, processing & reporting of data & assists Principal Investigator (PI) in judging the validity of test data obtained in biomedical and bioinformatic research study(ies) of limited complexity involving co-investigators, multiple campuses &/or universities. Completes all activities by following and ensuring compliance with all relevant current local, state, & federal laws, regulations, guidance, policy & procedure developed by the NU Institutional Review Board (IRB), Food & Drug Administration (FDA) Code of Federal Regulations (CFR), & the International Conference on Harmonization (ICH). Please note: Most duties can be performed remotely, however, EE duties include selecting slides to scan, transporting to the scanner, and retrieving slides. EE may also run a lab slide scanner if one is purchased. These duties must be performed in person on campus. Supervisor provides objectives, deadlines and specific instructions only for new, difficult, and/or unusual work. Work is reviewed upon completion and only occasionally to verify technical accuracy and compliance with practice, policy, and procedures. EE informs supervisor of on-going progress and/or potentially controversial matters. Specific Responsibilities: Technical * Participates in the planning & conduct of research study including participant recruitment and retention. * Administers tests &/or questionnaires following protocols. * Collects, compiles, tabulates & processes responses. * Gathers information. * Extracts & analyzes data from medical charts. Administration * Collects, records, reviews & summarizes research data. * Collates relevant mathematical results & prepares tables, charts & graphs reflecting relationships of multiple tests. * Prepares reports for investigators and sponsors on recruitment status and other pertinent study data. * Writes portions of grant applications & co-author scientific papers. * Completes documents associated with current local, state, & federal regulatory guidelines, requirements, laws & research protocols. Supervision * May provide work direction &/or train other research staff to interview/test participants. * May act as a mentor in regard to education of junior coordinators. Miscellaneous Performs other duties as assigned. Preferred Qualifications: Bachelors-level education/experience in biology, medical science, engineering, or computer science. 2+ years experience in a computational or image analysis focused lab or work setting Previous experience reading + interpreting medical reports + documents Preferred Competencies: (Skills, knowledge, and abilities) Microscope use Programming in Python or R Project management Benefits: At Northwestern, we are proud to provide meaningful, competitive, high-quality health care plans, retirement benefits, tuition discounts and more! Visit us at *************************************************** to learn more. Work-Life and Wellness: Northwestern offers comprehensive programs and services to help you and your family navigate life's challenges and opportunities, and adopt and maintain healthy lifestyles. We support flexible work arrangements where possible and programs to help you locate and pay for quality, affordable childcare and senior/adult care. Visit us at ************************************************************* to learn more. Professional Growth & Development: Northwestern supports employee career development in all circumstances whether your workspace is on campus or at home. If you're interested in developing your professional potential or continuing your formal education, we offer a variety of tools and resources. Visit us at *************************************************** to learn more. Northwestern University is an Equal Opportunity Employer and does not discriminate on the basis of protected characteristics, including disability and veteran status. View Northwestern's non-discrimination statement. Job applicants who wish to request an accommodation in the application or hiring process should contact the Office of Civil Rights and Title IX Compliance. View additional information on the accommodations process.

This position may be filled at the coordinator level 1 or level 2, based on experience/qualifications and requires the incumbent to reside in Central Oregon: Level 1 Pay range: $25.18 - $37.77 per hour. Level 2 Pay range: $27.20 - $40.79 per hour. St. Charles Health System is a leading healthcare provider in Central Oregon, offering a comprehensive range of services to meet the needs of our community. We are committed to providing high-quality, compassionate care to all patients, regardless of their ability to pay. Our values of compassion, excellence, integrity, teamwork, and stewardship guide our work and shape our culture. What We Offer: Competitive Salary Comprehensive benefits including Medical, Dental, Vision for you and your immediate family 403b with up to 6% match on Retirement Contributions Generous Earned Time Off Growth Opportunities within Healthcare ST. CHARLES HEALTH SYSTEM JOB DESCRIPTION TITLE: Clinical Research Coordinator I REPORTS TO POSITION: Research Manager DEPARTMENT: Research DATE LAST REVIEWED: November 15, 2024 OUR VISION: Creating America's healthiest community, together OUR MISSION: In the spirit of love and compassion, better health, better care, better value OUR VALUES: Accountability, Caring and Teamwork DEPARTMENTAL SUMMARY: St. Charles Research Department conducts clinical trials for promising new treatments and therapies in a wide variety of medical fields, including cancer treatment and prevention, cardiovascular disease and supportive care. POSITION OVERVIEW: The Clinical Research Coordinator I is responsible for conducting clinical trials in compliance with FDA regulation, ICH Guidelines and applicable industry standards. The Clinical Research Coordinator 1 will oversee up to ten clinical trials as the main research coordinator. This position does not directly manage other caregivers, however may be asked to review and provide feedback on the work of other caregivers. ESSENTIAL FUNCTIONS AND DUTIES: Maintains surveillance system to identify potential subjects for study eligibility, prescreen patients, and assists physicians in determining eligibility. Obtains informed consent according to GCP and ICH guidelines. Performs study procedures and assessments following protocol specific guidelines. Assures research is conducted in an ethical and safe manner according to FDA, ICH and St. Charles Health System guidelines. Adheres to St. Charles Health System's compliance plan. Attends IRB meetings as requested by the IRB. Supports the processing of study alerts, protocol revisions, amendments, accrual suspension notices, informed consent modifications, product information and advertisement, and related memoranda. Supports the modification of template informed consent forms for local application in compliance with federal guidelines for patients in lay language at appropriate reading level Prepares for and participates in required sponsor and regulatory audits. Attend Investigator meetings as required to assure seamless study start-up. Assists with subject education and informed consent process, including tissue and genetics consent when indicated. Surveys for re-consent and obtains from eligible subjects. Educates patients regarding protocol diagnostic tests and assists with appointments. Process tissue/blood specimens and prepare it for shipment. Manages treatment and follow-up schedules to assure protocol compliance. Attends subject clinic visits and interacts with subjects and staff as appropriate to assist in protocol adherence. Track study drug usage per protocol and oversee study drug