Clinical Research Coordinator jobs at Medix - 328 jobs

Screens potential patients for protocol eligibility. Presents trial concepts and details to the patients, participates in the informed consent process, and enrolls patients on protocol. Coordinates patient care in compliance with protocol requirements. May disburse investigational drug and provide patient teaching regarding administration. Maintains investigational drug accountability. -In collaboration with the physician, reviews patients for changes in condition, adverse events, concomitant medication use, protocol compliance, response to study drug and thoroughly documents all findings. Responsible for accurate and timely data collection, documentation, entry, and reporting. Schedules and participates in monitoring and auditing activities. Maintains regulatory documents in accordance with USOR SOP and applicable regulations. Participates in required training and education programs. Responsible for education of clinic staff regarding clinical research. May collaborate with Research Site Leader in the study selection process. Additional responsibilities may include working directly with other (non-USOR) research bases and/or sponsors. Identify quality and performance improvement opportunities and collaborates with staff in the development of action plans to improve quality. May be responsible for compiling and reporting protocol activity, accrual data, and research financial information to practice administration and physicians. May oversee the preparation of orders by physicians to assure that protocol compliance is maintained. Communicates with physician regarding study requirements, need for dose modification, and adverse event reporting. Provides a safe environment for patients, families, and clinical staff at all times through compliance with all federal, state, and professional regulatory standards as issued through OSHA and the CDC. Maintains strict patient confidentiality according to HIPAA regulations and applicable law. Qualifications Associate's degree in a clinical or scientific related discipline required, Bachelor's degree preferred. Minimum five years of experience in a clinical or scientific related discipline required, preferably in oncology. SoCRA or ACRP certification preferred. OR Graduate from an accredited program for nursing education (BSN preferred). Minimum 3 years of nursing experience, preferably in oncology. Experience in clinical research preferred. Current licensure as a registered nurse in state of practice. Current BLCS or ACLS certification required. OCN, SoCRA or ACRP certification preferred. We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable federal, state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance (FCIHO), Los Angeles Fair Chance Ordinance for Employers (ULAC), The San Francisco Fair Chance Ordinance (FCO), and the California Fair Chance Act (CFCA). This position is subject to a background check based on its job duties, which may include patient care, working with vulnerable populations, access to financial and confidential information, driving, working with heavy machinery, or working in a warehouse or laboratory environment. Due to these job duties, this position has a significant impact on the business operations and reputation, as well as the safety and well-being of individuals who may be cared for as part of the job position or who may interact with staff or clients.

A global clinical research organization is seeking a Clinical Study Specialist to manage site operations and provide support for clinical trials. Your role includes organizing reports, scheduling meetings, and overseeing site activations. Ideal candidates will have a Bachelor's Degree and at least 2 years of relevant experience, with strong communication skills and experience in TMF and CTMS. This position offers a competitive salary and various benefits, emphasizing inclusivity and a supportive workplace culture. #J-18808-Ljbffr

A global clinical research organization is seeking a Clinical Study Specialist to manage site operations and provide support for clinical trials. Your role includes organizing reports, scheduling meetings, and overseeing site activations. Ideal candidates will have a Bachelor's Degree and at least 2 years of relevant experience, with strong communication skills and experience in TMF and CTMS. This position offers a competitive salary and various benefits, emphasizing inclusivity and a supportive workplace culture. #J-18808-Ljbffr

