Clinical Research Associate II
Clinical research associate job in Oakland, MI
Responsible for providing Clinical Research support for all clinical trials. Under the direction of supervisor or designee, this position will serve as support for the clinical study team.
Essential Duties And Responsibilities
Participate and assist in design and preparation of protocols and case report forms.
Generate clinical SOPs, policies, charters, and plans according to US and international guidelines.
Participate in the evaluation of potential clinical sites according to established criteria of acceptability.
Responsible for procurement of budgets, contracts, regulatory documents, and other administrative documents as related to clinical research functions.
Initiate studies performing initiation site visits, arrange for shipment of clinical supplies, case report forms, and other necessary materials.
Conduct ongoing study monitoring, including frequent periodic site visits, protocol adherence checks, material handling procedures, inspection of study files, and related monitoring functions.
Prepare site visit reports with identification of key accomplishments, key issues for resolution and recommendations for follow -up actions for assigned study sites.
Conduct study termination visits, obtain final reports from investigators, and participate in the preparation of final reports for regulatory submission.
Assist with the maintenance of clinical archive and electronic files.
Other tasks as assigned.
Requirements
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
BA, BS, RN, BSN or equivalent
Basic knowledge and adherence to GCPs
1 -2 years of clinical research experience or equivalent experience or training
Strong attention to detail
Ability to multi -task
Unquestionable integrity and highest ethical standards
Excellent written and verbal communication skills
Self -motivated, assertive, and driven
BenefitsDental, Medical, Vision and 401K
Clinical Research Associate
Clinical research associate job in Grosse Pointe Woods, MI
The Clinical Research Associate will focus primarily on data management for clinical trials and act as a backup for regulatory associates. Initially, the role involves working with Registry studies, including pre-screening, recruiting, consenting, and following up with participants. This will occupy approximately 40% of the time, with the remainder dedicated to data entry, data management, and assisting the Research Nurse during patient visits.
Responsibilities
* Manage data for clinical trials and serve as a backup for regulatory associates.
* Work with Registry studies, including pre-screening, recruiting, consenting, and follow-up activities.
* Perform data entry and data management tasks.
* Assist the Research Nurse with patient visits.
Essential Skills
* Chart review
* Pre-screening patients
* Clinical research experience
* Clinical trial management
* Data entry
* Data management
* Minimum of 1 year of clinical research experience
* Understanding of clinical trials terminology
* Proficiency in EDC systems, with the ability to learn various systems
Additional Skills & Qualifications
* Experience in oncology is ideal
* Willingness to undergo oncology training
Job Type & Location
This is a Contract position based out of Grosse Pointe Woods, MI.
Pay and Benefits
The pay range for this position is $20.00 - $31.00/hr.
Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave)
Workplace Type
This is a fully onsite position in Grosse Pointe Woods,MI.
Application Deadline
This position is anticipated to close on Jan 5, 2026.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.
Senior Clinical Research Coordinator
Clinical research associate job in Southfield, MI
Flourish Research is looking for motivated, talented, creative individuals who want to learn and grow in their careers while contributing to research that changes lives! We offer an excellent comprehensive benefits package, a supportive and collaborative work environment, and endless growth opportunities.
We are actively hiring Senior Clinical Research Coordinators at our Detroit, MI location!
The Senior Clinical Research Coordinator assists the Investigators in executing Phase I, II, III, and IV clinical research trials in accordance with Standard Operating Procedures (SOPs), FDA and GCP guidelines, and study protocols while providing an impeccable patient experience in every, single interaction.
Shift: Monday-Friday, 9 AM - 5 PM; one Saturday each month (9am - 1pm)
Location: 20755 Greenfield Rd # 107, Southfield, MI 48075
Compensation: $30 - $36 based on experience + quarterly discretionary performance bonuses
Benefits: Health, dental, and vision insurance plans, 401k with 4% match, tuition reimbursement, parental leave, referral program, employee assistance program, life insurance, disability insurance, and 15 days of PTO + 10 company holidays.
RESPONSIBILITIES
The Clinical Research Coordinator (CRC) obtains study participant informed consent.
Executes study protocol procedures in a detailed, organized, and professional manner.
Performs human specimen lab draws and processing, and packages specimen shipments.
Creates and completes study source documents and adverse event reporting on an e-source system.
Maintains study-specific files and supplies.
Communicate with the Study Sponsor/CRO regarding study-specific questions.
Participates in site visits from Sponsors/CROs, including site initiation and monitoring visits.
Additional duties as assigned by management
QUALIFICATIONS
Bachelor's degree preferred but not required
Phlebotomy experience is required; EKG or other patient labs/processes preferred
5+ years of experience as a Clinical Research Coordinator
Familiar with e-source reporting via an electronic platform
A clear understanding of ICH, FDA, and GCP regulations
Impeccable organizational skills and attention to detail
Excellent communication and interpersonal skills to effectively interact with the Principal Investigator, research team, Study Sponsor/CROs, potential subjects, and referral sources
An ethical compass that compels the candidate to be honest, detail-oriented, and self-driven
High-level critical thinking skills
Working knowledge of medical terminology and lab collection/processing/storage procedures
Proficiency with computers and Microsoft Office Suite
Flourish Research offers an excellent comprehensive benefits package, a supportive and collaborative work environment, and endless growth opportunities. Apply today to learn more about how you can join us in our mission to save and improve the lives of others!
Flourish Research is where clinical trials thrive.
Flourish Research represents one of the industry's most progressive and diversified clinical trial companies with robust capabilities in the therapeutic areas of cardiology/metabolic disorders/renal, CNS, pulmonology, and vaccines.
At Flourish Research, we strive toward excellence. In clinical trials and healthcare, excellence means everyone deserves the best care, regardless of their race, color, gender identity, religion, ethnicity, physical abilities, age, sexual orientation, or veteran status. We embrace employees, customers, and patients from these underrepresented groups to help make this vision a reality.