supply. Maintains subject research records including long-term follow up and reporting. Participates in institutional research activities (committee meetings, Tumor Boards, Grand Rounds, other conferences, etc.) that are relevant to the Position. Keeps current with new developments in research methodologies. Participates in quality assurance program for St. Charles Health System and affiliated research partners. Supports the vision, mission and values of the organization in all respects. Supports Value Improvement Practice (VIP- Lean) principles of continuous improvement with energy and enthusiasm, functioning as a champion of change. Provides and maintains a safe environment for caregivers, patients and guests. Conducts all activities with the highest standards of professionalism and confidentiality. Complies with all applicable laws, regulations, policies and procedures, supporting the organization's corporate integrity efforts by acting in an ethical and appropriate manner, reporting known or suspected violation of applicable rules, and cooperating fully with all organizational investigations and proceedings. Delivers customer service and/or patient care in a manner that promotes goodwill, is timely, efficient and accurate May perform additional duties of similar complexity within the organization, as required or assigned. EDUCATION: Required: Bachelor of Science degree, or combination of college level education and Research experience to perform the full scope of position duties. Preferred: Bachelor of Science degree in related field. LICENSURE/CERTIFICATION/REGISTRATION Required: Association of Clinical Research Professional (ACRP) or Society of Clinical research Associates (SOCRA) certification or must obtain within 2 years of full time employment. Current American Heart Association (AHA) Basic Life Support for Healthcare Provider certification. Preferred: N/A EXPERIENCE: Required: None Required. Preferred: Experience as a Clinical Research Coordinator. Experience dealing with multidisciplinary teams. Basic Clinical task knowledge. ADDITIONAL POSITION INFORMATION: N/A Schedule Weekly Hours: 40 Caregiver Type: Regular Shift: First Shift (United States of America) Is Exempt Position? No Job Family: COORDINATOR CLERICAL Scheduled Days of the Week: Monday-Friday Shift Start & End Time: Variable

The Senior Clinical Research Coordinator (SCRC) is responsible for the facilitation and coordination of daily clinical trial activities. USRC has a research Partnership with the principal investigator (PI) and their physician practice. The local oversight and direction for activities related to the conduct of the clinical research is directed by the PI. The SCRC will work collaboratively with the principal investigator (PI), the clinical site, sponsor(s), clinical research organization(s) (CROs), institutional review boards (IRBs), and study participants to ensure Execution of the clinical trial in accordance with the Study Protocol, the Food and Drug Administration (FDA), International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) and applicable state and local regulations. The SCRC will assist the PI in protecting the rights, safety and welfare of all study participants. Essential Duties and Responsibilities include the following. Other duties and tasks may be assigned. Coordinate all aspects of participant care from screening through study completion as defined by the protocol and PI delegation. Ensure and document that the informed consent process has occurred properly according to the Code of Federal Regulations (45 CFR part 46). Maintain and update each study participant's source records, including collection of medical history, assessment of eligibility and documentation of all study related procedures and relevant information. Promptly report adverse events, protocol deviations and unanticipated problems involving risk to human subjects or others to the PI, the Sponsor, the IRB and in accordance with the Federal Code of Regulations (21 CFR 312). Ensure thorough, individualized, protocol-based study subject education on all study processes including but not limited to informed consent, study participation obligations, appropriate use of investigational product(IP), IP side effects and safety, communication with study staff and research rights. Provide timely and accurate exchange of participant information with the PI and research team as it pertains to study conduct and patient safety. Adhere to the Health Insurance Portability and Accountability Act (HIPAA Privacy Rule) and protect participant confidentiality at all times. Dispense, administer and instruct participants on proper use of the investigational product (IP) in accordance with the protocol, coordinator's scope of practice and at the direction of the PI. Engage and collaborate with the USRC clinical team. Provide study specific training, oversee trial implementation, and ensure compliance with the study protocol by our clinical partners. Perform accurate and timely data collection, source documentation, and entry into the USRC databases and sponsor Case Report Forms (CRFs)/ interactive web response systems (IWRS). Address queries and sponsor requests in a timely manner. Coordinate long-term storage of research records in accordance with contractual requirements. Timely preparation for, accommodation of and attendance during site initiation, monitoring visits, audit visits or regulatory authority inspections. Maintains records of all reports as well as the site's response. Responsible for the preparation and ongoing maintenance of Essential Documents (The Trial Master File). This includes those documents that will allow for the evaluation of the clinical trial and demonstrate compliance of the sponsor and PI with the study protocol and GCP. (Including but not limited to: Form FDA 1572, financial disclosures, laboratory certifications, protocol, investigator brochure, institutional review board (IRB) related documents, IND reports delegation of authority (DOA), study specific enrollment logs, monitoring reports. Assists in the coordination of efforts of internal and external resources (industry partners, clinical research organizations) to ensure efficient trial selection, proper patient recruitment, achieving target enrollment goals and trial plan execution. Fosters a patient-care culture that emphasizes patient safety and quality in all aspects. Responsible for the patient stipend automated payment process including registration into the system and processing payments per the USRC policy and ongoing maintenance of payments during the trial. Adheres to the USRC Research quality assurance program guidelines. Travel to Investigator Meetings or similar research related meetings is required. Travel may be required between dialysis facilities or nephrology practices within the community. Maintains a working knowledge of current clinical research practice standards and regulatory requirements. For example, but not limited to; (FDA Federal Code of Regulations Good Clinical Practice (GCP), Health Insurance Portability and Accountability Act (HIPPA), International Air and Transportation Association (IATA) - Shipping of Dangerous Goods. Maintains their industry standard licensures and certifications. May provide training and oversight of Clinical Research Coordinators and/or Research Assistants. Actively promotes GUEST customer service standards; develop effective relationships at all levels of the organization. Participate in team concepts and promote a team effort; perform duties in accordance with company policies and procedures. Participate in staff meetings as required. Regular and reliable attendance is required for the job.

