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Clinical research coordinator jobs in Kalamazoo, MI

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  • CLINICAL ID POSITIONS

    Metro Infectious Disease Consultants

    Clinical research coordinator job in Detroit, MI

    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.
    $57k-152k yearly est. 1d ago
  • Weights and Research Coordinator

    R+L Carriers 4.3company rating

    Clinical research coordinator job in Ypsilanti, MI

    Full-Time Monday-Friday, Various shifts, 60-65k yearly Come and experience the difference with R+L Carriers Earn 1 week of vacation after 90 days of employment Requirements: Any type of LTL experience preferred but not required Ability to self-motivate and self-manage Willingness to learn Analytical skills Computer proficiency Able to work in a fast-paced environment Excellent Benefits R+L Carriers offers an excellent compensation and comprehensive benefits package, including Medical/Dental/Vision Insurance, 401(k) Retirement Plan with matching contributions, Paid Vacation & Holidays, and vacation lodging at our exclusive employee resorts in Daytona Beach, FL, Big Bear Lake, CA, Pigeon Forge, TN and Ocean Isle Beach, NC. Click here ****************************
    $58k-74k yearly est. Auto-Apply 38d ago
  • Research Scientist - Clinical

    Eli Lilly and Company 4.6company rating

    Clinical research coordinator job in Indianapolis, IN

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Clinical Research Scientist - Medical Affairs Allergy, Immunology BU Purpose: The Medical function throughout the Lilly enterprise brings scientific objectivity, clinical expertise and experience in patient care that enhance Lilly's R&D, but Medical Affairs extends those benefits in its interactions with the customer and uses those customer experiences to inform ongoing development and use of Lilly's medications. Medical Affairs (MA) plays a critical role in anticipating and interpreting the constant and rapid changes happening in the complex world of healthcare. Medical Affairs leads efforts to identify and address Clinical Care Gaps, generate evidence, and share science across communication channels. The application of scientific and clinical training, and expertise, positions the Medical Affairs Clinical Research Scientist (CRS) an integral member of the medical affairs team. The Medical Affairs CRS supports the medical strategic planning supporting launch and commercialization of our treatments. Additionally, the MA CRP leads the medical strategy addressing patients' needs and ultimately enhancing the customers' experience in interacting with the company. The definition of "customer" here includes patients, providers (HCPs), and payers. Specific activities include developing or contributing to the global and/or regional clinical/medical plan in his/her therapeutic area of responsibility, the development, conduct and reporting of local clinical trials; the implementation of global clinical trials conducted in local affiliates/countries; the reporting of adverse events as mandated by corporate patient safety; review process for protocols, study reports, publications and data dissemination for products; new and updated labels, documents and tools supporting product pricing, reimbursement, and access (PRA), grant submissions and contracts; contacts with regulatory and other governmental agencies; the outreach medical activities aimed at the external clinical customer community, including thought leaders; and various medical activities in support of demand realization. In addition, with input from the Director-Medical and Business Unit Team Physician/Regional Medical Leader, the CRS is responsible for assuring that his/her activities are clearly aligned with the strategic priorities of the respective Medical Affairs business unit brand team(s), global Development team, Therapeutic Area Program Phase, Early Phase I Clinical Pharmacology, and Translational Medicine team(s). The Clinical Research Scientist serves as a scientific resource for study teams, departments, and others as needed. The CRS is aware of and ensures that all activities of the medical team (and direct reports, if applicable) are in compliance with current local and international regulations, laws, guidance (for example, FDA, ICH, and CPMP etc.), Good Clinical Practices (GCPs), company standards, Lilly policies and procedures, global quality standards, the Principles of Medical Research and activities are aligned with the medical vision. Primary Responsibilities: This is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position. The primary responsibility of the Medical Affairs CRS is to provide expert scientific and clinical support to all aspects of the local and global business, to ultimately enhance the customers' experience and develop medical strategies that improve patient outcomes. This includes informing the identification of Clinical Care Gaps (CCG), Integrated Evidence Generation (IEG) planning, product lifecycle planning, and evidence dissemination plans aligned with medical strategy. This includes local marketed product support (participate in the development of the "patient journey" and the strategic plan for the compound), medical support for regulatory affairs and interactions with government agencies (medical support for New and Supplemental New Drug Submissions and participating and presenting at meetings with government regulatory agencies), medical support for PRA (providing medical guidance on the PRA plan and interacting with government PRA agencies as needed), and leading in local scientific data dissemination (leading and presenting at conferences, advisory boards, etc., and overseeing the development of the scientific content of educational programs). These responsibilities are generally related to late-phase and marketed compounds but can also include early phase trials (for example, phase I and II trials). The global team CRS is responsible for collaborating with the global development teams in the planning, startup and conduct of phase 3b/4 studies (and phase I and II studies where applicable), as well as non-clinical trial solutions/activities that are conducted in affiliates/countries as described in the clinical plan. In addition, the CRS, if assigned, is responsible for support of global Development studies conducted in affiliates/countries. The core job responsibilities may include those listed below as deemed appropriate by line management, as well as all other duties as assigned. Business/ customer support (pre and post launch support) Understand and anticipate the scientific information needs of all local/regional customers (payers, patients, health care providers) Actively address customer (payer, patient and health care providers) questions in a timely fashion by leading data analyses and new clinical or health outcomes research efforts. Contribute to the development of medical strategies to support brand commercialization activities by working closely with the global Medical Affairs and brand teams, Global Patient Outcomes/Real World Evidence and global PRA, clinical management or personnel and other cross-functional management during the development of the local business plan. Contribute as a scientific and clinical expert to activities and deliverables of the PRA organization, giving clinical input and insight to develop payer partnership programs and defend the product value. Support business-to-business and business-to-government activities as medical expert. Contribute actively on an ongoing basis to the strategic planning for currently marketed brands. By offering scientific and creative input, contribute to the development, review, and approval of promotional materials for the brand team. Support training of sales representatives, and other medical representatives. Become familiar with market archetypes and potential influence on the medical interventions for the product. Take a leadership role in defining the Patient Journey and corresponding Moments of Truth based on his/her medical knowledge. Become patient advocate, as well as a medical expert supporting identification of Clinical Care Gaps (CCGs). Provide medical insight and training to patient support programs (for example, Diabetes Nurse Educators Service). Understand and apply knowledge of customer insights to all customer-related activities. Participate in local or national trade associations as appropriate. Scientific Data Dissemination/Exchange Knowledge of and compliance with local laws and regulations, and global policies and procedures, compliance guidelines with respect to data dissemination and interactions with external health care professionals. Understand and actively address the unsolicited scientific information needs of external health care professionals according to guidelines above. Support the planning of symposia, advisory board meetings, and and/or the facilitation of other meetings with health care professionals. Support medical information associates in preparation and review of medical letters and other medical information materials. Support training of local medical personnel, including medical and/or outcome liaisons and health outcomes staff. Prepare or review scientific information in response to customer questions or media requests. Provide follow-up to information requested by health care professionals as per global SOPs. Support data analysis and the development of slide sets (through reviewing and/or approving) and publications (abstracts, posters, manuscripts). Establish and maintain appropriate collaborations and relationships with external scientific experts, thought leaders, and the general medical community on a local, national, regional, and possibly international basis. Develop and maintain appropriate collaborations and relationships with relevant professional societies. Support the design of customer research as medical expert. Provide congress support (for example, availability to answer questions at exhibits, provide oral and poster presentations, staff medical booth, meet thought leaders, and participate in customer events). Support efforts in Integrated Evidence Generation (IEG) planning, participate in data analyses, development of scientific data dissemination including personal and non-personal channel strategy, and preparation of final reports and publications. Participate in reporting of clinical trial data in