Flourish Research is driven by a diverse and inclusive community of passionate people who are committed to improving the quality of life of communities around the world. Flourish is committed to a safe work environment where all employees, customers, and patients are included, and treated with dignity and respect.
Flourish Research strives to build an organization that attracts and leverages diversity in our staff, which reflects the diversity of our local communities. We promote education, acceptance, and inclusion because there is beauty in diversity. The more diversity we have in our team, the more unique perspectives, and ideas we share, and the better prepared we are to serve our communities. WE SEE YOU. WE ARE YOU. WE EMBRACE YOU. WE CELEBRATE YOU!
It is the policy of Flourish Research not to discriminate against any applicant for employment, or any employee because of age, color, sex, disability, national origin, race, religion, or veteran status.
Auto-ApplySenior Clinical Research Coordinator
Clinical research associate 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.
Clinical Research Study Assistant II - Neurology
Clinical research associate job in Taylor, MI
Scheduled Hours40Under direction, participates in clinical research study activities; screens, obtains consent, and enrolls participants in study; performs a variety of duties involved in the collection, documentation, and reporting of clinical research data.Job Description
Primary Duties & Responsibilities:
Participates in the recruitment of study participants as identified in related protocol; visits with study participants to explain study, screens for eligibility and obtains informed consent of participants.
Completes all necessary paperwork/documentation according to study protocol; obtains consent, interviews study subjects and schedules follow-ups as needed.
Performs basic/scripted assessments to confirm eligibility to participate in study; explains and schedules laboratory and diagnostic procedures and/or treatment as required in the study; refers participants to basic resources as necessary.
Collects data from study participants, medical records, interviews, questionnaires, diagnostic tests and other sources; performs basic evaluation and interpretation of collected data and prepares appropriate reports and documentation as necessary; prepares and distributes study packets and information.
Performs other duties as assigned.
Working Conditions:
Job Location/Working Conditions:
Normal office environment.
Physical Effort:
Typically sitting at desk or table.
Repetitive wrist, hand or finger movement.
Equipment:
Office equipment.
The above statements are intended to describe the general nature and level of work performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all job duties performed by the personnel so classified. Management reserves the right to revise or amend duties at any time.Required Qualifications
Education:
High school diploma or equivalent high school certification or combination of education and/or experience.
Certifications:
The list below may include all acceptable certifications and issuers. More than one credential or certification may be required depending on the role.Basic Life Support - American Heart Association, Basic Life Support - American Red Cross
Work Experience:
Administrative Or Research (2 Years)
Skills:
Not Applicable
Driver's License:
A driver's license is not required for this position.More About This JobRequired Qualifications:
Basic Life Support certification must be obtained within one month of hire date
Basic Life Support certification (Online Basic Life Support certifications, those without a skills assessment component, are not sufficient to meet the Basic Life Support requirements).
Preferred Qualifications
Education:
Associate degree
Certifications:
No additional certification unless stated elsewhere in the job posting.
Work Experience:
No additional work experience unless stated elsewhere in the job posting.
Skills:
Interpersonal Communication, Oral Communications, Organizing, Written CommunicationGradeC07-HSalary Range$19.21 - $28.85 / HourlyThe salary range reflects base salaries paid for positions in a given job grade across the University. Individual rates within the range will be determined by factors including one's qualifications and performance, equity with others in the department, market rates for positions within the same grade and department budget.Questions
For frequently asked questions about the application process, please refer to our External Applicant FAQ.
Accommodation
If you are unable to use our online application system and would like an accommodation, please email **************************** or call the dedicated accommodation inquiry number at ************ and leave a voicemail with the nature of your request.
All qualified individuals must be able to perform the essential functions of the position satisfactorily and, if requested, reasonable accommodations will be made to enable employees with disabilities to perform the essential functions of their job, absent undue hardship.Pre-Employment ScreeningAll external candidates receiving an offer for employment will be required to submit to pre-employment screening for this position. The screenings will include criminal background check and, as applicable for the position, other background checks, drug screen, an employment and education or licensure/certification verification, physical examination, certain vaccinations and/or governmental registry checks. All offers are contingent upon successful completion of required screening.Benefits Statement
Personal
Up to 22 days of vacation, 10 recognized holidays, and sick time.
Competitive health insurance packages with priority appointments and lower copays/coinsurance.
Take advantage of our free Metro transit U-Pass for eligible employees.
WashU provides eligible employees with a defined contribution (403(b)) Retirement Savings Plan, which combines employee contributions and university contributions starting at 7%.
Wellness
Wellness challenges, annual health screenings, mental health resources, mindfulness programs and courses, employee assistance program (EAP), financial resources, access to dietitians, and more!
Family
We offer 4 weeks of caregiver leave to bond with your new child. Family care resources are also available for your continued childcare needs. Need adult care? We've got you covered.
WashU covers the cost of tuition for you and your family, including dependent undergraduate-level college tuition up to 100% at WashU and 40% elsewhere after seven years with us.
For policies, detailed benefits, and eligibility, please visit: ******************************
EEO StatementWashington University in St. Louis is committed to the principles and practices of equal employment opportunity and especially encourages applications by those from underrepresented groups. It is the University's policy to provide equal opportunity and access to persons in all job titles without regard to race, ethnicity, color, national origin, age, religion, sex, sexual orientation, gender identity or expression, disability, protected veteran status, or genetic information.Washington University is dedicated to building a community of individuals who are committed to contributing to an inclusive environment - fostering respect for all and welcoming individuals from diverse backgrounds, experiences and perspectives. Individuals with a commitment to these values are encouraged to apply.
Auto-ApplyCLINICAL TRIALS STUDY COORDINATOR
Clinical research associate 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.