Job DescriptionClinical Research Coordinator - Washington DCClinical Research CoordinatorTrusted Medical (************************ is a value-driven organization dedicated to delivering direct, high-quality healthcare services across 22 states. Our expanding network of clinics and research operations supports active military personnel, Veterans, and the broader community through comprehensive care and cutting-edge clinical trials. We are seeking a full-time Clinical Research Coordinator (CRC) to join our national clinical trials team. The CRC will support multiple clinical studies, playing a pivotal role in coordinating daily operations and ensuring compliance with regulatory requirements and protocol standards. The CRC will apply their experience to program refinement and improvements for all those accessing and associated with our clinical trials including registrants, participants, vendors, and key stakeholders.In addition, they will support our program in leading clinical trials with an innovative approach, creating massive opportunity of inclusivity and expanding clinic trial accessibility to all. The ideal candidate will demonstrate strong organizational skills, attention to detail, and a compassionate approach to participant engagement.Type of Employment: Full-time, W2Work Location/Travel: Regional based approach, employee will need to report to an established Trusted Medical clinic. Occasional travel is required to support national study meetings or site activities. Salary Range: $60,000-$80,000. Base pay. Competitive salary/pay, potential for bonus based on key performance indicators. There are multiple factors that are considered in determining final pay for a position, including, but not limited to, relevant work experience, skills, certifications and competencies that align to the specified role, geographic location, education and certifications as well as contract provisions regarding labor categories that are specific to the position. The pay range for this position is highly competitive and dependent upon employment type. Role Reports to: Nurse Executive Direct Reports: This role has no direct reports, however, will be working in collaboration with Trusted Medical clinic and call center staff daily. Responsibilities:• Coordinate daily operations for assigned clinical trials from initiation to closeout • Recruit, screen, and enroll study participants according to protocol eligibility criteria Clinical Research Coordinator - Washington DC • Obtain and document informed consent in compliance with ICH-GCP and IRB requirements • Maintain accurate and complete source documentation, case report forms (CRFs), and logs • Prepare and submit regulatory documents to Institutional Review Boards (IRBs) and sponsors • Schedule and conduct study visits, procedures, and follow-up appointments • Administer study questionnaires, assessments, and ePROs (electronic patient-reported outcomes) • Ensure protocol adherence and proactively identify deviations or violations • Manage and track investigational product (IP) inventory, storage, dispensing, and return • Monitor participant safety and report adverse events (AEs) and serious adverse events (SAEs) • Serve as primary contact for study monitors, sponsors, auditors, and regulatory agencies • Facilitate and participate in site selection, initiation, monitoring, and closeout visits • Enter and verify data in electronic data capture (EDC) systems • Reconcile study data queries and ensure timely resolution of discrepancies • Maintain study files, regulatory binders, and essential documentation per FDA 21 CFR Part 11 • Coordinate specimen collection, processing, and shipping to central labs or biorepositories • Support budget development, invoicing, and payment tracking for study-related procedures • Train and oversee study support staff, interns, or volunteers (if applicable) • Prepare for and participate in audits, monitoring visits, and quality assurance reviews • Maintain credentialing, licenses, and required study training documentation • Ensure compliance with HIPAA and data privacy regulations during research activities • Track enrollment targets, retention, and study milestones to ensure timely progress • Support development and updates of standard operating procedures (SOPs) • Communicate study updates to investigators, sponsors, and internal stakeholders • Collaborate with pharmacy, radiology, lab, and clinical teams for protocol-specific coordination • Participate in feasibility assessments for new research opportunities • Assist in drafting study materials, recruitment tools, and IRB communication. • Provide participants with study education, visit reminders, and engagement support • Manage scheduling software, calendars, and workflow tools to maintain operational efficiency • Attend sponsor, CRO, or consortium training meetings onsite, or virtual as required Clinical Research Coordinator - Washington DC Knowledge and Skills Required: - Working knowledge of FDA, ICH-GCP, and OHRP regulations - Expert understanding of clinical research protocols and informed consent procedures - Proficiency in Microsoft Office Suite and electronic data capture (EDC) systems - Excellent written and verbal communication skills - Attention to detail with ability to track items to resolution - Ability to work independently and collaboratively across teams Education/Certification Required:- Bachelor's degree in life sciences, healthcare, or a related field - Clinical Research Coordinator certification (ACRP-CRC or SOCRA-CCRC) preferred Experience Required:- Proven success of supporting 5 or more years of experience in CLINICAL research - Experience working on multi-site or national studies - Expertise in regulatory submissions and IRB processes - Experience working with NIH, CMS, or FDA-sponsored studies is highly desired Technical Skills Required: - Proficiency in creating and presenting materials with Microsoft Products: Word, Excel, PowerPoint -Experience with electronic regulatory and EDC platforms - Proficiency in research database tools (e.g., REDCap, Medidata Rave) All applicants must be US citizens and able to obtain a Public Trust clearance. Trusted Medical participates in the E-Verify program and is a drug-free workplace. Trusted Medical is an Equal Opportunity and Affirmative Action Employer. We prohibit discrimination against individuals based on their race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other category protected by law. We take affirmative action to employ and advance in employment individuals without regard to protected status..

