Research Nurse
Research nurse job at Tennessee Oncology
Tennessee Oncology, one of the nation's largest, community-based cancer care specialists, is home to one of the leading clinical trial networks in the country. Established 1976 in Nashville, Tennessee Oncology's mission remains unchanged: To provide access to high-quality cancer care and the expertise of clinical research for all patients, at convenient locations within their community and close to their home. Our growing network of physicians and locations is based on this mission. Tennessee Oncology is committed to advancing both the science of detection and targeted treatments, and to making these advances available to every patient. We believe caring for cancer patients is a privilege.
Why Join Us? We are looking for talented and highly-motivated individuals who demonstrate a natural desire to support the meaningful work of community oncologists and the patients we serve.
Job Description:
As the Research Nurse for Tennessee Oncology your primary responsibility is to screen, enroll and follow study subjects, ensuring protocol compliance and close monitoring while the subjects are on study. You are responsible for source documentation and recording of adverse events. You are also responsible for dispensing oral investigational products and ensuring patient compliance with these medications
ESSENTIAL FUNCTIONS:
* You will be enrolling patients onto clinical trials through recruitment, screening, enrollment, treatment, and follow-up of eligible participants according to protocol requirements.
* Obtains and maintains informed consents of each patient for the duration of a study
* You will review the study design and inclusion/exclusion criteria with physician and patient.
* You will ensure the protection of study patients by verifying informed consent procedures and adhering to protocol requirements.
* You will complete and document screening/eligibility accurately.
* You will complete and document the informed consent process accurately and has all parties sign/date as required, including HIPAA Authorization.
* You will accurately complete and submit on-study forms within required timelines
* You will document all specific tools required by the protocol (i.e., oral medication forms, pill count diaries, quality of life questionnaires, neuro exams, vital signs sheets, times of PK draws, etc.)
* You will screen every new patient or patient returning to office with scan results and document appropriately on the patient tracking logs
* You will ensure that patient documentation is completed at each clinic visit while in screening.
* You will ensure that all medications are approved prior to initiating treatment or when changing medication regimens, such as crossover studies.
* You will accurately calculate and document BSA, Creatinine Clearance, Urine Protein: Creatinine ratio, and any other calculations or conversions required per protocol.
* You will ensure that follow-up appointments, scans, or related procedures are scheduled correctly according to protocol requirements.
* You will document appropriately when patients are removed from protocol.
* You will ensure reconsent of patients at the next scheduled visit, following availability of updated ICF, and documents process appropriately
* provides patient education and medical information to study patients to ensure understanding or proper medication dosage, administration, and disease treatment.
* maintains medication inventory and reconciliation
KNOWLEDGE, SKILLS & ABILITIES:
* Knowledge of medical and research terminology
* Knowledge of FDA Code of Federal Regulations and GCP
* Knowledge of the clinical research processes
* At least on year of oncology experience, preferably hematology and/or transplant.
* At least one year of experience in a research setting preferred
* Research Certification (ACRP or CCRP) Preferred
EDUCATION & EXPERIENCE:
* An Associate Degree; preferably a bachelor's degree
* RN License
PHYSICAL REQUIREMENTS:
Job Title:
Physical Activity Required
Amount of time
None
Less than 1/3
(Occasionally)
1/3 to 2/3
(Frequently)
More than 2/3
(Regularly)
Standing
Walking
Sitting
Fingering or manual dexterity
Repetitive finger motion
Lifting or exerting force
Up to 10 pounds
Up to 25 pounds
Up to 50 pounds
Up to 100 pounds
Over 100 pounds
Reaching or stretching
Climbing or balancing
Crouching or stooping
Speaking
Hearing
Seeing (with correction)
Auto-ApplyResearch Nurse
Research nurse job at Tennessee Oncology
Tennessee Oncology, one of the nation's largest, community-based cancer care specialists, is home to one of the leading clinical trial networks in the country. Established 1976 in Nashville, Tennessee Oncology's mission remains unchanged: To provide access to high-quality cancer care and the expertise of clinical research for all patients, at convenient locations within their community and close to their home. Our growing network of physicians and locations is based on this mission. Tennessee Oncology is committed to advancing both the science of detection and targeted treatments, and to making these advances available to every patient. We believe caring for cancer patients is a privilege.
Why Join Us? We are looking for talented and highly-motivated individuals who demonstrate a natural desire to support the meaningful work of community oncologists and the patients we serve.
Job Description:
As the Research Nurse for Tennessee Oncology Greco Hainsworth Center for Research, you will play a critical role in advancing oncology research by ensuring the successful execution of clinical trials. You will be responsible for screening, enrolling, documenting, and monitoring study subjects, ensuring strict protocol compliance and delivering exceptional patient care.
ESSENTIAL FUNCTIONS:
* Enroll patients in clinical trials through recruitment, screening, enrollment, treatment, and follow-up of eligible participants according to protocol requirements.
* Provide thorough education about study requirements and expectations.
* Complete and document the informed consent process accurately, ensuring all parties sign and date as required, including obtaining HIPAA Authorization.
* Obtains and maintains informed consent of each patient for the duration of a study.
* Review the study design and inclusion/exclusion criteria with the physician and the patient.
* Complete and submit on-study forms within required timelines.
* Maintain accurate and detailed source documentation, including study visits findings, and outcomes.
