Clinical Research Coordinator Jobs in Madison Heights, MI

Piper Companies is currently seeking a motivated Clinical Research Associate with Oncology Clinical Trials experience to workfor a well-established clinical research organization and pharmaceutical company focused on improving the drug development process. Candidates for this opportunity must be located in Michigan. Responsibilities of the Senior Clinical Research Associate / CRA II:Develop and maintain relationships with investigative sites and client personnel Monitor sites for accuracy and validity of entries related to patient records and clinical notes Provide and communicate trial status and progress reports to trial manager and client Manage and maintain the data and documents required by local and ICH regulatory authorities Ensure SOPs are being followed and assist with client audits and regulatory inspections Qualifications of the Senior Clinical Research Associate / CRA II:3+ years of clinical monitoring experience required; CRO preferred Experience with FDA, ICH GCP, and local regulations1+ years of experience within the therapeutic area of OncologyStrong communication, interpersonal and organization skills necessary Bachelor's degree or equivalent experience required Compensation for the Senior Clinical Research Associate / CRA II:Salary Range: $110,000-$120,000 based on experience Comprehensive Benefits including Medical, Dental, Vision, 401k, PTO, Sick Leave if required by law, & HolidaysThis job opens for applications on 1/5/2025. Applications for this job will be accepted for at least 30 days from the posting date. Keywords: Clinical Research Associate, CRA, Oncology, Neuro, Infectious Disease, Vaccines, Rare Disease, Site Management, FDA, Regulatory, Regulatory Affairs, Clinical Operations, Clinical Research, Clinical Trials, CRO, Clinical Research Organization, Clinical Team, ICH, GCP, Contract, Biopharmaceutical, Biopharma, Pharmaceutical, Pharma, Medical Device, Therapeutics, Monitoring, Clinical, Management, Biological, Scientific, Patient Recruitment, Health, Dental, Vision, Retirement, Benefits, Remote, Michigan, Detroit, MI, Lansing#LI-PB2 #LI-REMOTE

**Up to $25,000 Sign on Bonus, based on amount of relevant experience** Unit Specializes in: 4 west is a cardiac telemetry unit designated for the care of the acutely ill adult patient with a variety of diagnoses. Whether it is assisting to manage chronic illnesses or help treat acute conditions, our collaborative team lives to serve our Community and strives to provide safe, reliable, quality care. We proudly promote professional nurse advancement and offer ACLS and arrhythmia/EKG interpretation training. RN ratios of 1:5 with acuity based assignments and PCA ratio of 1:8. We do what we do because we are driven to make a difference in the patients we serve. Come help the helpers and be a part of our team! DMC Sinai-Grace Hospital is DMC's largest hospital, offering a comprehensive heart center, cancer care, gerontology, emergency medicine, obstetrics/gynecology and cosmetic services. Sinai-Grace's joint replacement program features a revolutionary minimally invasive knee and hip replacement surgery that attracts patients from all over the country. Sinai-Grace operates more than 21 outpatient care sites and ambulatory surgery centers throughout Wayne and Oakland Counties and is one of 10 hospitals in the nation to be awarded a Robert Wood Johnson Foundation grant to help set the standards of cardiac care for hospitals and physicians throughout the nation. Job Summary In addition to the staff nurse role, assumes shift responsibilities for the care delivery team. Assists in coordinating the provision of care through assigning and scheduling staff, as well as prioritizing, delegating and evaluating patient care. Assists in evaluating patient care provided by nursing staff. Assists in Process Improvement activities. Works with the interdisciplinary team to problem-solve system and unit-based issues. Provides input into nursing staff performance appraisals. Assists with Staff Educational requirements as needed. Participates in activities pertinent to the unit and hospital Demonstrates own commitment to personal and professional goals. The Clinical Coordinator will supplement staffing under direction of Administrative Director and/or Clinical Manager. The Clinical Care Coordinator takes an abbreviated patient care assignment in order to assure the leadership responsibilities are fulfilled. 1. Functions as lead and resource person for nursing personnel. Acts as a clinical resource person and assists clinical manager in planning and facilitating staff meetings and staff development. 2. Collaborates with manager in prospective monitoring of the schedule to assure adequate nurse-patient ratio on a given shift. Reviews monthly schedule, communicating with staffing office regarding staffing changes. 3. Facilitates shared decision making among staff. Facilitates unit throughput on given shift to improve LOS (Length of Stay). 4. Coordinates/provides in-service programs to assist staff to maintain or enhance their competence in fulfilling job responsibilities based on identified needs of patient care personnel. 5. May assist manager with interview, selection, retention, mentoring, and evaluation of staff. 6. Participates in development of policies, procedures and standards for the department. 7. Assists with department Process Improvement and Peer Review. Qualifications: 1. Associates Degree/Diploma required. BSN preferred. 2. Licensed to practice as a Registered Nurse by the state of Michigan. 3. One to two years of progressively more responsible experience with evidence of increasing leadership abilities. 4. Demonstrated ability to prioritize work, delegate to others and facilitate processes. 5. Minimum Level 6 of the Promoting Excellence Performance Criteria, if an internal candidate, preferred. 6. BLS required, ACLS preferred. Job: Cardio/Coronary/Tele Primary Location: Detroit, Michigan Facility: DMC Sinai-Grace Hospital Job Type: Full Time Shift Type: Night ********** Employment practices will not be influenced or affected by an applicant's or employee's race, color, religion, sex (including pregnancy), national origin, age, disability, genetic information, sexual orientation, gender identity or expression, veteran status or any other legally protected status. Tenet will make reasonable accommodations for qualified individuals with disabilities unless doing so would result in an undue hardship.

