Clinical research associate jobs in Kentwood, MI - 100 jobs

Responsible for providing Clinical Research support for all clinical trials. Under the direction of supervisor or designee, this position will serve as support for the clinical study team. Essential Duties And Responsibilities Participate and assist in design and preparation of protocols and case report forms. Generate clinical SOPs, policies, charters, and plans according to US and international guidelines. Participate in the evaluation of potential clinical sites according to established criteria of acceptability. Responsible for procurement of budgets, contracts, regulatory documents, and other administrative documents as related to clinical research functions. Initiate studies performing initiation site visits, arrange for shipment of clinical supplies, case report forms, and other necessary materials. Conduct ongoing study monitoring, including frequent periodic site visits, protocol adherence checks, material handling procedures, inspection of study files, and related monitoring functions. Prepare site visit reports with identification of key accomplishments, key issues for resolution and recommendations for follow -up actions for assigned study sites. Conduct study termination visits, obtain final reports from investigators, and participate in the preparation of final reports for regulatory submission. Assist with the maintenance of clinical archive and electronic files. Other tasks as assigned. Requirements To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. BA, BS, RN, BSN or equivalent Basic knowledge and adherence to GCPs 1 -2 years of clinical research experience or equivalent experience or training Strong attention to detail Ability to multi -task Unquestionable integrity and highest ethical standards Excellent written and verbal communication skills Self -motivated, assertive, and driven BenefitsDental, Medical, Vision and 401K

Shoulder Innovations is a medical device startup that is revolutionizing shoulder replacements. Led by a seasoned team with over a century of orthopedic expertise, we've developed a disruptive shoulder replacement system and secured substantial funding to drive rapid growth. (NYSE: SI). We're seeking entrepreneurial talent to join us on this exciting journey. Our culture is built on: People First: Authentically human. One Team: Empowered and aligned. Innovation: Bold, creative, and daring. Growth Mindset: Always curious. Ready to make an impact in orthopedics? Let's grow together! We are seeking a Clinical Trial Associate who is responsible for administrative and other support related duties for clinical studies conducted by Shoulder Innovations. This position requires a good understanding of clinical study processes and regulatory standards such as Good Clinical Practice (GCP) and FDA regulations. In addition, your responsibilities will include, but are not limited to the following: Provide comprehensive administrative support for clinical trial operations, including organizing, maintaining, and updating study documentation to ensure accuracy and completeness within the Trial Master File (TMF) Manage and oversee documentation processes, ensuring all regulatory and compliance requirements are met and that files adhere to Good Clinical Practice (GCP) standards Assist in the preparation, review, and submission of Institutional Review Board (IRB) documents, ensuring timely approvals and compliance with ethical standards Monitor adherence to study protocols and regulatory guidelines, proactively identifying and addressing compliance gaps to maintain the integrity of the trial Support day-to-day trial operations, collaborating with cross-functional teams to resolve operational issues and maintain smooth study progress Track and manage study data, including accurate handling of Case Report Forms (CRFs), ensuring data integrity and timely entry into relevant systems Monitor trial progress and performance metrics, maintaining effective communication with study sites, drafting detailed status reports, and escalating issues as needed Coordinate site communications, serving as a point of contact for inquiries and updates, and ensuring timely dissemination of information to stakeholders We believe to be successful as a Clinical Trial Associate; you will have the following: Bachelor's degree or an equivalent combination of experience, education and training considered 2+ years' experience at the Sponsor or CRO level, or 5 years at the SMO or site level Experience with medical device clinical studies preferred Experience with shoulder arthroplasty or orthopedics is a benefit but not essential Familiarity with clinical development standards and regulatory requirements (GCP, FDA) Excellent communication, organization, and problem-solving skills Detail-oriented and dependable, with the ability to manage multiple priorities under tight deadlines Excellent analytical and problem-solving skills Proficient written and verbal communication skills Solid organizational and time management skills Ability to be independently motivated If you are looking to further your career in a pioneering and evolving industry, apply today for our Clinical Trial Associate position. We value and appreciate our employees and will support you with great company culture, opportunities for professional growth, competitive wages, and benefits. To learn more about us, visit us online at ********************************

Cardiology With principal investigator oversight, prepares, evaluates and implements research studies to enhance the advancement of clinical practice. Essential Functions May serve as primary coordinator / project manager on a variety of research studies with low or moderate regulatory, clinical, and operational complexity; supports the PI and research team members. Evaluates and prepares research studies for implementation including assessment of operational feasibility; budget development; preparation of IRB documents; institutes protocol operations (generation of data collection tools, case report forms); attends study meetings. Identifies, recruits, screens, and enrolls eligible subjects per protocol; with appropriate training and delegation, performs protocol-required research activities and/or protocol-required research procedures with low clinical complexity (e.g. six-minute walk test, SF-36, etc.). With appropriate training and delegation, monitors patient status; collects, reviews, and documents data into a variety of systems per protocol. Maintains research studies in compliance with federal, state, and local law, GCP, contracts, and institutional policies. Coordinates and/or performs study activities which may include identification of adverse events; assist with management of investigational product/test article (drug or device); collection, processing, and shipment of research specimens; and other research activities to the extent permitted by law and policy. Communicates, collaborates, networks, and acts as a consultant to the study sponsor and/or CRO, research study centers, academic institutions, investigators, physicians/physician offices, ancillary departments, and the multidisciplinary team (including students and residents). Occasional need to drive to different Corewell Health locations, potential for off hours work. Qualifications Required Bachelor's Degree in health or science related field or equivalent CRT-Basic Life Support (BLS) - ARC American Red Cross 90 Days required Or CRT-Basic Life Support (BLS) - AHA American Heart Association 90 Days Preferred 1 year of relevant experience in clinical research and project management Cardiology experience About Corewell Health As a team member at Corewell Health, you will play an essential role in delivering personalized health care to our patients, members and our communities. We are committed to cultivating and investing in YOU. Our top-notch teams are comprised of collaborators, leaders and innovators that continue to build on one shared mission statement - to improve health, instill humanity and inspire hope. Join a nationally recognized health system with an ambitious vision of continued advancement and excellence. How Corewell Health cares for you Comprehensive benefits package to meet your financial, health, and work/life balance goals. Learn more here. On-demand pay program powered by Payactiv Discounts directory with deals on the things that matter to you, like restaurants, phone plans, spas, and more! Optional identity theft protection, home and auto insurance, pet insurance Traditional and Roth retirement options with service contribution and match savings Eligibility for benefits is determined by employment type and status Primary Location SITE - 330 Barclay Ave NE - Grand Rapids Department Name Heart and Vascular Institute Research Operations - Grand Rapids Hosp Employment Type Full time Shift Day (United States of America) Weekly Scheduled Hours 40 Hours of Work 8:00 a.m. - 4:30 p.m. Variable Days Worked Monday - Friday Weekend Frequency Variable weekends CURRENT COREWELL HEALTH TEAM MEMBERS - Please apply through Find Jobs from your Workday team member account. This career site is for Non-Corewell Health team members only. Corewell Health is committed to providing a safe environment for our team members, patients, visitors, and community. We require a drug-free workplace and require team members to comply with the MMR, Varicella, Tdap, and Influenza vaccine requirement if in an on-site or hybrid workplace category. We are committed to supporting prospective team members who require reasonable accommodations to participate in the job application process, to perform the essential functions of a job, or to enjoy equal benefits and privileges of employment due to a disability, pregnancy, or sincerely held religious belief. Corewell Health grants equal employment opportunity to all qualified persons without regard to race, color, national origin, sex, disability, age, religion, genetic information, marital status, height, weight, gender, pregnancy, sexual orientation, gender identity or expression, veteran status, or any other legally protected category. An interconnected, collaborative culture where all are encouraged to bring their whole selves to work, is vital to the health of our organization. As a health system, we advocate for equity as we care for our patients, our communities, and each other. From workshops that develop cultural intelligence, to our inclusion resource groups for people to find community and empowerment at work, we are dedicated to ongoing resources that advance our values of diversity, equity, and inclusion in all that we do. We invite those that share in our commitment to join our team. You may request assistance in completing the application process by calling ************.