* Screen all new patients or patients returning to the office with scan results and document appropriately on patient tracking logs.
* Monitor subjects throughout the study, ensuring protocol compliance and patient safety.
* Ensure that all medications are approved before initiating treatment or changing medication regimens, such as crossover studies.
* Dispense oral investigational products to study participants and provide guidance to ensure compliance with medication regimens.
* Accurately calculate and document BSA, Creatinine Clearance, Urine Protein: Creatinine ratio, and any other calculations or conversions required per protocol.
* Ensure that follow-up appointments, scans, or related procedures are scheduled correctly per protocol requirements.
* Record and report adverse events according to study protocols and regulatory requirements.
* Document appropriately when patients are removed from the protocol.
* Ensure reconsent of patients at the next scheduled visit, following the availability of the updated ICF, and document the process appropriately.
* Provide patient education and medical information to study patients to ensure understanding of proper medication dosage, administration, and disease treatment.
* Maintains medication inventory and reconciliation.
* Collaborate with the clinical research team to ensure the timely completion of study-related tasks and reporting.
* Liaison between study participants, investigators, and the research team to address questions and concerns.
* Float to other research Tennessee Oncology clinics as needed.
KNOWLEDGE, SKILLS & ABILITIES:
* Strong attention to detail and organizational skills.
* Ability to work independently while collaborating effectively with a multidisciplinary team.
* Knowledge of medical and research terminology
* Knowledge of the FDA Code of Federal Regulations and GCP
* Knowledge of the clinical research processes
* At least one year of experience in a research setting is preferred.
* Research Certification (ACRP or CCRP) Preferred
EDUCATION & EXPERIENCE:
* An Associate Degree, preferably a bachelor's degree
* RN License
* At least one year of oncology experience
PHYSICAL REQUIREMENTS:
Job Title:
Physical Activity Required
Amount of time
None
Less than 1/3
(Occasionally)
1/3 to 2/3
(Frequently)
More than 2/3
(Regularly)
Standing
X
Walking
X
Sitting
X
Fingering or manual dexterity
X
Repetitive finger motion
X
Lifting or exerting force
Up to 10 pounds
Up to 25 pounds
X
Up to 50 pounds
Up to 100 pounds
Over 100 pounds
Reaching or stretching
X
Climbing or balancing
X
Crouching or stooping
X
Speaking
X
Hearing
X
Seeing (with correction)
X
Auto-ApplyClinical Research Coordinator III
Stone Mountain, GA jobs
Denali Health is a fast-growing clinical research organization dedicated to improving patient outcomes through innovative, high-quality clinical trials. We partner with leading physicians and sponsors to accelerate breakthrough treatments and foster greater access to research opportunities across diverse communities.
Position Summary
The Clinical Research Coordinator III (CRC III) is responsible for leading the coordination and execution of complex clinical research studies, ensuring compliance with study protocols, regulatory requirements, and institutional guidelines. The ideal candidate is a proactive professional with strong organizational and leadership skills, capable of managing multiple studies and mentoring junior coordinators.
Key Responsibilities
Coordination of Clinical Trials:
Oversee all aspects of assigned clinical studies, including start-up, recruitment, informed consent, data collection, and study close-out. Serve as the primary liaison between investigators, sponsors, CROs, and regulatory agencies.
Study Management:
Ensure that study activities are conducted in accordance with GCP, IRB guidelines, and sponsor requirements. Maintain accurate and up-to-date source documentation and regulatory binders.
Participant Coordination:
Schedule and coordinate participant visits, assessments, and follow-ups while maintaining excellent communication and care for study participants.
Regulatory and Compliance Oversight:
Prepare and submit IRB documents, safety reports, and study updates. Ensure audit readiness at all times.
Data Management:
Enter, review, and verify data in EDC systems and ensure timely query resolution.
Team Coordination & Leadership:
Mentor and support CRC I and II staff, ensuring consistent application of best practices and promoting a culture of quality and accountability.
Communication & Reporting:
Coordinate communication among multidisciplinary teams to ensure efficient trial operations and timely reporting of progress and outcomes.
Qualifications
Bachelor's degree in health sciences, nursing, or a related field (advanced degree preferred).
Minimum 3-5 years of experience in clinical research coordination.
Strong understanding of GCP, ICH, and FDA regulations.
Exceptional coordination, multitasking, and communication skills.
Experience with EDC systems and clinical trial management software preferred.
CCRC/CCRP certification a plus.
Why Join Denali Health
Work with a mission-driven team advancing clinical research accessibility.
Competitive salary and comprehensive benefits package.
Professional growth and leadership opportunities.
Collaborative environment focused on innovation and patient care.
To Apply:
Please send your resume, video recording as to why you feel you would be a good fit for this role, and cover letter to ********************
with the subject line
“Clinical Research Coordinator III - Stone Mountain.”
Clin Research Nurse Coord
Knoxville, TN jobs
Registered Nurse Coordinator, Oncology Clinical Research Full Time, 80 Hours Per Pay Period, Day Shift Thompson Cancer Survival Center is our region's largest cancer-fighting network, with more imaging centers, more board-certified physicians and surgeons, and more cancer and radiation centers closer to where you call home. And, we are a proud member of Covenant Health, our region's top-performing healthcare network with 10 hospitals, outpatient and specialty services, and Covenant Medical Group, our area's fastest-growing physician practice division.