Clinical Trial Registry activities. Clinical Planning Communicate and collaborate with Director-Medical and Business Unit Team Physician/Regional Medical Leader as needed to ensure life cycle plans for drugs in development address customer needs or communicate and collaborate such needs as delegated by Director-Medical and Business Unit Team Physician/Regional Medical Leader, as needed, to global Medical Affairs and Development teams, Global Patient Outcomes/Real World Evidence, PRA, Therapeutic Area Program Phase, and Early Phase /EPM/Translational Medicine teams. Communicate local/regional research needs and collaborate with other regions and the global Development and Medical Affairs teams, Global Patient Outcomes/Real World Evidence, and PRA teams to ensure Phase 3, 3b, and 4 (and Phase I and II where applicable) clinical programs meet the needs of local/regional customers (for example, through global medical planning processes). Understand and keep updated with the pre-clinical and clinical data relevant to the molecule. Represent the clinical needs of the country/region to the business unit medical leadership in the development of clinical strategies, development plans and study protocol design. Clinical Research/Trial Execution and Support Review and approve local informed consent documents and risk profiles to ensure appropriate communication of risk to study subjects. Collaborate with clinical research staff in the design, conduct and reporting of local clinical trials (for example, sample size, patient commitment, timelines, grants, and governance review interactions). Collaborate with clinical research staff, regional clinical operations staff, statisticians, global patient outcomes, research scientists and selected investigators in the development of protocols and data collection requirements. Participate in investigator identification and selection, in conjunction with clinical teams. Ensure that the clinical operations team has documented the completion of administrative requirements for study initiation and conduct (i.e., ethical review board, informed consent, regulatory approval/notification) consistent with Good Clinical Practices (GCPs) and local laws and requirements. Assist in the planning process and participate in study start-up meetings and other activities to provide the appropriate scientific training and information to investigators and site personnel. Serve as resource to clinical research site monitors, investigators and ethical review boards to address any questions or clarify issues arising during the conduct of study. Review lIT proposals and publications, as requested. Contribute to global alignment of Phase 3b/4 clinical studies (and Phase I and II studies where applicable) planned by country(ies) or global Development and Medical Affairs teams. Understand and actively address the scientific information needs of all investigators and personnel. Monitor patient safety during the conduct of studies and conduct the appropriate tracking and follow-up of adverse events, in alignment with corporate patient safety policies and procedures. Regulatory Support Activities Participate in development and review of local labeling and labeling modifications in collaboration with global Development, brand teams, regulatory, and legal. Demonstrate deep knowledge of local label. Provide medical expertise to regulatory scientists. Support I assist in the preparation of regulatory reports, preparation for regulatory agency advisory committee hearings and label discussions, local registration efforts, and communication and resolution of regulatory issues, including regulatory response, from an affiliate/country perspective. Participate in advisory committees. Participate in risk management planning along with global Development team(s), business unit, local area, and Global Patient Safety (GPS). Scientific / Technical Expertise and continued development Be aware of current trends and projections for clinical practice and access in the therapeutic area(s) relevant to the product, both near term (1-2 years) and longer-term (3-5 years). Critically read and evaluate the relevant medical literature; know the status and data from competitive products; and keep updated with medical and other scientific developments relevant to the product. Responsible for the scientific training of the clinical study team. Acts as scientific consultant and protocol expert for clinical study team members and others in medical. Explore and take advantage of opportunities for extramural scientific experiences. Attend, contribute and participate in medical congresses/scientific symposia. General Responsibilities Support the business unit management team, including medical leadership in preparation and administration of the local or business unit medical budget. Use knowledge of specific disease states and available treatments to provide scientific and medical input, contribute to the development, review, and approval of promotional and medical materials ensuring high integrity and quality. Actively set and meet individual professional development goals and contribute to the development of others by being an active source of coaching and feedback to co-workers, and direct reports as applicable. Collaborate proactively and productively with all alliance, business, and vendor partners. Participates in active coaching by providing timely and constructive feedback to co-workers, others on the clinical medical team, in the spirit of development, increased team effectiveness and cohesiveness. Actively participate in recruitment, diversity, and retention and hiring efforts as applicable. Participate in committees, Six Sigma initiatives and task forces as requested by business unit/corporate management. Model the leadership behaviors. Be an ambassador of both patients and the Lilly Brand. Minimum Qualification Requirements: PhD with 3+ years of industry experience) OR (BS Degree or equivalent experience in Health-related field with 10+ years' industry experience Clinical trial experience in drug discovery Drug/clinical development experience (for example, epidemiology, toxicology, pharmacology, regulatory affairs, medical affairs) Other Information/Additional Preferences: Demonstrated ability to balance scientific priorities with business priorities with examples of successful leadership skills. Demonstrated strong communication, interpersonal, teamwork, organizational and negotiation skills. Demonstrated ability to influence others (both cross-functionally and within the function) in order to create a positive working environment. Ability to engage in domestic and international travel to the degree appropriate to support the business of the team. Fluent in English, verbal and written communication Primary internal interactions include, but not limited to: Therapeutic area directors, managers, or project managers Product directors, managers, and associates of the brand Clinical research staff Statisticians Scientific communication associates Medical information associates Medical liaisons Global patient outcomes research consultants/research scientists and health outcomes liaisons Regulatory directors, scientists, and associates Sales representatives Legal counsel Therapeutic area physicians, global brand physicians, early phase physicians, clinical research scientists, and Regional Medical Leader, Directors-Medical. Corporate or regional patient safety physician(s) External Contacts Scientific and clinical experts, thought leaders Lilly clinical investigators Practicing physicians/prescribers Regulatory agency personnel Professional association staff and leaders Disease advocates and lay organizations focused on relevant health issues Formulary representatives (private and government) Demonstrates the following competencies Making Business Decisions with data - Harnesses the power of data and analytics to solve problems, make good decisions and measure results. Job-Based Skills: Defines the problem or decision to be made within context of strategy or goals/objectives. Identifies relevant sources and validates accuracy of data. Analyzes and synthesizes data and identifies trends. Draws conclusions and makes timely, well-informed decisions. Engages data and analytics colleagues appropriately when needed. Scientific/Information Exchange - Maximizes engagement with key customers and colleagues through the integration of personal and/or non-personal channels when collaborating, discussing, and sharing science/information. Job-Based Skills: Identifies challenges, information gaps, education needs, and delivery preferences. Creates an engaging narrative. Generates content with the channel(s) and medium(s) in mind. Adjusts style and tone to meet the unique needs of each audience. Uses preferred channel(s) to deliver at the time of need. Measures knowledge gained. Technical/Functional Expertise - Leads with technical and functional expertise. Job-Based Skills: Establishes appropriate scientific and medical subject matter expertise (e.g., disease states, therapeutic landscapes, drug development processes, portfolio, etc.). Maintains relevant knowledge of the healthcare landscape (e.g., health, payer, and regulatory systems and processes) and environment (e.g., HCP experience models and patient flow maps, value/accountable care, and population health landscape, etc.). Understands the advancements in technology that are influencing area of expertise and function (i.e., real-world clinical practice, AI techniques, tools and platforms). Develops appropriate knowledge of activities that can be used to influence and deliver on organizational purpose (i.e., shape clinical practice, systems, tools and platforms). Masters individual workstream tools and processes. Strategic Agility - Defines and commits to an initial strategy or approach; monitors effectiveness; and adapts based on new information and/or insights. Job-Based Skills: Develops an actionable strategy or approach-involving colleagues and engaging stakeholders appropriately. Creates a clearly defined measurement plan with key metrics and triggers. Monitors progression and impact against key metrics. Identifies opportunities to improve. Reassesses strategy/approach and pivots when appropriate. Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $151,500 - $244,200 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly
    $151.5k-244.2k yearly Auto-Apply 8d ago
  • Clinical Research Associate 1