This 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 senior study coordinator to execute trials conducted within physician practices, including but not limited to: a. Visit preparation activities b. Visit follow-up activities c. Supply and inventory management d. Third party vendor management Conduct patient recruitment and enrollment of eligible patients. Lead patient study visits, which may also include clinical and lab procedures such as ECG, phlebotomy, vitals signs and body measurements, laboratory processing, etc. 4. Independently administer the informed consent process with care and quality 5. Ensure protocol adherence and high data integrity Provide high quality source data capture and documentation Support study start-up and planning, including PSVs and SIVs Support IRB submission and correspondence Facilitate monitoring visits (IMVs) and sponsor correspondence including managing the follow-up process 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 Train and mentor junior research staff 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 Conduct 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 experience Ability to be on site 5 days a week in Chevy Chase, MD 5+ years of experience as a Clinical Research Coordinator, Research Assistant, or other similar role 5+ years of experience independently coordinating studies, from study startup to close out 5+ years demonstrated track record of delivering clean data and a high-quality patient experience Expert knowledge of FDA regulations and ICH/GCP guidelines Strong communication skills, teamwork, cooperation, self-awareness, and flexibility 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.

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 senior study coordinator to execute trials conducted within physician practices, including but not limited to: a. Visit preparation activities b. Visit follow-up activities c. Supply and inventory management d. Third party vendor management Conduct patient recruitment and enrollment of eligible patients. Lead patient study visits, which may also include clinical and lab procedures such as ECG, phlebotomy, vitals signs and body measurements, laboratory processing, etc. 4. Independently administer the informed consent process with care and quality 5. Ensure protocol adherence and high data integrity Provide high quality source data capture and documentation Support study start-up and planning, including PSVs and SIVs Support IRB submission and correspondence Facilitate monitoring visits (IMVs) and sponsor correspondence including managing the follow-up process 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 Train and mentor junior research staff 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 Conduct 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 experience Ability to be on site 5 days a week in Chevy Chase, MD5+ years of experience as a Clinical Research Coordinator, Research Assistant, or other similar role 5+ years of experience independently coordinating studies, from study startup to close out5+ years demonstrated track record of delivering clean data and a high-quality patient experience Expert knowledge of FDA regulations and ICH/GCP guidelines Strong communication skills, teamwork, cooperation, self-awareness, and flexibility 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.

Department Clinical Operations - Detroit, MI Employment Type Full-Time Minimum Experience Experienced DM Clinical Research, the largest privately-owned research management organization in the Houston area and one of the top 50 in the country, is looking for a Senior Clinical Research Coordinator experienced in coordinating studies for one of our research sites in Detroit, MI. This position works closely with our Clinical Research staff to provide excellent care to patients participating in our clinical trials. Responsibilities: Completing DMCR-required training, including GCP and IATA. Maintaining a working knowledge of current FDA regulations, GCP/ICH guidelines, organizational SOPs, guidance documents, and study protocols. Adhering to their assigned protocols at their respective site(s). Maintain working knowledge of current FDA GCP/ICH guidelines, organizational SOPs, guidance documents, and study protocols. Collecting source and submitting source per Sponsor requirements via the Sponsor-specified CRF system. Completing Sponsor-required training prior to study-start, to include, but not limited to: a. Sponsor provided and IRB approved protocol b. All amendments c. Investigator Brochure d. Sponsor-specified EDC and/or IVRS Continued recruitment and screening for their assigned protocols at their respective site(s) at all times as applicable Being prepared for and available at all required company meetings and monitoring visits for their assigned protocols at their respective site(s). Utilizing the most recent version of the Protocol, Informed Consent, and Investigator Brochures at their respective site(s). Compiling and organizing all regulatory and administrative binders for their assigned protocols at their respective site(s) upon initial receipt of and wherever applicable. Creating source documents for their assigned protocols at their respective site(s). Conducting patient visits, and all other protocol-required procedures and documenting these in a timely manner. Reporting all Adverse and Serious Adverse Events to the appropriate authorities per Sponsor, IRB, and ICH Guidelines. Completing data entry and query resolution in a timely manner. Submitting required administrative paperwork per company timelines. Occasionally attending out-of-town Investigator Meetings. Ensuring data quality in all trials being conducted at their respective site(s). Addressing and resolving all issues from that monitor letters for all assigned protocols at their respective site(s) in a timely manner. Striving to meet Sponsor goals for their assigned protocols at their respective site(s). Strive to ensure weekly, monthly, and quarterly assigned goals are met for their respective site(s). Any other matters as assigned by management. Requirements: Have at least three (5) years of experience as a CRC, preferably with practice coordinating industry sponsored trials in a private setting. Foreign Medical Graduate a plus. Be an energetic, go-getter who is detail-oriented and can multi-task. Be goals-driven while continuously maintaining quality. Have ACRP certification, which is a plus. Bilingual in Spanish is a plus.