Clinical Research Coordinator
Clinical research associate job in Clinton, MI
Job Description
We are seeking a highly organized and motivated Clinical Research Coordinator (CRC) to join our research team. The CRC will coordinate and support all aspects of clinical trials and research studies, including subject recruitment, data collection, regulatory compliance, and specimen handling. Candidates with current Phlebotomy certification or Medical Assistant (MA) certification are strongly preferred, as this role may include specimen collection and basic clinical procedures.
Key Responsibilities:
Coordinate day-to-day clinical research activities to ensure study protocols are followed.
Recruit, screen, and enroll study participants.
Obtain informed consent and ensure ethical conduct in all study interactions.
Collect, process, and ship biological specimens per protocol (e.g., blood draws, urine samples).
Perform basic clinical procedures as permitted by certification (e.g., vital signs, EKGs).
Maintain accurate and timely documentation in case report forms and electronic databases.
Communicate with sponsors, monitors, and IRBs regarding study progress and compliance.
Schedule participant visits and follow-ups; ensure visit windows are met.
Ensure proper storage, handling, and accountability of investigational products, if applicable.
Maintain regulatory documents and assist with IRB submissions.
Qualifications:
Bachelor's degree in a health-related field or equivalent experience.
At least 2 years of experience in clinical research preferred.
State Phlebotomy license required
MA certification preferred
Knowledge of Good Clinical Practice (GCP) and regulatory guidelines.
Excellent organizational skills and attention to detail.
Strong interpersonal and communication skills.
Proficiency in Microsoft Office and electronic data capture systems (e.g., REDCap, EDC platforms).
Ability to work independently and as part of a multidisciplinary team.
Preferred Qualifications:
Experience working in clinical trials at the research site level
Familiarity with IRB processes and clinical trial documentation.
Bilingual skills (depending on patient population) may be a plus.
Clinical Research Coordinator - Rheumatology
Clinical research associate job in Sterling Heights, MI
Job Description
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, & 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 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 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!!!
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Research Study Coordinator / Clinical Research Coordinator
Clinical research associate 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.
Clinical Research Assistant / Medical Assistant
Clinical research associate job in Farmington Hills, MI
Job DescriptionDescriptionAlcanza is a growing multi-site, multi-phase clinical research company with a network of locations in MA, NH, MI, VA, SC, FL, GA, AL, MO, TX and Puerto Rico. We have established a strong presence across Phase I-IV studies and several therapeutic areas including vaccine, neurology, dermatology, psychiatry, and general medicine. Join us as we continue to grow.
The Research Assistant (RA) provides support to the Clinical Research Coordinators (CRCs), Site Manager, Principal and Sub Investigators, and other site staff in compliance with GCP, ICH, HIPAA, FDA Regulations and SOPs. The RA performs clinical, lab, and administrative tasks as needed for the successful operation of the clinical research site.
Key ResponsibilitiesEssential Job Duties: In collaboration with other members of the clinical research site team, assists with the execution of assigned studies, and support functions as needed. Responsibilities may include but are not limited to:
Under the direction of the Site Manager/Director and the Principal/Sub Investigators, assists the CRCs and other site staff in their responsibilities by conducting the following according to study protocol:
Assists with the basic screening of patients for study enrollment;
Assists with patient follow-up visits;
Documents in source clinic charts;
Enters data in EDC and answers queries;
Obtains vital signs and ECGs;
May perform blood draws;
Perform basic lab procedures per protocol, such as: blood specimen collection, centrifuge operation, storing and shipping of lab specimens, accountability of specimens and notification of courier for specimen pick-up;
Request and track medical record requests;
Enters data in EDC and answers queries;
Assists the CRC with updating and maintaining logs and filing in charts, and with chart filing; and
Schedules subjects for study visits, conducts appointment reminders, and reschedules visits if needed;
Ensures study related reports and patient results are reviewed by the Research Coordinator and/or investigator in a timely manner.
Assists the CRC and/or Manager with study recruitment, patient enrollment, and tracking as needed;
Maintains strict confidentiality of patients, employees, customers and company information at all times and adheres to HIPAA Guidelines; and
Perform all other duties as requested or assigned.
Skills, Knowledge and ExpertiseMinimum Qualifications: A High School diploma and 1 year of administrative / clinical experience is required. 1 year or more years of clinical research or clinical experience is preferred. Bi-lingual (English / Spanish) proficiency is a plus.
Required Skills:
Proficiency with computer applications such as Microsoft applications, email, electronic health records, web applications, and the ability to type proficiently (40+ wpm).
Must possess strong organizational skills and attention to detail.
Well-developed written and verbal communication skills.
Well-developed interpersonal and listening skills and the ability to work well independently as well as with co-workers, subjects, managers and external customers.
Ability to effectively handle multiple tasks and adapt to changes in workloads and priorities.
Must be professional, respectful of others, self-motivated, and have a strong work ethic.
Must possess a high degree of integrity and dependability.
Ability to work under minimal supervision, identify problems and implement solutions.
Ability to handle highly sensitive information in a confidential and professional manner, and in compliance with HIPAA guidelines.
Benefits
Full-time employees regularly scheduled to work at least 30 hours per week are benefits-eligible, with coverage starting on the first day of the month following date of hire.
Medical, dental, vision, life insurance, short and long-term disability insurance, health savings accounts, supplemental insurances, and a 401k plan with a safe harbor match are offered.