Postdoctoral Research Scientist & Clinical Psychologist - PTSD & Addiction Research Location: Rockville, MD | Full-Time Join a dynamic team advancing evidence-based treatment for addiction and PTSD. Maryland Treatment Centers (MTC) is seeking a full-time Research Scientist and Clinical Psychologist to support innovative addiction research within our Rockville treatment center. This role offers the chance to develop a research-oriented career in substance use disorder (SUD) and trauma treatment while working alongside a multidisciplinary clinical team. What You'll Do: · Coordinate a clinical trial for the treatment of PTSD taking place within a residential addiction treatment setting. · Provide direct clinical services (Written Exposure Therapy for PTSD) as a study therapist on the project. · Supervise research staff and assist with data collection and analysis. · Collaborate with senior researchers on publications, grant development, and new studies. · Mentor trainees and participate in extern supervision and teaching. Why Join Us: · Be part of a robust research division housed within a community treatment program · Work in a supportive, collaborative, and mission-driven environment. · Receive mentorship, professional development, and travel support for research dissemination. · Grow into leadership roles in clinical research or program development. What We're Looking For: · PhD or PsyD in Clinical Psychology (or related field). · Licensed or license-eligible in Maryland (supervision possible). · Interest or experience in addiction and trauma research preferred. · Masters-level clinicians with research curiosity encouraged to apply (e.g., LCPC, LCSW).

Job Title: Clinical Research Coordinator Contract Duration: Open-ended (expected duration between 3-6 months) Schedule: 30 hours per week (Monday-Friday, during normal business hours) We are seeking a detail-oriented and motivated Clinical Research Coordinator to support a Cardiology focused clinical trial. Key Responsibilities * Accurately manage and enter patient data into electronic systems. * Resolve data queries and maintain clear, professional communication with study participants and research teams. Qualifications & Skills * Minimum of 2 years of experience in clinical research coordination. * Proficiency with Electronic Data Capture (EDC) systems and clinical trial management tools. * Strong attention to detail and problem-solving skills, especially in query resolution. * Experience working with oncology trials is a plus. Work Environment * This role operates during standard business hours in a dynamic, fast-paced research setting. It requires precision, adaptability, and a commitment to high-quality data management. Job Type & Location This is a Contract position based out of Falls Church, VA. Pay and Benefits The pay range for this position is $25.00 - $35.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: * Medical, dental & vision * Critical Illness, Accident, and Hospital * 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available * Life Insurance (Voluntary Life & AD&D for the employee and dependents) * Short and long-term disability * Health Spending Account (HSA) * Transportation benefits * Employee Assistance Program * Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in Falls Church,VA. Application Deadline This position is anticipated to close on Nov 17, 2025. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

Clinical Research Coordinator, UVA Health Affiliate Research Program This is a new position that will support the Affiliate Research Program within the Health Systems Strategy Office. This position is responsible for coordinating and overseeing clinical research activities across affiliated partners. The incumbent will facilitate study start-up, regulatory and compliance oversight, and support infrastructure development and on-site patient visits at affiliate locations to enable participation in clinical research studies. Candidate must have the ability to travel regularly to UVA Community Health hospitals, including Culpeper, Haymarket, and Prince William Medical Centers and Riverside Health Systems (Newport News). The final title and level (CRC level 3 or CRC level 4,) will be determined based on the qualifications of the selected candidate. JOB SUMMARY Clinical Research Coordinator- 4, Non-Licensed (CRC-4, NL), plan, organize, lead, and perform comprehensive and advanced level clinical research duties for multiple and/or complex clinical trials. A CRC 4 has the ability to directly impact the overall efficiency, productivity and success of each clinical trial they coordinate. The CRC in this role is able to work independently and has the authority to interact with internal or external stakeholders involved in a clinical trial or modify clinical trial workflow or processes within their respective Department or Division to meet the needs of a given study. A CRC in this role may manage or support a research team of CRCs. Manage multiple Principal Investigator relationships with internal and external research stakeholders. Provide guidance and assistance to Principle Investigators for grant submissions, budget management and research compliance oversight to ensure full compliance with local, state and federal policies and procedures. Serve as the primary liaison with the Sponsor for assigned studies. Assist Principal Investigator in developing clinical trial protocols and submit the required documentation to the Institutional Review Board, the University, federal regulators n industry or government sponsor. Coordinate and manage all aspects of clinical trial conduct for multiple ongoing clinical trials of any level of complexity. Prepare and submit all types of clinical research documentation to the IRB of record (central or local) for review and approval. Participate in planning and analysis of research portfolios, in conjunction with department management and Principal Investigators. Oversee the financial management of multiple clinical research projects, including budget development, billing reconciliation, and quarterly review of all Principal Investigator accounts. Manage a team of Clinical Research Coordinators and/or laboratory or research support staff, with responsibilities that include hiring, scheduling, workload management, compensation, rewards, professional development, and performance management. Coordinate clinical research education, training and/or orientation for new Faculty, Fellows, Residents or medical students. Develop administrative and financial recommendations