Opportunity to join a growing nationwide Clinical Research Site Network with a new site presence in Greater Detroit! We are open to experienced Clinical Research Coordinators or Medical Assistants looking to break into clinical research. Medical Assistants will start as Clinical Research Assistants. Highlights Play a major role in cutting-edge clinical trials - a meaningful healthcare position! Full Benefits (Health, Dental, Vision, 401k w/ 4% Match, PTO, Paid Holidays) Gain experience in the fast-growing world of clinical research and develop skills that are in high-demand Monday - Friday 9 am - 5 pm $27 - $33/hr Company Our client is one of the fastest-growing clinical research site networks in the US, with over 25 research sites across eight states. Their sites conduct Phase I-IV trials in a wide variety of therapeutic areas. The site in Detroit runs clinical trials in vaccines, respiratory, and liver health. This is a multi-therapeutic site running phase I-IV trials. Qualifications Education: Bachelor's degree preferred; however, is not required. Preferably a minimum of 1 year of CRC experience Phlebotomy, EKG's, and Vital Signs experience highly preferred but not required. Exceptional knowledge of clinical research methods. Strong management and leadership skills with the ability to think independently and influence when appropriate. Strong negotiation and conflict management skills. Demonstrated ability to collaborate and align with operations. Excellent oral, written communication skills, and excellent computer skills to include Office 365 products. Experience in writing and reviewing Standard Operating Procedures. Strong problem solving, risk assessment, and impact analysis abilities. Demonstrated experience in process improvement. Flexible and able to multitask and prioritize competing demands.

METRO INFECTIOUS DISEASE CONSULTANTS CLINICAL ID POSITIONS Metro Infectious Disease Consultants is recruiting ambitious infectious disease clinicians for the Detroit, Michigan area. Full or part time positions are available. Primary responsibilities will include outpatient and inpatient ID consultations, outpatient antibiotic therapy, HIV medicine, antibiotic stewardship, and infection control. As a member of the largest ID private practice in the country we offer a stimulating, balanced 100% ID practice with a comfortable call schedule and lifestyle .

Department: Internal Medicine Schedule: 40hrs, Day Shift, Monday - Friday Participate in the design, administration and monitoring of clinical trials. + Plan, organize, perform and monitor daily project protocols. + Collect, prepare and maintain required research documentation, such as informed consent records, case records, clinical notes and medical reports. + Report and assist with the management of protocol deviations, adverse events and other project-related issues. + Assist with the preparation and delivery of internal and external presentations, conference reports and lectures, and publishing submissions. + Understanding of the Food and Drug Administration (FDA) rules is beneficial. EDUCATION/EXPERIENCE REQUIRED: + High School diploma equivalency with 2 years of cumulative experience OR Associate's degree/Technical degree OR 4 years of applicable cumulative job specific experience required. + Bachelor Degree preferred. + Research experience, including knowledge of FDA regulated trials strongly preferred. + Strong computer skills including Microsoft Office and Google Suite. Additional Information + Organization: Henry Ford Health St. John Hospital + Department: Inter Medicine GME + Henry Ford Health Location: Henry Ford St. John Hospital + Shift: Day Job + Union Code: Not Applicable Additional Details This posting represents the major duties, responsibilities, and authorities of this job, and is not intended to be a complete list of all tasks and functions. It should be understood, therefore, that incumbents may be asked to perform job-related duties beyond those explicitly described above. Overview Henry Ford Health partners with millions of people on their health journey, across Michigan and around the world. We offer a full continuum of services - from primary and preventative care to complex and specialty care, health insurance, a full suite of home health offerings, virtual care, pharmacy, eye care and other health care retail. With former Ascension southeast Michigan and Flint region locations now part of our team, Henry Ford's care is available in 13 hospitals and hundreds of ambulatory care locations. Based in Detroit, Henry Ford is one of the nation's most respected academic medical centers and is leading the Future of Health: Detroit, a $3 billion investment anchored by a reimagined Henry Ford academic healthcare campus. Learn more at henryford.com/careers . Benefits The health and overall well-being of our team members is our priority. That's why we offer support in the various components of our team's well-being: physical, emotional, social, financial and spiritual. Our Total Rewards program includes competitive health plan options, with three consumer-driven health plans (CDHPs), a PPO plan and an HMO plan. Our team members enjoy a number of additional benefits, ranging from dental and eye care coverage to tuition assistance, family forming benefits, discounts to dozens of businesses and more. Employees classified as contingent status are not eligible for benefits. Equal Employment Opportunity/Affirmative Action Employer Equal Employment Opportunity / Affirmative Action Employer Henry Ford Health is committed to the hiring, advancement and fair treatment of all individuals without regard to race, color, creed, religion, age, sex, national origin, disability, veteran status, size, height, weight, marital status, family status, gender identity, sexual orientation, and genetic information, or any other protected status in accordance with applicable federal and state laws.

Scheduled Hours40Assists investigators as coordinator of a complex clinical research study; may be responsible for multiple research studies simultaneously, acting as a liaison with the school, sponsoring agency, community and the study participants; manages and records all phases of study protocol as required by sponsoring agency to ensure compliance.Job Description Primary Duties & Responsibilities: Assists in developing plans for research projects and discusses the interpretation of results; collaborates in the preparation of manuscripts for publications and preparation of grant proposals to sponsoring agencies; assists in the preparation of amendments to protocols and/or modifications to study design as appropriate. Coordinates the development of forms, questionnaires and the application of research techniques; assists in writing instructional procedure manuals for study progress, data collection and coding; reviews journals, abstracts and scientific literature to keep abreast of new developments and to obtain information regarding previous studies to aid in the planning of new studies. Implements and manages all phases of study/protocol; ensures compliance with protocol guidelines and requirements of regulatory agencies; establishes record-keeping systems; makes assessments and determinations of participants' progress in the study; analyzes, investigates and reports adverse events; makes decisions as when to notify physicians of issues, when to stop participant inclusion and/or to make and/or recommend adjustment of the protocol of particular participants; resolves protocol management issues and recommends corrective action as appropriate; serves as liaison with funding or sponsoring agency. Evaluates and interprets collected clinical data as appropriate; prepares oral or written presentations or reports and analyses setting forth progress trends and provides recommendations or conclusions of the same. Performs other duties as assigned. Working Conditions: Job Location/Working Conditions Patient care setting. Physical Effort Typically sitting at desk or table. 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: Bachelor's degree or combination of education and/or experience may substitute for minimum education. 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: Clinical Research (2 Years) Skills: Not Applicable Driver's License: A driver's license is not required for this position.More About This Job Required 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: No additional education beyond what is stated in the Required Qualifications section. Certifications: No additional certification beyond what is stated in the Required Qualifications section. Work Experience: No additional work experience beyond what is stated in the Required Qualifications section. Skills: Clinical Research, Clinical Study Protocols, Database Management, Research Projects, Spreadsheet Analysis, Statistical Analysis Software (SAS) GradeC10Salary Range$52,600.00 - $78,900.00 / AnnuallyThe 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/AA 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.Diversity StatementWashington University is dedicated to building a diverse 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.

