clinical trial coordinator

Thermo Fisher Scientific

<div>Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
At Thermo Fisher Scientific, you&rsquo;ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life &ndash; enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on &ndash; now and in the future.
Division Specific Information
Our global Clinical Research Group (CRG) colleagues within the Functional Service Partnership (FSP) solutions area provide support for clinical trials during feasibility, study start up, maintenance, close out, and database lock, depending on the client&rsquo;s needs. Client-dedicated Clinical Trial Coordinators (FSP CTCs) work directly with clients to provide administrative and technical support by performing day-to-day functions within the client organization to support clinical trial activities.
In the FSP CTC role, you will represent PPD, part of Thermo Fisher Scientific, while working alongside the client, as a partner, providing a specific service. This role is also referred to as a &quot;Records Management Associate&quot;. Tasks can include providing administrative and technical support to the client study team; supporting client audit readiness by ensuring client systems are accurate and up to date; providing administrative support for site activation activities; and managing assigned service providers and/or vendors. FSP CTC roles and responsibilities may vary based on client needs.
This role is 100% onsite in Greenwood, Indiana (M-F 8am - 5pm).
Sponsorship will not be provided. Relocation assistance will not be provided.
A Day in the Life:
Coordinates with study team during startup, maintenance, and closeout activities to include collection, review, and submission of documents to regulatory authorities Manages and contributes to the electronic Trial Master Files (eTMF) during feasibility, study startup, maintenance, and closeout activities (e.g., collecting and filing documents, uploading study team lists, adding/updating study site information, study milestones and other important data) Performs eTMF quality and completion checks and initiates follow-up on resolutions when needed Assists with feasibility and site selection activities Manages study system access for study team, site staff, and service providers/vendors
Attends internal/external meetings and supports scheduling, agenda and meeting minutes creation/distribution Creates, maintains, reviews and/or distributes study trackers, forms, newsletters, memos to study teams, sites and service providers/vendors Assists study lead with oversight of the client&rsquo;s service provider(s) to ensure assigned activities are completed accurately and on time (e.g., system completeness, product vendor(s) and site management) Assists with administrative requests for entering purchase orders, change orders and running financial reports, with oversight of study lead May assist with coordination of trial/site insurance, tracking of study supplies and/or shipments of drug supply Attends and/or assists in preparation for in-person meetings, such as Kick Off Meetings (KOMs), Investigator Meetings (IMs), or client Face to Face meetings May assist with additional client administrative projects and tasks as needed, such as supporting onboarding of new study team members
Keys to Success:
Education<ul><li>
High/Secondary school diploma or equivalent and relevant formal academic/vocational qualification. Bachelor&rsquo;s degree preferred.</li></ul>
Experience<ul><li>
Previous experience that provides the knowledge, skills and abilities to perform the job.</li><li>
In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.</li></ul>
Knowledge, Skills, Abilities<ul><li>
Good organizational skills and strong attention to detail, with shown ability to handle and prioritize/reprioritize multiple tasks efficiently and effectively</li><li>
Shown ability to effectively analyze project-specific data/systems to ensure accuracy and efficiency</li><li>
Demonstrated ability to attain and maintain a good working knowledge of applicable Country Regulations, ICH Good Clinical Practices, and organization/Client SOPs and WPDs for all non-clinical/clinical aspects of project implementation, execution and closeout</li><li>
Good English language and grammar skills and proficient local language skills as needed</li><li>
Good computer skills, including knowledge of Microsoft Office and/or Google Suite</li><li>
Ability to obtain knowledge and master all clinical trial database systems (e.g., Veeva, RAVE, SIP)</li><li>
Ability to identify and escalate risk as appropriate</li><li>
Ability to quickly learn and adapt to client processes and systems (as applicable)</li><li>
Ability to work in a team or independently as required</li><li>
Strong customer focus</li><li>
Self-motivated, positive attitude, and good social skills</li><li>
Effective oral and written communication skills</li><li>
Essential judgment, independent thinking, and decision-making skills</li><li>
Capable of accurately following project work instructions</li></ul>
Physical Requirements/Working Environment
Thermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:<ul><li>
Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensive and reasonable manner.</li><li>
Able to work upright and stationary for typical working hours.</li><li>
Ability to use and learn standard office equipment and technology with proficiency.</li><li>
Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.</li><li>
Travel may be required based on client needs.</li></ul></div>

FSP Clinical Trial Coordinator I - Onsite

SF Research Institute Inc.