for department management and Principal Investigators for research portfolio review. Compile data and documents during internal and external audits and is ultimately responsible for quality of submissions. Participate in at least 1 research-related working group at the institutional level, or lead a process improvement initiative at a department or division level. Conduct research data analysis and literature searches. Co-author scientific papers, publications or presentations Analysis: Analyzes processes and creates deliverables to provide information and recommendations for improvements. Breaks down problems and issues into sub-components and assesses the costs, benefits, and risks of various options. Is able to select and recommend the best solution based on a thorough examination of all considerations. Is able to explain and justify actions in a systematic and logical fashion. Communication: Shares and receives information using clear oral, written, and interpersonal communication skills. Demonstrates effective written and oral communication skills. Actively listens, provides constructive feedback, and demonstrates respect for differing views. Tailors communications to diverse audiences. Quality Improvement: Demonstrates involvement in the unit's annual and/or periodic assessment efforts, including efforts to improve the quality services. Understands the value of innovation and quality improvement. Improves processes and practices by identifying inefficiencies and redundancies. Demonstrates efficiency and quality in one's own work. Customer Service: Builds relationships and maintains strategic partnerships with key internal and external stakeholders. Understands the importance of quality service. Is able to adjust and adapt service delivery to diverse customer needs and sensitivities. Frequently suggests and implements changes to improve the quality of service. Financial Management: Manages tasks and resources within the department to achieve quality and meet budget requirements. Ensures that financial and material resources are used effectively and efficiently. Leverages resources to maximize utility and return on investment (ROI). Implements measures to minimize theft, damage, or equipment breakdown. The incumbent may be asked to perform additional duties as assigned. QUALIFICATIONS Education: Bachelor's Degree Required or equivalent combination of experience, education and or certifications. Experience: At least seven years of clinical research experience demonstrating progressive levels of responsibility and complexity of work. Master's or other advanced degree may substitute for one year of clinical research experience. Licensure: Clinical Research Coordinator (CCRC) and/or Certified Clinical Research Professional (CCRP) is required within one year of hire. Additional Skills/Requirements Preferred: PHYSICAL DEMANDS Physical Demand Code: Work Function/Activity: OTHER May require the use of safety equipment, such as HEPA mask, for infection prevention: Yes On call responsibilities as directed: Yes Ability to travel between campus buildings, remote facilities, and out of town as needed: Yes

Clinical Research Coordinator, UVA Health Affiliate Research Program This is a new position that will support the Affiliate Research Program within the Health Systems Strategy Office. This position is responsible for coordinating and overseeing clinical research activities across affiliated partners. The incumbent will facilitate study start-up, regulatory and compliance oversight, and support infrastructure development and on-site patient visits at affiliate locations to enable participation in clinical research studies. Candidate must have the ability to travel regularly to UVA Community Health hospitals, including Culpeper, Haymarket, and Prince William Medical Centers and Riverside Health Systems (Newport News). The final title and level (CRC level 3 or CRC level 4,) will be determined based on the qualifications of the selected candidate. JOB SUMMARY Clinical Research Coordinator- 4, Non-Licensed (CRC-4, NL), plan, organize, lead, and perform comprehensive and advanced level clinical research duties for multiple and/or complex clinical trials. A CRC 4 has the ability to directly impact the overall efficiency, productivity and success of each clinical trial they coordinate. The CRC in this role is able to work independently and has the authority to interact with internal or external stakeholders involved in a clinical trial or modify clinical trial workflow or processes within their respective Department or Division to meet the needs of a given study. A CRC in this role may manage or support a research team of CRCs. Manage multiple Principal Investigator relationships with internal and external research stakeholders. Provide guidance and assistance to Principle Investigators for grant submissions, budget management and research compliance oversight to ensure full compliance with local, state and federal policies and procedures. Serve as the primary liaison with the Sponsor for assigned studies. Assist Principal Investigator in developing clinical trial protocols and submit the required documentation to the Institutional Review Board, the University, federal regulators n industry or government sponsor. Coordinate and manage all aspects of clinical trial conduct for multiple ongoing clinical trials of any level of complexity. Prepare and submit all types of clinical research documentation to the IRB of record (central or local) for review and approval. Participate in planning and analysis of research portfolios, in conjunction with department management and Principal Investigators. Oversee the financial management of multiple clinical research projects, including budget development, billing reconciliation, and quarterly review of all Principal Investigator accounts. Manage a team of Clinical Research Coordinators and/or laboratory or research support staff, with responsibilities that include hiring, scheduling, workload management, compensation, rewards, professional development, and performance management. Coordinate clinical research education, training and/or orientation for new Faculty, Fellows, Residents or medical students. Develop administrative and financial recommendations for department management and Principal Investigators for research portfolio review. Compile data and documents during internal and external audits and is ultimately responsible for quality of submissions. Participate in at least 1 research-related working group at the institutional level, or