Thompson Cancer Survival Center (TCSC) was founded to bring world-class cancer care to East Tennessee. At Thompson, leading cancer specialists use the most advanced technologies to achieve breakthrough successes in treating many types of cancer. Our doctors have the support of a complete team: Dieticians, genetics counselors, physicists, pharmacists, therapists, technologists, oncology nurses, social workers and others are all there to treat - and beat - the disease.
Position Summary:
The Clinical Research Nurse Coordinator promotes good clinical practices in the conduct of oncology clinical trials by possessing in-depth knowledge of federal regulations and guiding documents for the conduct of clinical trials and human participant protection. In addition, the Clinical Research Nurse Coordinator assures compliance with protocol and regulatory requirements, manages patient protocol activities, assures patient safety, collects records and maintains data and source documentation. The Clinical Research Nurse Coordinator performs all the duties and responsibilities associated with high-level, professional nursing practice including autonomous decision making based on predetermined protocol guidelines, nursing assessment and oncology knowledge. Reports to the Clinical Trials Manager.
Recruiter: Sandra Simmons || *****************
Responsibilities
Trial Planning and Strategy
* Participates in protocol planning by applying knowledge of patient population and anticipated recruitment, considering the ability to maintain the rights, safety, and well-being of the patient and serving as the liaison between the investigator and the sponsor to clarify expectations, goals, procedures, questions, and concerns.
* Plans and implements pre-study activities by developing timelines for conducting the clinical trial protocol, attending and participating in investigator meetings at the manager's discretion and scheduling and coordinating pre-study site visits, initiation visits, monitoring visits, and close-out visits.
Trial Recruitment and Management
* Manages Subject Recruitment and Enrollment by monitoring enrollment goals and modifying the recruitment plan as necessary, maintaining patient screening/enrollment logs, reviewing information about the protocol including inclusion/exclusion criteria with investigator. Assuring that all screening, eligibility, and enrollment procedures are performed according to protocol requirements by reviewing source documents in the EMR. Attend multidisciplinary conferences/meetings to provide study-related information as needed to the physicians discussed during the conference/meeting.
* Coordinates patient enrollment in clinical trials by following randomization procedures as per protocol, scheduling patient office visits, required screening assessments, ensuring appropriate specimen collection, batching and shipping per protocol and assessing participant compliance with the test article and follow-up visits.
* Manages clinical trial patient by scheduling all protocol-required tests, physician and nurse assessment visits, monitoring patient's response to protocol treatment, accompanying the physician for all protocol-required visits at all offices, reporting all serious adverse effects to the appropriate agency and Covenant Health IRB according to protocol guidelines, manages/resolves complex patient/physician/clinical trial issues without supervision.
Regulatory Compliance and Safety
* Maintains federal guidelines for Informed Consent process by communicating information about the protocol, informed consent form and follow-up procedures with potential study patients, conducting interviews to assess the patient's ability and willingness to follow and complete study procedures and visits, obtaining informed consent from the patient prior to any study-related procedures and documenting appropriately.
* Ensures patient safety with ongoing patient education about cardiovascular treatments and disease process. Perform skilled nursing assessments and promptly report all findings to the investigator and study sponsor. Recognize laboratory values and assessments outside of normal limits.
* Documents and maintains all study-related procedures, processes, and events by obtaining and reviewing original source documents, i.e., office notes, imaging reports, lab reports, procedure notes, etc.), abstracting data to study forms and flowsheets, recording accurate and timely data entry into electronic or hard-copy case report forms, documenting protocol deviations and exemptions, planning and designing new forms/source document tools to utilize in protocol implementation. Resolve data queries and amend case report forms as appropriate.
Resource Management
* Maintain investigational agents and/or devices provided by study sponsor by accurately accounting for products received onsite. This includes all supplies provided by the study sponsor. Oversee the storage and integration of clinical trial product according to Covenant Health policy.
Communication and Report
* Protect participant confidentiality by adhering to HIPAA regulations, protecting patient privacy at all times, securing safe storage of study-related documents, assuring appropriate disposal of PHI, securely storing all archived files.
* Communicates effectively with patients, research team, IRB, study sponsor, and Clinical Trials Manager by providing protocol education to ancillary staff. Establishing a contact mechanism for participants regarding follow-up visits, new study information and instructing participants to report study-related events to the research team immediately. Effective communication with investigator and sponsor representative to ensure protocol compliance. Punctually submitting reports, making suggestions or raising concerns to the Clinical Trials Manager.
Quality Assurance
* Participants in monitoring visits and audits by collecting source documents for sponsor review, meeting with monitors during routine visits to discuss case report form completion, query resolution, and other protocol-related issues. Prepare and participate in all audit tasks and meetings as needed.
* Assists with reviewing and developing standard operating procedures for study-related tasks as needed. Participant in orienting and training new staff involved in study visits. Supervise clinical research associates as needed.
* Implement Quality Controls and Assurance Measures by monitoring compliance with study procedures and GCP standards, conducting quality assurance audits as requested, working with internal and external quality assurance teams.
* Local travel required. Will be traveling between Covenant Health Facilities as needed to meet with physicians and patients.