    Allen Spolden

    Clinical research coordinator job in Indiana

    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, PTO and 401K
    $53k-84k yearly est. 60d+ ago
  • Behavioral Research Coordinator II

    Ann & Robert H. Lurie Children's Hospital of Chicago 4.3company rating

    Clinical research coordinator job in Lincoln Park, MI

    Ann & Robert H. Lurie Children's Hospital of Chicago provides superior pediatric care in a setting that offers the latest benefits and innovations in medical technology, research and family-friendly design. As the largest pediatric provider in the region with a 140-year legacy of excellence, kids and their families are at the center of all we do. Ann & Robert H. Lurie Children's Hospital of Chicago is ranked in all 10 specialties by the U.S. News & World Report. Location Outpatient Services at 1440 N Dayton Job Description Coordinates all behavioral research activities with moderate supervision. Adheres to the service values and principles as well as the principles of research ethics. The balance between patient-facing and administrative data tasks varies according to the specific requirements of each research program. Essential Job Functions: * Manages research projects, including study start-up, protocol coordination, monitoring, and close-out activities. * Maintains strict adherence to study protocols and regulatory standards throughout all phases of the study. * Manages study regulatory activities by preparing and maintaining all regulatory documents and regulatory agencies, including protocols, informed consent documents, recruitment materials, initial submissions, modifications, and renewals. * Maintains comprehensive study documentation such as regulatory binders and correspondence. * Coordinates the conduct of behavioral research projects with various departments, adheres to standard operating procedures (SOPs) to ensure adherence to research protocols and regulatory standards, and track deadlines for grants and deliverables. * Identifies and recruits eligible study subjects, manage the informed consent/assent process, coordinate the reimbursement of study participants, and serve as the primary liaison for participant inquiries. * Arranges and conducts research visits, including delivering behavioral interventions, such as administering surveys, facilitating interviews, and leading focus groups. * Abstracts and enters data from medical records onto protocol-specific case report forms and electronic systems, record data on source documents and CRFs, and conduct statistical analysis under PI supervision. * Conducts quality assurance activities by adhering to research protocols and applicable regulations (OHRP, FDA, GCP), performing QA/QC checks for database validity, and ensuring ongoing data monitoring to maintain high standards of research integrity. * Attends research meetings and actively participate in educational conferences to promote the ethical conduct of research and stay informed about best practices. * Participates in the preparation and presentation of research findings through abstract and poster development and assists in the writing and editing manuscripts. * Other job functions as assigned. Knowledge, Skills, and Abilities: * Bachelor's degree and one year research experience required. A combination of education and/or experience may be considered in lieu of the degree when the experience is directly related to the duties of the job. * Proficient organizational skills with ability to manage multiple studies. Proficient verbal and written communications skills. * Proficient knowledge of FDA, HSR, and GCP Guidelines. * Proficient analytical skills with the ability to recognize quantitative and qualitative research methods and remain agile and adaptable to various technological systems. * Proficient entry level leadership skills. * Recognizes the need to prioritize tasks, problem solve, and work with others. * Assists to foster an inclusive environment where all team members feel valued and respect Education Bachelor's Degree (Required) Pay Range $49,920.00-$81,619.20 Salary At Lurie Children's, we are committed to competitive and fair compensation aligned with market rates and internal equity, reflecting individual contributions, experience, and expertise. The pay range for this job indicates minimum and maximum targets for the position. Ranges are regularly reviewed to stay aligned with market conditions. In addition to base salary, Lurie Children's offer a comprehensive rewards package that may include differentials for some hourly employees, leadership incentives for select roles, health and retirement benefits, and wellbeing programs. For more details on other compensation, consult your recruiter or click the following link to learn more about our benefits. Benefit Statement For full time and part time employees who work 20 or more hours per week we offer a generous benefits package that includes: Medical, dental and vision insurance Employer paid group term life and disability Employer contribution toward Health Savings Account Flexible Spending Accounts Paid Time Off (PTO), Paid Holidays and Paid Parental Leave 403(b) with a 5% employer match Various voluntary benefits: * Supplemental Life, AD&D and Disability * Critical Illness, Accident and Hospital Indemnity coverage * Tuition assistance * Student loan servicing and support * Adoption benefits * Backup Childcare and Eldercare * Employee Assistance Program, and other specialized behavioral health services and resources for employees and family members * Discount on services at Lurie Children's facilities * Discount purchasing program There's a Place for You with Us At Lurie Children's, we embrace and celebrate building a team with a variety of backgrounds, skills, and viewpoints - recognizing that different life experiences strengthen our workplace and the care we provide to the Chicago community and beyond. We treat everyone fairly, appreciate differences, and make meaningful connections that foster belonging. This is a place where you can be your best, so we can give our best to the patients and families who trust us with their care. Lurie Children's and its affiliates are equal employment opportunity employers. All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity or expression, religion, national origin, ancestry, age, disability, marital status, pregnancy, protected veteran status, order of protection status, protected genetic information, or any other characteristic protected by law. Support email: ***********************************
    $49.9k-81.6k yearly Auto-Apply 10d ago
  • Senior Clinical Research Coordinator

    DM Clinical Research

    Clinical research coordinator job in Detroit, MI

    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.
    $47k-74k yearly est. 60d+ ago
  • Clinical Research Coordinator II