lead a process improvement initiative at a department or division level. Conduct research data analysis and literature searches. Co-author scientific papers, publications or presentations Analysis: Analyzes processes and creates deliverables to provide information and recommendations for improvements. Breaks down problems and issues into sub-components and assesses the costs, benefits, and risks of various options. Is able to select and recommend the best solution based on a thorough examination of all considerations. Is able to explain and justify actions in a systematic and logical fashion. Communication: Shares and receives information using clear oral, written, and interpersonal communication skills. Demonstrates effective written and oral communication skills. Actively listens, provides constructive feedback, and demonstrates respect for differing views. Tailors communications to diverse audiences. Quality Improvement: Demonstrates involvement in the unit's annual and/or periodic assessment efforts, including efforts to improve the quality services. Understands the value of innovation and quality improvement. Improves processes and practices by identifying inefficiencies and redundancies. Demonstrates efficiency and quality in one's own work. Customer Service: Builds relationships and maintains strategic partnerships with key internal and external stakeholders. Understands the importance of quality service. Is able to adjust and adapt service delivery to diverse customer needs and sensitivities. Frequently suggests and implements changes to improve the quality of service. Financial Management: Manages tasks and resources within the department to achieve quality and meet budget requirements. Ensures that financial and material resources are used effectively and efficiently. Leverages resources to maximize utility and return on investment (ROI). Implements measures to minimize theft, damage, or equipment breakdown. The incumbent may be asked to perform additional duties as assigned. QUALIFICATIONS Education: Bachelor's Degree Required or equivalent combination of experience, education and or certifications. Experience: At least seven years of clinical research experience demonstrating progressive levels of responsibility and complexity of work. Master's or other advanced degree may substitute for one year of clinical research experience. Licensure: Clinical Research Coordinator (CCRC) and/or Certified Clinical Research Professional (CCRP) is required within one year of hire. Additional Skills/Requirements Preferred: PHYSICAL DEMANDS Physical Demand Code: Work Function/Activity: OTHER May require the use of safety equipment, such as HEPA mask, for infection prevention: Yes On call responsibilities as directed: Yes Ability to travel between campus buildings, remote facilities, and out of town as needed: Yes

About Us: Each of CenExel's research sites specialize in Phase I to Phase IV clinical trials. Our Centers of Excellence comprise some of the most well respected and long-standing research facilities in the country. Specialty areas of research across our sites include Psychiatry, Acute Post Op Pain, Asian Bridging, Dermatology, GI, and Neurology. Each of our Centers of Excellence has tremendous experience and expertise in complex early phase trials, and all our sites have in-patient capability. We focus on quality people, teamwork, and highly experienced clinical research managers with a history of success. Along with an exceptional work environment that promotes teamwork, positive leadership, and optimal work-life balance, CenExel Clinical Research also provides highly competitive compensation and a generous benefits package to full time employees after 30 days of employment including Health Insurance, Dental, Vision, LTD, STD, Life Ins, and 401k. Job Summary: Responsible for assisting with coordinating clinical trials with the strictest adherence to ICH (International Conference on Harmonization), GCP (Good Clinical Practices), protocol, and company guidelines, regulations, and policies. Compensation: $26-30/h. Essential Responsibilities and Duties: Assists Director with coordinating all aspects of patient involvement from study initiation until study completion. Organizes research information for clinical trials. Observes subjects and assists with data analysis and reporting. Schedules the collection of data. Documents adverse events, protocol deviations, and other unanticipated problems appropriately. Reports research data to maintain quality and compliance. Performs administrative and regulatory duties related to the study as appropriate. Participates in other protocol development activities. Ensures site receives accurate information and supplies from sponsors (i.e.: source, protocol, scales, supplies, approvals, contacts, etc.) Educates potential participants and caregivers on protocol specific details and expectations. Performs safety and efficacy assessments per protocol (vital signs, EKGs, blood draws and other assessments as assigned). Assumes other duties and responsibilities as assigned. The above responsibilities are a general description of the level and nature of the work assigned to this classification and are not to be considered as all inclusive. Education/Experience/Skills: High school graduate or equivalent; Bachelor's Degree, preferred. 1-2 years of coordinating experience, high volume of clinical trials, preferably with psych/CNS trials Knowledge and understanding of Federal regulations protecting human subjects in research and that govern the conduct of clinical trials. Strong leadership and mentorship skills. Developing and maintaining effective working relationships at all levels of the organization, along with those at the sponsor and vendor level. Crisis management and problem solving skills; ability to react calmly and effectively in emergent situations. Works independently as well as functioning as part of a team. Must be able to effectively communicate verbally and in writing. Working Conditions Indoor, Office environment. Shift work, depending on location. Essential physical requirements include sitting, typing, standing, and walking. Lightly active position, occasional lifting of up to 20 pounds. Rarely lift over 20 pounds. Reporting to work, as scheduled, is essential. Overnight travel may be required for training and/or investigative meetings. CenExel Clinical Research is an Equal Opportunity Employer. All applicants will be considered for employment without regards to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or status.