Clinical Research Assistant
Clinical research associate job in Flint, MI
Insight Institute of Neuroscience & Neurosurgery (IINN) aims to advance, challenge, and revolutionize neurosciences and medicine through scientific research and advanced technology, driven by a passion to help others regardless of any obstacles and challenges that may lie ahead. Our integrated team of medical professionals does so through creative, innovative techniques and care principles developed because of our continuous pursuit to improve the field of medicine. Our integrated team works together to find solutions to both common and complex medical concerns to ensure more powerful, reliable results. Having multiple specialties "under one roof" Insight achieves its purpose in providing a comprehensive, collaborative approach to neuromusculoskeletal care and rehabilitation to ensure optimal results. Our singular focus is Patient Care Second to None!
Job Summary:
We are seeking competent, proactive, self-directed individuals with effective time management skills to assist our clinical research site. The Clinical Research Assistant will support the clinical research team at our Research Dearborn location. They will work under the direction of the Clinical Research Manager.
Job Type:
* Full time (on-site, in-person)
* Monday to Friday, Full-time (8 hours), 8am - 5pm EST
* Ability and willingness to commute between our research locations as needed per study tasks
* Professional references may be required.
Benefits for our Full Time Team Members:
* Comprehensive health, dental, and vision insurance coverage
* Paid time off, including vacation, holidays, and sick leave
* 401K with Matching; offerings vested fully @ 3 months of employment paired with eligibility to contribute
* Short & Long Disability, and Life Term insurance, complementary of Full Time Employment
* Additional Supplementary coverages offered @ employee's elections: Accident, Critical Illness, Hospital Indemnity, AD&D, etc.
Duties and Responsibilities:
* Schedule visit appointments after coordination with relevant parties
* Coordinate collection, processing and shipping of study specimens
* Assemble study kits for study visits
* Attend and participate in study meetings, SIVs, monitoring visits and other sponsor and regulatory meetings
* Complete Data Entry for studies both in sponsor EDC and CTMS
* Ensure all paper sources are filed and securely kept in the binders
* Assist and work closely with the Clinical Research Coordinator and Clinical Research manager in executing and monitoring the overall clinical study to ensure compliance with protocol
* Report any adverse events according to the study protocol
* Identify and assist in pre-screening potential subject leads
* Assist in marketing the active trials in the community
* Actively meet with investigator and study team to discuss study progress/status
* Provides administrative updates on enrollment and queries if any
* Other duties as needed per assigned study protocol
Qualifications:
* Ability to demonstrate authorization to work in the U.S. for any employer
* Bachelor's degree or equivalent training required via work experience or education
* At least one year of previous job-related experience preferred
* Ability to follow oral and written instructions and established policies and procedures
* Ability to analyze and interpret data
* Ability to finish tasks in a timely manner
* Ability to maintain accuracy and consistency
* Ability to maintain confidentiality
* Ability to work as an effective team member
* Knowledge of medical terminology
* Ability to function independently and manage their own time and work tasks
* Diligent, thorough in their tasks, and show their commitment to their job
Insight is an equal opportunity employer and values workplace diversity!
Clinical Research Coord Assoc/Technician/Assistant
Clinical research associate job in Ann Arbor, MI
How to Apply A cover letter is required for consideration for this position and should be attached as the first page of your resume. The cover letter should address your specific interest in the position and outline skills and experience that directly relate to this position.
Job Summary
This position will serve as a Clinical Research Coordinator Associate in the Oncology Clinical Trial Support Unit (O-CTSU) - Clinic Research Group located in the Rogel Cancer Center providing administrative study coordination and data entry support to faculty and research teams for the University of Michigan Rogel Cancer Center - an NCI-Designated Comprehensive Cancer Center and a member of the National Comprehensive Cancer Network (NCCN). We are among the top-ranked national programs in research and patient care with members holding $120M in annual direct research funding. Our mission is to reduce the cancer burden and improve cancer outcomes through research, innovation, and transdisciplinary collaboration. With the Oncology CTSU, you will join a diverse team of 150 clinical research professionals dedicated in moving this mission forward through cutting-edge early phase trials to practice-changing phase III. As a team member, we will invest in your education, training, career development and certification. We also offer a variety of specialized roles and growth opportunities to fit your desired career path and goals. People want MichiganAnswers. Help discover them.
This clinical Research Coordinator (CRC) position my provide study coordination for multiple clinical research studies depending on complexity that range from moderate to complex. Coordinator experience and mastery of all job duties from the CRC-Technician position on the Michigan Medicine CRC Career Ladder is required. This position should be able to perform tasks and make decisions independently, consistently, and accurately, and demonstrate that they have achieved a moderate level of expertise in all their skills and abilities resulting in high quality work. It is presumed that this position is able to apply their skills to a broad range of different types of clinical studies, navigate available resources appropriately, effectively use all tools and job aids at their disposal and operate e-clinical technologies with a reasonable degree of proficiency. This position can perform the majority of tasks independently and perform quality checks of their work. They also know where and how to identify appropriate resources and support and are able to discern when to escalate issues needing additional intervention. Key behavioral competency descriptors include demonstrate, implement, execute, and use.
Why Join Michigan Medicine?
Michigan Medicine is one of the largest health care complexes in the world and has been the site of many groundbreaking medical and technological advancements since the opening of the U-M Medical School in 1850. Michigan Medicine is comprised of over 30,000 employees and our vision is to attract, inspire, and develop outstanding people in medicine, sciences, and healthcare to become one of the world's most distinguished academic health systems. In some way, great or small, every person here helps to advance this world-class institution. Work at Michigan Medicine and become a victor for the greater good.
What Benefits can you Look Forward to?
* Excellent medical, dental and vision coverage effective on your very first day
* 2:1 Match on retirement savings
Responsibilities*
Characteristic Duties and Responsibilities:
Independent knowledge, skills, and abilities within all 8 competency domains is expected:
* Scientific Concepts and Research Design
* Ethical Participant Safety Considerations
* Investigational Products Development and Regulation
* Clinical Study Operations (GCPs)
* Study and Site Management
* Data Management and Informatics
* Leadership and Professionalism
* Communication and Teamwork
Due to the complex nature of Oncology Clinical Trials, a team comprised of clinical research coordinators specializing in data management, regulatory, or clinic coordination work together to cover all aspects of the clinical research coordinator role. The clinical research coordinator hired for this posting will specialize in Clinic. Examples of duties a successful candidate in this role will perform:
Clinical Research Coordinator - Associate
* Demonstrates understanding of protocol elements/requirements and demonstrates the ability to execute study procedures.