    Care Access 4.3company rating

    Clinical research coordinator job in Indianapolis, IN

    Care Access is working to make the future of health better for all. With hundreds of research locations, mobile clinics, and clinicians across the globe, we bring world-class research and health services directly into communities that often face barriers to care. We are dedicated to ensuring that every person has the opportunity to understand their health, access the care they need, and contribute to the medical breakthroughs of tomorrow. With programs like Future of Medicine, which makes advanced health screenings and research opportunities accessible to communities worldwide, and Difference Makers, which supports local leaders to expand their community health and wellbeing efforts, we put people at the heart of medical progress. Through partnerships, technology, and perseverance, we are reimagining how clinical research and health services reach the world. Together, we are building a future of health that is better and more accessible for all. To learn more about Care Access, visit ******************* How This Role Makes a Difference The Clinical Research Coordinator's primary responsibilities are to utilize Good Clinical Practices (GCP)s in the process of screening, enrolling and closely monitoring clinical research study subjects while ensuring protocol and regulatory compliance. How You'll Make An Impact * Duties include but not limited to: * Ability to understand and follow institutional SOPs. * Review and assess protocol (including amendments) for clarity, logistical feasibility * Ensure that all training and study requirements are met prior to trial conduct. * Discuss study medication, required procedures, eligibility criteria and impact on office flow with Investigator and site staff. * Assist with planning and creation of appropriate recruitment materials * Assist in development of recruitment plan and obtain listing of potential candidates to contact from subject database. * Actively work with recruitment team in calling and recruiting subjects * Attend Investigator meetings as required. * Coordinate and attend pre-study site visits, site initiation visits, and monitor visits with clinical staff and Sponsor/CRO representatives. * Assist in the creation and review of source documents. * Ensure adequate supplies have arrived on site for protocol initiation (lab kits, study medication, specialized equipment, IVRS/EDC access and passwords) * Study Management * Prioritize activities with specific regard to protocol timelines * Maintain adherence to FDA regulations and ICH guidelines in all aspects of conducting clinical trials * Maintain effective relationships with study participants and other care Access Research personnel. * Interact in a positive, professional manner with patients, sponsor representatives, investigators and Care Access Research personnel and management. * Communicate clearly verbally and in writing. * Patient Coordination * Prescreen study candidates * Obtain informed consent per Care Access Research SOP * Complete visit procedures in accordance with protocol. * Train others and complete basic clinical procedures, such as blood draws, vital signs, ECGs, etc. * Review laboratory results, ECGs, and other test results (e.g., MRIs) for completeness and alert values, ensuring investigator review in a timely fashion. * Identify adverse events (AEs) and Serious Adverse Events (SAEs) and promptly notify Principal Investigator and Sponsor (where appropriate) * Documentation * Record data legibly and enter in real time on paper or e-source documents * Accurately record study medication inventory, medication dispensation, and patient compliance. * Resolve data management queries and correct source data within sponsor provided timelines * Assist regulatory personnel with completion and filing of regulatory documents. * Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive. The Expertise Required * Excellent working knowledge of medical and research terminology * Excellent working knowledge of federal regulations, good clinical practices (GCP) * Ability to communicate and work effectively with a diverse team of professionals. * Strong organizational, prioritization and leadership skills and capabilities with a strong attention to detail * Strong computer skills with demonstrated abilities using clinical trials database, IVR systems, electronic data capture, MS word and excel. * Critical thinker and problem solver * Friendly, outgoing personality; maintain a positive attitude under pressure. * High level of self-motivation and energy * Excellent professional writing and communication skills * Ability to work independently in a fast-paced environment with minimal supervision. Certifications/Licenses, Education, and Experience: * Bachelor's Degree preferred, or equivalent combination of education, training and experience. * A minimum of 3 years prior Clinical Research Coordinator experience required * Prefer 1 year of experience as a Care Access Research Clinical Research Coordinator * Recent phlebotomy experience required * Bilingual in Spanish-preferred How We Work Together * Location: This is an on-site position with regional commute requirements. Position requires onsite work 5 days per week at the Indianapolis, IN clinic. * Travel: Regularly planned travel within the region will be required as part of the role. * Physical demands associated with this position Include: The ability to use keyboards and other computer equipment. The expected salary range for this role is $60,000 - $90,000 USD per year for full time team members. Benefits & Perks * Paid Time Off (PTO) and Company Paid Holidays * 100% Employer paid medical, dental, and vision insurance plan options * Health Savings Account and Flexible Spending Accounts * Bi-weekly HSA employer contribution * Company paid Short-Term Disability and Long-Term Disability * 401(k) Retirement Plan, with Company Match Diversity & Inclusion We work with and serve people from diverse cultures and communities around the world. We are stronger and better when we build a team representing the communities we support. We maintain an inclusive culture where people from a broad range of backgrounds feel valued and respected as they contribute to our mission. We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to, and will not be discriminated against on the basis of, race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law. Care Access is unable to sponsor work visas at this time. If you need an accommodation to apply for a role with Care Access, please reach out to: ********************************
    $60k-90k yearly 23d ago
  • CLINICAL TRIALS STUDY COORDINATOR

    Dermatology Specialists

    Clinical research coordinator job in Ann Arbor, MI

    Job Description We are seeking a Full Time on-site Clinical Trials Study Coordinator. The Clinical Research Coordinator is responsible for managing clinical trial performance and ensuring the conduct of their clinical trials is congruent with the vision and mission of the company. The CRC plans, coordinates, evaluates, and manages the care of both the participants and the data for their assigned trials. The CRC follows study specific protocol guideline and communicates and interacts with Investigators, clinic staff, CROs and Sponsors to effectively perform clinical research and coordinate research activities. All duties carried out by the CRC are done so in accordance with company policies, SOPs, and Good Clinical Practice (GCP) as well as all applicable local, state and federal regulations. Primary Responsibilities: · Coordinate clinical trials conducted by a supervising Principal Investigator in accordance with FDA, GCP and protocol guidelines. · Identify potential problems or inconsistencies and take action as appropriate. · Articulate protocol issues to CRO and/or Sponsor, Site Lead, Manager, Principal or Sub-Investigator, and other members of the study team. · Collect initial subject health and demographic information by interviewing subjects and accessing other appropriate sources. · Review subject comprehensive medical documentation to determine protocol eligibility under the supervision of the Principal Investigator. · Ensure a flow of communication including telephone conferences between subject, study staff, referral sources and recruitment team, Sponsor and/or CRO, Monitor(s) and Auditors, if applicable. · Perform clinical tasks including, but not limited to: vital signs, height and weight, ECG, phlebotomy, specimen processing and packaging. · Maintain timely internal source documentation as well as sponsor-required information. · Maintain timely EDC data entry and query resolution. · Maintain timely CTMS data entry of patient visits and study information. · Complete Verification of subjects before consenting. · Report hospital census data, if applicable. · Dispense and maintain accurate records of investigational and study product. · Educate subject and family members regarding specific studies and clinical drug trials in general. · Complete all monitor and sponsor queries in a timely manner. · Perform Quality Control (QC) checks on all trials per company SOP and interface with QA Director as needed. Recruitment Responsibilities: · Send “All Users” email upon enrollment activation or enrollment closure · Participate in recruitment planning meetings prior to study start · Provide weekly updates to Active Studies Report · Communicate all advertising needs to recruitment team · Maintain weekly communication with recruitment team in order to maximize recruitment in all enrolling trials · Communicate the need for study or company flyers Secondary Responsibilities: Maintains Quality Service and Departmental Standards by · Reading, understanding and adhering to organizational Standard Operating Procedures (“SOP”) · Assisting in establishing and enforcing departmental standards Contributes to team effort by · Working with internal staff to resolve issues · Exploring new opportunities to add value to the organization and departmental processes · Helping others at the site to achieve site goals · Performing other duties as assigned · Support the organization's mission and goals Maintains Technical and Industry Knowledge by · Attending and participating in applicable company-sponsored training · Attending and participating in Sponsor investigator meetings, recruitment meetings, and trainings Skills And Qualifications: CCRC or CCRP certification preferred · Strong motivational skills and abilities - promoting a team-based approach · Strong interpersonal and communication skills, both verbal and written · Strong organizational and leadership skills · Goal oriented · Ability to maintain a professional and positive attitude · Detail Oriented · Strong critical thinking skills · Strong ability to multi-task · Strong computer skills · Ability to support and demonstrate the mission and goals of the company · Excellent interpersonal and customer service skills · Knowledge of medical terminology and clinical practices Experience: At least 2 years of experience as a CRC in clinical research or relevant clinical role Nothing in this position description restricts management's rights to assign or reassign duties and responsibilities to this position at any time.
    $40k-62k yearly est. 4d ago
  • Work Study Coordinator