The NSABP Foundation has an opening for Clinical Research Associate - Level 3. This is a hybrid position located in Pittsburgh, PA requiring 3 days in the office and 2 days remote work. PURPOSE This role supports breast and colorectal cancer clinical trial operations and the primary deliverables of ensuring accrual to NSABP protocols, data integrity and regulatory compliance. The Clinical Research Associate, Level 3 role is one that includes responsibilities both as an individual contributor and leader. Leadership responsibilities focus online management of study monitors. ESSENTIAL FUNCTIONS Actively plans, executes and assesses performance of activities across the life span of study. Ensures timely study start-up. Examples include but are not limited to study timeline start-up development, site selection and Principal Investigator review. Assists with site activation requirements including ICF review, site access to study platforms and other needs as they arise. Facilitates daily or weekly team huddles to assess, plan, review and prioritize activities to ensure timely site activation, accrual, metrics review, compliance with CMP and other study requirements and audit prep. Completes required trainings with appropriate documentation. Develops relationships with site staff and NSABP monitors. Acts as a liaison for NSABP, site staff and external partners. Conducts weekly performance metrics review, identifies gaps and initiates contact with study monitor to review performance as needed. Examples include the number of queries, query resolution, source data verification, protocol deviation reporting and other study specific metrics. Responsible for providing regular metrics assessment to leadership team. Identifies key metrics with poor performance and develops an action plan to remediate the issue. Develops and implements recruitment strategies to ensure accrual targets are met. Ensures site initiation visits, interim monitoring visits and close out visits are compliant with the Clinical Monitoring Plan (CMP). Reviews and approves itineraries to ensure CMP compliance and associated expense reports. Follows Standard Operating Procedures (SOPs), Work Instructions (WIs), GCP and ICH guidelines. Develops, writes and implements Study Start-Up Plans, Clinical Monitoring Plans, Roles and Responsibilities grids and other study-specific documents. Collaborates with clinical research organizations and centralized services such as laboratories. Collaborates with data management regarding CRF development and UAT testing. Acts as a resource to sites and investigators. Accompanies study monitors within 3 months of onboarding to confirm that the CMP is implemented accurately, and that PI/site needs are met. Reviews SIV and monitoring reports to ensure expected quality compliance standards are met. These include compliance with CMP, SOPs, WIs and training requirements. Supports study monitors with resolution of significant site issues. Performs other job-related duties as assigned. OTHER RESPONSIBILITIES Knowledge of randomized clinical trials principles and procedures. Knowledge of federal and state regulations and guidelines pertaining to the conduct of clinical trials. Knowledge of the infrastructure and operational characteristics of successful patient accrual related to site and study management. EXPERIENCE/SKILLS Bachelor's degree required. Prior CRA experience required. Research certification strongly preferred Prior experience at CRO strongly preferred. Familiarity with electronic TMF, EDC and CTMS systems required. Strong verbal, written and organizational skills with a team-oriented approach required. Ability to handle and prioritize multiple tasks to meet deadlines in a dynamic environment. Proficiency in Microsoft Office Suite HYBRID POSITION This is a hybrid position consisting of 2 days of remote work (Wednesday and Friday) and 3 days onsite in our office in Pittsburgh, PA (Monday, Tuesday and Thursday). The NSABP Foundation, Inc. is an Equal Employment Opportunity and Affirmative Action Employer committed to the value of workforce diversity. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, gender identity, national origin, physical or mental disability, protected veterans, genetic information, and sexual orientation.

About Us: Each of CenExel's research sites specialize in Phase I to Phase IV clinical trials. Our Centers of Excellence comprise some of the most well respected and long-standing research facilities in the country. Specialty areas of research across our sites include Psychiatry, Acute Post Op Pain, Asian Bridging, Dermatology, GI, and Neurology. Each of our Centers of Excellence has tremendous experience and expertise in complex early phase trials, and all our sites have in-patient capability. We focus on quality people, teamwork, and highly experienced clinical research managers with a history of success. Along with an exceptional work environment that promotes teamwork, positive leadership, and optimal work-life balance, CenExel Clinical Research also provides highly competitive compensation and a generous benefits package to full time employees after 30 days of employment including Health Insurance, Dental, Vision, LTD, STD, Life Ins, and 401k. Job Summary: Responsible for assisting with coordinating clinical trials with the strictest adherence to ICH (International Conference on Harmonization), GCP (Good Clinical Practices), protocol, and company guidelines, regulations, and policies. Essential Responsibilities and Duties: Assists with coordinating all aspects of patient involvement from study initiation until study completion. Organizes research information for clinical trials. Observes subjects and assists with data analysis and reporting. Schedules the collection of data. Documents adverse events, protocol deviations, and other unanticipated problems appropriately. Reports research data to maintain quality and compliance. Performs administrative and regulatory duties related to the study as appropriate. Participates in other protocol development activities. Ensures site receives accurate information and supplies from sponsors (i.e.: source, protocol, scales, supplies, approvals, contacts, etc.) Educates potential participants and caregivers on protocol specific details and expectations. Performs safety and efficacy assessments per protocol (vital signs, EKGs, blood draws and other assessments as assigned). Assumes other duties and responsibilities as assigned. The above responsibilities are a general description of the level and nature of the work assigned to this classification and are not to be considered as all inclusive. Education/Experience/Skills: High school graduate or equivalent; Bachelors Degree, preferred. 0-3 years of experience in the medical field. Knowledge and understanding of Federal regulations protecting human subjects in research and that govern the conduct of clinical trials. Strong leadership and mentorship skills. Developing and maintaining effective working relationships at all levels of the organization, along with those at the sponsor and vendor level. Crisis management and problem solving skills; ability to react calmly and effectively in emergent situations. Works independently as well as functioning as part of a team. Must be able to effectively communicate verbally and in writing in English and Spanish. Working Conditions Indoor, Office environment. Shift work, depending on location. Essential physical requirements include sitting, typing, standing, and walking. Lightly active position, occasional lifting of up to 20 pounds. Rarely lift over 20 pounds. Reporting to work, as scheduled, is essential. Overnight travel may be required for training and/or investigative meetings. CenExel Clinical Research is an Equal Opportunity Employer. All applicants will be considered for employment without regards to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or status. Equal Opportunity Employer This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.