* Demonstrates the ability to anticipate and mitigate the potential for protocol non-compliance.
* Describes protocol structure and explains how to interpret study requirements to ensure study compliance.
* Demonstrates accurate implementation of protocol procedures.
* Explains and performs non-GCP-related study management activities.
* Performs study procedures with minimal supervision.
* Triages simple subject issues appropriately.
* Ensures integrity of specimen management (collection, processing, packing/shipping, storing, labeling, tracking, etc.).
* Comfortable with basic clinical lab equipment such as a centrifuge, various freezers, pipettes, and standard laboratory safety requirements and guidelines.
* Explains the role of the Clinical Trial Support Unit (CTSU) for initiating new studies, and for subject visit billing.
This position reports directly to a CRC-Lead, CRC-Project Manager, or a unit Administrator, Director.
Clinical Research Coordinator - Technician
This position may independently provide study coordination for simple and moderately complex clinical research studies. As a member of a coordination team, this position may help support a portfolio of projects with varying levels of complexity. Mastery of all job duties from the Clinical Research Assistant position is required.
* Performs moderately complex study procedures with accuracy.
* Triages simple subject concerns appropriately.
* Assesses studies for execution and troubleshoots potential implementation issues.
* Completes simple to moderately complex data collection during study visits.
* May work with CTSUs to reconcile financial accounts for study participants.
* Assists with local quality control efforts.
Clinical Research Coordinator - Assistant
This is an entry level position that provides administrative and coordination support for multiple projects in the conduct of clinical research projects. This position may assist with study coordination but will not be assigned clinical trials independently. This position may provide coordination for clinical research projects such as registries, retrospective data reviews, studies in long-term follow-up, and other non-interventional studies.
* Demonstrates the ability to screen participants for study eligibility.
* Performs simple study procedures with accuracy.
* Understands protocol structure and how to interpret study requirements to ensure study compliance.
* Understands proper documentation techniques, as outlined in the ICH-GCP guidelines.
* May complete simple study reimbursement with partners such as the Human Subjects Incentive Program (HSIP) and the CTSU finance team.
* Demonstrates the ability to find and utilize information from EMR and databases/CTMS/EDC.
* May mark visits as planned/occurred in OnCore.
* May provide lab results, not interpretation, to participants.
* May assist research coordinator in conduct of SIV; attends SIV.
* May assist in and attend monitor visits and/or audits.
Required Qualifications*
Clinical Research Coordinator - Associate
* Bachelor's Degree in Health Science or equivalent in combined education and clinical research experience
* Certification is required through Association of Clinical Research Professionals (ACRP) as a Certified Clinical Research Coordinator (CCRC) or Society of Clinical Research Association (SOCRA) as a Certified Clinical Research Professionals (CCRP) or equivalent. Candidates must be eligible to register or take the exam at date of hire and the certification must be completed or passed etc. within six months of date of hire. (Please review eligibility criteria from SoCRA
Clinical Research Associate
Clinical research associate job in Grosse Pointe Woods, MI
The Clinical Research Associate will focus primarily on data management for clinical trials and act as a backup for regulatory associates. Initially, the role involves working with Registry studies, including pre-screening, recruiting, consenting, and following up with participants. This will occupy approximately 40% of the time, with the remainder dedicated to data entry, data management, and assisting the Research Nurse during patient visits.
Responsibilities
+ Manage data for clinical trials and serve as a backup for regulatory associates.
+ Work with Registry studies, including pre-screening, recruiting, consenting, and follow-up activities.
+ Perform data entry and data management tasks.
+ Assist the Research Nurse with patient visits.
Essential Skills
+ Chart review
+ Pre-screening patients
+ Clinical research experience
+ Clinical trial management
+ Data entry
+ Data management
+ Minimum of 1 year of clinical research experience
+ Understanding of clinical trials terminology
+ Proficiency in EDC systems, with the ability to learn various systems
Additional Skills & Qualifications
+ Experience in oncology is ideal
+ Willingness to undergo oncology training
Job Type & Location
This is a Contract position based out of Grosse Pointe Woods, MI.
Pay and Benefits
The pay range for this position is $20.00 - $31.00/hr.
Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: - Medical, dental & vision - Critical Illness, Accident, and Hospital - 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available - Life Insurance (Voluntary Life & AD&D for the employee and dependents) - Short and long-term disability - Health Spending Account (HSA) - Transportation benefits - Employee Assistance Program - Time Off/Leave (PTO, Vacation or Sick Leave)
Workplace Type
This is a fully onsite position in Grosse Pointe Woods,MI.
Application Deadline
This position is anticipated to close on Jan 5, 2026.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.
Senior Clinical Research Coordinator
Clinical research associate job in Southfield, MI
Job Description
Flourish Research is looking for motivated, talented, creative individuals who want to learn and grow in their careers while contributing to research that changes lives! We offer an excellent comprehensive benefits package, a supportive and collaborative work environment, and endless growth opportunities.
We are actively hiring Senior Clinical Research Coordinators at our Detroit, MI location!
The Senior Clinical Research Coordinator assists the Investigators in executing Phase I, II, III, and IV clinical research trials in accordance with Standard Operating Procedures (SOPs), FDA and GCP guidelines, and study protocols while providing an impeccable patient experience in every, single interaction.