Regulatory Coordinator/Contractor for Clinical Research studies (at the Site level)MUST have prior experience and understand Clinical Research studies from the Site level.MUST have experience in Site start up activities and Site close outsResponsible for:&middot; Move study from feasibility questionnaire to study activation&middot; Including IRB submissions, Regulatory documents, ICF preparation, Site qualification visit, site initiation visit, preparing site regulatory binder.&middot; Maintain study startup tracker&middot; Clinical trial billing&middot; Clinical trial agreement&middot; Assist in budget negotiation&middot; Maintain the clinical trial pipeline&middot; Quality assurance of each visit done by the coordinator&middot; Maintain proper audit logo Setting up process flow for each trialo Setting up billing structureo Setting up clinical research dept and SOP&rsquo;so CRIO, ConfluenceIJob Types: Full-time, Contract, Part-timePay: $30.00 - $40.00 per hourEducation:<ul><li>Bachelor's (Preferred)</li></ul>Experience:<ul><li>Clinical Trials: 1 year (Preferred)</li><li>Clinical Research: 1 year (Preferred)</li></ul>Work Location: In person

Experienced Regulatory Affairs Coordinator/Contractor (Must have Clinical Research Experience)

M3 Wake Research

<div>
 
 M3 Wake Research, an M3USA Company, is an integrated network of premier investigational sites meeting the clinical research needs of global biopharmaceutical, biotechnology, medical device, pharmaceutical and clinical research organizations (CROs). With close to 30 owned and managed research sites across the country, M3 Wake Research is one of the largest independent, multi-site clinical research companies in the US. M3 Wake Research continues to grow through acquisitions and uncompromising commitment to careful planning and execution in accordance with regulatory compliance.
 
 
 
 
 Conducting studies since 1984, M3 Wake Research owns a proprietary patient database of potential clinical trial participants across the US. As of today, our board-certified physicians have completed more than 7,000+ successful clinical trials, while consistently exceeding sponsor expectations for integrity, timeliness, subject enrollment, human protection, and expeditious delivery of accurate evaluable data.
 
 
 
 
 Due to our continued growth, we are hiring for a
 
 Clinical Research Coordinator
 
 at
 
 Wake Research,
 
 an M3 company. This position is on-site and located in
 
 Raleigh, NC
 
 .
 
 
 
 
 
 
 Job Description
 
 
 
 
 The Clinical Research Coordinator (CRC) is a specialized research professional working with and under the guidance of the clinical research site management and Principal Investigator (PI). While the PI is primarily responsible for the overall conduct of the clinical trial, the CRC manages, supports, facilitates and coordinates the daily clinical trial activities and plays a critical role in the conduct of the study.
 
 
 
 
 
 Essential Duties and Responsibilities:
 
 
 
 
 <ul>
 <li>
 Assisting trial Investigator in screening and review of potential study participants eligibility
 </li>
 <li>
 Maintaining case report forms, charts and documentation
 </li>
 <li>
 Mentoring, training, and high-level oversight of other clinical research coordinators and research assistants
 </li>
 <li>
 Ensuring that all clinical activities are carried out in accordance with established research protocol and standards in compliance with all applicable laws, regulations, policies, and procedural requirements
 </li>
 <li>
 Collecting and entering data as necessary
 </li>
 <li>
 Assist management with potential new hire selection and shadowing process
 </li>
 <li>
 Assist with study start-up, maintenance, and close-out of studies as needed for those on the team
 </li>
 <li>
 Ability to be flexible with study assignments
 
 
 </li>
 </ul>
 
 Qualifications
 
 
 