I'm working with a university, ranked in the top 100 of National Universities, to hire a Clinical Research Coordinator to their drug studies team. Contract Duration: 3 month contract with high potential to convert Pay Rate: $28-34/hr About this role: Coordinate recruitment and enrollment of research participants Establish and maintain databases of subjects Schedule and conduct study visits Collect and enter data; register subjects and study visits in OnCore Perform Epic research billing review Maintain an up to date regulatory binder Schedule and attend sponsor visits and prepare and submit IRB paperwork to ensure compliance with IRB regulations. Experience: Bachelor's degree in life science or health professions field and at least three years of directly related clinical research coordinator experience Experience with drug studies is nice to have Knowledge of FDA, IRB, Pennsylvania and related regulations Prior experience with IRB submissions both local and central is nice to have Prior Electronic Data Capture (eDC) data entry skills is nice to have Strong written and verbal communication skills with the ability to interact with a diverse population of students, faculty, staff, sponsors, and research participants Interested? Apply now!

Clinical Research Coordinator I Client: Large Healthcare Organization Duration: 1-year contract - possibility of FTE conversion MUST RESIDE IN SALT LAKE CITY, UT OR NEARBY Position Summary: The Research Coordinator position is responsible for Coordinating multiple research protocols and serving as a liaison with local investigators and Sponsors. Under direct supervision, this individual will mature in their understanding of research operations and regulations in order to achieve a fundamental understanding of human subject research. Major Responsibilities: Practice and adhere to the “Code of Conduct” philosophy and “Mission and Value Statement” During your employment you will be routinely assigned training requirements. You are expected to complete any training assignments by the due date. Performs routine operational activities for multiple research protocols Liaise between site research personnel, industry sponsors, and Supervisor Collaborates closely with various site departments/teams, including finance, relevant hospital administrative representatives, and the local IRB, if applicable Coordinates schedule of assessments from initial submission of feasibility until study closeout Reviews the study design and inclusion/exclusion criteria with physician and patient Ensures the protection of study patients by verifying informed consent procedures and adhering to protocol requirements Ensures the integrity of the data submitted on Case Report Forms or other data collection tools by careful source document review; monitors data for missing or implausible data Creates study specific tools for source documentation when not provided by sponsor Collects, completes, and enters data into study specific case report forms or electronic data capture systems Generates and tracks drug shipments, device shipments, and supplies as needed Ensures timely and accurate data completion Tracks and reports adverse events, serious adverse events, protocol waivers, deviations, and violations Communicates all protocol-related issues to appropriate study personnel or manager Attends study specific on-site meetings, investigator meetings, conference calls and monthly CRC meetings, as required Reviews and responds to any monitoring and auditing findings Qualifications: Bachelor's degree - Required 1+ years of relevant experience - Required Phlebotomy - Required Certified Clinical Research Coordinator - Preferred