Shift: Monday-Friday, 9 AM - 5 PM; one Saturday each month (9am - 1pm)
Location: 20755 Greenfield Rd # 107, Southfield, MI 48075
Compensation: $30 - $36 based on experience + quarterly discretionary performance bonuses
Benefits: Health, dental, and vision insurance plans, 401k with 4% match, tuition reimbursement, parental leave, referral program, employee assistance program, life insurance, disability insurance, and 15 days of PTO + 10 company holidays.
RESPONSIBILITIES
The Clinical Research Coordinator (CRC) obtains study participant informed consent.
Executes study protocol procedures in a detailed, organized, and professional manner.
Performs human specimen lab draws and processing, and packages specimen shipments.
Creates and completes study source documents and adverse event reporting on an e-source system.
Maintains study-specific files and supplies.
Communicate with the Study Sponsor/CRO regarding study-specific questions.
Participates in site visits from Sponsors/CROs, including site initiation and monitoring visits.
Additional duties as assigned by management
QUALIFICATIONS
Bachelor's degree preferred but not required
Phlebotomy experience is required; EKG or other patient labs/processes preferred
5+ years of experience as a Clinical Research Coordinator
Familiar with e-source reporting via an electronic platform
A clear understanding of ICH, FDA, and GCP regulations
Impeccable organizational skills and attention to detail
Excellent communication and interpersonal skills to effectively interact with the Principal Investigator, research team, Study Sponsor/CROs, potential subjects, and referral sources
An ethical compass that compels the candidate to be honest, detail-oriented, and self-driven
High-level critical thinking skills
Working knowledge of medical terminology and lab collection/processing/storage procedures
Proficiency with computers and Microsoft Office Suite
Flourish Research offers an excellent comprehensive benefits package, a supportive and collaborative work environment, and endless growth opportunities. Apply today to learn more about how you can join us in our mission to save and improve the lives of others!
Flourish Research is where clinical trials thrive.
Flourish Research represents one of the industry's most progressive and diversified clinical trial companies with robust capabilities in the therapeutic areas of cardiology/metabolic disorders/renal, CNS, pulmonology, and vaccines.
At Flourish Research, we strive toward excellence. In clinical trials and healthcare, excellence means everyone deserves the best care, regardless of their race, color, gender identity, religion, ethnicity, physical abilities, age, sexual orientation, or veteran status. We embrace employees, customers, and patients from these underrepresented groups to help make this vision a reality.
Flourish Research is driven by a diverse and inclusive community of passionate people who are committed to improving the quality of life of communities around the world. Flourish is committed to a safe work environment where all employees, customers, and patients are included, and treated with dignity and respect.
Flourish Research strives to build an organization that attracts and leverages diversity in our staff, which reflects the diversity of our local communities. We promote education, acceptance, and inclusion because there is beauty in diversity. The more diversity we have in our team, the more unique perspectives, and ideas we share, and the better prepared we are to serve our communities. WE SEE YOU. WE ARE YOU. WE EMBRACE YOU. WE CELEBRATE YOU!
It is the policy of Flourish Research not to discriminate against any applicant for employment, or any employee because of age, color, sex, disability, national origin, race, religion, or veteran status.
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Clinical Research Coordinator II
Clinical research associate job in Detroit, MI
Clinical Research Coordinator II The Clinical Research Coordinator II, will ensure that quality research is conducted at the assigned investigative sites in accordance with the sponsor protocol, FDA Regulations, and ICH/GCP guidelines and to provide the best quality data to the sponsor. The CRC II will also ensure study enrollment meets or exceeds Sponsors' expectations. To ensure company goals are achieved on a timely basis. Duties & Responsibilities:
Completing all the DMCR-required training, including but not limited to ICH-GCP Certification and IATA Certification on a timely basis.
Completing all the relevant training prior to study-start and on a continued basis in a timely manner. This will include but is not limited to:
Sponsor-provided and IRB-approved Protocol Training
All relevant Protocol Amendments Training
Any study-specific Manuals Training, as applicable
Sponsor-specified EDC and/or IVRS and any other relevant Electronic Systems training.
Conducting study subject visits, and all other relevant protocol-required procedures and documenting these in a timely manner.
Adherence to ALCOA-C Standards with all the relevant clinical trial documentation.
Completing data entry and query resolution in a timely manner as per internal company guidelines and as per sponsor expectations.
Demonstration of appropriate and timely follow-up on the action items, at their respective sites.
Demonstrated understanding and implementation of Laboratory Manuals and protocol-specified laboratory procedures, storage, temperature monitoring, equipment calibration, and laboratory kit inventory, under the direction of the Site/Study Management Team, for assigned protocols.
Liaising with the Laboratory team, Data team, Administrative staff, Clinical Investigators, Research Participants and Sponsor/CRO representatives, under the direction of the Site/Study Management Team, for assigned protocols.
Demonstrating adherence and compliance to the assigned protocols at their respective site(s).
Maintaining a working knowledge of current FDA regulations, ICH-GCP guidelines, all the organizational SOPs, all the guidance documents, and assigned study protocol(s)
Maintaining a working knowledge of the recruitment and retention process for their assigned protocol(s) at their respective site(s).
Demonstrating visit preparedness for all the relevant sponsor and CRO visits for their assigned protocol(s)
Demonstration of appropriate and timely follow-up on the action items, at their respective sites.
Maintaining a working knowledge of the most recent versions of the Study Protocols, Informed consents, Study Manuals, and all the other relevant study-related documents that are utilized and implemented for the assigned protocols at their respective site(s).
Oversee reporting of all Adverse and Serious Adverse Events and any other relevant Safety Information to the appropriate authorities per internal company guidelines, Sponsor, IRB, and ICH-GCP Guidelines.
Completing data entry and query resolution in a timely manner as per internal company guidelines and as per sponsor expectations.