 <ul>
 <li>
 Clinical Research Coordinator with 1-2 years of experience
 </li>
 <li>
 Phlebotomy experience is highly preferred
 </li>
 <li>
 Previous experience as a medical assistant, LPN, or RN
 </li>
 <li>
 Excellent verbal &amp; written communication skills
 </li>
 <li>
 Ability to learn quickly, read and understand complex protocols, follow very detailed directions, and multi-tasking
 </li>
 <li>
 Must be able to maintain strict confidentiality of patients, employees, and company information at all times and adhere to HIPAA Guidelines
 </li>
 <li>
 Extensive clinical trial knowledge through education and/or experience
 </li>
 <li>
 Successful completion of GCP Certification and Advanced CRC preferred
 </li>
 <li>
 Detail-oriented
 </li>
 <li>
 Familiarity with the Code of Federal Regulations as they pertain to human subject protection
 </li>
 <li>
 Strong interpersonal skills
 
 
 </li>
 </ul>
 
 Additional Information
 
 
 
 
 
 About M3:
 
 
 
 
 
 M3 USA is at the forefront of healthcare innovation, offering digital solutions across healthcare, life sciences, pharmaceuticals, and more. Since our inception in 2000, we&rsquo;ve seen remarkable growth, fueled by our mission to utilize the internet for a healthier world and more efficient healthcare systems.
 
 
 
 
 Our success is anchored in our trusted digital platforms that engage physician communities globally, facilitating impactful medical education, precise job placement, and insightful market research. M3 USA prides itself on a dynamic and innovative work environment where every team member contributes to global health advancements.
 
 
 
 
 Joining M3 USA means being part of a dedicated team striving to make a significant difference in healthcare. We provide a unique opportunity for you to be at the cutting edge of healthcare innovation, shaping the future in a meaningful career. Embrace the chance to drive change with M3 USA.
 
 
 
 
 
 Benefits:
 
 
 
 
 
 A career opportunity with M3 Wake Research offers competitive wages, and benefits such as:
 
 
 
 <ul>
 <li>
 401(k), 401(k) matching
 </li>
 <li>
 Dental insurance
 </li>
 <li>
 Disability insurance
 </li>
 <li>
 Employee assistance program
 </li>
 <li>
 Flexible spending account
 </li>
 <li>
 Health insurance
 </li>
 <li>
 Life insurance
 </li>
 <li>
 Paid time off
 </li>
 <li>
 Vision insurance
 </li>
 </ul>
 
 *M3 reserves the right to change this job description to meet the business needs of the organization
 
 
 
 
 
 
 
 
 
 
 