    Livingston ESA

    Clinical research coordinator job in Michigan

    Work Study Coordinator FSLA: Exempt REPORTS TO: Director of Transition Services and Job Attainment UPDATED: 2025 SALARY/BENEFITS: Per LIPSA Master Agreement SCHEDULE: 10 - month Develops and maintains work experiences and procedures for the LESA Adult Transition program. Supports employment curriculum and classroom activities in conjunction with community-based work experiences. ESSENTIAL FUNCTIONS Note: These duties and responsibilities are judged to be "essential functions" in terms of the Americans With Disabilities Act or ADA. 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. The statements below are intended to describe the general nature and level of work being performed by a person in this position. They are not to be construed as an exhaustive list of all duties that may be performed by such a person. Other duties may be assigned. Work with Adult Transition teachers to identify and arrange Work-Based Learning opportunities for students. Responsible for exploring and developing Work-Based Learning opportunities within the Livingston County school and business communities. Specific duties include maintaining required pupil accounting paperwork, developing sites, on boarding/training staff, and staff supervision. Collaborate with Adult Transition Program staff to determine student(s) readiness for work-based learning. Consult with on-site job coaches to ensure that they are collecting data and performing duties as assigned. Work in collaboration with the LESA Transition Coordinator to support the Work Readiness Assessment Program (WRAP) within the local school districts Work with MRS counselor(s) and vendor(s) to identify appropriate services and readiness for job development. Coordinate job coaches and assist with problem solving, development of reasonable accommodations, maintenance, and implementation of specific job duties for sites. Supervise and evaluate job coaching staff providing continuous feedback and professional learning opportunities. Provide work-based learning data to student case managers and coordinate problem-solving team meetings when needed. Attend IEP meetings when deemed appropriate. Additional Duties Performs other duties as assigned. Supervisory Responsibilities May supervise students. QUALIFICATIONS PROFILE Education and/or Experience Master's degree in education or a field of study related to special education. Minimum of three years satisfactory teaching experience, 2 of which shall be in a special education classroom. Experience teaching to MI-Access curriculum preferred. Demonstration of competencies that will render him/her effective in assisting students with a disability to be employable. Certificates, Licenses, Registrations Michigan Teaching Certificate with a special education endorsement. LANGUAGE SKILLS Ability to read, analyze, and interpret professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of staff, parent, and the general public. MATHEMATICAL SKILLS Ability to calculate figures and amounts such as proportions and percentages. Ability to apply concepts of basic algebra and geometry. REASONING ABILITY Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables. OTHER SKILLS & ABILITIES Ability to apply knowledge of current research and theory in specific field. Ability to establish and maintain effective working relationships with students, staff and the community. Ability to communicate clearly and concisely both in oral and written form. Ability to perform duties with awareness of all district requirements and Board of Education policies. PHYSICAL DEMANDS While performing the duties of this job, the employee is regularly required to sit use hands to finger, handle, or feel; talk and hear. The employee is occasionally required to stand; walk; reach with hands and arms; and stoop, kneel, crouch, or crawl. The employee must occasionally lift and/or move up to 30 pounds. Specific vision abilities required by this job include close vision, and ability to adjust focus, especially due to concentration on a computer screen and small numbers. WORK ENVIRONMENT The noise level in the work environment can vary. When visiting a building the noise level will be loud, in the office, quiet and at meetings, moderate. The employee shall remain free of any alcohol or non-prescribed controlled substance in the workplace throughout his/her employment in the District. The Board of Education does not discriminate on the basis of race, color, national origin, sex, (including sexual orientation or transgender identity), disability, age, religion, height, weight, marital or family status, military status, ancestry, genetic information, or any other legally protected category, (collectively, "Protected Classes"), in its programs and activities, including employment opportunities. Inquiries regarding non-discrimination policies should be directed to the Superintendent.
    $39k-57k yearly est. 29d ago
  • Clinical Research Coordinator

    Dermatology Associates of West Mi

    Clinical research coordinator job in Grand Rapids, MI

    Must be located in Michigan whereas you must report to the office as needed. About Us Dermatology Associates of West Michigan is a patient-centered dermatology office dedicated to advancing skin health through compassionate care and cutting-edge research. We partner with leading sponsors to conduct clinical trials in medical and cosmetic dermatology. We are seeking a motivated, detail-oriented Clinical Research Coordinator (CRC) to join our growing research team. Position Summary The Clinical Research Coordinator will oversee and coordinate all aspects of clinical trials within the dermatology practice. This role requires strong organizational skills, excellent communication and leadership, and a commitment to regulatory compliance and patient safety. The CRC will serve as a key liaison between investigators, participants, sponsors, and regulatory bodies. Key Responsibilities Coordinate day-to-day study activities for dermatology clinical trials (Phase II-IV and device studies) Recruit, screen, and enroll eligible study participants Obtain informed consent and maintain high standards of patient communication and care Schedule study visits and ensure protocol adherence throughout the study lifecycle Collect, document, and enter study data accurately in electronic data capture (EDC) systems Collect and process biological samples according to study protocols Maintain regulatory binders and ensure ongoing compliance with FDA, GCP, IRB, and sponsor requirements Communicate with sponsors, CROs, monitors, and internal teams Assist with study start-up activities, including feasibility assessments and site qualifications Support investigators during patient visits, procedures, and query resolution Prepare for and participate in monitoring visits, audits, and inspections Qualifications Required: Previous experience as a Clinical Research Coordinator Strong understanding of clinical research processes and GCP guidelines Exceptional attention to detail and organizational skills Excellent communication and interpersonal abilities Ability to work independently and manage multiple studies simultaneously Preferred: Dermatology experience highly preferred Bachelor's degree in a health-related field or equivalent clinical experience Certification (ACRP, SOCRA) or willingness to obtain preferred but not required Experience working with EDC systems, CTMS platforms, and IRB submissions What We Offer Robust hands-on support to ensure foundational support for success within this role. Competitive compensation and benefits package Opportunities for professional development and certification Supportive, collaborative clinical and research environment The chance to participate in cutting edge research.
    $43k-63k yearly est. 17d ago
  • Research Study Coordinator / Clinical Research Coordinator