Striving to meet Sponsor subject enrollment goals for their assigned protocols at their respective site(s).
Being prepared for and available at all required company meetings.
Submitting required administrative paperwork per company timelines.
Occasionally attending out-of-town Investigator Meetings
Any other matters as assigned by management.
Knowledge & Experience:
Education:
High School Diploma or equivalent required
Bachelor's degree a preferred
Foreign Medical Graduates preferred
Experience:
At least 2 years of experience as a CRC, preferably with practice coordinating industry-sponsored vaccines in a private setting.
Credentials:
ACRP or equivalent certification is preferred
Knowledge and Skills:
Be an energetic, go-getter who is detail-oriented and can multi-task.
Be goals-driven while continuously maintaining quality.
Bilingual in Spanish is a plus
Clinical Research Coordinator
Clinical research associate job in Southfield, 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, and Arizona. We have been nationally acknowledged for our diligence to provide the highest quality of data for our clinical research trials.
As Revival Research Institute is growing, we are looking to add more qualified professionals to our team, who are looking for an opportunity to grow and learn with us.
We are seeking a full-time Clinical Research Coordinator with a minimum of 1 year of clinical experience. Additionally, someone with a strong interest in the Clinical Research field would be an excellent fit for our entry level position, with room to grow. However, this interest and background is not necessary, as our ideal candidate is an individual who is detail orientated, being able to maintain organized records, as well as someone who is motivated to learn new things, as our company is always growing and expanding into new therapeutic areas. We are looking for individuals that want the opportunity to learn and grow with us.
Clinical Research Coordinators here at Revival Research Institute, should be genuinely respectful of diverse points-of-view and strive for an environment in which inclusiveness drives productivity and results. Clinical Research Coordinators are responsible to coordinate and manage multiple studies. They are also responsible for assisting the Investigators along with other clinical staff, with any study related tasks as follows but not limited to:
Participates in research participant screening, recruitment and enrollment. Consent and conduct research visits for data collection/no risk trials or no study article/minimal risk trials with oversight. Responsible for collecting, processing and shipping of research specimens, where applicable.
Documents study related information in case report forms or electronic data capture systems, handles data queries and participates in monitoring visits. Obtain, review and maintain source documents.
Maintains organization of all trial related documents and correspondence. Implement quality control and assurance methods.
Communicate with study sponsors, research team and the Institutional Review Board. Assist with basic regulatory document preparation, with oversight e.g. study amendments, adverse event reporting, protocol deviation reporting.
Maintain professional and technical knowledge about Clinical trials.
Research participant/family communication, protect patient confidentiality.
Preferred Qualifications:
Education/ Training: Bachelor's degree in health-related field with one to two years relevant clinical experience OR Master's degree in medical related field with no research experience. Individuals with more experience are preferred, if qualifications exceed entry level, higher positions available.
Phlebotomy skills preferred.
Certifications, Licensures, and Registrations: National Certification (CRA or ACRP), BLS Certification.
Additional Qualifications: Expert database and computer skills: Microsoft Office (Word, Excel), Outlook, excellent verbal and written communication skills, ability to work independently and assume responsibility, excellent organizational skills, ability to meet data deadlines and maintain confidentiality. Maintain data integrity within the department. Must be able to work in a team consisting of physicians, nurses, technicians, secretarial staff and ancillary hospital staff. Knowledge of FDA Regulations and Good Clinical Practices.
IMPROVE THE FUTURE AS OUR CLINICAL RESEARCH COORDINATOR!!!
Auto-ApplyClinical Research Assistant / Medical Assistant
Clinical research associate job in Farmington, MI
Department
Operations
Employment Type
Full Time
Location
Quest Research Institute - Farmington Hills, MI
Workplace type
Onsite
Reporting To
Heather Fasczewski
Key Responsibilities Skills, Knowledge and Expertise Benefits About Alcanza Clinical Research Alcanza Clinical Research (“Alcanza”) is a national, collaborative network of clinical research sites, founded on the mission to accelerate the development of new therapies by reducing barriers to clinical research participation for all.
We conduct research on dozens of conditions in several therapeutic areas including psychiatry, neurology, dermatology, and infectious disease. Our work is important to the patients who participate, the scientists who develop these new therapies, and the entire medical community. Because all approved medications require clinical trials, the impact of your work is exponential, reaching many thousands of future patients and improving their quality of life.
Alcanza is a culturally competent organization. We treat each other with dignity, creating an environment where all individuals feel welcome, heard, and respected for their unique perspectives and aspirations. We put considerable effort into finding exceptional employees who mirror the values most important to us: Inclusive, Impactful, Compassionate, and Determined.
Alcanza Clinical Research is an Equal Opportunity Employer that values and respects the importance of a diverse and inclusive workforce. It is the policy of the company to recruit, hire, train and promote persons in all job titles without regard to race, color, religion, sex, age, national origin, marital status, veteran status, disability, sexual orientation, gender identity or expression, genetic information, or any other category protected by law. We recognize that diversity and inclusion is a driving force in the success of our company.
Clinical Research Assistant (term limited)
Clinical research associate job in Ann Arbor, MI
on the Michigan Medicine CRC Career Ladder
Clinical Research Coordinator
Clinical research associate job in Dearborn Heights, MI
Job Description
Unique opportunity to make an Impact in the healthcare industry…
Revival Research Institute, LLC was established in 2015, and headquartered in the Metro Detroit Region, and has been growing ever since. Revival now has a national presence in the Metro-Detroit Region, Texas, Illinois, and Arizona. We have been nationally acknowledged for our diligence to provide the highest quality of data for our clinical research trials.
As Revival Research Institute is growing, we are looking to add more qualified professionals to our team, who are looking for an opportunity to grow and learn with us.