Apply Now This clinical research coordinator (CRC) position may provide study coordination for multiple clinical research studies depending on complexity that range from moderate to complex. Coordinator experience and mastery of all job duties from the CRC-Technician position on the Michigan Medicine CRC Career Ladder is required. This position should be able to perform tasks and make decisions independently, consistently, and accurately, and demonstrate that they have achieved a moderate level of expertise in all their skills and abilities resulting in high quality work. It is presumed that this position is able to apply their skills to a broad range of different types of clinical studies, navigate available resources appropriately, effectively use all tools and job aids at their disposal and operate e-clinical technologies with a reasonable degree of proficiency. This position can perform the majority of tasks independently and perform quality checks of their work. They also know where and how to identify appropriate resources and support and are able to discern when to escalate issues needing additional intervention. Key behavioral competency descriptors include demonstrate, implement, execute, and use. **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*** Characteristic Duties and Responsibilities: 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 Responsibilities: The Allergy/Immunology research team at the University of Michigan is looking to expand our research capabilities. We are looking for a research associate to assist on a number of on-going trials, with more soon to start. We are looking for someone with excellent people skills, who enjoys working with others and making a difference in people's health and lives. Tasks will include calling research participants, data entry, scheduling team meetings, assisting research participants when they come in for visits, screening for new participants, and assistance on tasks that may arise. You will also gain valuable experience in conducting research trials, and gain multiple skills that can be used in the future. Conduct and oversight of clinical trials in allergy. + Responsibilities will include recruitment of subjects, maintenance of accurate source documentation as well as electronic data entry. + This job will also include working on regulatory aspects with the sponsor, local and central IRB's, and the CTSU. + Duties include close monitoring of patients after receiving investigational product + Assist with the execution of industry sponsored clinical trials and NIH funded studies, including recruitment and retention of subjects, scheduling of procedures, obtaining informed consent, and collection of data. + Communicate with patients to set up appointment dates and times, document these interactions electronically, and follow up on lab tests as directed by the PI. + Perform study-specific tests in clinic or other designated research space in person + Design work flow and develop quality assurance processes for study start up, execution and conduct. Maintain accurate research records and transcribe collected data onto study documents, forms, and electronic research databases. + Assist with identification and documentation of adverse events according to standard operating procedures and protocol requirements. + Assists with reviewing billing calendars. + Reconcile research billing, payments and invoices and finance issues in concert with department grant managers and financial team. + Assures compliance with protocols, adherence to good clinical practice guidelines, sponsor regulations, and all other federal, local, and University guidelines. + Other duties as assigned or required for the research project. + Act as liaison between patient, investigators, other departments, sponsors, vendors and regulatory agencies. **Required Qualifications*** CRC Associate + Bachelor's degree in Health Science or an equivalent combination of related education and experience is necessary. + Certification is required through Association of Clinical Research Professionals (ACRP) as a Certified Clinical Research Coordinator (CCRC) or Society of Clinical Research Association (SOCRA) as a Certified Clinical Research Professionals (CCRP) and must be achieved by 01/01/24. After 01/01/24, certification is required within six months of date of hire. + Minimum 2 years of directly related experience in clinical research and clinical trials is necessary. + Previous experience with subject recruitment and retention, and coordination and management of NIH studies and/or clinical trials required, minimum 3 years. + Ability to work independently or as a member of a team. + Certification of Good Clinical Practice Training required, such as CITI or Transcelerate. + Demonstration of understanding of Medical Terminology. + Exceptional organizational and computer skills in Microsoft software applications. + Ability to work with minimal supervision with diverse teams of physicians, coordinators, collaborators, Institutional Review Board, and Office of Research and Sponsored Projects in a diplomatic, collaborative and effective manner. + Demonstrated problem solving and conflict resolution skills. + Ability to multi-task, work well under time constraints and meet deadlines. + Excellent interpersonal, collaborative, oral and written communication skills with exceptional attention to detail and exercise of good judgement. CRC Technician + 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 SoCRA'sDefinition 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. CRC Assistant + High school diploma or GED is necessary. + Experience in a medical setting + Previous experience with subject recruitment and retention, and coordination and management of clinical trials required. + Experience in the regulatory aspect of clinical trial management. + Ability to work independently or as a member of a team. + Demonstration of understanding of Medical Terminology. + Exceptional organizational and computer skills in Microsoft software applications. + Ability to work with minimal supervision while maintaining productivity standards. + Demonstrated problem solving and conflict resolution skills. + Ability to multi-task, work well under time constraints and meet deadlines. + Excellent interpersonal, collaborative, oral and written communication skills with exceptional attention to detail and exercise of good judgement. **Desired Qualifications*** CRC Associate + 4+ years of direct related experience + Previous experience with REDCAP or a similar clinical research database desired. CRC Technician + Bachelor's 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. CRC Assistant + 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 + Knowledge of university policies and procedures is desirable. + Previous experience with spirometry testing and/or sputum induction desired, however on-site training is available. + Clinical experience with respiratory patients is highly desired. + Certification through ACRP or SOCRA. + 3+ Years of Clinical Research Experience. **Work Schedule** Monday - Friday onsite **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 thework modes (************************************************************************************************************************* . **Underfill Statement** This position may be underfilled at a lower classification depending on the qualifications of the selected candidate. **Additional Information** Supervision Received: This position reports directly to PI. Supervision Exercised: None. Michigan Medicine (or unit specific name) is firmly committed to advancing inclusion, diversity, equity, accessibility, and belonging, which are core to the culture and values of the Medical School Office of Research. Our community supports recruiting and cultivating a diverse workforce as a reflection of our commitment to serve the diverse people of Michigan and the world. We strive to create a work culture where each team member feels respected, valued, and safe. **Background Screening** Michigan Medicine conducts background screening and pre-employment drug testing on job candidates upon acceptance of a contingent job offer and may use a third party administrator to conduct background screenings. Background screenings are performed in compliance with the Fair Credit Report Act. Pre-employment drug testing applies to all selected candidates, including new or additional faculty and staff appointments, as well as transfers from other U-M campuses. **Application Deadline** Job openings are posted for a minimum of seven calendar days. The review and selection process may begin as early as the eighth day after posting. This opening may be removed from posting boards and filled anytime after the minimum posting period has ended. **U-M EEO/AA Statement** The University of Michigan is an equal opportunity/affirmative action employer. **Job Detail** **Job Opening ID** 256322 **Working Title** Clinical Research Coordinator Associate underfill Clinical Research Coordinator Technician, Clinical Research Coordinator Assistant **Job Title** Clinical Research Coord Assoc **Work Location** Ann Arbor Campus Ann Arbor, MI **Modes of Work** Onsite **Full/Part Time** Full-Time **Regular/Temporary** Regular **FLSA Status** Nonexempt **Organizational Group** Medical School **Department** MM Allergy Division **Posting Begin/End Date** 1/09/2025 - 2/06/2025 **Career Interest** Research Apply Now