Job Description Flourish Research is looking for motivated, talented, creative individuals who want to learn and grow in their careers while contributing to research that changes lives! We offer an excellent comprehensive benefits package, a supportive and collaborative work environment, and endless growth opportunities. We are actively hiring Senior Clinical Research Coordinators at our Detroit, MI location! The Senior Clinical Research Coordinator assists the Investigators in executing Phase I, II, III, and IV clinical research trials in accordance with Standard Operating Procedures (SOPs), FDA and GCP guidelines, and study protocols while providing an impeccable patient experience in every, single interaction. Shift: Monday-Friday, 9 AM - 5 PM; one Saturday each month (9am - 1pm) Location: 20755 Greenfield Rd # 107, Southfield, MI 48075 Compensation: $30 - $36 based on experience + quarterly discretionary performance bonuses Benefits: Health, dental, and vision insurance plans, 401k with 4% match, tuition reimbursement, parental leave, referral program, employee assistance program, life insurance, disability insurance, and 15 days of PTO + 10 company holidays. RESPONSIBILITIES The Clinical Research Coordinator (CRC) obtains study participant informed consent. Executes study protocol procedures in a detailed, organized, and professional manner. Performs human specimen lab draws and processing, and packages specimen shipments. Creates and completes study source documents and adverse event reporting on an e-source system. Maintains study-specific files and supplies. Communicate with the Study Sponsor/CRO regarding study-specific questions. Participates in site visits from Sponsors/CROs, including site initiation and monitoring visits. Additional duties as assigned by management QUALIFICATIONS Bachelor's degree preferred but not required Phlebotomy experience is required; EKG or other patient labs/processes preferred 5+ years of experience as a Clinical Research Coordinator Familiar with e-source reporting via an electronic platform A clear understanding of ICH, FDA, and GCP regulations Impeccable organizational skills and attention to detail Excellent communication and interpersonal skills to effectively interact with the Principal Investigator, research team, Study Sponsor/CROs, potential subjects, and referral sources An ethical compass that compels the candidate to be honest, detail-oriented, and self-driven High-level critical thinking skills Working knowledge of medical terminology and lab collection/processing/storage procedures Proficiency with computers and Microsoft Office Suite Flourish Research offers an excellent comprehensive benefits package, a supportive and collaborative work environment, and endless growth opportunities. Apply today to learn more about how you can join us in our mission to save and improve the lives of others! Flourish Research is where clinical trials thrive. Flourish Research represents one of the industry's most progressive and diversified clinical trial companies with robust capabilities in the therapeutic areas of cardiology/metabolic disorders/renal, CNS, pulmonology, and vaccines. At Flourish Research, we strive toward excellence. In clinical trials and healthcare, excellence means everyone deserves the best care, regardless of their race, color, gender identity, religion, ethnicity, physical abilities, age, sexual orientation, or veteran status. We embrace employees, customers, and patients from these underrepresented groups to help make this vision a reality. Flourish Research is driven by a diverse and inclusive community of passionate people who are committed to improving the quality of life of communities around the world. Flourish is committed to a safe work environment where all employees, customers, and patients are included, and treated with dignity and respect. Flourish Research strives to build an organization that attracts and leverages diversity in our staff, which reflects the diversity of our local communities. We promote education, acceptance, and inclusion because there is beauty in diversity. The more diversity we have in our team, the more unique perspectives, and ideas we share, and the better prepared we are to serve our communities. WE SEE YOU. WE ARE YOU. WE EMBRACE YOU. WE CELEBRATE YOU! Flourish Research is an equal employment opportunity employer. Employment decisions are based on merit and business needs, and not on race, color, sex, (including pregnancy and gender identity), citizenship status, national origin, ancestry, gender, sexual orientation, age, religion, creed, physical or mental disability, genetic information, marital status, veteran status, political affiliation, or any other factor protected by law. Flourish Research complies with the law regarding reasonable accommodation for handicapped and disabled employees. Powered by JazzHR DPd1apIQ1W

Scheduled Hours40Under direction, participates in clinical research study activities; screens, obtains consent, and enrolls participants in study; performs a variety of duties involved in the collection, documentation, and reporting of clinical research data.Job Description Primary Duties & Responsibilities: Participates in the recruitment of study participants as identified in related protocol; visits with study participants to explain study, screens for eligibility and obtains informed consent of participants. Completes all necessary paperwork/documentation according to study protocol; obtains consent, interviews study subjects and schedules follow-ups as needed. Performs basic/scripted assessments to confirm eligibility to participate in study; explains and schedules laboratory and diagnostic procedures and/or treatment as required in the study; refers participants to basic resources as necessary. Collects data from study participants, medical records, interviews, questionnaires, diagnostic tests and other sources; performs basic evaluation and interpretation of collected data and prepares appropriate reports and documentation as necessary; prepares and distributes study packets and information. Performs other duties as assigned. Working Conditions: Job Location/Working Conditions: Normal office environment. Physical Effort: Typically sitting at desk or table. Repetitive wrist, hand or finger movement. Equipment: Office equipment. The above statements are intended to describe the general nature and level of work performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all job duties performed by the personnel so classified. Management reserves the right to revise or amend duties at any time.Required Qualifications Education: High school diploma or equivalent high school certification or combination of education and/or experience. Certifications: The list below may include all acceptable certifications and issuers. More than one credential or certification may be required depending on the role.Basic Life Support - American Heart Association, Basic Life Support - American Red Cross Work Experience: Administrative Or Research (2 Years) Skills: Not Applicable Driver's License: A driver's license is not required for this position.More About This JobRequired Qualifications: Basic Life Support certification must be obtained within one month of hire date Basic Life Support certification (Online Basic Life Support certifications, those without a skills assessment component, are not sufficient to meet the Basic Life Support requirements). Preferred Qualifications Education: Associate degree Certifications: No additional certification unless stated elsewhere in the job posting. Work Experience: No additional work experience unless stated elsewhere in the job posting. Skills: Interpersonal Communication, Oral Communications, Organizing, Written CommunicationGradeC07-HSalary Range$19.21 - $28.85 / HourlyThe salary range reflects base salaries paid for positions in a given job grade across the University. Individual rates within the range will be determined by factors including one's qualifications and performance, equity with others in the department, market rates for positions within the same grade and department budget.Questions For frequently asked questions about the application process, please refer to our External Applicant FAQ. Accommodation If you are unable to use our online application system and would like an accommodation, please email **************************** or call the dedicated accommodation inquiry number at ************ and leave a voicemail with the nature of your request. All qualified individuals must be able to perform the essential functions of the position satisfactorily and, if requested, reasonable accommodations will be made to enable employees with disabilities to perform the essential functions of their job, absent undue hardship.Pre-Employment ScreeningAll external candidates receiving an offer for employment will be required to submit to pre-employment screening for this position. The screenings will include criminal background check and, as applicable for the position, other background checks, drug screen, an employment and education or licensure/certification verification, physical examination, certain vaccinations and/or governmental registry checks. All offers are contingent upon successful completion of required screening.Benefits Statement Personal Up to 22 days of vacation, 10 recognized holidays, and sick time. Competitive health insurance packages with priority appointments and lower copays/coinsurance. Take advantage of our free Metro transit U-Pass for eligible employees. WashU provides eligible employees with a defined contribution (403(b)) Retirement Savings Plan, which combines employee contributions and university contributions starting at 7%. Wellness Wellness challenges, annual health screenings, mental health resources, mindfulness programs and courses, employee assistance program (EAP), financial resources, access to dietitians, and more! Family We offer 4 weeks of caregiver leave to bond with your new child. Family care resources are also available for your continued childcare needs. Need adult care? We've got you covered. WashU covers the cost of tuition for you and your family, including dependent undergraduate-level college tuition up to 100% at WashU and 40% elsewhere after seven years with us. For policies, detailed benefits, and eligibility, please visit: ****************************** EEO StatementWashington University in St. Louis is committed to the principles and practices of equal employment opportunity and especially encourages applications by those from underrepresented groups. It is the University's policy to provide equal opportunity and access to persons in all job titles without regard to race, ethnicity, color, national origin, age, religion, sex, sexual orientation, gender identity or expression, disability, protected veteran status, or genetic information.Washington University is dedicated to building a community of individuals who are committed to contributing to an inclusive environment - fostering respect for all and welcoming individuals from diverse backgrounds, experiences and perspectives. Individuals with a commitment to these values are encouraged to apply.