* Maintains professional and technical knowledge by attending conferences at the discretion of the Clinical Trials Manager; presenting professional education to colleagues, performing self-directed study, reviewing professional publications and participating in professional societies. Completes all IT training to access various EDC systems and EMR. Be proficient with basic office software such as Microsoft Office.
* Follows policies, procedures, and safety standards. Completes required education assignments annually. Works toward achieving goals and objectives, and participates in quality improvement initiatives as requested.
* Performs other duties as assigned.
Qualifications
Minimum Education:
None specified; however must be sufficient to meet the standards for achievement of the below indicated license and/or certification as required by the issuing authority.
Minimum Experience:
Two (2) years of experience in cardiology nursing/relevant nursing care or two (2) years' experience in clinical trials. Excellent written and oral communication skills, project management skills. Good Interpersonal and leadership skills. Excellent computer skills.
Licensure Requirement:
Must have and maintain Tennessee RN licensure. Employee must have a valid Tennessee driver's license Class D and state mandated minimum insurance coverage. Driving record must meet Covenant Health minimum standards at the date of hire and throughout employment tenure.#cb
Auto-ApplyClin Research Nurse Coord
Knoxville, TN jobs
Registered Nurse Coordinator, Cardiology Clinical Research Full Time, 80 Hours Per Pay Period, Day Shift Thompson Cancer Survival Center is our region's largest cancer-fighting network, with more imaging centers, more board-certified physicians and surgeons, and more cancer and radiation centers closer to where you call home. And, we are a proud member of Covenant Health, our region's top-performing healthcare network with 10 hospitals, outpatient and specialty services, and Covenant Medical Group, our area's fastest-growing physician practice division.
Thompson Cancer Survival Center (TCSC) was founded to bring world-class cancer care to East Tennessee. At Thompson, leading cancer specialists use the most advanced technologies to achieve breakthrough successes in treating many types of cancer. Our doctors have the support of a complete team: Dieticians, genetics counselors, physicists, pharmacists, therapists, technologists, oncology nurses, social workers and others are all there to treat - and beat - the disease.
Position Summary:
The Clinical Research Nurse Coordinator promotes good clinical practices in the conduct of oncology clinical trials by possessing in-depth knowledge of federal regulations and guiding documents for the conduct of clinical trials and human participant protection. In addition, the Clinical Research Nurse Coordinator assures compliance with protocol and regulatory requirements, manages patient protocol activities, assures patient safety, collects records and maintains data and source documentation. The Clinical Research Nurse Coordinator performs all the duties and responsibilities associated with high-level, professional nursing practice including autonomous decision making based on predetermined protocol guidelines, nursing assessment and oncology knowledge. Reports to the Clinical Trials Manager.
Recruiter: Sandra Simmons || *****************
Responsibilities
Trial Planning and Strategy
* Participates in protocol planning by applying knowledge of patient population and anticipated recruitment, considering the ability to maintain the rights, safety, and well-being of the patient and serving as the liaison between the investigator and the sponsor to clarify expectations, goals, procedures, questions, and concerns.
* Plans and implements pre-study activities by developing timelines for conducting the clinical trial protocol, attending and participating in investigator meetings at the manager's discretion and scheduling and coordinating pre-study site visits, initiation visits, monitoring visits, and close-out visits.
Trial Recruitment and Management
* Manages Subject Recruitment and Enrollment by monitoring enrollment goals and modifying the recruitment plan as necessary, maintaining patient screening/enrollment logs, reviewing information about the protocol including inclusion/exclusion criteria with investigator. Assuring that all screening, eligibility, and enrollment procedures are performed according to protocol requirements by reviewing source documents in the EMR. Attend multidisciplinary conferences/meetings to provide study-related information as needed to the physicians discussed during the conference/meeting.
* Coordinates patient enrollment in clinical trials by following randomization procedures as per protocol, scheduling patient office visits, required screening assessments, ensuring appropriate specimen collection, batching and shipping per protocol and assessing participant compliance with the test article and follow-up visits.
* Manages clinical trial patient by scheduling all protocol-required tests, physician and nurse assessment visits, monitoring patient's response to protocol treatment, accompanying the physician for all protocol-required visits at all offices, reporting all serious adverse effects to the appropriate agency and Covenant Health IRB according to protocol guidelines, manages/resolves complex patient/physician/clinical trial issues without supervision.
Regulatory Compliance and Safety
* Maintains federal guidelines for Informed Consent process by communicating information about the protocol, informed consent form and follow-up procedures with potential study patients, conducting interviews to assess the patient's ability and willingness to follow and complete study procedures and visits, obtaining informed consent from the patient prior to any study-related procedures and documenting appropriately.
* Ensures patient safety with ongoing patient education about cardiovascular treatments and disease process. Perform skilled nursing assessments and promptly report all findings to the investigator and study sponsor. Recognize laboratory values and assessments outside of normal limits.
* Documents and maintains all study-related procedures, processes, and events by obtaining and reviewing original source documents, i.e., office notes, imaging reports, lab reports, procedure notes, etc.), abstracting data to study forms and flowsheets, recording accurate and timely data entry into electronic or hard-copy case report forms, documenting protocol deviations and exemptions, planning and designing new forms/source document tools to utilize in protocol implementation. Resolve data queries and amend case report forms as appropriate.
Resource Management
* Maintain investigational agents and/or devices provided by study sponsor by accurately accounting for products received onsite. This includes all supplies provided by the study sponsor. Oversee the storage and integration of clinical trial product according to Covenant Health policy.