</div>

Clinical Research Coordinator

CARE Institute

CARE Institute, LLC | Mid-Level | Full-Time | HourlyPosition SummaryThe Clinical Research Coordinator II (CRC II) is a mid-level position responsible for independently managing all aspects of assigned clinical trials, ensuring protocol compliance, ethical conduct, and adherence to regulatory standards. The CRC II manages multiple studies simultaneously and serves as lead CRC on assigned protocols. This role requires demonstrated proficiency in clinical research operations, the ability to work independently with minimal oversight, and readiness to begin supporting the development of junior team members. The CRC II works collaboratively with the Recruitment Specialist, Regulatory Specialist, and Site Manager to maintain high-quality trial execution across the site.ResponsibilitiesClinical Trial Operations<ul><li>Independently supervise study site activities and ensure adherence to protocols, ethical standards, and regulatory requirements</li><li>Serve as lead CRC on assigned studies, managing daily activities and monitoring subject and researcher activities</li><li>Screen potential study participants through medical record reviews, interviews, and healthcare provider follow-ups</li><li>Perform medical procedures, including but not limited to: patient vitals, phlebotomy, lab processing, and EKGs</li><li>Independently manage interactions with trial compliance monitors, answering all queries and making necessary corrections</li><li>Identify and escalate potential safety issues promptly; contribute to root cause analysis when deviations occur</li><li>Dispense medication upon provider approval and maintain drug accountability records per protocol and FDA guidelines</li><li>Manage patient care and collection of medical history, medications, and data necessary for conducting clinical trials</li></ul>Documentation &amp; Data Management<ul><li>Review and validate source documents while adhering to protocol requirements independently</li><li>Ensure proper transmission of clinical case data to data management centers; review case report questions and resolve or escalate data discrepancies</li><li>Maintain research records of study activity including case report forms and regulatory forms per FDA guidelines</li><li>Demonstrate thorough knowledge of informed consent requirements and ensure all documentation is completed accurately per regulatory and ethical standards</li><li>Understand and independently apply regulatory documentation requirements</li><li>Maintain high data quality standards with timely query resolution in EDC systems</li></ul>Team Development &amp; Collaboration<ul><li>Assist with onboarding and orientation of new CRC I team members</li><li>Provide guidance and support to CRC I staff on day-to-day study procedures</li><li>Collaborate effectively with Regulatory Specialists, Recruitment Specialists, and Principal Investigators</li><li>Participate in preparation for sponsor monitoring visits and assist in resolving audit findings</li></ul>Site &amp; Administrative Operations<ul><li>Ensure all study equipment is in good working order; coordinate maintenance and calibration</li><li>Maintain supplies inventory, anticipate needs, and manage ordering processes</li><li>Provide comprehensive patient education on all trial details</li><li>Process, package, and ship laboratory specimens per protocol and IATA regulations</li><li>Support front office duties as needed including scheduling, reminder calls, and patient tracking</li><li>Maintain cleanliness and organization of patient care, lab, and equipment areas</li><li>Maintain confidentiality of patient PHI, sponsor confidential information, and CARE confidential information</li><li>Other duties as assigned</li></ul>Skills &amp; Qualifications<ul><li>Strong written and oral communication skills</li><li>Demonstrated ability to manage multiple studies simultaneously with minimal oversight</li><li>Superior problem-solving, deductive reasoning, and decision-making skills</li><li>Ability to build and maintain effective relationships with colleagues, sponsors, and monitors</li><li>Strong time management skills with ability to prioritize competing demands efficiently</li><li>Knowledge of statistical data collection, validation, editing, and analysis techniques</li><li>Ability to provide technical guidance and support to CRC I staff</li><li>Knowledge of laboratory certification processes and standards</li><li>Excellent attention to detail with strong record-keeping skills</li><li>Proficiency with Microsoft Office, Adobe Acrobat, and clinical trial management systems (e.g., Clinical Research IO)</li><li>Strong knowledge of medical terminology</li><li>Professionalism, reliability, and strong interpersonal skills</li><li>Demonstrates initiative and ability to work independently</li></ul>Education &amp; Experience Requirements<ul><li>High school diploma or equivalent education required</li><li>Minimum of two years of experience as a Clinical Research Coordinator</li><li>Must have two years of experience as a Medical Assistant or have obtained a Certified Medical Assistant degree</li><li>Must be proficient in performing EKGs, blood collection, obtaining vitals, and documenting medical history</li><li>Served as lead CRC on a minimum of 4 studies (cumulative)</li><li>CCRC certification preferred; must be actively pursuing or have a plan to obtain within 24 months</li><li>Valid driver&rsquo;s license and current automobile insurance</li></ul>Physical DemandsThe employee must have the ability to lift, pull, push, and manipulate equipment and patients, which requires strength and gross motor and fine motor coordination. The employee must be able to administer prescribed treatments. The position requires sitting and/or standing for long periods of time and the ability to operate a computer.Position Details<ul><li>Job Type: Full-time, Hourly, Monday to Friday, In Person</li><li>Salary Range: $22&ndash;$29/hr depending on experience</li><li>Benefits: 401(k) with matching, Paid Time Off, Health Insurance, Bonus eligibility</li></ul>Pay: $22.00 - $29.00 per hourBenefits:<ul><li>401(k)</li><li>Health insurance</li><li>Paid time off</li></ul>Experience:<ul><li>Clinical research: 2 years (Preferred)</li></ul>Work Location: In person

Clinical Research Coordinator - II

Scientific Search

<div>
 
 Location:
 
 Winter Park, FL
 
 
 This is an exciting opportunity for an experienced Clinical Research Coordinator to take on a more influential role in the execution of clinical trials that advance modern medicine. In this position, you&rsquo;ll work directly with patients and investigators while helping ensure studies are conducted with precision, integrity, and impact. It&rsquo;s an ideal next step for a coordinator ready to deepen their expertise and grow within clinical research.
 