Profound Research **The Company** Profound enables community physicians to offer clinical research as a therapeutic option to their patients. We provide all the infrastructure, non-clinical services, and administrative heavy lifting. The physicians practice medicine, we do everything else, and patients get access to the newest therapies available. **Mission, Vision, Values** o **Mission:** Improving Lives by Providing Advanced Therapeutic Options o **Vision:** Creating the Absolute Best Patient-Physician Experience in Clinical Research. o **Values:** o Compassion: We value the patient-physician relationship above all else and are committed to a service-oriented approach to all interactions. o Urgency: We work hard and practice selflessness, acting swiftly and decisively to meet the needs of our patients, partners, and colleagues. o Solution Oriented: We are relentlessly positive, and we communicate directly to efficiently identify and implement effective solutions. o 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 **Role & Responsibilities:** -Maintain site compliance for all clinical trial activities in accordance with established research protocols and standards in compliance with all applicable laws, regulations, policies, and procedural requirements. -Maintain working knowledge of current FDA regulations, ICH-GCP guidelines, all the organizational SOPs, all the guidance documents, and assigned study protocol(s). -Responsible for immediate supervision and performance of the assigned site including conducting performance reviews as well as coaching, counseling, and implementing disciplinary action if needed. -Responsible for ensuring appropriate training of all staff to ensure compliance and inspection readiness. -Work closely with Operations and Business Development leadership on feasibility and study placement. -Accountable for enrollment planning and success at sites across all studies; understand revenue expectations. -Coordinate as primary CRC on at least one trial of medium to high complexity and serve as a back-up CRC for other study procedures and trials when needed. This includes completing all relevant training in a continued timely manner. -Share best practices with other Profound site locations with the goal of raising the overall level of operational competencies at Profound. -Work closely with the Quality Assurance team to ensure quality at the site; create processes and CAPAs to improve trends as needed. -Identify and build relationships with outside medical practices, pharmacies, and other healthcare professionals/organizations to aid in the patient recruitment process. -Act as a site liaison and champion by communicating effectively and professionally with coworkers, leadership, study subjects, sponsors, CROs, and vendors. -Ensure weekly, monthly, and quarterly assigned goals are met for the respective sites. -In addition to trial specific responsibilities, support in building and implementing a scalable operations infrastructure at new, regional Profound Research sites as needed. -Other duties as assigned by leadership. **Requirements & Skills:** -Associate degree or BS / BA in Life Sciences or related discipline. -8+ years prior experience as a clinical research coordinator -3-5 years of direct line management responsibilities -Successful completion of GCP certification and Certified Clinical Research Coordinator (CCRC) certification preferred. -Experience performing clinical assessments, including but not limited to obtaining vital signs, EKGs, blood draws, processing/shipping lab specimens. -Demonstrated ability to foster concepts of teamwork, cooperation, self- control, and flexibility to get the work done. -Excellent attention to detail, organization, and communication with varied stakeholders. -Able to travel regionally and to professional meetings as required. **Physical Requirements** · Prolonged periods of sitting at a desk and working on a computer, standing and walking. · Must be able to lift 25 pounds at times. · Picking, pinching, typing or otherwise working, primarily with fingers rather than with whole hand or arm as in handling. · Talking: Expressing or exchanging ideas by means of the spoken word; those activities where detailed or important spoken instructions must be conveyed to other workers accurately, loudly, or quickly. · Hearing: Perceiving the nature of sounds at normal speaking levels with or without correction and having the ability to receive detailed information through oral communication and making fine discriminations in sound. · The worker is required to have close visual acuity to perform an activity such as: preparing and analyzing data and figures; transcribing; viewing a computer terminal; extensive reading; visual inspection involving small defects, small parts, and/or operation of machines (including inspection); using measurement devices; and/or assembly or fabrication of parts at distances close to the eyes.