Communication and Report
* Protect participant confidentiality by adhering to HIPAA regulations, protecting patient privacy at all times, securing safe storage of study-related documents, assuring appropriate disposal of PHI, securely storing all archived files.
* Communicates effectively with patients, research team, IRB, study sponsor, and Clinical Trials Manager by providing protocol education to ancillary staff. Establishing a contact mechanism for participants regarding follow-up visits, new study information and instructing participants to report study-related events to the research team immediately. Effective communication with investigator and sponsor representative to ensure protocol compliance. Punctually submitting reports, making suggestions or raising concerns to the Clinical Trials Manager.
Quality Assurance
* Participants in monitoring visits and audits by collecting source documents for sponsor review, meeting with monitors during routine visits to discuss case report form completion, query resolution, and other protocol-related issues. Prepare and participate in all audit tasks and meetings as needed.
* Assists with reviewing and developing standard operating procedures for study-related tasks as needed. Participant in orienting and training new staff involved in study visits. Supervise clinical research associates as needed.
* Implement Quality Controls and Assurance Measures by monitoring compliance with study procedures and GCP standards, conducting quality assurance audits as requested, working with internal and external quality assurance teams.
* Local travel required. Will be traveling between Covenant Health Facilities as needed to meet with physicians and patients.
* Maintains professional and technical knowledge by attending conferences at the discretion of the Clinical Trials Manager; presenting professional education to colleagues, performing self-directed study, reviewing professional publications and participating in professional societies. Completes all IT training to access various EDC systems and EMR. Be proficient with basic office software such as Microsoft Office.
* Follows policies, procedures, and safety standards. Completes required education assignments annually. Works toward achieving goals and objectives, and participates in quality improvement initiatives as requested.
* Performs other duties as assigned.
Qualifications
Minimum Education:
None specified; however must be sufficient to meet the standards for achievement of the below indicated license and/or certification as required by the issuing authority.
Minimum Experience:
Two (2) years of experience in cardiology nursing/relevant nursing care or two (2) years' experience in clinical trials. Excellent written and oral communication skills, project management skills. Good Interpersonal and leadership skills. Excellent computer skills.
Licensure Requirement:
Must have and maintain Tennessee RN licensure. Employee must have a valid Tennessee driver's license Class D and state mandated minimum insurance coverage. Driving record must meet Covenant Health minimum standards at the date of hire and throughout employment tenure.#cb
Auto-ApplyClinical Research Associate - NAMSA Future Openings USA
Atlanta, GA jobs
NAMSA pioneered the industry and was the first independent company in the world to focus solely on medical device materials for safety. NAMSA started testing medical devices before the U.S. Food and Drug Administration started regulating such products in 1976.
We are shaping the industry. NAMSA has been a key contributor to the development of the test methods that govern our industry. We have become the industry's premier provider. We provide support for clients during every step of the product development lifecycle and beyond.
Come and work for an organization with the:
Vision to inspire innovative MedTech solutions that advance global healthcare, improve patient lives and accelerate Client success and the
Mission to deliver best-in-class global MedTech development solutions through our people, expertise and technology by adhering to our core
Values:
Act with integrity in everything we do.
Provide best-in-class customer experiences.
Develop superior talent and deliver expertise.
Respond with agility and provide timely results.
Embrace collaboration, diverse perspectives and ideas.
Job Description:
• Works on assigned studies to ensure that human subject protection is maintained, Good Clinical Practice (GCP), and applicable regulations are followed.
• Coordinates and manages clinical site monitoring responsibilities for assigned studies in accordance with contractual agreements, SOPs, and applicable regulatory guidelines.
• May conduct on-site and remote site qualification, site initiation, interim, and site close-out monitoring visits.
• Serve as primary point of contact for site questions relating to study enrollment, conduct, and close-out issues: liaise with appropriate study team members as needed.
• Communicates through verbal and written communication with site investigator and project team overall site performance, trends, deficiencies, and concerns.
• Supports study start-up activities such as tracking and performing quality review of study documents, completing, and distributing site activation letters, etc.
• Performs study-related training.
• Manages the development and maintenance of study documents, processes and systems as assigned.
• Ensures quality and completeness of central and site master files. Tracks and maintains required study documents, performs quality control review, manages renewals.
• Tracks study site and over all study metrics including but not limited to enrollment, deviations, adverse events, trial master file maintenance.
• Attends internal and external meetings as required.
• Provides all job-related progress reports and visit documentation as required.
• May support safety activities such as narrative writing, managing the CEC/DSMB, etc.
• OUS: Prepares and coordinates submissions to regulatory authorities.
• May perform other activities as assigned.
Qualifications & Technical Competencies:
• Fluency in English and local language, if different, required.
• Higher education degree or equivalent education, training, and experience.
• Preferred 2 years clinical trial experience.
• Preferred monitoring experience.
• Able to work independently once trained.
• Good verbal and written communication skills.
• Strong organizational skills.
• Basic computer proficiency.
• Understanding of clinical research processes and regulations.
• Certifications such as Society of Clinical Research Associates (SoCRA) or Association of Clinical Research Professionals (ACRP) Certification preferred but not required
Working Conditions:
• Up to 20% travel for In-House Clinical Research Associates; up to 80% travel for Field Clinical Research Associates.