    R&D Partners

    Clinical research coordinator job in Detroit, MI

    R&D Partners is seeking to hire a Research Study Coordinator / Clinical Research Coordinator in Detroit, MI. Your main responsibilities as a Research Study Coordinator / Clinical Research Coordinator: Coordinates research projects within guides of regulatory compliance and/or Code of Federal Regulation. Provides technical support to Principal Investigators. Interacting with both internal and external customers at all levels and oversight of recruitment and coordinating day-to-day operations of the study. Direct contact with potential and enrolled study participants expected. Provides other support as required. What we are looking for in a Research Study Coordinator / Clinical Research Coordinator: One (1) year of research project coordination experience. (But as per update from the AM- could be better if we can have someone with 3yrs experience) SOCRA or ACRP and IATA certification preferred. Why Choose R&D Partners? As an employee, you have access to a comprehensive benefits package including: Medical insurance PPO, HMO & HSA Dental & Vision insurance 401k plan Employee Assistance Program Long-term disability Weekly payroll Expense reimbursement Online timecard approval Pay Scale: $65,000 - $70,000 ( Dependent on Experience) R&D Partners is a global functional service provider and strategic staffing resource specializing in scientific, clinical research & engineering. We provide job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies. R&D Partners is an equal-opportunity employer.
    $65k-70k yearly 60d+ ago
  • Clinical Research Coordinator Registered Nurse

    Michigan Institute of Urology

    Clinical research coordinator job in Troy, MI

    Full-time Description Clinical Research Coordinator, RN's are primarily responsible for study coordination and data management, with a central focus on managing subject recruitment and enrollment, consistency of study implementation, data management and integrity, and compliance with regulatory requirements and reporting. Requirements ESSENTIAL JOB FUNCTION/COMPETENCIES The responsibilities and duties described in this job description are intended to provide a general overview of the position. Duties may vary depending on the specific needs of the affiliate or location you are working at and/or state requirements. Responsibilities include but are not limited to: 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). Complete all relevant Profound Research required training, including but not limited to ICH-GCP certification and IATA certification in a timely manner. Educates and directs protocol compliance with physicians and staff. Assists in developing tools to meet requirements of new protocols. Manages protocols with increased clinical complexities including translational investigator-initiated research as well as multi center trials. 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. Acts as a patient advocate by providing education to and responding to questions from patients about protocols. Works with patients to ensure adherence with the protocol. Collaborates with scheduling staff to assure that future appointments for the patients (follow up visits and diagnostic testing) are scheduled correctly and timely. Collaborates with the physician to assure orders for treatment are written per protocol and delivered at the prescribed protocol intervals. Performs other position related duties as assigned. Employees shall adhere to high standards of ethical conduct and will comply with and assist in complying with all applicable laws and regulations. This will include and not be limited to following the Solaris Health Code of Conduct and all Solaris Health and Affiliated Practice policies and procedures; maintaining the confidentiality of patients' protected health information in compliance with the Health Insurance Portability and Accountability Act (HIPAA); immediately reporting any suspected concerns and/or violations to a supervisor and/or the Compliance Department; and the timely completion the Annual Compliance Training. CERTIFICATIONS, LICENSURES OR REGISTRY REQUIREMENTS BLS certification required, ACLS preferred. RN licensure and certifications as required by State. Clinical research certification from SoCRA (Society of Clinical Research Associates) or ACRP (Association of Clinical Research Professionals) preferred. KNOWLEDGE | SKILLS | ABILITIES Ability to Start IVs and Administer IV medications Ability to draw blood Understanding of all aspects of biomedical research protocols, ensuring applicable regulations, and guidelines. Maintains patient confidentially. Excellent verbal and written communication skills. Skill in using computer programs and applications. Maintains current knowledge and awareness of organizational and regulatory standards, policies and procedures. Excellent organizational skills and attention to detail. Ability to build relationships with patients and display empathy and compassion to patients Skill in using computer programs and applications including Microsoft Office. Complies with HIPAA regulations for patient confidentiality. Complies with all health and safety policies of the organization. EDUCATION REQUIREMENTS Must be a Registered Nurse (RN) with a current and valid license. Associate's or Bachelor's degree in Nursing (ASN or BSN) required. EXPERIENCE REQUIREMENTS 2 or more years Nursing experience in ICU, ER, oncology or clinical trial experience, preferred. REQUIRED TRAVEL May require travel to other site locations in practice. May require travel to Investigator and other meetings. PHYSICAL DEMANDS Carrying Weight Frequency 1-25 lbs. Frequent from 34% to 66% 26-50 lbs. Occasionally from 2% to 33% Pushing/Pulling Frequency 1-25 lbs. Seldom, up to 2% 100 + lbs. Seldom, up to 2% Lifting - Height, Weight Frequency Floor to Chest, 1 -25 lbs. Occasional: from 2% to 33% Floor to Chest, 26-50 lbs. Seldom: up to 2% Floor to Waist, 1-25 lbs. Occasional: from 2% to 33% Floor to Waist, 26-50 lbs. Seldom: up to 2% Version 6.2.25
    $43k-64k yearly est. 60d+ ago
  • Clinical Research Coordinator- Cardiology (Detroit, MI)

    Profound Research

    Clinical research coordinator job in Detroit, MI

    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) 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.
    $43k-64k yearly est. Auto-Apply 2d ago
  • Clinical Research Coordinator

    Alliance for Multispecialty Research

    Clinical research coordinator job in Dearborn, MI

    The Clinical Research Coordinator will perform and manage tasks that are critical to clinical research studies. The Clinical Research Coordinator must ensure compliance with federal regulations, study protocol guidelines, as well as monitor study participants, and take a proactive approach to identify issues on an ongoing basis throughout the clinical research study. To consistently embody AMR Clinical's Core Values: United We Achieve Celebrate Diverse Perspectives Do the Right Thing Adapt and Persevere The Clinical Research Coordinator reports to the Site Manager/Team Lead. Classification: Non-Exempt Primary Responsibilities: Focuses on compliance responsibilities, including protocol deviations, SAE reporting, and informed consent. Strong focus on compliance responsibilities, including managing protocol deviations, SAE reporting, and ensuring proper informed consent procedures. Coordinate clinical trials per FDA requirements and GCP Guidelines per sponsor protocols. Manage and document Adverse Event and Serious Adverse Event reporting in compliance with FDA, IRB, and sponsor requirements, ensuring timely follow-up and resolution. Establish understanding of SOP's and implement the SOP's Gain understanding of the pharmaceutical drug per clinical trial. Develop detailed knowledge of protocol and procedures per clinical research study. Communicate effectively with study sponsors, CROs, monitors/CRA's, IRBs, laboratories, and clinical personnel within the research industry. Be the study ambassador on assigned studies to advise team members on protocols and procedures to ensure successful implementation and completion of the clinical research study. Establish and maintain patient rapport. Clinical data collection (vital signs, EKG recording, weight, height, etc.) Obtain medical records and review as required. Phlebotomy Specimen collection, processing, and storage Transporting clinical specimens to the laboratory. Educate subjects on diaries and oversees compliance with diary completion. Provides subjects instructions per study (diaries, restricted meds, study reminders, etc.) Responsible for completing patient phone call visits in accordance to the standard protocol period. Ensure documentation follows ALCOA standards and is completed in a timely manner. Ensure all necessary documents are completed, signed and dated. Provides required information to Contract Research Organization (CRO), Institutional Review Board (IRB), sponsoring organization, Food and Drug Administration (FDA), and/or other appropriate agency as required. Manage study inventory and order supplies as needed. Prepare and assist study monitors during onsite visits. Maintain familiarity with all ongoing clinical research studies. Travel to Investigator meetings as needed. Promote team mentality by working flexible hours as needed and completing tasks outside the scope of everyday duties Position may require occasional weekend and/or overtime hours. Other duties as assigned Desired Skills and Qualifications: 1 year of experience in clinical research. Completion of formal medical training, educational program, or healthcare experience Strong medical terminology Ability to perform clinical, laboratory, and diagnostic tests (vital signs, height, weight, temperature, etc.). Ability to work independently and lead study-related tasks. Ability to multi-task in a high-paced evolving environment. Exceptional listening, written, and verbal communication skills as well. Demonstrate proficiency in office equipment and software programs. Excellent organizational and task management skills. Ability to be ambulatory most of the workday. Ability to lift/transfer/push/manipulate equipment and patients, which requires strength, gross motor and fine motor coordination. AMR Clinical does not discriminate in employment on the basis of race, color, religion, sex (including pregnancy and gender identity), national origin, political affiliation, sexual orientation, marital status, disability, genetic information, age, retaliation, parental status, military service, or other non-merit factor. ** This job description is intended to be a representative summary of the major responsibilities and accountabilities of the staff holding this position. The staff may be requested to perform job-related tasks other than those stated in this description.
    $43k-64k yearly est. Auto-Apply 60d+ ago
  • Clinical Research Coordinator II