Clinical Research Coordinator Duration: 6 month contract with potential to extend up to 1 year or more Pay Rate: starts at $30/hr Responsible for Coordinating multiple research protocols and serving as a liaison with local investigators and Sponsors. Under direct supervision, this individual will mature in their understanding of research operations and regulations in order to achieve a fundamental understanding of human subject research. Duties include but are not limited to: · Practice and adhere to the “Code of Conduct” philosophy and “Mission and Value Statement” · During your employment with HRI you will be routinely assigned training requirements. You are expected to complete any training assignments by the due date. · Performs routine operational activities for multiple research protocols · Liaise between site research personnel, industry sponsors, and Supervisor · Collaborates closely with various site departments/teams, including finance, relevant hospital administrative representatives, and the local IRB, if applicable · Coordinates schedule of assessments from initial submission of feasibility until study closeout · Reviews the study design and inclusion/exclusion criteria with physician and patient · Ensures the protection of study patients by verifying informed consent procedures and adhering to protocol requirements · Ensures the integrity of the data submitted on Case Report Forms or other data collection tools by careful source document review; monitors data for missing or implausible data · Creates study specific tools for source documentation when not provided by sponsor · Collects, completes, and enters data into study specific case report forms or electronic data capture systems · Generates and tracks drug shipments, device shipments, and supplies as needed · Ensures timely and accurate data completion · Tracks and reports adverse events, serious adverse events, protocol waivers, deviations, and violations · Communicates all protocol-related issues to appropriate study personnel or manager · Attends study specific on-site meetings, investigator meetings, conference calls and monthly CRC meetings, as required · Reviews and responds to any monitoring and auditing findings

Clinical Research Coordinator I Client: Large Healthcare Organization Duration: 1-year contract - possibility of FTE conversion MUST RESIDE IN ASHEVILLE, NC OR NEARBY Position Summary: The Research Coordinator position is responsible for Coordinating multiple research protocols and serving as a liaison with local investigators and Sponsors. Under direct supervision, this individual will mature in their understanding of research operations and regulations in order to achieve a fundamental understanding of human subject research. Major Responsibilities: Practice and adhere to the “Code of Conduct” philosophy and “Mission and Value Statement” During your employment you will be routinely assigned training requirements. You are expected to complete any training assignments by the due date. Performs routine operational activities for multiple research protocols Liaise between site research personnel, industry sponsors, and Supervisor Collaborates closely with various site departments/teams, including finance, relevant hospital administrative representatives, and the local IRB, if applicable Coordinates schedule of assessments from initial submission of feasibility until study closeout Reviews the study design and inclusion/exclusion criteria with physician and patient Ensures the protection of study patients by verifying informed consent procedures and adhering to protocol requirements Ensures the integrity of the data submitted on Case Report Forms or other data collection tools by careful source document review; monitors data for missing or implausible data Creates study specific tools for source documentation when not provided by sponsor Collects, completes, and enters data into study specific case report forms or electronic data capture systems Generates and tracks drug shipments, device shipments, and supplies as needed Ensures timely and accurate data completion Tracks and reports adverse events, serious adverse events, protocol waivers, deviations, and violations Communicates all protocol-related issues to appropriate study personnel or manager Attends study specific on-site meetings, investigator meetings, conference calls and monthly CRC meetings, as required Reviews and responds to any monitoring and auditing findings Qualifications: Bachelor's degree - Required 1+ years of relevant experience - Required Phlebotomy - Required Certified Clinical Research Coordinator - Preferred