We are seeking a full-time Clinical Research Coordinator with a minimum of 2 year of clinical experience, for our Woman's Health site. Someone with a strong interest in the Clinical Research field would be an excellent fit for our entry level position, with room to grow. However, this interest and background is not necessary, as our ideal candidate is an individual who is detail orientated, being able to maintain organized records, as well as someone who is motivated to learn new things, as our company is always growing and expanding into new therapeutic areas. We are looking for individuals that want the opportunity to learn and grow with us.
Clinical Research Coordinators here at Revival Research Institute, should be genuinely respectful of diverse points-of-view and strive for an environment in which inclusiveness drives productivity and results. Clinical Research Coordinators are responsible to coordinate and manage multiple studies. They are also responsible for assisting the Investigators along with other clinical staff, with any study related tasks as follows but not limited to:
Participates in research participant screening, recruitment and enrollment. Consent and conduct research visits for data collection/no risk trials or no study article/minimal risk trials with oversight. Responsible for collecting, processing and shipping of research specimens, where applicable.
Documents study related information in case report forms or electronic data capture systems, handles data queries and participates in monitoring visits. Obtain, review and maintain source documents.
Maintains organization of all trial related documents and correspondence. Implement quality control and assurance methods.
Communicate with study sponsors, research team and the Institutional Review Board. Assist with basic regulatory document preparation, with oversight e.g. study amendments, adverse event reporting, protocol deviation reporting.
Maintain professional and technical knowledge about Clinical trials.
Research participant/family communication, protect patient confidentiality.
Preferred Qualifications:
Education/ Training: Bachelor's degree in health-related field with one to two years relevant clinical experience OR Master's degree in medical related field with no research experience. Individuals with more experience are preferred, if qualifications exceed entry level, higher positions available.
Phlebotomy skills preferred.
Certifications, Licensures, and Registrations: National Certification (CRA or ACRP), BLS Certification.
Additional Qualifications: Expert database and computer skills: Microsoft Office (Word, Excel), Outlook, excellent verbal and written communication skills, ability to work independently and assume responsibility, excellent organizational skills, ability to meet data deadlines and maintain confidentiality. Maintain data integrity within the department. Must be able to work in a team consisting of physicians, nurses, technicians, secretarial staff and ancillary hospital staff. Knowledge of FDA Regulations and Good Clinical Practices.
IMPROVE THE FUTURE AS OUR CLINICAL RESEARCH COORDINATOR!!!
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Clinical Research Assistant / Medical Assistant
Clinical research associate job in Farmington, MI
Department: Operations Employment Type: Full Time Reporting To: Heather Fasczewski Description Alcanza is a growing multi-site, multi-phase clinical research company with a network of locations in MA, NH, MI, VA, SC, FL, GA, AL, MO, TX and Puerto Rico. We have established a strong presence across Phase I-IV studies and several therapeutic areas including vaccine, neurology, dermatology, psychiatry, and general medicine. Join us as we continue to grow.
The Research Assistant (RA) provides support to the Clinical Research Coordinators (CRCs), Site Manager, Principal and Sub Investigators, and other site staff in compliance with GCP, ICH, HIPAA, FDA Regulations and SOPs. The RA performs clinical, lab, and administrative tasks as needed for the successful operation of the clinical research site.
Key Responsibilities
Essential Job Duties: In collaboration with other members of the clinical research site team, assists with the execution of assigned studies, and support functions as needed. Responsibilities may include but are not limited to:
* Under the direction of the Site Manager/Director and the Principal/Sub Investigators, assists the CRCs and other site staff in their responsibilities by conducting the following according to study protocol:
* Assists with the basic screening of patients for study enrollment;
* Assists with patient follow-up visits;
* Documents in source clinic charts;
* Enters data in EDC and answers queries;
* Obtains vital signs and ECGs;
* May perform blood draws;
* Perform basic lab procedures per protocol, such as: blood specimen collection, centrifuge operation, storing and shipping of lab specimens, accountability of specimens and notification of courier for specimen pick-up;
* Request and track medical record requests;
* Enters data in EDC and answers queries;
* Assists the CRC with updating and maintaining logs and filing in charts, and with chart filing; and
* Schedules subjects for study visits, conducts appointment reminders, and reschedules visits if needed;
* Ensures study related reports and patient results are reviewed by the Research Coordinator and/or investigator in a timely manner.
* Assists the CRC and/or Manager with study recruitment, patient enrollment, and tracking as needed;
* Maintains strict confidentiality of patients, employees, customers and company information at all times and adheres to HIPAA Guidelines; and
* Perform all other duties as requested or assigned.
Skills, Knowledge and Expertise
Minimum Qualifications: A High School diploma and 1 year of administrative / clinical experience is required. 1 year or more years of clinical research or clinical experience is preferred. Bi-lingual (English / Spanish) proficiency is a plus.
Required Skills:
* Proficiency with computer applications such as Microsoft applications, email, electronic health records, web applications, and the ability to type proficiently (40+ wpm).
* Must possess strong organizational skills and attention to detail.
* Well-developed written and verbal communication skills.
* Well-developed interpersonal and listening skills and the ability to work well independently as well as with co-workers, subjects, managers and external customers.
* Ability to effectively handle multiple tasks and adapt to changes in workloads and priorities.
* Must be professional, respectful of others, self-motivated, and have a strong work ethic.
* Must possess a high degree of integrity and dependability.
* Ability to work under minimal supervision, identify problems and implement solutions.
* Ability to handle highly sensitive information in a confidential and professional manner, and in compliance with HIPAA guidelines.
Benefits
* Full-time employees regularly scheduled to work at least 30 hours per week are benefits-eligible, with coverage starting on the first day of the month following date of hire.
* Medical, dental, vision, life insurance, short and long-term disability insurance, health savings accounts, supplemental insurances, and a 401k plan with a safe harbor match are offered.