Our Mission: At The Cancer & Hematology Centers we are dedicated to help, healing and hope for cancer patients and their families. We provide our patients with advanced treatments, innovative research and, above all else, compassionate care. Our patients receive the most comprehensive, contemporary cancer care balanced with the compassion of a dedicated nursing and support staff. Treating cancer requires a team of committed and caring health care professionals working together to understand and address your needs. In addition to caring physicians, we have a full range of support staff available to assist you and your family, such as oncology-certified nurses, social workers, experienced lab and pharmacy personnel and a psychologist. Our focus is not just on healing but also on helping and offering hope. We know that being diagnosed with cancer is a life-changing event, and it takes a lot of adjustment to accept the emotional and physical realities of this disease. Our staff understands what you're going through and can offer compassion and resources to help. To us, it's important that healing isn't just centered on your disease site. Our cutting-edge cancer care is available close to home. Our medical staff have close ties to prominent hospitals and ongoing cancer research, and we bring those breakthrough advances to our regional centers to progress the level of care that is offered right here at home. Why Join Us? We are looking for talented and high-motivated individuals who demonstrate a natural desire to support the meaningful work of community oncologists and the patients we serve. Job Description: Position Overview: The Clinical Research Coordinator is responsible for the day-to-day functions of the research clinical trials for CHCWM. This includes obtaining trials, screening and consenting of patients, education of the staff on available trials, data management, drug accountability, as well as regulatory document management of the available clinical trials. This is a full time on-site position. Desired/Required Qualifications: Education: • Bachelor's degree in health/biomedical sciences, health administration, biology or chemistry, preferred. Specific skills & abilities: • 2 years research experience; clinical oncology research highly preferred • Working knowledge of medical and pharmaceutical terminology. Primary Duties and Responsibilities 1. Screen daily for potential patients; communicate with physicians and other staff of potential and active patients. Responsible for managing study drug and laboratory supplies. 2. Serve as a liaison for enrolled clinical trial patients to address patient concerns while on study and help facilitate study treatment assessments to include, attending patient doctor visits, capturing and reporting adverse events, coordinating logistical requirements with physicians (i.e. radiology tests), and ensure accurate invoiceables. 3. Ensure completion of all study-required assessments. 4. Process, catalog and ship biologic samples to central laboratories as required by clinical trials. 5. Ensure clinical trial documentation from staff involved in research and investigational sites meets FDA requirements. Assist investigators, field clinical staff, clinical research organizations and sponsor companies in collecting data in a timely manner that meets the protocol requirements. 6. Assist in the proper maintenance of current/pending regulatory documents in conjunction with regulatory coordinator. Assist in filing/organizing of clinical research essential documentation. 7. Organize data systematically to allow for efficient and accurate clinical reports. 8. Communicate via telephone/email with research sponsor companies on the status and progress of clinical trials, patient screening efforts and enrollment. Maintains the current status of research protocols, updating, amending and interpreting as necessary and communicates appropriate changes to members of the health care team. 9. Develops required materials for study as directed according to study guidelines and regulatory requirements and facilitates process of protocol approval / re-approval. Maintains database and system for patient enrollment data, patient files, statistical data and other information pertinent to studies. 10. Participates in on-going process and programmatic improvement activities. 11. Participates in the audit process by preparing patient records and follow-up, as necessary. 12. Function as a team member by expanding his/her responsibilities as directed by management to facilitate optimal workflow within the cancer center. 13. Communicates and interacts with peers and other departments in a manner that is viewed as having a positive effect on patient services and CHCWM staff morale. Interacts effectively with patients/family members and demonstrates sensitivity regarding cultural diversity, age specific needs and confidentiality. 14. This employee has access to medical records. The parts of the medical record needed to perform this position is as follows: Lab Information System, Pharmacy Information System, Electronic Medical Record, Clinical Trial Management System, and Electronic Regulatory System. 15. All other duties as assigned. Position Requirements Able to see clearly in an environment which is equipped with typical lighting. Able to perform manual tasks that require the use of fine muscle motor skills. Able to walk approximately one mile per workday. Able to lift 25 pounds. Able to stand and / or sit for prolonged periods. Able to freely bend/stretch. Able to access, input and retrieve information from computers. Able to tolerate frequent handwashing. Very fast-paced and ever-changing office environment. Demanding regarding deadlines and time frames. Very detailed and challenging work. Constant demand for updating knowledge.