    Dm Clinical Research Group

    Clinical research coordinator job in Indianapolis, IN

    Job Details Indianapolis - Indianapolis, INClinical 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: a. Sponsor-provided and IRB-approved Protocol Training b. All relevant Protocol Amendments Training c. Any study-specific Manuals Training, as applicable d. 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) 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 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 2Any other matters as assigned by management. KNOWLEDGE & EXPERIENCE Education: High School Diploma or equivalent required; Bachelor's degree 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. 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.
    $40k-59k yearly est. 56d ago
  • Trial Specialist

    Ford Global

    Clinical research coordinator job in Dearborn, MI

    The Trial Specialist is responsible for the comprehensive management, coordination, and facilitation of stamping and material trials within the organization. This role serves as the primary point of contact for internal and external stakeholders regarding trial requests and ensures the efficient execution, tracking, and reporting of all trial activities. The specialist also leads efforts for critical "special project" trial-related matters, addressing significant business interruptions and strategic resourcing initiatives. Qualifications (Desired): Proven experience in project management or coordination, preferably within a manufacturing or engineering environment. Strong organizational and time management skills with the ability to manage multiple complex trials simultaneously. Excellent communication and interpersonal skills to effectively liaise with diverse internal and external stakeholders. Ability to facilitate meetings, gather feedback, and drive consensus. Proficiency in tracking and reporting tools. Knowledge of stamping processes, material trials, and supply chain logistics is highly desirable. Problem-solving skills with a proactive approach to addressing challenges and business interruptions. Key Responsibilities: Manage all stamping trial actions from initiation to completion. Facilitate the development and submission of trial proposals. Serve as the Single Point of Contact (SPOC) for other organizations, mills, and material processors concerning trial requests. Establish and maintain clear points of contact for each phase of every trial. Manage and update trial tracking sheets to ensure accurate status reporting. Coordinate the timing of material orders effectively with Material Planning & Logistics (MP&L). Collect and synthesize trial feedback from all designated points of contact. Facilitate Material Trial Cost Reimbursement Requests, ensuring timely processing. Schedule and coordinate regular trial meetings (monthly or bi-weekly) with trial administrators across eleven stamping facilities to monitor and update trial statuses. Act as the lead for "special project" trial-related matters, including critical resourcing initiatives (e.g., Cliffs, Constellium), responses to significant events (e.g., Novelis fire, Tariff actions), and recovery from business interruptions (e.g., SET Enterprises bankruptcy, Cliffs Dearborn Works BOF shutdown).
    $55k-95k yearly est. Auto-Apply 3d ago
  • Clinical Research Coordinator

    Revival Research Institute

    Clinical research coordinator job in Dearborn Heights, MI

    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!!!
    $43k-64k yearly est. 60d+ ago
  • Clinical Research Coordinator