• The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required to stand; walk; sit; use hands to finger, handle, or feel and reach with hands and arms. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, depth perception, and ability to adjust focus.
• Extensive use of a computer keyboard.
Pay Range Minimum:
$54,400.00
Pay Range Target:
$80,100.00
Pay Frequency:
Annual
Please Note: Individual base pay depends on various factors, in addition to primary work location, such as complexity and responsibility of role, job duties/requirements, and relevant experience and skills.
NAMSA is an equal employment opportunity company. NAMSA participates in pre-employment background and drug screen processes aligned to local, state and federal laws.
Fair Chance Employment Statement:
At NAMSA, we are committed to providing equal employment opportunities to all qualified applicants, including those with arrest or conviction records. In accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act, we will consider qualified applicants with a criminal history.
Please note that NAMSA conducts a review of criminal history after the interview process and offer acceptance. This review is conducted to ensure that there is no direct, adverse, or negative relationship between the criminal history and the material job duties of the specific position. The following is a list of material job duties for this position:
• May operate equipment
• Records data timely and accurately
• May analyze and interpret data
• Conducts studies on medical devices that have an impact on human life
A criminal history that directly impacts the ability to perform these duties may result in the withdrawal of a conditional offer of employment. We believe in fair chance hiring and are committed to evaluating each applicant on a case-by-case basis.
Auto-ApplyClinical Research Associate - NAMSA Future Openings USA
Atlanta, GA jobs
NAMSA pioneered the industry and was the first independent company in the world to focus solely on medical device materials for safety. NAMSA started testing medical devices before the U.S. Food and Drug Administration started regulating such products in 1976.
We are shaping the industry. NAMSA has been a key contributor to the development of the test methods that govern our industry. We have become the industry's premier provider. We provide support for clients during every step of the product development lifecycle and beyond.
Come and work for an organization with the:
Vision to inspire innovative MedTech solutions that advance global healthcare, improve patient lives and accelerate Client success and the
Mission to deliver best-in-class global MedTech development solutions through our people, expertise and technology by adhering to our core
Values:
* Act with integrity in everything we do.
* Provide best-in-class customer experiences.
* Develop superior talent and deliver expertise.
* Respond with agility and provide timely results.
* Embrace collaboration, diverse perspectives and ideas.
Job Description:
* Works on assigned studies to ensure that human subject protection is maintained, Good Clinical Practice (GCP), and applicable regulations are followed.
* Coordinates and manages clinical site monitoring responsibilities for assigned studies in accordance with contractual agreements, SOPs, and applicable regulatory guidelines.
* May conduct on-site and remote site qualification, site initiation, interim, and site close-out monitoring visits.
* Serve as primary point of contact for site questions relating to study enrollment, conduct, and close-out issues: liaise with appropriate study team members as needed.
* Communicates through verbal and written communication with site investigator and project team overall site performance, trends, deficiencies, and concerns.
* Supports study start-up activities such as tracking and performing quality review of study documents, completing, and distributing site activation letters, etc.
* Performs study-related training.
* Manages the development and maintenance of study documents, processes and systems as assigned.
* Ensures quality and completeness of central and site master files. Tracks and maintains required study documents, performs quality control review, manages renewals.
* Tracks study site and over all study metrics including but not limited to enrollment, deviations, adverse events, trial master file maintenance.
* Attends internal and external meetings as required.
* Provides all job-related progress reports and visit documentation as required.
* May support safety activities such as narrative writing, managing the CEC/DSMB, etc.
* OUS: Prepares and coordinates submissions to regulatory authorities.
* May perform other activities as assigned.
Qualifications & Technical Competencies:
* Fluency in English and local language, if different, required.
* Higher education degree or equivalent education, training, and experience.
* Preferred 2 years clinical trial experience.
* Preferred monitoring experience.
* Able to work independently once trained.
* Good verbal and written communication skills.
* Strong organizational skills.
* Basic computer proficiency.
* Understanding of clinical research processes and regulations.
* Certifications such as Society of Clinical Research Associates (SoCRA) or Association of Clinical Research Professionals (ACRP) Certification preferred but not required
Working Conditions:
* Up to 20% travel for In-House Clinical Research Associates; up to 80% travel for Field Clinical Research Associates.
* The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
* While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required to stand; walk; sit; use hands to finger, handle, or feel and reach with hands and arms. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, depth perception, and ability to adjust focus.
* Extensive use of a computer keyboard.
Pay Range Minimum:
$54,400.00
Pay Range Target:
$80,100.00
Pay Frequency:
Annual
Please Note: Individual base pay depends on various factors, in addition to primary work location, such as complexity and responsibility of role, job duties/requirements, and relevant experience and skills.
NAMSA is an equal employment opportunity company.
NAMSA participates in pre-employment background and drug screen processes aligned to local, state and federal laws.
Fair Chance Employment Statement:
At NAMSA, we are committed to providing equal employment opportunities to all qualified applicants, including those with arrest or conviction records. In accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act, we will consider qualified applicants with a criminal history.
Please note that NAMSA conducts a review of criminal history after the interview process and offer acceptance. This review is conducted to ensure that there is no direct, adverse, or negative relationship between the criminal history and the material job duties of the specific position. The following is a list of material job duties for this position:
* May operate equipment
* Records data timely and accurately
* May analyze and interpret data
* Conducts studies on medical devices that have an impact on human life
A criminal history that directly impacts the ability to perform these duties may result in the withdrawal of a conditional offer of employment. We believe in fair chance hiring and are committed to evaluating each applicant on a case-by-case basis.