Role Description Manager I (Parasitology) US Clinical Operations Global Clinical Research and Development Veterinary Medicine Research & Development (VMRD) The successful applicant embodies Zoetis' Core Beliefs: Our Colleagues Make The Difference, Always Do The Right Thing, Customer Obsessed, Run It Like You Own It, and We Are One Zoetis. Within US Clinical Operations, the candidate will be assigned to one or more Project Teams and will have the following duties and responsibilities: Participate on project teams to develop and license veterinary parasiticides. As a member of the clinical team, coordinate or lead the coordination of all study activities, including start up, Investigator training, conduct, site monitoring and close out. These may include, but are not limited to: Prepare study protocols, amendments, deviations, data capture forms, electronic data capture systems, test article documentation and study reports in preparation for submission to regulatory agencies. Collaborate with multiple internal partner groups to plan, coordinate, conduct, analyze, and report studies. Develop training materials and conduct training of Investigators and other study site personnel. Coordinate animal related study activities (i.e. clinical sampling, test material administration and clinical observations). Serve as the principal communication link between the Sponsor and study sites. Maintain study files in accordance with SOPs and regulatory requirements. Implement and execute data management processes including paper and electronic data capture, entry, review, tracking, and verification utilizing electronic tools and centralized data management systems. Prepare study files, author study reports and review technical section summaries for submission to regulatory agencies (FDA, EMA, EPA). Lead multi-functional team(s) serving as a project team member or clinical team lead. Contribute to, review and/or author manuscripts for journal publication. Present results, as needed, both internally and to external scientific audiences. Travel: approximately 10 - 40% on an annual basis. Variable, depending upon project status. EDUCATION AND EXPERIENCE: Educational Background: Minimum: Bachelor's degree Desirable: Master's degree Work Experience/Skills: Minimum: Five years' experience as a clinical study coordinator/monitor or in research/product development in the animal health pharmaceutical industry Experience in the study design and execution of parasitology laboratory clinical studies. Familiarity with parasitology study designs and models as well as regulatory guidance/expectations for the conduct and execution of parasitology studies. Previous experience with preparation of regulatory submissions for FDA, EPA and/or EMA for product registration Previous experience working with veterinary clinics and/or research facilities. Experience with Good Clinical Practice and/or Good Laboratory Practices. Ability to work both as a member of a team and independently in a self-directed and self-motivated manner. Excellent skills in the following competencies: organizing, planning, time management, quality, attention to detail. Well-developed critical thinking skills with the ability to learn on the fly and problem solve. Excellent interpersonal skills with very good written and oral communication skills. Competence with Microsoft Office Products (Outlook, Word, Excel, OneNote, Teams). Experience in configuring studies in an electronic data capture platform/ eClinical software. Desirable: Experience and interest in the conduct and leadership of companion animal clinical field studies. Education and clinical experience in the field of veterinary technology. Competence with electronic data capture, eClinical software or remote communication tools. MS or MPS in Veterinary Parasitology, Veterinary Biomedical Science or Veterinary Public Health. Full time RegularColleague Any unsolicited resumes sent to Zoetis from a third party, such as an Agency recruiter, including unsolicited resumes sent to a Zoetis mailing address, fax machine or email address, directly to Zoetis employees, or to Zoetis resume database will be considered Zoetis property. Zoetis will NOT pay a fee for any placement resulting from the receipt of an unsolicited resume. Zoetis will consider any candidate for whom an Agency has submitted an unsolicited resume to have been referred by the Agency free of any charges or fees. This includes any Agency that is an approved/engaged vendor but does not have the appropriate approvals to be engaged on a search. Zoetis is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status or any other protected classification. Disabled individuals are given an equal opportunity to use our online application system. We offer reasonable accommodations as an alternative if requested by an individual with a disability. Please contact Zoetis Colleague Services at ********************************** to request an accommodation. Zoetis also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must possess or obtain authorization to work in the US for Zoetis. 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Profound Research:Profound Research seeks to drive clinical innovation by partnering with community physicians to offer clinical research as a therapeutic option to their patients. Profound enables providers with the right people and tools to launch clinical research operations, often for the first time, to offer new care pathways to patients. Profound Research is looking to grow its energetic team inspired by changing how patients and providers engage in clinical research. Our Mission: Improving Lives by Providing Advanced Therapeutic Options Our Vision: Creating the Absolute Best Patient-Physician Experience in Clinical Research Our Values: Compassion: We value the patient-physician relationship above all else and are committed to a service-oriented approach to all interactions. Urgency: We work hard and practice selflessness, acting swiftly and decisively to meet the needs of our patients, partners, and colleagues. Solution Orientation: We are relentlessly positive, and we communicate directly to efficiently identify and implement effective solutions. Excellence: We insist on excellence, holding ourselves accountable and empowering each other to deliver best-in-class service while maintaining the highest ethical and scientific standards. Profound Ethos o Physicians are the Vanguard o All Decisions Improve Patient Care o Never Compromise Quality Why this Role Exists The Clinical Research Coordinator will manage all clinical trial activities under supervision in compliance with all applicable laws, regulations, and procedures of study protocol while maintaining company mission, vision and values. Responsibilities-Conduct and manage all clinical trial activities in accordance with established research protocols and standards in compliance with all applicable laws, regulations, policies, and procedural requirements. -Complete all relevant Profound Research required training, including but not limited to ICH-GCP certification and IATA certification in a timely manner. -Mentor and train staff in the conduct of clinical trials, protocol requirements, communication and trial management skills. -Lead, implement and coordinate duties for assigned clinical trials including but not limited to study start up, vendor management, subject recruitment, source document review and completion, protocol training, collection of regulatory documents, participant visits, timely data collection and documentation, management and reporting of adverse events, serious adverse events, and deviations, and monitoring visits and follow up. -Ensure good documentation practices are applied by all team members when collecting, maintaining and correcting study data and required records of clinical trial activity including but not limited to source documentation, case report forms, queries, drug dispensation records, and regulatory forms. -Communicate effectively and professionally with coworkers, leadership, study subjects, sponsors, CROs, and vendors. -Collect and account for supplies from sponsors such as lab kits, ancillary supplies, and investigational products. -Other duties as assigned. Requirements-Bachelor's degree and 2 years relevant experience in the life science industry OR -Associate's degree with 4 years relevant experience in the life science industry OR -High School Graduate and/or technical degree with minimum of 6 years relevant experience in the life science industry AND 1 year -Clinical Research Coordinator experience -Successful completion of GCP certification and Certified Clinical Research Coordinator (CCRC) certification within 6 months of being in the role -Experience performing clinical assessments, including but not limited to obtaining vital signs, EKGs, blood draws, processing/shipping lab specimens -Proficient ability to work independently, plan and prioritize with minimal guidance -Excellent attention to detail, organization, and communication with varied stakeholders -Ability to work as a team player with the ability to adapt to changing schedules and assignments Travel RequirementsDaily commute to site(s) Why Join Profound Research? · Flexible PRN scheduling that works with your availability· Exposure to diverse therapeutic areas and cutting-edge treatments· Supportive team environment with comprehensive training· Opportunity to make a direct impact on patient access to innovative therapies· Professional development in the growing field of clinical research

The Clinical Research Coordinator I will work at site to help ensure that quality research is conducted at the assigned investigative sites in accordance with the sponsor protocol, FDA Regulations, and ICH/GCP guidelines and to provide the best quality data to the sponsor. The CRC I will also ensure study enrollment meets or exceeds Sponsors' expectations. To ensure company goals are achieved on a timely basis. DUTIES & RESPONSIBILITIES Completing all the DMCR-required training, including but not limited to ICH-GCP Certification and IATA Certification on a timely basis. Completing all the relevant training prior to study-start and on a continued basis in a timely manner. This will include but is not limited to: Sponsor-provided and IRB-approved Protocol Training All relevant Protocol Amendments Training Any study-specific Manuals Training, as applicable Sponsor-specified EDC and/or IVRS and any other relevant Electronic Systems training. Conducting study subject visits, and all other relevant protocol-required procedures and documenting these in a timely manner. Adherence to ALCOA-C Standards with all the relevant clinical trial documentation. Completing data entry and query resolution in a timely manner as per internal company guidelines and as per sponsor expectations. Demonstration of appropriate and timely follow-up on the action items, at their respective sites. Demonstrated understanding and implementation of Laboratory Manuals and protocol-specified laboratory procedures, storage, temperature monitoring, equipment calibration and laboratory kit inventory, under the direction of the Site/Study Management Team, for assigned protocols. Liaising with Laboratory team, Data team, Administrative staff, Clinical Investigators, Research Participants and Sponsor/CRO representatives, under the direction of the Site/Study Management Team, for assigned protocols. Submitting required administrative paperwork per company timelines. Participating in subject recruitment and retention efforts. Engaging with Research Participants and understanding their concerns. Conduct patient consent discussions and ensure comprehension of medical procedures, risks, benefits, and alternatives Provide clear explanations of study protocols and ensure patients' understanding before obtaining their consent Facilitate effective communication between patients, healthcare providers, and research staff Any other matters, as assigned by management. KNOWLEDGE & EXPERIENCE Education: High School Diploma or equivalent required Bachelor's degree a plus Foreign Medical Graduates preferred Experience: 1+ years of experience as a CRC, preferably with practice coordinating industry-sponsored vaccines in a private setting. 2+ years of experience as a research assistant, data coordinator, laboratory personnel, or equivalent experience in a clinical research setting Credentials: ACRP or equivalent certification is preferred Registered Medical Assistant certification or equivalent is preferred Knowledge and Skills: Be an energetic, go-getter who is detail-oriented and can multi-task. Be goals-driven while continuously maintaining quality. Proficient communication and comprehension skills both verbal and written in the English language are required. Proficient Bi-lingual (English/Spanish) communication and comprehension skills both in verbal and written are preferred.