Adecco Healthcare & Life Sciences is hiring a Clinical Research Nurse for our Medical Supply and Instrumentation Partner in Ocala, FL. The anticipated hourly wage for this position is between $39 and $40.24. Hourly wage may depend upon experience, education, geographic location, and other factors. Benefit offerings include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits, Daily Pay, and 401K plan. Our program provides employees the flexibility to choose the type of coverage that meets their individual needs. Available paid leave may include Paid Sick Leave, where required by law; any other paid leave required by Federal, State, or local law; and Holiday pay upon meeting eligibility criteria Summarized Purpose: Acts as a Lead Coordinator in a site setting whereby they may be leading logistics, vendor/stakeholder management, answer complex protocol and Alzheimer's questions. Oversee multiple ongoing clinical trials involving patients. Completes all paperwork required to capture all data as specified by a study protocol, and for ensuring subject safety, understanding, and cooperation during the study process. Interacts with the research site team and other interdepartmental staff. Engages in the entire site operations process, which includes recruitment, enrollment, and retention of study participants. Essential Functions: - Conducts clinical studies according to FDA/GCP and ICH regulations and guidelines. - Provides medical care to patients, always ensuring patient safety comes first. - Schedules subject visits within protocol windows, ensuring scheduling capacity is maximized. - Performs all defined study activities (i.e., informed consent, screening, and protocol procedures which include but not limited to vital signs, pregnancy tests, height, weight, ECG's, etc.). - Records all patient information and results from tests as per protocol on required forms. - Where required, may complete IP accountability logs and associated information. - Reports suspected non-compliance to relevant site staff. - Ensures that IRB approval is obtained prior to study initiation and IRB requirements are met throughout the study. - Promotes the company and builds a positive relationship with patients to ensure retention. - Attends site initiation meetings and all other relevant meetings to receive training on protocol. - May be required to call patients, do patient bookings and follow-up calls to confirm bookings or provide information or results. - Logs/completes information on sponsor systems and ensures all information provided is accurate (i.e., case report forms, EDC, etc.) and ensures it is completed within timeframe. - Gathers and maintains source documents, updates patient files and notes, always ensuring relevant and most up to date information is recorded. - Adheres to company COP/SCOP. - May be required to dispose of waste according to standards and assist in keeping a general neat appearance of the facility. Education and Experience: - Bachelor's degree or equivalent and relevant formal academic / vocational qualification in the clinical / medical field - Must hold a valid nursing license (RN, LVN, LPN) within the country operating. Must be registered with local health care authority. - Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years). Knowledge, Skills and Abilities: - Solid understanding of the clinical research process (i.e., GCP, SOPs, informed consent, safety monitoring, etc.) - Capable of working independently, analyzing and working with attention to detail, processing and prioritizing sensitive complex information and problem solving - Demonstrated ability to exercise discretion and sound judgement - Good decision-making, negotiation and influencing skills - Good communication skills and English fluency will be an advantage - Good organizational skills - Good proficiency in basic computer applications - Good interpersonal skills to work in a team environment **Comments** Monday-Friday 9-5 **Pay Details:** $39.00 to $40.24 per hour Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable. Equal Opportunity Employer/Veterans/Disabled Military connected talent encouraged to apply To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to ********************************************** The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable: + The California Fair Chance Act + Los Angeles City Fair Chance Ordinance + Los Angeles County Fair Chance Ordinance for Employers + San Francisco Fair Chance Ordinance **Massachusetts Candidates Only:** It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

** Seeking a Clinical Research Coordinator in Las Vegas, Neveda** Reports To: Senior Clinical Research Site Manager Department: Clinical Research Operations Employment Type: Full-time, onsite, 40 hrs a week Position Overview The Clinical Research Coordinator (CRC) plays a key role in the successful execution of clinical research studies by supporting investigators and ensuring studies are conducted in compliance with protocol requirements, Good Clinical Practice (GCP), and applicable regulatory guidelines. This position involves direct participant interaction, study coordination, and accurate documentation throughout all phases of clinical trials. Key Responsibilities -Collaborate closely with Principal Investigators to coordinate all aspects of assigned clinical studies, including participant recruitment, eligibility assessment, scheduling, treatment coordination, and study-related procedures. -Perform clinical and study-related procedures, including phlebotomy, vital signs collection, centrifuge operation, ECG administration, and other protocol-required tasks. -Utilize Microsoft Office and electronic research systems efficiently, including source documentation platforms, IXRS/IWRS, and Electronic Data Capture (EDC) systems such as Medidata, Veeva, and Inform. - Monitor participant health status throughout the study and promptly communicate relevant findings to the Principal Investigator. -Identify, document, and report Serious Adverse Events (SAEs) and other safety concerns to investigators and sponsors in accordance with protocol and regulatory requirements. -Coordinate the collection, processing, packaging, and shipment of biological specimens to designated central laboratories, ensuring accuracy and compliance with laboratory and shipping guidelines. -Maintain accurate, complete, and organized study documentation in compliance with GCP and regulatory standards. Qualifications -Minimum of 3 years of hands-on experience as a Clinical Research Coordinator, preferably in Phase II-IV pharmaceutical clinical trials. -Bachelor's degree in a scientific, healthcare, or related field. -Strong attention to detail with the ability to maintain accurate and well-organized research records. -Excellent written and verbal communication skills, with the ability to interact professionally with investigators, sponsors, participants, and study team members. -Working knowledge of ethical principles, regulatory requirements, and GCP guidelines governing clinical research. -Ability to recognize potential risks, protocol deviations, and adverse events and respond promptly and appropriately.