Profound Research **The Company** Profound enables community physicians to offer clinical research as a therapeutic option to their patients. We provide all the infrastructure, non-clinical services, and administrative heavy lifting. The physicians practice medicine, we do everything else, and patients get access to the newest therapies available. **Mission, Vision, Values** o **Mission:** Improving Lives by Providing Advanced Therapeutic Options o **Vision:** Creating the Absolute Best Patient-Physician Experience in Clinical Research. o **Values:** o Compassion: We value the patient-physician relationship above all else and are committed to a service-oriented approach to all interactions. o Urgency: We work hard and practice selflessness, acting swiftly and decisively to meet the needs of our patients, partners, and colleagues. o Solution Oriented: We are relentlessly positive, and we communicate directly to efficiently identify and implement effective solutions. o 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 **Role & Responsibilities:** -Maintain site compliance for all clinical trial activities in accordance with established research protocols and standards in compliance with all applicable laws, regulations, policies, and procedural requirements. -Maintain working knowledge of current FDA regulations, ICH-GCP guidelines, all the organizational SOPs, all the guidance documents, and assigned study protocol(s). -Responsible for immediate supervision and performance of the assigned site including conducting performance reviews as well as coaching, counseling, and implementing disciplinary action if needed. -Responsible for ensuring appropriate training of all staff to ensure compliance and inspection readiness. -Work closely with Operations and Business Development leadership on feasibility and study placement. -Accountable for enrollment planning and success at sites across all studies; understand revenue expectations. -Coordinate as primary CRC on at least one trial of medium to high complexity and serve as a back-up CRC for other study procedures and trials when needed. This includes completing all relevant training in a continued timely manner. -Share best practices with other Profound site locations with the goal of raising the overall level of operational competencies at Profound. -Work closely with the Quality Assurance team to ensure quality at the site; create processes and CAPAs to improve trends as needed. -Identify and build relationships with outside medical practices, pharmacies, and other healthcare professionals/organizations to aid in the patient recruitment process. -Act as a site liaison and champion by communicating effectively and professionally with coworkers, leadership, study subjects, sponsors, CROs, and vendors. -Ensure weekly, monthly, and quarterly assigned goals are met for the respective sites. -In addition to trial specific responsibilities, support in building and implementing a scalable operations infrastructure at new, regional Profound Research sites as needed. -Other duties as assigned by leadership. **Requirements & Skills:** -Associate degree or BS / BA in Life Sciences or related discipline. -8+ years prior experience as a clinical research coordinator -3-5 years of direct line management responsibilities -Successful completion of GCP certification and Certified Clinical Research Coordinator (CCRC) certification preferred. -Experience performing clinical assessments, including but not limited to obtaining vital signs, EKGs, blood draws, processing/shipping lab specimens. -Demonstrated ability to foster concepts of teamwork, cooperation, self- control, and flexibility to get the work done. -Excellent attention to detail, organization, and communication with varied stakeholders. -Able to travel regionally and to professional meetings as required. **Physical Requirements** · Prolonged periods of sitting at a desk and working on a computer, standing and walking. · Must be able to lift 25 pounds at times. · Picking, pinching, typing or otherwise working, primarily with fingers rather than with whole hand or arm as in handling. · Talking: Expressing or exchanging ideas by means of the spoken word; those activities where detailed or important spoken instructions must be conveyed to other workers accurately, loudly, or quickly. · Hearing: Perceiving the nature of sounds at normal speaking levels with or without correction and having the ability to receive detailed information through oral communication and making fine discriminations in sound. · The worker is required to have close visual acuity to perform an activity such as: preparing and analyzing data and figures; transcribing; viewing a computer terminal; extensive reading; visual inspection involving small defects, small parts, and/or operation of machines (including inspection); using measurement devices; and/or assembly or fabrication of parts at distances close to the eyes.

**Job Summary:** Responsible for providing supervision, oversight, and quality control of Phase I clinical trial staff under the direction of the Vice President Clinical Trials Office. Responsible for the business development of the Phase I Clinical Trials Department and the integration of the department across various teams within the Karmanos and McLaren networks. **Responsibilities:** * Direct supervision of Phase I clinical trial staff. Evaluate staff performance with input from the Karmanos Vice President, Clinical Trials Office, the Medical Director - Phase I Clinical Trials, and other Management as applicable. * Actively participates in the recruitment, hiring, discipline, and termination of Phase I clinical trial staff. * Implements and maintains a Quality Assurance Program for Phase I clinical trial staff activities. This includes adherence to Standard Operating Procedures (SOPs), Food and Drug Administration (FDA) guidelines, International Conference on Harmonisation (ICH) guidelines, and Good Clinical Practice (GCP) guidelines. Ensures compliance to both internal and external regulatory guidelines. Meets regularly with the Vice President, Clinical Trials Office, the Medical Director - Phase I Clinical Trials, Managers of various ancillary departments as needed in order to coordinate Phase I clinical trial activities with Karmanos CTO initiatives. * Assists the Vice President, Clinical Trials Office, the Medical Director - Phase I Clinical Trials, and Phase I Medical/Grant Writers in providing clinical trials information for grant preparation and continuations as needed. Manages peer reviewed grants. * Responsible for business development of the Phase I Clinical Trials Office including setting and monitoring quality metrics, tracking clinical trial portfolio, managing feasibility reviews for incoming potential clinical trials, and working with sponsors to bring in new clinical trials. **Qualifications:** * Science based Bachelor's degree required; Master's degree in a health- or a science-related field preferred. * Medical and/or science experience/education strongly preferred. * Experience with scientific writing preferred. * SOCRA or equivalent certification for at least 1 year required. If the candidate does not hold this certification, they must agree to obtain it within 2 years of hire. * Minimum of two years prior management or supervisory experience including responsibility for hiring, training, discipline, and oversight of professional staff preferably in a clinical research setting. * Minimum of five years of experience working in an oncology clinical trials setting at a research institution and/or pharmaceutical company. * Experience working in Phase 1 oncology clinical research preferred. * Demonstrated record of effectiveness in a management or supervisory position (clinic and/or administrative). * Demonstrated leadership abilities and ability to analyze problems and affect resolution. * Demonstrated ability to maintain cooperative working relations with internal and external units in a clinical research environment. * Demonstrated ability to provide excellent customer service. * Demonstrated initiative and attention to detail. * Skilled in communicating sensitive/difficult information and maintaining highly confidential information. * Proficient in computerized information systems and databases. Demonstrated expertise with the Microsoft suite. * Knowledgeable in internal and external research regulations, GCP guidelines, Code of Federal Regulations, clinical trials monitoring, regulatory compliance, research budgets, etc. Equal Opportunity Employer of Minorities/Females/Disabled/Veterans Additional Information

Department: Internal Medicine Schedule: 40hrs, Day Shift, Monday - Friday Participate in the design, administration and monitoring of clinical trials. * Plan, organize, perform and monitor daily project protocols. * Collect, prepare and maintain required research documentation, such as informed consent records, case records, clinical notes and medical reports. * Report and assist with the management of protocol deviations, adverse events and other project-related issues. * Assist with the preparation and delivery of internal and external presentations, conference reports and lectures, and publishing submissions. * Understanding of the Food and Drug Administration (FDA) rules is beneficial. EDUCATION/EXPERIENCE REQUIRED: * High School diploma equivalency with 2 years of cumulative experience OR Associate's degree/Technical degree OR 4 years of applicable cumulative job specific experience required. * Bachelor Degree preferred. * Research experience, including knowledge of FDA regulated trials strongly preferred. * Strong computer skills including Microsoft Office and Google Suite. Additional Information * Organization: Henry Ford Health St. John Hospital * Department: Inter Medicine GME * Henry Ford Health Location: Henry Ford St. John Hospital * Shift: Day Job * Union Code: Not Applicable