Unique opportunity to make an Impact in the healthcare industry Revival Research Institute, LLC was established in 2015, and headquartered in the Metro Detroit Region, and has been growing ever since. Revival now has a national presence in the Metro-Detroit Region, Texas, Illinois, Nebraska and North Carolina. We have been nationally acknowledged for our diligence to provide the highest quality of data for our clinical research trials. As Revival Research Institute is growing, we are looking to add more qualified professionals to our team, who are looking for an opportunity to grow and learn with us. The role of a Clinical Research Coordinator builds upon the foundational responsibilities of an Assistant Clinical Research Coordinator, expanding into more autonomous management of clinical research activities with moderate supervision. This role requires a blend of specific certifications, detailed knowledge of clinical trial processes, regulatory compliance, and practical skills in managing both the operational and administrative aspects of clinical studies. Here's a detailed overview of the responsibilities and skills required for a CRC: Core Responsibilities: Regulatory Document Management: Manage essential regulatory documents, including Institutional Review Board (IRB) submissions and safety reports, ensuring compliance with all regulatory authorities and guidelines (e.g., FDA, DSMB). Data Management: Complete and maintain accurate source documentation and data entry. Address queries and action items promptly to ensure the integrity and timeliness of trial data. Perform E-source data entry and maintain real-time data accuracy, as applicable. Regulatory Submissions and Communications: Submit necessary documents to regulatory authorities and/or review/monitoring boards, including DSMB and independent safety officers, in a timely and compliant manner. Site and Study Visit Facilitation: Facilitate pre-study, site qualification, study initiation, and monitoring visits, as well as study close-out activities. Team Coordination and Communication: Coordinate research/project team meetings, ensuring effective communication and collaboration among team members. Specimen Management: Collect, process, and ship laboratory specimens following study protocols and regulatory requirements. Patient Management: Schedule subject visits and procedures, ensuring participants' compliance with the study schedule. Conduct recruitment, pre-screening, screening, baseline enrollment, and follow-up visits, maintaining a participant-centered approach. Inventory and Records Management: Manage inventory and maintain accountability logs for investigational products, devices, and study-related supplies. Retain records and archive documents after study close out, following regulatory guidelines and best practices. Phlebotomy and Clinical Procedures: Requires Phlebotomy certification, indicating the ability to perform blood draws and other specimen collection as part of the study procedures. Required Skills and Abilities: Effective Writing and Communication: Capable of clear and concise documentation, and excellent interpersonal communication skills for interactions with study participants, team members, and regulatory bodies. Teamwork: Ability to work collaboratively within a research team, contributing positively to team dynamics and supporting team members. Multitasking: Proficiency in managing multiple tasks and priorities efficiently, adapting to changing demands with attention to detail and accuracy. Regulatory Knowledge: In-depth understanding of clinical trial regulations, ethical guidelines, and compliance standards, with the ability to apply these in practical settings. Organizational Skills: Strong organizational and project management skills to oversee study activities, manage documentation, and ensure compliance with study protocols Preferred Qualifications: The preferred qualifications for a Clinical Research Coordinator 1 (CRC 1) typically encompass a blend of educational achievements, practical experience, and specialized skills that equip the individual to effectively manage and coordinate clinical research studies. Here is a detailed outline of these qualifications: Educational Background Bachelor's Degree: A bachelor's degree in life sciences, nursing, public health, or a related field is often the minimum educational requirement. This background provides a foundational understanding of biological principles, research methodologies, and ethical considerations in clinical research. Master's Degree: A master's degree in a relevant field (such as clinical research, biostatistics, epidemiology, or healthcare management) may be preferred or allow candidates to enter the role with less practical experience, given the advanced knowledge and research skills acquired during their studies. Professional Experience For Bachelor's Degree Holders: Typically, 1-2 years of relevant experience in clinical research or a closely related field is preferred. This experience should demonstrate familiarity with clinical trial processes, regulatory compliance, patient interaction, and data management. For Master's Degree Holders: No practical experience is necessary, but any internships, training, or exposure to clinical research during academic studies will be advantageous. Skills Regulatory Knowledge: A thorough understanding of regulatory requirements and guidelines governing clinical research, including Good Clinical Practice (GCP), HIPAA, and IRB processes. Data Management Skills: Proficiency in data management software and systems, with the ability to perform accurate data entry, manage databases, and resolve queries. Communication Skills: Strong verbal and written communication skills are crucial for liaising with research participants, team members, regulatory bodies, and sponsors. Organizational and Multitasking Abilities: The capacity to efficiently manage multiple tasks and priorities, coordinate study activities, and maintain detailed records. Personal Attributes Attention to Detail: Essential for ensuring accurate data collection, regulatory compliance, and adherence to study protocols. Problem-Solving Skills: Ability to identify issues and develop effective solutions in a timely manner. Adaptability: Flexibility to adapt to changing study requirements, protocols, and research environments. Teamwork: Demonstrated ability to work collaboratively within a multidisciplinary team, supporting colleagues and contributing to a positive work environment. Additional Considerations Experience with Specific Populations or Therapeutic Areas: Depending on the focus of the research institution or the clinical trials being conducted, experience with specific patient populations or therapeutic areas may be preferred. Technology Proficiency: Familiarity with electronic health records (EHR), electronic data capture (EDC) systems, and other clinical research technologies. These qualifications ensure that a CRC is well-equipped to handle the complexities of clinical trials, contribute effectively to research objectives, and uphold the highest standards of ethical and scientific integrity. IMPROVE THE FUTURE AS OUR CLINICAL RESEARCH COORDINATOR!!!