 
 Why You Should Apply
 
 
 <ul>
 <li>
 Play a hands-on role in clinical trials that bring new therapies to patients
 </li>
 <li>
 Take ownership of a growing study portfolio with increased responsibility
 </li>
 <li>
 Collaborate closely with investigators, sponsors, and CRO partners
 </li>
 <li>
 Build the skills and visibility needed to progress to a CRC III role
 </li>
 <li>
 Salary and incredible incentive compensation
 </li>
 <li>
 Strong benefit package including matching 401k, medical dental and weekly catered lunches!! Also, early out on Fridays
 
 
 </li>
 </ul>
 What You&rsquo;ll Be Doing
 
 
 <ul>
 <li>
 Coordinating and managing day-to-day clinical trial activities
 </li>
 <li>
 Guiding patients through informed consent, visits, and procedures
 </li>
 <li>
 Conducting study visits including vitals, blood draws, ECGs, and specimen processing
 </li>
 <li>
 Ensuring strict compliance with protocols, GCP, and ALCOA-C standards
 </li>
 <li>
 Communicating with sponsors, CRAs, investigators, and clinic leadership
 </li>
 <li>
 Supporting audits, monitoring visits, and study start-up activities
 
 
 </li>
 </ul>
 
 About You
 
 
 
 <ul>
 <li>
 Bachelor&rsquo;s degree in psychology, biology, health sciences, or a related field
 </li>
 <li>
 Strong knowledge of medical terminology and clinical research operations
 </li>
 <li>
 Highly organized with excellent attention to detail
 </li>
 <li>
 Professional, patient-focused, and able to work independently
 </li>
 <li>
 Collaborative mindset with a positive, adaptable attitude
 
 
 </li>
 </ul>
 How To Apply
 
 
 We&rsquo;d love to see your resume, but we don&rsquo;t need it to have a conversation. Send us an email to
 
 tori@scientificsearch.com
 
 and tell me why you&rsquo;re interested. Or, feel free to email your resume. Please include
 
 Job#19707
 
 .
 
 
</div>

Clinical Research Coordinator II

MaximaTek

<div>
 
 About the Role: Clinical Research Coordinator (CRC)
 
 
 We are seeking a detail-oriented
 
 Clinical Research Coordinator (CRC)
 
 to manage and oversee the daily operations of clinical trials. In this role, you will act as the vital link between the clinical site, the study sponsors, and the regulatory bodies, ensuring that all research is conducted with the highest integrity, patient safety, and adherence to strict regulatory standards (such as
 
 ICH-GCP
 
 and
 
 FDA 21 CFR
 
 ).
 
 
 Core Responsibilities
 
 <ul>
 <li>
 
 Study Management:
 
 Coordinate the daily activities of clinical trials, including patient recruitment, screening, enrollment, and follow-up visits.
 </li>
 <li>
 
 Regulatory Compliance:
 
 Maintain comprehensive Essential Document files and ensure all study activities align with
 
 IRB/IEC
 
 requirements and
 
 SOPs
 
 .
 </li>
 <li>
 
 Data Integrity:
 
 Perform accurate data entry into Electronic Data Capture (EDC) systems and ensure the "ALCOA+" principles of data integrity are upheld.
 </li>
 <li>
 
 Patient Safety:
 
 Monitor participant well-being, report Adverse Events (AEs) and Serious Adverse Events (SAEs) promptly to sponsors and regulatory boards.
 </li>
 <li>
 
 Quality Assurance:
 
 Author and maintain source documentation and assist in internal and external audits to ensure
 
 GxP
 
 and
 
 cGMP
 
 requirements are met.
 </li>
 <li>
 
 Site Liaison:
 
 Serve as the primary point of contact for Clinical Research Associates (CRAs) during monitoring visits.
 </li>
 </ul>
 
 Qualifications
 
 <ul>
 <li>
 
 Education:
 