Job DescriptionOVERVIEWThis role will coordinate research in an exciting new environment, with the full backing of a new type of research architecture and a top-tier technology team, challenging the paper-heavy, old-school way that studies are run. This role will require the desire to learn and grow rapidly, and include the opportunity to help spearhead on-site efforts for Topography's partner healthcare groups. This role will be evaluated on provider success, patient experience, protocol management and adherence, and data quality. This role will require a track record of excellence as a Research Assistant or CRC or other similar role, including developing successful relationships with providers. You will need to be able to thrive with multiple balls in the air, and where independent problem solving is a daily need. You will need to lead with empathy for patients, and care deeply about creating new access to clinical research in communities across the country. KEY RESPONSIBILITIES Act as study coordinator to execute trials conducted within physician practices, including but not limited to: Visit preparation activities Visit follow-up activities Supply and inventory management Third party vendor coordination Conduct patient recruitment and enrollment of eligible patients Conduct patient study visits, which may also include clinical and lab procedures such as ECG, phlebotomy, vitals signs and body measurements, laboratory processing, etc. Independently administer the informed consent process with care and quality Ensure protocol adherence and high data integrity Provide high quality source data capture and documentation Attend study start-up and planning meetings, including PSVs and SIVs 8. Facilitating monitoring visits (IMVs) and sponsor correspondence including assisting with follow-up items IP management, dispensation and accountability Adverse Event management, tracking, and follow-up Data entry to CRF/EDC and query resolution in a timely manner Support study close-out, including COVs Protocol deviation tracking, reporting, and reconciliation Using and helping improve Topography's proprietary tool set Data Quality-understand and comply with all regulations, policies, and guidelines applicable to clinical research, including our SOPs Ensure adherence to study protocols while ensuring trial staff maintain meticulous accuracy in completing all documentation Assist in Quality Control activities including routine QC checks during and following study visits Any other duties assigned by manager MINIMUM QUALIFICATIONS Bachelor's degree or equivalent combination of training and experience3+ years of experience as a Clinical Research Coordinator, Research Assistant, or other similar role3+ years of experience independently coordinating studies, from study startup to close out3+ years of a demonstrated track record of delivering clean data and a high-quality patient experience 2+ years expert knowledge of FDA regulations and ICH/GCP guidelines We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.

Our clinical research company is looking to hire a qualified candidate for the full-time position of Clinical Research Coordinator. The ideal candidate will possess certification such as an MA, phlebotomy, or similar and have a strong desire to work directly with patients. Who We Are ObjectiveHealth is a clinical research company that uses proprietary technology to: * Increase patient access to research trials within our communities, * Provide physicians with enhanced care options for current patients, and * Deliver superior clinical research enrollment metrics to Pharma sponsors All with the goal of Improving Patient Outcomes at the Point of Care. We want you to join us in doing just that. Who You Are * A lover of patient interaction and skilled at providing patient care * A team player with a bias for action and an attitude that takes personal responsibility * Skilled in all aspects required for conducting an IRB approved clinical trial protocol: identification, screening, randomization, and enrollment of patients, conducting clinic visits, etc. * Skilled at performing and assisting with direct patient care activities: consenting patients, physical assessments, blood draws, medication administration, ECG, etc. * Possess an acute attention to detail for clean data entry, regulatory compliance, productive site visits, efficient study set-up and maintenance, and strict protocol adherence * An expert communicator with the goal of fostering relationships between the research team, PIs, Sponsors, Monitors, and others * A strong advocate for Company values, mission, and initiatives * Not easily distracted: You have the ability to stay focused while running different protocols, resolving and submitting IRB responses and audit findings, tracking AE and SAE events, and maintaining eSource material for assigned studies * Energized by the idea of playing a role in the future of new therapy development in the areas of Gastroenterology, Urology, Dermatology, and/or Oncology What Success Looks Like for This Role * Taking ownership of assigned studies and patients * Communicating promptly and effectively with leadership and coworkers when you have a question or see something that needs correction * Showing up on time, every time * Ensuring strict compliance to the laws, regulations, and requirements of all applicable governing bodies * Learning and using the technologies we provide to increase efficiency in your day-to-day activities * Embodying our core values of Compassion, Integrity, Collaboration, Innovation, Velocity, and Dedication What We Offer Competitive compensation, 401(k) with Company match, a clear career pathway for advancement within the Company, Short- and Long-Term Disability, Health Savings and Flexible Spending Accounts, Health, Dental and Vision insurance Plans, Generous PTO, Adoption Assistance, Paid Holidays, and a wide selection of other voluntary benefits. Requirements This job requires legal authorization to work in the US. We are not currently accepting work visas. ObjectiveHealth is an EEO Employer and an E-Verify participant.