Auto-ApplyEnrollment Research Nurse
Nashville, TN jobs
It's More Than a Career, It's a Mission.
Our people are the foundation of our success. By joining our growing team at Sarah Cannon Research Institute (SCRI), a subsidiary of McKesson, you will have the opportunity to become part of one of the largest community-based cancer programs to advance oncology treatments and improve outcomes for cancer patients across the globe. We look for mission-driven candidates who have a desire to advance the fight against cancer and make a difference in the lives of patients diagnosed with cancer every day.
Our Mission
People who live with cancer - those who work to prevent it, fight it, and survive it - are at the heart of every decision we make. Bringing the most innovative medical minds together with the most passionate caregivers in their communities, we are transforming care and personalizing treatment. Through clinical excellence and cutting-edge research, SCRI is redefining cancer care around the world.
As an Enrollment Research Nurse your primary responsibility is to screen and enroll oncology research study subjects ensuring protocol compliance. You will enroll patients onto clinical trials through recruitment, screening, enrollment and follow-up of eligible subjects.
You will be familiar with the protocols on which the patients are enrolled, screen and treat.
You will review the study design and inclusion/exclusion criteria with physician and patient.
You will complete and document screening/eligibility and consent accurately and have all parties fully execute the document including HIPAA Authorization.
You will complete the inclusion/exclusion form and standard enrollment form accurately and assess the patient and document findings at each clinic visit while on protocol.
You will document all specific tools required by the protocol (i.e. oral medication forms, pill count diaries, quality of life questionnaires, neuro exams, vital signs sheets, times of PK draws, etc.).
You will screen every new patient or patient returning to office with scan results and document appropriately on the patient tracking logs.
You will complete the study medication order form and have the physician or nurse practitioner sign orders prior to treatment and ensure that all medications, including antiemetics, are approved by the registrar prior to initiating treatment or when changing medication regimens, such as crossover studies
You will accurately calculate and the BSA, creatinine clearance, urine protein:creatinine ratio or any other conversions needed per protocol.
You will obtain completed and signed waivers prior to submitting forms to enrollment coordinator for investigator-initiated protocols and re-consent patients in a timely manner and document process appropriately.
What you should have for this role:
Associate of Nursing Degree; Bachelor of Nursing is preferred.
Nursing license for the State of Tennessee
Knowledge of medical and oncology research terminology and of federal regulations, good clinical practices (GCP).
One year of clinical nursing experience
One year of clinical research experience is preferred
One year of experience treating oncology patients is preferred
About Sarah Cannon Research Institute
Sarah Cannon Research Institute (SCRI) is one of the world's leading oncology research organizations conducting community-based clinical trials. Focused on advancing therapies for patients over the last three decades, SCRI is a leader in drug development. In 2022, SCRI formed a joint venture with former US Oncology Research to expand clinical trial access across the country. It has conducted more than 750 first-in-human clinical trials since its inception and contributed to pivotal research that has led to the majority of new cancer therapies approved by the FDA today. SCRI's research network brings together more than 1,300 physicians who are actively enrolling patients into clinical trials at more than 250 locations in 24 states across the U.S. Please click here to learn more about our research offerings.
We care about the well-being of the patients and communities we serve, and that starts with caring for our people. That's why we have a Total Rewards package that includes comprehensive benefits to support physical, mental, and financial well-being. Our Total Rewards offerings serve the different needs of our diverse colleague population and ensure they are the healthiest versions of themselves. For more information regarding benefits through our parent company, McKesson, please click here.
As part of Total Rewards, we are proud to offer a competitive compensation package. This is determined by several factors, including performance, experience and skills, equity, regular job market evaluations, and geographical markets. In addition to base pay, other compensation, such as an annual bonus or long-term incentive opportunities may be offered.
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
Auto-ApplyCardiology Research Nurse Manager
Sandy Springs, GA jobs
Northside Hospital is award-winning, state-of-the-art, and continually growing. Constantly expanding the quality and reach of our care to our patients and communities creates even more opportunity for the best healthcare professionals in Atlanta and beyond. Discover all the possibilities of a career at Northside today.
The Research Nursing Manager is responsible for overseeing nursing operations, including the Northside Hospital Heart Institute or Northside Hospital Cancer Institute Research Network. This role will be responsible for the day-to-day management and oversight of the quality and validity of clinical research data and research patient care and will oversee the work of the Lead Research Coordinators, Clinical Research Nurses (CRN), the Clinical Research Coordinators (CRC), Data Management and regulatory staff.
PRIMARY DUTIES AND RESPONSIBILITIES
* Oversee Cardiology or Oncology research nursing and maintain awareness of all relevant clinical research projects.
* Ensure clinical and regulatory quality and integrity of research conducted.
* Develop and implement training programs for CRN, CRC, Data Management Staff and Regulatory staff.
* Manage special projects to expand the capabilities of the Research Program or as assigned.
* Identifies the needs of those service areas and individuals served by the department and assists in the development of goals, objectives, policies, and procedures to align with strategic initiatives.
* Serve as a member or leader of appropriate committees and work groups.