The section of Oncology has a cadre of Phase 1 and 2 trials, investigator-initiated studies, and industry sponsored studies. The CRC will be assigned to studies based on need and review of clinical trial roster. The CRC will work with investigators, study staff, Scientific Review Committee (SRC) and institutional review boards (IRB), clinical trial sponsors and federal regulatory agencies to assure compliance with study protocols, data documentation, reporting requirements, ensure that regulatory requirements for clinical trials are met. The CRC will work under the supervision of the Section Head, Divisional Administrator and CTO Program Manager. Responsibilities Schedule all protocol required evaluations (physical exams, radiology, labs, etc.). Coordinate patient appointments with physicians, nurses and all test areas. Attend Investigator meetings which establish required procedures. Coordinate, obtain, process (e.g. spin/separate/freeze samples), and ship (e.g. utilization of specific packaging and ensuring proper handling and shipping of samples) protocol required samples. Obtain vital signs and EKGs as indicated. Maintain accurate patient research files and records of sample procurement. Develop protocol specific flow charts, intake sheets and other tools as needed to ensure protocol compliance and proper data acquisition. Maintain study supplies and utilizes study specific supplies as required. Assists the PI in development of materials and tools necessary to appropriately train individuals involved in the conduct of the study around issues related to (but not limited to) protocol requirements, schedule of visits, execution of research plan. Maintains documentation of training. Assists Principal Investigator to assure that all key personnel or persons ‘engaged' in the research project have met training requirements in accordance with federal regulations and university and sponsoring agency policies and procedures. Cooperates with university compliance and monitoring efforts related to sponsored program administration and reports instances of noncompliance to the appropriate compliance office. Coordinates and facilitates monitoring and auditing visits. Notifies appropriate institutional officials of external audits by FDA and sponsors. Collaborates with PI and institution to respond to any audit findings and implement approved recommendations. Cooperates with university and sponsoring agency compliance and monitoring efforts related to human research participant protection and reports instances of noncompliance to the appropriate compliance office. Establish and maintain regular communication with study team, study sponsor, and applicable regulatory agencies to ensure all required information is communicated. Serve as facilitator for study team and sponsor with regard to study status information, safety issues, upcoming protocol amendments and consent changes and applicable protocol training. Prepares and submits all protocol applications, amendments, continuing reviews, and informed consent documents for SRC and IRB review and approval. Prepares and submits regulatory documentation that may include; IND/IDE applications, FDA annual reports, Serious Adverse Event reports, to the appropriate regulatory agencies including the Food and Drug Administration (FDA) etc. Coordinates assigned study monitoring and auditing visits with study coordinator, investigator, industry sponsors, and internal/external auditors. Performs related duties & responsibilities as assigned/requested. Minimum Qualifications Bachelor's degree or equivalent and experience required. Preferred Qualifications Two years of related experience. Protocol oversight; monitoring and reporting of study events; data collection; adherence to study protocols; in-service education of physicians, nurses, and support staff to protocol requirements; coordinate research activities.