Clinical Research Coordinator - (2500023U) Description The Clinical Research Coordinator participates in or leads day-to-day operations of clinical research studies conducted by a principal investigator. The Research Coordinator performs a variety of duties involved in the collection, compilation, documentation and analysis of clinical research data. The Research Coordinator will develop a progressive functional knowledge of Good Clinical Practices (GCP), Office of Human Research Protections (OHRP) regulations and Food and Drug Administration (FDA) regulations. This position may direct the work of junior staff, train personnel and direct the work of a Clinical Research Assistant as assigned. Qualifications Minimum EducationB.A./B.S. degree in a science, technical, health-related field or other applicable discipline (Required) Minimum Work Experience1 year of applicable work, research or internship experience (e.g. research assistant, data manager, clinician or other interaction with a research population). (Required) Functional AccountabilitiesResponsible Conduct of Research Consistently demonstrates adherence to the standards for the responsible conduct of research. Plans, conducts and manages research projects within federal and institutional regulations and policies under the direction of the principal investigator. Stays informed of and adheres to institutional policies and federal regulations (e.g. Titles 21 and 45 of the Code of Federal Regulations) and guidance (International Counsel on Harmonization) regarding human subjects research and use of protected health information. Uses research funds and resources appropriately. Maintains confidentiality of data as required. Meets all annual job-related training and compliance requirements. Research Administration Maintains knowledge and comprehension of assigned research protocols, including study procedures, timelines and eligibility. Accurately creates, completes, maintains and organizes study documents. Accounts for study materials, including participant lists and visit logs, regulatory binders, case report forms, laboratory kits, investigational product(s) and participation incentives. Uses and accounts for research funds and resources at performance level, including reconciling research subject billing if assigned. Reviews current literature to obtain information relevant to clinical research program, as directed. Attends study meetings, which could include overnight travel, as requested by principal investigator. Works well with other members of the research team and seeks and provides input when appropriate. Serves as an effective liaison between the investigators, sponsors, hospital departments involved with research studies and the Clinical Research Center. Participant Enrollment Employs strategies to recruit and retain research participants, while adhering to the IRB-approved recruitment plan. Screens subjects for eligibility per the protocol and institutional policies. Communicates effectively and provides information to a diverse, vulnerable subject population in accordance with institutional policies. Independently coordinates, conducts and documents visits and protocol-specific testing/interviews according to study protocol, operational plans of clinical departments and SOPs for minimal risk studies or for other studies under direction. Interacts with study participants and/or legally authorized representatives (LARs) to communicate study purpose and participation details and to assess participation interest. Engages participants/LARs in the informed consent process according to institutional policies. Follows procedures for documentation of study payments and participation incentives. Study Management Plans, conducts and manages research activities in accordance with federal regulations and guidance documents and sponsor and institutional policies under the direction of a senior study team member. Ensures regulatory integrity of protocols through the accurate and timely preparation and submission of documents and reports to the sponsor, IRB and other oversight bodies in accordance with federal regulations, sponsor SOPs and institutional policies. Collects, prepares, processes, ships and maintains accurate inventory of research specimens, and trains others in performing these tasks. Suggests improvements to specimen handling processes, when needed. Authors study documents, including informed consents, protocol-specific source documents and IRB contingency responses. Registers and records participant visits in the appropriate tracking system. Anticipates study needs and subject caseload in order to meet organizational objectives and deadlines in a timely manner. Coordinates, prepares for and responds to routine oversight body visits and audits. Performs query resolution and assists with addressing and correcting audit findings. Data Collection Collects data from patient medical records, interviews, questionnaires, diagnostic tests and other sources. Ensures data is collected as required by protocol and in accordance with research data principles (ALCOAC: Attributable, Legible, Contemporaneous, Original, Accurate and Complete). Ensures that queries are resolved within sponsor and institutional timelines. Plans and performs research specimen collection, labeling and storage/shipping if assigned; maintains accurate sample accountability/chain of custody documentation. Ensures secure storage of study documents. Anticipate and responds to customer needs; follows up until needs are met Teamwork/Communication Demonstrate collaborative and respectful behavior Partner with all team members to achieve goals Receptive to others' ideas and opinions Performance Improvement/Problem-solving Contribute to a positive work environment Demonstrate flexibility and willingness to change Identify opportunities to improve clinical and administrative processes Make appropriate decisions, using sound judgment Cost Management/Financial Responsibility Use resources efficiently Search for less costly ways of doing things Safety Speak up when team members appear to exhibit unsafe behavior or performance Continuously validate and verify information needed for decision making or documentation Stop in the face of uncertainty and takes time to resolve the situation Demonstrate accurate, clear and timely verbal and written communication Actively promote safety for patients, families, visitors and co-workers Attend carefully to important details - practicing Stop, Think, Act and Review in order to self-check behavior and performance Primary Location: District of Columbia-WashingtonWork Locations: CN Hospital (Main Campus) 111 Michigan Avenue NW Washington 20010Job: ResearchOrganization: Ctr Cancer & Immunology RsrchPosition Status: R (Regular) - FT - Full-TimeShift: DayWork Schedule: 9:00-5:30 PMJob Posting: Aug 6, 2025, 7:26:03 PMFull-Time Salary Range: 50252.8 - 83761.6