 Bachelor&rsquo;s degree in Life Sciences, Nursing, Biomedical Sciences, or a related healthcare field (Required).
 </li>
 <li>
 
 Experience:
 
 0&ndash;5 years of experience in clinical research, healthcare administration, or academic laboratory environments.
 </li>
 <li>
 
 Technical Skills (Required):
 
 </li>
 <li>
 Strong understanding of
 
 ICH-GCP
 
 guidelines and
 
 Human Subjects Protection
 
 .
 </li>
 <li>
 Proficiency in clinical trial management software and
 
 EDC
 
 platforms.
 </li>
 <li>
 Familiarity with
 
 21 CFR Part 11
 
 regarding electronic records and signatures.
 </li>
 <li>
 Excellent medical writing and documentation skills.
 </li>
 <li>
 
 Preferred Skills:
 
 </li>
 <li>
 Certification (or eligibility) for
 
 CCRC
 
 (ACRP) or
 
 CCRP
 
 (SoCRA).
 </li>
 <li>
 Experience with medical device clinical trials (ISO 14155).
 </li>
 <li>
 Knowledge of Phlebotomy or basic clinical assessment skills.
 </li>
 </ul>
 
 What We Offer
 
 <ul>
 <li>
 
 Targeted Placement:
 
 Direct marketing to our network of hiring managers in the Life Sciences and MedTech industries.
 </li>
 <li>
 
 Technical Resume Rebuild:
 
 Optimization of your profile to highlight clinical expertise alongside regulatory documentation skills.
 </li>
 <li>
 
 Interview Coaching:
 
 Guidance on behavioral interviews and regulatory compliance case studies.
 </li>
 </ul>
 
 Ready to Take the Next Step?
 