This position may independently provide study coordination for simple and moderately complex clinical research studies. As a member of a coordination team, this position may help support a portfolio of projects with varying levels of complexity. Mastery of all job duties from the CRC-Assistant position on the Michigan Medicine CRC Career Ladder

Employment Type:Full time Shift:Day ShiftDescription: Supports department leadership in creating and maintaining quality of clinical pharmacy practice and the medication use process. Responsible for student and resident pharmacist education. Provides training, feedback, and coaching to staff. Coordinates with internal and external stakeholders to support the safe, efficient, and effective use of medications throughout the hospital system. QUALIFICATIONS Education Bachelor's of Science in Pharmacy or PharmD Credentials/Licensure Minimum: Registered Pharmacist, Michigan Pharmacist and Controlled Substance Licensure Preferred: American Society of Health System Pharmacists (ASHP) Accredited PGY-1 Residency and PGY-2 specialty residency in an area applicable to acute care pharmacy practice. Board certification in pharmacotherapy or specialty Related Experience Minimum: Five years of experience in practice as a clinical pharmacist. Qualification as a PGY-1 Residency Program Director, as defined by ASHP. Preferred: Five years of experience in practice as a clinical pharmacist in acute care. One year of experience as an ASHP accredited residency program director Other Knowledge, Skills and Abilities Expert level knowledge of clinical pharmacy practice and the medication use process. Strong knowledge of student and resident pharmacist education/training. Strong communication and coaching skills. Advanced ability to use electronic health record and software for communication, collaboration, and completing office tasks. Experience, education, or training in leadership. Computer Competency Familiarity with standard desktop and Windows based computer system, including email, e-learning, intranet, and computer navigation. Ability to use other software required to perform essential functions. Physical/Mental Sitting for extended periods of time. Frequent standing, walking. Occasional bending stooping, twisting. Ability to hear speech, speak, use near-far vision and fine motor skills. Ability to perform continuously detailed tasks with frequent interruptions and work prioritization. WORKING CONDITIONS Work in an environment with medications and chemicals typical for an inpatient pharmacy. ESSENTIAL FUNCTIONS • Provides training, audit, and feedback for Pharmacy staff on clinical practice and medication use process. • Oversees resident pharmacists, serves as program director for residency program(s), oversees student pharmacists, and coordinates education programs. • Assesses the safety, efficiency, and effectiveness of pharmacy practice and leads process improvement work in these areas. • Works with stakeholders to establish and implement best practices in pharmaceutical care. • Serves as a liaison to nursing and medical staff and works directly with these groups to meet the needs of the department and organization. • Assures compliance with policies, procedures, and TJC Medication Management standards. • Supports leadership in designing and maintaining appropriate pharmacist coverage plans. • Serves on committees as assigned. • Works with department leadership to develop new pharmacy programs and services. • Develops and executes goals that align with the strategic priorities of the department and organization. • Maintains competency in a clinical or operational practice area. • Performs other related duties as assigned. SYSTEMS AND INFORMATION To ensure appropriate utilization of Protected Health Information (PHI) associated with the Health Insurance Portability and Accountability Act (HIPAA) and Mercy Health Saint Mary's Confidentiality of Information Standards, as well as other regulatory entities, individuals employed in this position will be granted systems and information access as appropriate for this position. DISCLAIMER The above statements are intended to describe the general nature and level of work being performed by the people assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of personnel so classified. The listed duties may be changed at the Our Commitment Rooted in our Mission and Core Values, we honor the dignity of every person and recognize the unique perspectives, experiences, and talents each colleague brings. By finding common ground and embracing our differences, we grow stronger together and deliver more compassionate, person-centered care. We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other status protected by federal, state, or local law.

This role involves working directly with patients and conducting patient visits. The Clinical Research Coordinator will collaborate closely with research nurses and will have the support of Data and Regulatory teams. While a basic understanding of these functions is required, the Coordinator will not be responsible for them. The position involves working within teams divided by disease group, potentially including Phase 1 clinical trials. Responsibilities + Conduct patient visits and work directly with patients. + Collaborate with research nurses as needed during patient visits. + Participate in recruitment activities using methods such as referrals, tumor board, and new consults. + Conduct chart reviews to support studies. + Support all studies within the team, without owning or leading any specific study. + Manage a patient load of no more than 10 patients a week, with patient visits varying by team and study phase. Essential Skills + At least one year of clinical trial experience, including patient-facing roles, consenting patients, and conducting patient visits. + Experience in oncology or other complex therapeutic area. + Bachelor's Degree. + Experience with Phase 1 clinical trials. Job Type & Location This is a Contract to Hire position based out of Detroit, MI. Pay and Benefits The pay range for this position is $27.00 - $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 hybrid position in Detroit,MI. Application Deadline This position is anticipated to close on Jan 30, 2026. 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 (%20actalentaccommodation@actalentservices.com) for other accommodation options.

OVERVIEWThis 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 senior study coordinator to execute trials conducted within physician practices, including but not limited to: a. Visit preparation activities b. Visit follow-up activities c. Supply and inventory management d. Third party vendor management Conduct patient recruitment and enrollment of eligible patients. Lead patient study visits, which may also include clinical and lab procedures such as ECG, phlebotomy, vitals signs and body measurements, laboratory processing, etc. 4. Independently administer the informed consent process with care and quality 5. Ensure protocol adherence and high data integrity Provide high quality source data capture and documentation Support study start-up and planning, including PSVs and SIVs Support IRB submission and correspondence Facilitate monitoring visits (IMVs) and sponsor correspondence including managing the follow-up process 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 Train and mentor junior research staff 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 Conduct 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 experience Ability to be on site 5 days a week in Chevy Chase, MD5+ years of experience as a Clinical Research Coordinator, Research Assistant, or other similar role 5+ years of experience independently coordinating studies, from study startup to close out5+ years demonstrated track record of delivering clean data and a high-quality patient experience Expert knowledge of FDA regulations and ICH/GCP guidelines Strong communication skills, teamwork, cooperation, self-awareness, and flexibility

Flourish Research is looking for motivated, talented, creative individuals who want to learn and grow in their careers while contributing to research that changes lives! We offer an excellent comprehensive benefits package, a supportive and collaborative work environment, and endless growth opportunities. We are actively hiring Senior Clinical Research Coordinators at our Detroit, MI location! The Senior Clinical Research Coordinator assists the Investigators in executing Phase I, II, III, and IV clinical research trials in accordance with Standard Operating Procedures (SOPs), FDA and GCP guidelines, and study protocols while providing an impeccable patient experience in every, single interaction. Shift: Monday-Friday, 9 AM - 5 PM; one Saturday each month (9am - 1pm) Location: 20755 Greenfield Rd # 107, Southfield, MI 48075 Compensation: $30 - $36 based on experience + quarterly discretionary performance bonuses Benefits: Health, dental, and vision insurance plans, 401k with 4% match, tuition reimbursement, parental leave, referral program, employee assistance program, life insurance, disability insurance, and 15 days of PTO + 10 company holidays. RESPONSIBILITIES The Clinical Research Coordinator (CRC) obtains study participant informed consent. Executes study protocol procedures in a detailed, organized, and professional manner. Performs human specimen lab draws and processing, and packages specimen shipments. Creates and completes study source documents and adverse event reporting on an e-source system. Maintains study-specific files and supplies. Communicate with the Study Sponsor/CRO regarding study-specific questions. Participates in site visits from Sponsors/CROs, including site initiation and monitoring visits. Additional duties as assigned by management QUALIFICATIONS Bachelor's degree preferred but not required Phlebotomy experience is required; EKG or other patient labs/processes preferred 5+ years of experience as a Clinical Research Coordinator Familiar with e-source reporting via an electronic platform A clear understanding of ICH, FDA, and GCP regulations Impeccable organizational skills and attention to detail Excellent communication and interpersonal skills to effectively interact with the Principal Investigator, research team, Study Sponsor/CROs, potential subjects, and referral sources An ethical compass that compels the candidate to be honest, detail-oriented, and self-driven High-level critical thinking skills Working knowledge of medical terminology and lab collection/processing/storage procedures Proficiency with computers and Microsoft Office Suite Flourish Research offers an excellent comprehensive benefits package, a supportive and collaborative work environment, and endless growth opportunities. Apply today to learn more about how you can join us in our mission to save and improve the lives of others! Flourish Research is where clinical trials thrive. Flourish Research represents one of the industry's most progressive and diversified clinical trial companies with robust capabilities in the therapeutic areas of cardiology/metabolic disorders/renal, CNS, pulmonology, and vaccines. At Flourish Research, we strive toward excellence. In clinical trials and healthcare, excellence means everyone deserves the best care, regardless of their race, color, gender identity, religion, ethnicity, physical abilities, age, sexual orientation, or veteran status. We embrace employees, customers, and patients from these underrepresented groups to help make this vision a reality. Flourish Research is driven by a diverse and inclusive community of passionate people who are committed to improving the quality of life of communities around the world. Flourish is committed to a safe work environment where all employees, customers, and patients are included, and treated with dignity and respect. Flourish Research strives to build an organization that attracts and leverages diversity in our staff, which reflects the diversity of our local communities. We promote education, acceptance, and inclusion because there is beauty in diversity. The more diversity we have in our team, the more unique perspectives, and ideas we share, and the better prepared we are to serve our communities. WE SEE YOU. WE ARE YOU. WE EMBRACE YOU. WE CELEBRATE YOU! It is the policy of Flourish Research not to discriminate against any applicant for employment, or any employee because of age, color, sex, disability, national origin, race, religion, or veteran status.