Job Title: Unblinded Clinical Research Coordinator Pay Range: Up to $27 per hour Schedule: Monday - Friday, 8:00 AM - 5:00 PM Duration: 90-day contract with potential for extension or conversion to a permanent position based on performance and trial needs. Position Summary: This full-time role supports the day-to-day operations of clinical trials, with a strong focus on Investigational Product (IP) management while maintaining study integrity between blinded and unblinded staff. The Unblinded CRC serves as the subject-matter expert for IP handling and works closely with the Site Manager, study team, sponsors, and participants to ensure compliance with protocols and SOPs. Key Responsibilities: Managing all aspects of Investigational Product (receipt, storage, dispensing, administration, accountability, and return/destruction) Maintaining the study blind and communicating appropriately with blinded and unblinded team members Conducting patient-facing visits, including vitals, ECGs, lab collection, and protocol-required procedures Completing accurate source documentation and EDC entry within required timelines Monitoring study activities for regulatory and protocol compliance Recording and reporting adverse events and resolving sponsor queries Participating in site audits, monitor visits, investigator meetings, and site initiation visits Maintaining temperature logs, pharmacy binders, and master study logs This position reports directly to the Site Manager/Director and plays a critical role in ensuring studies run smoothly and compliantly. Required Qualifications: Recent, heavy hands-on injection or vaccine administration experience, including independent injection administration in accordance with medication protocols Patient-facing clinical experience (Medical Assistant, Clinical Research Assistant, Research Assistant, LPN, etc.) Ability to work directly with study participants in a clinical setting Strong attention to detail and accurate documentation skills Ability to complete source documentation during patient visits and enter data into EDC within required timelines Ability to follow study protocols, SOPs, and regulatory requirements Basic understanding of GCP and FDA regulations (training acceptable) Strong communication and organizational skills Ability to work Monday-Friday, 8:00 AM-5:00 PM Ability to start ASAP Preferred Qualifications: Previous experience as a Clinical Research Coordinator (CRC) Unblinded CRC or Investigational Product (IP) management experience Experience with drug accountability, temperature logs, and pharmacy binders Experience with Investigational Product preparation and administration Experience participating in monitor visits, audits, SIVs, and investigator meetings Experience using EDC systems and resolving sponsor queries Work Environment: On-site clinical research site supporting active clinical trials and patient-facing activities.

Patient Care & Recruitment: Screen, enroll, and educate patients about trial protocols, manage appointments, and collect follow-up data. Protocol Adherence: Ensure all study activities (drug administration, data collection) strictly follow the study protocol and Good Clinical Practice (GCP). Data Management: Collect, enter, and manage accurate study data; communicate with labs about results. Regulatory Compliance: Work with Institutional Review Boards (IRBs) and sponsors to maintain compliance with laws and regulations. Team Collaboration: Work with doctors, nurses, and other staff; train new personnel; and communicate with sponsors and regulatory bodies. Administrative Tasks: Manage study budgets, supplies, and development of recruitment materials.

Employment Type: 6-month contract to hire Schedule: 8:00am-5:00pm (may require flexibility based on patient visits) Need (at least) 2 years of prior CRC experience Clinical Research Coordinator - Independence MO Key Responsibilities Assist with the design, coordination, and execution of research projects under the guidance of senior researchers. Collect, organize, and manage quantitative and qualitative data from clinical, survey, and digital health sources. Conduct literature reviews and summarize findings to support study development and publication efforts. Ensure compliance with research protocols, ethical standards, and data privacy regulations (e.g., HIPAA). Prepare research materials, consent forms, and documentation for IRB submissions. Support the preparation of reports, presentations, and manuscripts for internal and external use. Collaborate with interdisciplinary teams, including clinicians, data scientists, and policy experts. Maintain accurate project records and track study milestones and deliverables. Occasional travel may be required for audits, site visits, or team meetings (confirmed talent will not be driving while on the clock). Required Qualifications Strong organizational and time-management skills Proficiency in Microsoft Office Suite and basic data management tools (e.g., Excel, REDCap, Qualtrics) Excellent written and verbal communication skills Detail-oriented, proactive, and able to work independently and collaboratively Preferred Qualifications Experience in clinical, epidemiological, or behavioral health research Familiarity with research ethics, IRB processes, and data protection standards Interest in digital health, health equity, or outcomes research

Fully onsite - Direct Hire - ideally 2 years of CRC experience needed prior. Job Title: Clinical Research Coordinator (CRC) The Clinical Research Coordinator (CRC) is responsible for the day-to-day coordination and management of clinical research studies. This role ensures studies are conducted in compliance with protocol requirements, Good Clinical Practice (GCP), institutional policies, and regulatory guidelines. The CRC works closely with investigators, study sponsors, research participants, and regulatory bodies to ensure the successful execution of clinical trials. Key Responsibilities Coordinate and manage clinical research studies from start-up through close-out Screen, recruit, and enroll study participants according to protocol criteria Obtain and document informed consent in accordance with regulatory requirements Schedule and conduct study visits, procedures, and follow-ups Collect, document, and maintain accurate study data in source documents and electronic data capture (EDC) systems Ensure compliance with study protocols, GCP, IRB requirements, and applicable regulations Prepare and maintain regulatory documents, including IRB submissions, amendments, and continuing reviews Serve as the primary point of contact for sponsors, monitors, and study participants Assist with monitoring visits, audits, and inspections Track and report adverse events and protocol deviations Maintain study supplies, investigational product accountability, and inventory Collaborate with investigators and research team members to ensure study timelines and goals are met Public - Required Skills 2 Years of CRC Experience Comfortable working in a small team setting in a fast paced environment Public - Preferred Skills Spirometry training Public - Schedule/Shift Monday-Friday 8am-5pm