 
 Email your updated resume to: sharifsk@maximatek.com
 
</div>

CARE Institute, LLC | Mid-Level | Full-Time | HourlyAbout CARE Institute: CARE Institute (CardioRenalInstitute.com) is dedicated to providing quality clinical research that significantly impacts the health of patients and communities. Our mission is to advance scientific and medical knowledge within the industry. With a focus on growth and innovation, CARE Institute offers a dynamic environment with ample opportunities for professional development and career advancement. Join us at CARE Institute and be part of a dynamic team dedicated to making a meaningful difference in clinical research and healthcare. Apply now to embark on an exciting career journey with us!CARE is proud to be an Equal Opportunity Employer that values and treasures Diversity, Equity, and Inclusion. We are committed to creating an environment of dignity and respect for all our employees, patients, and families (EEO/AA).Position SummaryThe Clinical Research Coordinator II (CRC II) is a mid-level position responsible for independently managing all aspects of assigned clinical trials, ensuring protocol compliance, ethical conduct, and adherence to regulatory standards. The CRC II manages multiple studies simultaneously and serves as lead CRC on assigned protocols. This role requires demonstrated proficiency in clinical research operations, the ability to work independently with minimal oversight, and readiness to begin supporting the development of junior team members. The CRC II works collaboratively with the Recruitment Specialist, Regulatory Specialist, and Site Manager to maintain high-quality trial execution across the site.ResponsibilitiesClinical Trial Operations<ul><li>Independently supervise study site activities and ensure adherence to protocols, ethical standards, and regulatory requirements</li><li>Serve as lead CRC on assigned studies, managing daily activities and monitoring subject and researcher activities</li><li>Screen potential study participants through medical record reviews, interviews, and healthcare provider follow-ups</li><li>Perform medical procedures, including but not limited to: patient vitals, phlebotomy, lab processing, and EKGs</li><li>Independently manage interactions with trial compliance monitors, answering all queries and making necessary corrections</li><li>Identify and escalate potential safety issues promptly; contribute to root cause analysis when deviations occur</li><li>Dispense medication upon provider approval and maintain drug accountability records per protocol and FDA guidelines</li><li>Manage patient care and collection of medical history, medications, and data necessary for conducting clinical trials</li></ul>Documentation &amp; Data Management<ul><li>Review and validate source documents while adhering to protocol requirements independently</li><li>Ensure proper transmission of clinical case data to data management centers; review case report questions and resolve or escalate data discrepancies</li><li>Maintain research records of study activity including case report forms and regulatory forms per FDA guidelines</li><li>Demonstrate thorough knowledge of informed consent requirements and ensure all documentation is completed accurately per regulatory and ethical standards</li><li>Understand and independently apply regulatory documentation requirements</li><li>Maintain high data quality standards with timely query resolution in EDC systems</li></ul>Team Development &amp; Collaboration<ul><li>Assist with onboarding and orientation of new CRC I team members</li><li>Provide guidance and support to CRC I staff on day-to-day study procedures</li><li>Collaborate effectively with Regulatory Specialists, Recruitment Specialists, and Principal Investigators</li><li>Participate in preparation for sponsor monitoring visits and assist in resolving audit findings</li></ul>Site &amp; Administrative Operations<ul><li>Ensure all study equipment is in good working order; coordinate maintenance and calibration</li><li>Maintain supplies inventory, anticipate needs, and manage ordering processes</li><li>Provide comprehensive patient education on all trial details</li><li>Process, package, and ship laboratory specimens per protocol and IATA regulations</li><li>Support front office duties as needed including scheduling, reminder calls, and patient tracking</li><li>Maintain cleanliness and organization of patient care, lab, and equipment areas</li><li>Maintain confidentiality of patient PHI, sponsor confidential information, and CARE confidential information</li><li>Other duties as assigned</li></ul>Skills &amp; Qualifications<ul><li>Strong written and oral communication skills</li><li>Demonstrated ability to manage multiple studies simultaneously with minimal oversight</li><li>Superior problem-solving, deductive reasoning, and decision-making skills</li><li>Ability to build and maintain effective relationships with colleagues, sponsors, and monitors</li><li>Strong time management skills with ability to prioritize competing demands efficiently</li><li>Knowledge of statistical data collection, validation, editing, and analysis techniques</li><li>Ability to provide technical guidance and support to CRC I staff</li><li>Knowledge of laboratory certification processes and standards</li><li>Excellent attention to detail with strong record-keeping skills</li><li>Proficiency with Microsoft Office, Adobe Acrobat, and clinical trial management systems (e.g., Clinical Research IO)</li><li>Strong knowledge of medical terminology</li><li>Professionalism, reliability, and strong interpersonal skills</li><li>Demonstrates initiative and ability to work independently</li></ul>Education &amp; Experience Requirements<ul><li>High school diploma or equivalent education required</li><li>Minimum of two years of experience as a Clinical Research Coordinator</li><li>Must have two years of experience as a Medical Assistant or have obtained a Certified Medical Assistant degree</li><li>Must be proficient in performing EKGs, blood collection, obtaining vitals, and documenting medical history</li><li>Served as lead CRC on a minimum of 4 studies (cumulative)</li><li>CCRC certification preferred; must be actively pursuing or have a plan to obtain within 24 months</li><li>Valid driver&rsquo;s license and current automobile insurance</li></ul>Physical DemandsThe employee must have the ability to lift, pull, push, and manipulate equipment and patients, which requires strength and gross motor and fine motor coordination. The employee must be able to administer prescribed treatments. The position requires sitting and/or standing for long periods of time and the ability to operate a computer.Position Details<ul><li>Job Type: Full-time, Hourly, Monday to Friday, In Person</li><li>Salary Range: $22&ndash;$29/hr depending on experience</li><li>Benefits: 401(k) with matching, Paid Time Off, Health Insurance, Bonus eligibility</li></ul>Pay: $22.00 - $29.00 per hourBenefits:<ul><li>401(k)</li><li>Health insurance</li><li>Paid time off</li></ul>Experience:<ul><li>Clinical research: 2 years (Preferred)</li></ul>Work Location: In person

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FSP Clinical Trial Coordinator I - Onsite

Experienced Regulatory Affairs Coordinator/Contractor (Must have Clinical Research Experience)

Clinical Research Coordinator

Clinical Research Coordinator - II

Clinical Research Coordinator II

Clinical Research Coordinator

Clinical Research Coordinator - II