Full-time Description Job ID AF9599 -0301-1744 Classification FT Administrator The Office of Undergraduate Research and Graduate Opportunities (OURS+GO) Coordinator serves a pivotal role in the coordination and communication of activities that enhance undergraduate students opportunities for undergraduate research and promote the professional growth of students pursuing research &/or pre-health careers. This position will work in collaboration with the Pre-Health Programs Team and the Director(s) of Undergraduate Research and Graduate Opportunities, ensuring effective communication with students, faculty, and stakeholders and providing organizational support. Essential Duties and Responsibilities Collaboration with Pre-Health Program Team. Assist with coordinating communications with students, Admissions, Pre-Health Director/Advisor. Assisting with the coordination of the Pre-Health Committee letter writing. Assist with gathering/updating/reporting information for Pre-Health online resources (Blackboard site, blog, etc.). Coordinate Pre-Health program events. Engage with Pre-Health student organizations. Engage with prospective pre-health students. Collaboration with Director(s) of Undergraduate Research and Graduate Opportunities. Assist with coordination of communications with students, faculty, Director(s). Assist with gathering/updating/reporting information for UG Research online resources (website, etc.). Assist with coordination of research and graduate school program events. Assist students with preparation and application for graduate program. Provide Administrative Support for the College of Engineering & Science OURS+GO and Co-op Office. Receive students/visitors to the Pre-Health/Graduate Opportunities/OURS/Co-op Office. Manage and communicate list of activities and events offered through this office. Collaborate with other offices, faculty, and staff. Provide project management support. Other duties as assigned Requirements Minimum Qualifications Education - A bachelor's degree is required. Experience - Up to six months in a role with project management and/or student support activities. Preferred Qualifications Experience with graduate science programs and/or professional health programs. Experience with undergraduate scientific research. Experience mentoring and advising college students. Experience in effectively communicating with college students in a variety of mediums. Demonstrated commitment to diversity, equity and inclusion in a college or work setting. Knowledge, Skills, and Abilities Attention to detail in providing supportive feedback to students Empathy and culturally sensitive mentoring and advising Strong communication skills in multiple modalities Growth mindset Project management skills; ability to initiate and follow through on project Technical and reporting skills, including updating and maintaining online information Ability to offer insight for improving operational efficiency and strategic priorities. Physical Requirements Job may require lifting light weight objects (1 to 10 pounds) with no repetitive bending or stooping. Occasionally lift average weight objects (1 to 10 pounds). Work Environment Regular exposure to favorable conditions such as those found in a normal office. Salary/Pay Information Commensurate with experience Anticipated Schedule Monday - Friday 8:30 am - 5:00 pm, on-campus Employee Benefits At the University of Detroit Mercy, we continually strive to provide a high-quality, comprehensive benefits package to our valued employees. We offer our employees the following benefits: · Medical - o Three health plans to choose from with a large national provider network · Dental - o UDM's School of Dentistry FREE to you and your dependents o Option to purchase additional dental plan through UNUM · Vision - o Exams and lenses every 12 months · Health Savings Account and Flexible Spending Accounts offered. · Employee Assistance Program - o Provided to everyone in your household. · Short-Term and Long-Term Disability. · Life and AD&D - o One times base salary up to a hundred thousand dollars. · Option to purchase additional life insurance, accident insurance, and/or critical illness insurance · Tuition Remission Benefit for you, your spouse, and children. · Retirement Plan - o UDM provides matches up to 8% Michigan's largest, most comprehensive private University, University of Detroit Mercy is an independent Catholic institution of higher education sponsored by the Sisters of Mercy and Society of Jesus. Detroit Mercy seeks qualified candidates who will contribute to the University's mission, diversity, and excellence of its academic community. University of Detroit Mercy is an Equal Opportunity Affirmative Action Employer with a diverse student body and welcomes persons of all backgrounds.

Clinical Research Coordinator II The Clinical Research Coordinator II, will 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 II 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 the 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. Demonstrating adherence and compliance to the assigned protocols at their respective site(s). Maintaining a working knowledge of current FDA regulations, ICH-GCP guidelines, all the organizational SOPs, all the guidance documents, and assigned study protocol(s) Maintaining a working knowledge of the recruitment and retention process for their assigned protocol(s) at their respective site(s). Demonstrating visit preparedness for all the relevant sponsor and CRO visits for their assigned protocol(s) Demonstration of appropriate and timely follow-up on the action items, at their respective sites. Maintaining a working knowledge of the most recent versions of the Study Protocols, Informed consents, Study Manuals, and all the other relevant study-related documents that are utilized and implemented for the assigned protocols at their respective site(s). Oversee reporting of all Adverse and Serious Adverse Events and any other relevant Safety Information to the appropriate authorities per internal company guidelines, Sponsor, IRB, and ICH-GCP Guidelines. Completing data entry and query resolution in a timely manner as per internal company guidelines and as per sponsor expectations. Striving to meet Sponsor subject enrollment goals for their assigned protocols at their respective site(s). Being prepared for and available at all required company meetings. Submitting required administrative paperwork per company timelines. Occasionally attending out-of-town Investigator Meetings Any other matters as assigned by management. Knowledge & Experience: Education: High School Diploma or equivalent required Bachelor's degree a preferred Foreign Medical Graduates preferred Experience: At least 2 years of experience as a CRC, preferably with practice coordinating industry-sponsored vaccines in a private setting. Credentials: ACRP or equivalent certification 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. Bilingual in Spanish is a plus