Protocol compliance when performing procedures and assisting physicians with IP administration. Ordering and tracking of clinical supplies related to the protocols. Detailed record keeping of IP accountability. Ensures all IP is stored at appropriate temperature. Ensures all shipments are documented and recorded per sponsor requirements. Ensures all IP is returned to Sponsor according to specifications. Follows randomization procedures for the protocol and ensures accuracy in dispensing. Works closely with unmasked investigators to follow procedures for administration and mixing of IP. Follows CRA SOP regarding IP transport. Performance of Protocol Related Procedures (Research Assistant): Duties include but are not limited to: Labeling, Processing and shipping of specimens in accordance to protocol specifications Documentation and record keeping for study related procedures. Scheduling of subjects for visits Scheduling of outside procedures related to the protocol (example: MRI's)

Coordinates with Principal Investigator to ensure that clinical research trials and activities are performed in accordance with the study protocol, FDA, GCP, ICH Guidelines. Participant pre-screening, recruitment and scheduling Complete protocol and trial system training Maintenance of regulatory documents Conducts or participates in the informed consent process and discussions with trial participants, including answering any questions related to the study. Conducting participant visits Ability to perform basic lab and clinical procedures per protocol, such as: blood specimen collection (phlebotomy), blood pressure, vitals, EKGs, centrifuge operation, storing and shipping of lab specimens, and accountability of specimens and notification of courier for specimen pick-up Entering data in the EDC and resolving all queries Updating and maintaining trial logs and participant charts

Job Title: Unblinded Clinical Research Coordinator Pay Range: Up to $25 per hour Schedule: Monday - Friday, 8:00 AM - 5:00 PM Duration: 90-day contract with potential for extension or conversion to a permanent position based on performance and trial needs. Position Summary: This full-time role supports the day-to-day operations of clinical trials, with a strong focus on Investigational Product (IP) management while maintaining study integrity between blinded and unblinded staff. The Unblinded CRC serves as the subject-matter expert for IP handling and works closely with the Site Manager, study team, sponsors, and participants to ensure compliance with protocols and SOPs. Key Responsibilities: Managing all aspects of Investigational Product (receipt, storage, dispensing, administration, accountability, and return/destruction) Maintaining the study blind and communicating appropriately with blinded and unblinded team members Conducting patient-facing visits, including vitals, ECGs, lab collection, and protocol-required procedures Completing accurate source documentation and EDC entry within required timelines Monitoring study activities for regulatory and protocol compliance Recording and reporting adverse events and resolving sponsor queries Participating in site audits, monitor visits, investigator meetings, and site initiation visits Maintaining temperature logs, pharmacy binders, and master study logs This position reports directly to the Site Manager/Director and plays a critical role in ensuring studies run smoothly and compliantly. Required Qualifications: Recent, heavy hands-on injection or vaccine administration experience, including independent injection administration in accordance with medication protocols Patient-facing clinical experience (Medical Assistant, Clinical Research Assistant, Research Assistant, LPN, etc.) Ability to work directly with study participants in a clinical setting Strong attention to detail and accurate documentation skills Ability to complete source documentation during patient visits and enter data into EDC within required timelines Ability to follow study protocols, SOPs, and regulatory requirements Basic understanding of GCP and FDA regulations (training acceptable) Strong communication and organizational skills Ability to work Monday-Friday, 8:00 AM-5:00 PM Ability to start ASAP Preferred Qualifications: Previous experience as a Clinical Research Coordinator (CRC) Unblinded CRC or Investigational Product (IP) management experience Experience with drug accountability, temperature logs, and pharmacy binders Experience with Investigational Product preparation and administration Experience participating in monitor visits, audits, SIVs, and investigator meetings Experience using EDC systems and resolving sponsor queries Work Environment: On-site clinical research site supporting active clinical trials and patient-facing activities.