    Iterative Health

    Clinical research coordinator job in New Albany, IN

    Iterative Health is a healthcare technology and services company powering the acceleration of clinical research to transform patient outcomes. The Iterative Health Site Network is a premier network of 70+ clinical research sites across US and Europe accelerating the path to market for gastrointestinal (GI) and hepatology novel therapies. Our focus is on driving the success and growth of our partner sites by empowering them with tech-enabled services. By combining deep expertise in clinical trials with cutting-edge AI, we empower research teams and study sponsors to expand and expedite access to novel therapeutics for patients in need. Reports To: Manager, Clinical Research Job Summary: The Clinical Research Coordinator is responsible to coordinate and administer research study associated activities and ensures that regulatory requirements are followed including adherence to the principles of good clinical practices (GCPs) and adequate human subject protection (HSP). Conduct clinical drug trials in a manner which ensures compliance with regulatory standards, sponsor requirements, patient safety and confidentiality and high professional standards. FLSA: Non-Exempt Supervisory Responsibility: This position has no supervisory responsibilities Key Responsibilities Administratively and clinically manage industry sponsored clinical trials. Adhere to Research SOP's, Good Clinical Practices, and the study protocols. Assist in patient recruitment by performing detailed chart reviews and patient interviews. Discuss study protocols with patients and verify the informed consent documentation. Review medical history of patient against inclusion/exclusion criteria of studies. Perform blood draws, process and ship blood/urine specimens per study protocol and IATA regulations. Schedule all patient research visits and procedures consistent with protocol requirements. Dispense study medication, collect vital signs, and perform ECGs. Assist with routine data verification and quality control, ensuring data integrity and consistency with prescribed study protocol. Complete and maintain case report forms per FDA guidelines and review them against the patient's medical record for completeness and accuracy. Function in a clinical role by conducting clinical research studies. Monitor patients and providing information to the medical staff and other staff members to assure optimal outcomes. Develop written concise research study information and/or tools to be used for the education of staff and the recruitment of patients. Maintain compliance of protocols and regulatory guidelines for studies performed in the research area. Act as a resource for other staff members regarding investigational issues or guidelines. Coordinate the availability and distribution of medications for patients in a timely manner. Perform phlebotomy for lab work as required and completes all necessary forms. Responsible for the education of patients in all aspects of the disease process and/or clinical study in which the patient may be involved. Plan and coordinate the initiation of research study protocols, and the establishment of operating policies and procedures. Assist the principal investigator and research director with various administrative tasks associated with the day-to-day operations of research studies and projects. Plan and coordinate with the research director the staffing of research studies, to include the recruitment and administration of research support staff, as appropriate to the activity. Plan, implement, and maintain data collection and analysis systems in support of the research protocol. Monitor the progress of research activities; develop and maintain records of research activities, and prepare periodic and ad hoc reports, as required by investigators, administrators, funding agencies, and/or regulatory bodies. Facilitate assigned clinical trial from start to finish. Screen participants for all studies independently. Summarize and clarify for study teams, the professional guidelines and code of ethics related to the conduct of clinical research. Triage phone calls from subjects, be able to answer clinical care questions within the scope of practice; determine when escalation is required. Adhere to infection control/safety guidelines and confidentiality policies. Core Competencies Flexible, Detail oriented, Customer focus, Team working, Initiative, Problem solving, Organized, Self-motivated General Adopt the One GI culture of respect, integrity and accountability that contribute to an internal environment of teamwork and promote a positive brand image to our external customers. Incorporate a leadership mindset to your role. Comply with One GI procedures, policies, and regulations relevant to your role. Successfully completes all One GI training requirements (i.e. OSHA, HIPAA, HealthStream, compliance, etc.) Responsible for compliance with all regulatory requirements and/or guidelines. These requirements/guidelines include, but are not limited to: OSHA, HIPAA, Federal Fraud and Abuse laws. Computer skills - good working knowledge of MS office. Ability to communicate effectively with others, both verbally and in writing. Proven ability to manage time, meet deadlines and prioritize. Able to maintain standards and professionalism during periods of fluctuating workloads. Provide professional service to direct customers of One GI in all interactions. Build effective working relationships with other team members. Manage daily tasks to ensure business needs are consistently met. Education and Qualifications High School Diploma or equivalent required. Associates degree in a clinical or scientific related discipline required. Bachelor's degree preferred. One (1) year previous experience as a clinical research coordinator for pharmaceutical phase II or III trials required. Previous GI trials experience preferred. Clinical experience in an office or hospital setting. Research experience or equivalent. Must maintain current licensure and/or certification. Basic Life Support certification required. Knowledge of medical terminology, anatomy, physiology, and pathophysiology. Familiarity with health care systems, regulations, policies, and functions. Understanding of clinical research documentation standards. Knowledge of equipment, supplies, and materials needed for medical treatment. Understanding of basic laboratory procedures including phlebotomy, preparation, and screening Working knowledge of industry standards and regulatory requirements relevant to clinical drug trails. Registered Nurse with five (5) years experience required. BSN preferable. Membership in local, state and national societies is encouraged. Understanding of Code of Federal Regulations for Human Subjects. Certified in GCP's and HSP. Periodic local travel to other practice locations on an as-needed basis. Phlebotomy experience preferred. Physical Demands The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this job, the employee is regularly requiredto speak and hear. Understand/comprehend English as well as read/follow written English instructions. This role requires continuous activity levels in areas such as walking, standing, pushing, pulling, lifting, and reaching. It also requires dexterity in motion/flexibility. Ability to lift, push or pull 35+ or more. Must be able to differentiate colors and successfully pass color blind screening. Work Environment This job operates in a clinic and procedure room environment. There is potential to be exposed to blood, tissue, and bodily fluids. Involves exposure to Glutaraldehyde/Rapicide (Refer to SDS manual as needed). Occasional exposure to communicable diseases and biohazards. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above 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. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at anytime with or without notice. Accommodations Reasonable accommodations will be made to enable a qualified individual with a disability to perform the non-essential or essential functions of this job. All accommodations will be investigated on an individual basis with theneeds of the department and current staff resources considered. Accommodations will not be made that compromise the safety and health of any associate. At Iterative Health, we're actively working towards creating an environment that is representative of the diversity of patients our technology serves. We are focused on building an equitable and inclusive culture, and by extension, hiring process. If you require any accommodations to make the application process or interviewing experience more accessible to you, please contact CandidateAccommodations@iterative.health.
    $40k-58k yearly est. Auto-Apply 60d+ ago
  • Parasitology - Clinical Research

    Zoetis 4.9company rating

    Clinical research coordinator job in Kalamazoo, MI

    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 Regular Colleague 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. Zoetis retains sole and exclusive discretion to pursue sponsorship for the acquisition or maintenance of nonimmigrant status and employment eligibility, considering factors such as availability of qualified US workers. Individuals requiring sponsorship must disclose this fact. Please note that Zoetis seeks information related to job applications from candidates for jobs in the U.S. solely via the following: (1) our company website at ********************** site, or (2) via email to/from addresses using only the Zoetis domain of "@zoetis.com". In addition, Zoetis does not use Google Hangout for any recruitment related activities. Any solicitation or request for information related to job applications with Zoetis via any other means and/or utilizing email addresses with any other domain should be disregarded. In addition, Zoetis will never ask candidates to make any type of personal financial investment related to gaining employment with Zoetis.
    $50k-68k yearly est. Auto-Apply 52d ago
  • Clinical Research Coordinator II

    Objectivehealth 3.7company rating

    Clinical research coordinator job in South Bend, IN

    Our clinical research company is looking to hire a qualified candidate for the full-time position of Clinical Research Coordinator II. The ideal candidate will possess 3+ years of clinical research coordination experience, and have a strong desire to work directly with patients. Who We Are ObjectiveHealth is a clinical research company that uses proprietary technology to: * Increase patient access to research trials within our communities, * Provide physicians with enhanced care options for current patients, and * Deliver superior clinical research enrollment metrics to Pharma sponsors All with the goal of Improving Patient Outcomes at the Point of Care. We want you to join us in doing just that. Who You Are * A lover of patient interaction and skilled at providing patient care * A team player with a bias for action and an attitude that takes personal responsibility * Skilled in all aspects required for conducting an IRB approved clinical trial protocol: identification, screening, randomization, and enrollment of patients, conducting clinic visits, etc. * Skilled at performing and assisting with direct patient care activities: consenting patients, physical assessments, blood draws, medication administration, ECG, etc. * Possess an acute attention to detail for clean data entry, regulatory compliance, productive site visits, efficient study set-up and maintenance, and strict protocol adherence * An expert communicator with the goal of fostering relationships between the research team, PIs, Sponsors, Monitors, and others * A strong advocate for Company values, mission, and initiatives * Not easily distracted: You have the ability to stay focused while running different protocols, resolving and submitting IRB responses and audit findings, tracking AE and SAE events, and maintaining eSource material for assigned studies * Energized by the idea of playing a role in the future of new therapy development in the areas of Gastroenterology, Urology, Dermatology, and/or Oncology What Success Looks Like for This Role * Taking ownership of assigned studies and patients * Communicating promptly and effectively with leadership and coworkers when you have a question or see something that needs correction * Showing up on time, every time * Ensuring strict compliance to the laws, regulations, and requirements of all applicable governing bodies * Learning and using the technologies we provide to increase efficiency in your day-to-day activities * Embodying our core values of Compassion, Integrity, Collaboration, Innovation, Velocity, and Dedication What We Offer Competitive compensation, 401(k) with Company match, a clear career pathway for advancement within the Company, Short- and Long-Term Disability, Health Savings and Flexible Spending Accounts, Health, Dental and Vision insurance Plans, Generous PTO, Adoption Assistance, Paid Holidays, and a wide selection of other voluntary benefits. Requirements This job requires legal authorization to work in the US. We are not currently accepting work visas. ObjectiveHealth is an EEO Employer and an E-Verify participant.
    $41k-61k yearly est. 51d ago

Learn more about clinical research coordinator jobs

How much does a clinical research coordinator earn in Kalamazoo, MI?

The average clinical research coordinator in Kalamazoo, MI earns between $35,000 and $74,000 annually. This compares to the national average clinical research coordinator range of $37,000 to $72,000.

Average clinical research coordinator salary in Kalamazoo, MI

$51,000
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