Powered by **Clinical Research Coordinator I (Detroit, MI)** The role involves providing support for study coordination, data management, and regulatory activities within a Clinical Trials Office (CTO). This position ensures compliance with protocol guidelines, internal procedures, and regulatory requirements, while assisting multidisciplinary teams in research activities. **Responsibilities:** * Ensure all study requirements are documented and comply with internal and external regulations, following protocol guidelines. * Maintain logs, including tracker submissions, and update the CTO OnCore database in a timely manner per CTO SOPs. * Respond to queries promptly and accurately. * Schedule and participate in monitoring visits. * Attend multidisciplinary team program meetings as required. * Assist multidisciplinary teams in various research activities. **Requirements:** * Bachelor's degree or an equivalent combination of education and experience. * Medical and/or science education or experience is preferred. * Proficiency in Microsoft Office Suite, including Excel and PowerPoint. * Strong attention to detail and organizational skills. Department: Direct Clients This is a full time position **Personal Information** **Attachments** **Other Information**

| | **Clinical Research Coordinator** Full Time Farmington Hills, MI, Michigan, Southfield, MI, Troy Posted 2 years ago Finding Cure And Saving Life **Unique opportunity to make an Impact in the healthcare industry…** **IMPROVE THE FUTURE AS OUR CLINICAL RESEARCH COORDINATOR!** The professional we select for Revival Research Institute will have an overall responsibility to enhance our operational efficiency, market presence, affiliated partnerships, and staff development/performance. **The qualified candidate we are looking for should be genuinely respectful of diverse points-of-view and strive for an environment in which inclusiveness drives productivity and results.** **Other requirements include:** * Bachelor's degree with a Masters in a science-related field highly desired, or extensive experience in Clinical Research * 2+ years of increasingly responsible management experience in the healthcare sector that includes strategy development, positive retention results, and creative problem-solving * Strong analytical skills with the ability to assess current operational effectiveness and needs * Engaging verbal/written communication skills and ability to comfortably interact with people from all kinds of backgrounds * Powerful professional interpersonal skills with the ability to establish/nurture connections * Successful background in healthcare and/or clinical research * Proven ability to coach and motivate team members to reach new levels of accomplishment and professional fulfillment * Must possess proficiency with modern technology * Availability for some travel (domestic) * Oversight of clinical trials * Collection of data and timely entry * Communicate with the study monitor * Informing participants about study objectives * Administering questionnaires as needed per study * Monitor participants to ensure adherence to study rules * Follow GCP guidelines and other regulatory standards * Participate in subject recruitment efforts * Obtaining informed consent of participants Along with competitive base salary, there is potential for performance-based rewards. Committed to work/life balance, Revival Research Institute, LLC is invested in our staffs personal development and offer a number of opportunities for growth. **If this position is of interest to you, we here at Revival Research would love to see your resume.** **Job Features** Job CategoryClinical Research **Apply For This Job** A valid phone number is required. A valid email address is required. No file chosen Browse **Leave a Reply** You must be to post a comment.

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, and Arizona. 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. We are seeking a full-time Clinical Research Coordinator with a minimum of 1 year of clinical experience, for our Additionally, someone with a strong interest in the Clinical Research field would be an excellent fit for our entry level position, with room to grow. However, this interest and background is not necessary, as our ideal candidate is an individual who is detail orientated, being able to maintain organized records, as well as someone who is motivated to learn new things, as our company is always growing and expanding into new therapeutic areas. We are looking for individuals that want the opportunity to learn and grow with us. Clinical Research Coordinators here at Revival Research Institute, should be genuinely respectful of diverse points-of-view and strive for an environment in which inclusiveness drives productivity and results. Clinical Research Coordinators are responsible to coordinate and manage multiple studies. They are also responsible for assisting the Investigators along with other clinical staff, with any study related tasks as follows but not limited to: Participates in research participant screening, recruitment and enrollment. Consent and conduct research visits for data collection/no risk trials or no study article/minimal risk trials with oversight. Responsible for collecting, processing and shipping of research specimens, where applicable. Documents study related information in case report forms or electronic data capture systems, handles data queries and participates in monitoring visits. Obtain, review and maintain source documents. Maintains organization of all trial related documents and correspondence. Implement quality control and assurance methods. Communicate with study sponsors, research team and the Institutional Review Board. Assist with basic regulatory document preparation, with oversight e.g. study amendments, adverse event reporting, protocol deviation reporting. Maintain professional and technical knowledge about Clinical trials. Research participant/family communication, protect patient confidentiality. Preferred Qualifications: Education/ Training: Bachelor's degree in health-related field with one to two years relevant clinical experience OR Master's degree in medical related field with no research experience. Individuals with more experience are preferred, if qualifications exceed entry level, higher positions available. Pulmonary experience in a clinical setting is preferred. Phlebotomy skills are preferred. Certifications, Licensures, and Registrations: National Certification (CRA or ACRP), BLS Certification. Additional Qualifications: Expert database and computer skills: Microsoft Office (Word, Excel), Outlook, excellent verbal and written communication skills, ability to work independently and assume responsibility, excellent organizational skills, ability to meet data deadlines and maintain confidentiality. Maintain data integrity within the department. Must be able to work in a team consisting of physicians, nurses, technicians, secretarial staff and ancillary hospital staff. Knowledge of FDA Regulations and Good Clinical Practices. IMPROVE THE FUTURE AS OUR CLINICAL RESEARCH COORDINATOR!!!

At Headlands Research, we are dedicated to enhancing clinical trial delivery within our communities. We're an exceptional family of next-generation clinical trial sites, integrating cutting edge technology and high-quality support services, and significantly expanding participant engagement Founded in 2018, our company operates 20+ clinical trial sites in the US and Canada with rapid plans for expansion. The Role Headlands Research Detroit is looking for a Clinical Research Coordinator to manage clinical research protocols. This individual will work directly with the investigators, and other research staff to ensure protocol visits are being conducted according to ICH GCP guidelines. Responsibilities Comprehend study design of each protocol that is assigned Perform procedures in compliance with the study protocol Recruit and screen study subjects according to specific protocol requirements Collect and record study data in source documents via electronic system (CRIO) Manage study related activities Adherence to protocol requirements Review laboratory data Assess and document compliance Manage investigational product Assess, record, and report Adverse Events as outlined in the protocol Manage/train ancillary staff Qualifications Education: Experience and training in conducting clinical trials with knowledge of ICH GCP OR Two years of college in a health-related program or LPN OR Bachelor's degree in a health or scientific related program A thorough understanding of regulatory requirements Excellent interpersonal and communication skills: Able to interact effectively with professional, administrative staff, sponsor and regulatory representatives, patients, potential subjects, and referral sources. Experience performing clinical assessments, including but not limited to obtaining vital signs, EKGs, blood draws, processing/shipping lab specimens Experience with CRIO (Clinical Trial Management System) is a plus Experience with administering vaccines is a plus