This hybrid position involves outcomes research related work on various registries and the Project My Heart Your Heart clinical trial. The Michigan Cardiovascular Outcomes Research and Reporting Program (MCORRP) is a small, collaborative group of researchers focused on studying uncommon conditions and improving patient health and processes of care at Michigan Medicine and globally. The employee will participate in studies on: pacemaker reuse in economically developing nations; cardiac sarcoidosis; fibromuscular dysplasia; acute aortic dissection; pulmonary hypertension; and critical care cardiology. The successful applicant should be organized and detail oriented as they will need to work with multiple faculty, staff, and students on several projects. This role requires 2 days per week on site, with time spent at the MCORRP office at Domino?s Farms in Ann Arbor as well as 1 day per week in Southfield at World Medical Relief. While at World Medical Relief, the employee will assist with all facets of pacemaker and ICD reprocessing to support a groundbreaking study of relief efforts aimed at re-purposing life-saving devices in countries where treatment is otherwise unavailable. The registry-based research will be done both in-person and remotely, and involves extensive abstraction duties, primarily focused on interpreting and entering data from the Electronic Medical Record to enhance our understanding of the cardiovascular conditions mentioned above. The 3 days of the full-time position not spent on-site can be performed remotely if desired or at Domino?s Farms. This position may independently provide study coordination for simple and moderately complex clinical research studies. As a member of a coordination team, this position may help support a portfolio of projects with varying levels of complexity. Mastery of all job duties from the CRC-Assistant position on the Michigan Medicine CRC Career Ladder is required. Mission Statement Michigan Medicine improves the health of patients, populations and communities through excellence in education, patient care, community service, research and technology development, and through leadership activities in Michigan, nationally and internationally. Our mission is guided by our Strategic Principles and has three critical components; patient care, education and research that together enhance our contribution to society. Why Join Michigan Medicine? Michigan Medicine is one of the largest health care complexes in the world and has been the site of many groundbreaking medical and technological advancements since the opening of the U-M Medical School in 1850. Michigan Medicine is comprised of over 30,000 employees and our vision is to attract, inspire, and develop outstanding people in medicine, sciences, and healthcare to become one of the world's most distinguished academic health systems. In some way, great or small, every person here helps to advance this world-class institution. Work at Michigan Medicine and become a victor for the greater good. What Benefits can you Look Forward to? * Excellent medical, dental and vision coverage effective on your very first day * 2:1 Match on retirement savings Responsibilities* * Abstract information from the electronic medical record and enter data into clinical registries; organize training materials and documentation; audit cases entered at Michigan Medicine and other participating institutions; assist statistician with queries. * On site at World Medical Relief, catalogue and organize pacemakers and ICDs; facilitate device shipments; sterilize and interrogate devices. * Create and maintain materials to facilitate communication with outside institutions, internal shareholders, volunteers, and potential participants and donors. * Assist with running and planning virtual and off-site meetings for investigators and coordinators, including scheduling and reservations. * Prepare and submit abstracts and manuscripts for publication, including development of graphical abstracts and posters. Independent knowledge, skills, and abilities within all 8 competency domains is expected: 1. Scientific Concepts and Research Design 2. Ethical Participant Safety Considerations 3. Investigational Products Development and Regulation 4. Clinical Study Operations (GCPs) 5. Study and Site Management 6. Data Management and Informatics 7. Leadership and Professionalism 8. Communication and Teamwork Supervision Received: This position receives direct supervision and reports directly to (a CRC-Lead, CRC-Project Manager, a unit Administrator, Director, or Faculty Principal Investigator). Supervision Exercised: None Required Qualifications* Technician Level: * Associate degree in Health Science or an equivalent combination of related education and experience is necessary. * Minimum 1 year of directly related experience in clinical research and clinical trials is necessary. (Please review SoCRAs Definition of a Clinical Research Professional for qualifying experience prior to applying.) or An advanced degree in a health-related areas such as: Health Sciences, Behavioral Sciences, Public Health, Health Care Administration, Clinical Research Administration, Social Work, Psychology, Epidemiology, Foreign MD. or Minimum 3 years of human subject experience (clinical, lab or health regulations) such as related patient care, related community health and wellness, related clinical information, and research. * Familiarity with basic medical terminology. * Proficiency in operating a Windows computer and using Microsoft Office software, including Word and Excel. Assistant Level: * High school diploma or GED is necessary. * Familiarity with basic medical terminology. * Proficiency in operating a Windows computer and using Microsoft Office software, including Word and Excel. Desired Qualifications* Technician Level: * Bachelors degree in Health Science or an equivalent combination of related education and experience is desirable. An understanding of medical terminology, experience in a large complex health care setting, ability to effectively communicate with staff and faculty of all levels, and knowledge of university policies and procedures is desirable. * Experience abstracting information from electronic medical records and entering data into an online data collection form. Familiarity with tools used to develop and capture data using online data collection forms for research purposes. Assistant Level: * Associate Degree in Health Science or an equivalent combination of related education and experience is desirable. An understanding of medical terminology, experience in a large complex health care setting, ability to effectively communicate with staff and faculty of all levels, and knowledge of university policies and procedures is desirable. Work Schedule This role requires 2 days total per week on site, divided between the MCORRP office at Domino?s Farms in Ann Arbor and in Southfield at World Medical Relief. Modes of Work Positions that are eligible for hybrid or mobile/remote work mode are at the discretion of the hiring department. Work agreements are reviewed annually at a minimum and are subject to change at any time, and for any reason, throughout the course of employment. Learn more about the work modes