** Unblinded Clinical Research Coordinator I** **Job Details** Detroit - Southfield, MI **Description** DM Clinical Research is looking to hire an **Unblinded Clinical Research Coordinator** to join our team. This individual will be responsible for dispensing Investigational Products (IP) as part of clinical research trials. **Duties & Responsibilities:** * Compound and dispense prescribed IP. * Supervise and maintain records of all medications * Ensure compliance with study-specific blinding plans. * Provide consultative support regarding the preparation and dosing of drugs. * Maintain documentation of IP accountability: receipt, dispensing, return to sponsor/destruction. * Interpret clinic schedule and protocol into a resource that can be used to identify the date/time to compound/prepare and dispense IP for clinical trials. * Understand and apply all applicable site procedures. * Ensure receipt and proper storage of IP and bioretention samples. * Manage inventory, ensuring that expired items are removed from the inventory prior to expiration, and purchasing, and delivery processes for the pharmacy. * Review protocols and provide input on clinical and pharmacy supply needs. * Meet with sponsors, monitors, auditors, and regulatory authorities to review drug accountability and other study-specific information. * Temperature reporting. * Any other duties/ tasks assigned by the manager, computer proficiency, especially Word, Excel, Outlook, and Google Docs. **Knowledge & Experience:** **Education:** * High School Diploma or equivalent required * Foreign Medical Graduate is a plus * Pharmacy Technician Certification a plus **Experience:** * Clinical Experience **Credentials:** * LPN (Licensed Professional Nurse) or CMA (Certified Medical Assistant) **Knowledge and Skills:** * Computer proficiency, especially Word, Excel, Outlook, and Google Docs. * Excellent communication and customer service skills. * Outgoing personality Well-organized with attention to detail. * Must be able to multitask. * Bilingual (Spanish) preferred but not required

Wayne State University is searching for an experienced Clinical Research Coordinator - Department of Psychiatry at its Detroit campus location. Wayne State is a premier, public, urban research university located in the heart of Detroit, Michigan where students from all backgrounds are offered a rich, high-quality education. Our deep-rooted commitment to excellence, collaboration, integrity, diversity and inclusion creates exceptional educational opportunities which prepare students for success in a global society. Essential functions (job duties): Recruit, screen, obtain informed consent, and enroll eligible participants according to protocol for clinical studies. Schedule and coordinate participants study visits and/or work with outpatient scheduler. Directly interact with subjects in a clinic setting, including subject interviews, administering survey instruments, etc., per protocol requirement. Collect and record participants study-related data into electronic and paper case report forms. Ensure all study related documentation is completed accurately, in a timely manner per sponsor requirements. Ensure compliance with protocol guidelines and regulatory agency requirements. Collect, process, label, store, and ship bio-specimens for clinical studies. May obtain blood samples (including blood draws), cultures, tissues, urine, stool, nasal swabs, plasma microbiological isolates and other specimens for laboratory analysis and processing, depending upon on the study. Track and monitor participants' condition and test results during the course of the clinical studies. Relay relevant results to the clinical team. Perform study drug accountability if needed, as per protocol. Manage all the regulatory activities and requirements relevant to the research. Manage the collection of essential regulatory documents and the execution of study protocol. Prepare IRB (Institutional Research Board) initial applications, amendments, continuations, closures and submit electronically (ePortal for example) as well as manually, as needed. Prepare for sponsor monitoring visits, site initiation and closeout visits. Assist the PrincipaI Investigator with the sponsor budget. Work with administrative staff to ensure appropriate billing for study-related care. Coordinate with billing department to make sure that all the research related activities are billed to the sponsor and paid by the sponsor. Review billing calendars and study budgets to ensure appropriate care designations and costs for clinical studies. Design source documents/ generic forms for data collection, recruitment materials, consent forms and other relevant documents for clinical studies as required. Perform general office and administrative duties related to clinical studies. Participate in recruitment strategy meetings to enhance subject awareness of studies and boost subject participation. Attend investigator meetings and training as a study team member. Other duties as assigned. Unique duties: Coordinate and participate in clinical research studies by performing activities involved in the collection, compilation, documentation of research data. The position will work with principal investigators and other research team members to accurately and efficiently carry out a range of tasks associated with a variety of clinical research studies. Qualifications: Education: Bachelor's degree in a medical or health science discipline or equivalent combination of education and experience. Years of Experience Required: Minimum one year experience working in a research or clinic environment and interaction with study populations. Knowledge, Skills and Abilities: Excellent interpersonal and communication skills. Experience with Microsoft Office products (i.e., Microsoft Word, Excel, Power Point) and Electronic Data Entry/Capture (EDC). Excellent multi-tasking, problem solving and record-keeping skills. Strong ability to work independently, exercising good judgement, with minimal supervision. Organizational and analytical and problem solving skills. Ability to function with diverse teams of people in a diplomatic, collaborative, and effective manner. Ability to work independently and adhere to established timelines to accomplish tasks. Understanding of ICH-GCP guidelines, OHRP, HIPAA, and FDA regulations. Ability to maintain data confidentiality and participant/subject/patient privacy. Working knowledge of medical terminology and assessment of laboratory values. Preferred qualifications: School/College/Division: H06 - School of Medicine Primary department: H0613 - Psychiatry Employment type: * Regular Employee * Job type: Full or Fractional Time * Job category: Staff/Administrative Funding/salary information: * Compensation type: Annual Salary * Salary minimum: 52,400 * Salary hire maximum: 62,877 Working conditions: Hospital, outpatient clinic and office environments. This position must be filled pursuant to the provisions of a collective bargaining agreement, and as such may be filled by a qualified bargaining unit member, should one apply. Job openings: * Number of openings: 1 Background check requirements: University policy requires certain persons who are offered employment to undergo a background check, including a criminal history check, before starting work. If you are offered employment, the university will inform you if a background check is required. Equal employment opportunity statement: Wayne State University provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability or genetics. The university encourages applications from women, people of color and other underrepresented people. Wayne State is an affirmative action/equal opportunity employer.