* Develop, implement, and analyze work flow procedures to maximize productivity and coordinate with other clinical areas to ensure system effectiveness.
* Prepare periodic reports of operations to include workload statistics and staffing needs; assists in development of workload standards and ongoing monitoring of standards to ensure adequate staff levels.
* Monitor all clinical research activity and maintain awareness of all clinical research projects.
* Develop, maintain, and evaluate SOPs for administering clinical research.
* Recruit, hire, orient, and evaluate performance of assigned personnel to assure that department is staffed with individuals who reflect behavior and performance consistent with the hospital's Mission and Values statement. Has authority to hire, terminate and/or take other disciplinary action as may be deemed appropriate and is in accordance with hospital policy
* Develop and submit to Director for approval, appropriate capital and operating budget and is accountable for the achievement of capital and operating budget objectives.
KNOWLEDGE SKILLS AND ABILITIES/LICENSE OR CERTIFICATION REQUIRED
* Bachelor's degree in nursing.
* Licensed as a RN in the state of Georgia in good standing, without limitations
* Minimum of three (3) years of experience in a clinical research setting.
* Minimum of two (2) years of experience in area of specialty nursing.
* Minimum of one (1) year experience managing employees.
Cardiology Research Nurse Manager
Atlanta, GA jobs
Northside Hospital is award-winning, state-of-the-art, and continually growing. Constantly expanding the quality and reach of our care to our patients and communities creates even more opportunity for the best healthcare professionals in Atlanta and beyond. Discover all the possibilities of a career at Northside today.
The Research Nursing Manager is responsible for overseeing nursing operations, including the Northside Hospital Heart Institute or Northside Hospital Cancer Institute Research Network. This role will be responsible for the day-to-day management and oversight of the quality and validity of clinical research data and research patient care and will oversee the work of the Lead Research Coordinators, Clinical Research Nurses (CRN), the Clinical Research Coordinators (CRC), Data Management and regulatory staff.
PRIMARY DUTIES AND RESPONSIBILITIES
* Oversee Cardiology or Oncology research nursing and maintain awareness of all relevant clinical research projects.
* Ensure clinical and regulatory quality and integrity of research conducted.
* Develop and implement training programs for CRN, CRC, Data Management Staff and Regulatory staff.
* Manage special projects to expand the capabilities of the Research Program or as assigned.
* Identifies the needs of those service areas and individuals served by the department and assists in the development of goals, objectives, policies, and procedures to align with strategic initiatives.
* Serve as a member or leader of appropriate committees and work groups.
* Develop, implement, and analyze work flow procedures to maximize productivity and coordinate with other clinical areas to ensure system effectiveness.
* Prepare periodic reports of operations to include workload statistics and staffing needs; assists in development of workload standards and ongoing monitoring of standards to ensure adequate staff levels.
* Monitor all clinical research activity and maintain awareness of all clinical research projects.
* Develop, maintain, and evaluate SOPs for administering clinical research.
* Recruit, hire, orient, and evaluate performance of assigned personnel to assure that department is staffed with individuals who reflect behavior and performance consistent with the hospital's Mission and Values statement. Has authority to hire, terminate and/or take other disciplinary action as may be deemed appropriate and is in accordance with hospital policy
* Develop and submit to Director for approval, appropriate capital and operating budget and is accountable for the achievement of capital and operating budget objectives.
KNOWLEDGE SKILLS AND ABILITIES/LICENSE OR CERTIFICATION REQUIRED
* Bachelor's degree in nursing.
* Licensed as a RN in the state of Georgia in good standing, without limitations
* Minimum of three (3) years of experience in a clinical research setting.
* Minimum of two (2) years of experience in area of specialty nursing.
* Minimum of one (1) year experience managing employees.
Research Coordinator- Trauma
Atlanta, GA jobs
Note: If you are CURRENTLY employed at Children's and/or have an active badge or network access, STOP here. Submit your application via Workday using the Career App (Find Jobs). Work Shift Variable Work Day(s) Monday-Friday, Variable Shift Start Time 11:00 AM
Shift End Time
7:00 PM
Worker Sub-Type
Regular
Children's is one of the nation's leading children's hospitals. No matter the role, every member of our team is an essential part of our mission to make kids better today and healthier tomorrow. We're committed to putting you first, and that commitment is at the heart of our company culture: People first. Children always. Find your next career opportunity and make a difference doing what you love at Children's.
Job Description
Develops, implements, and supports the research process by assisting investigators in study design, completion of the approval process, and management of data specific to the subspecialty of involvement. Proactively supports the efforts that ensure delivery of safe patient care and services and promotes a safe environment at Children's Healthcare of Atlanta.
Experience
* One year of research experience. May substitute required experience with equivalent years of education beyond the minimum education requirement
Preferred Qualifications
* Bachelor's degree in Health or Biological Sciences
Education
* Bachelor's degree in a scientific, health related, or business administration related program or relevant experience in lieu of education
Certification Summary
* Basic Life Support (BLS) within 30 days of employment if role requires patient contact
* ARUP Handling, Packaging and Shipping Infectious Substances or similar within 30 days of employment if role requires specimen acquisition
* Collaborative Institutional Training Initiative (CITI) within 30 days of employment
Knowledge, Skills, and Abilities
* Working knowledge of state and federal regulatory guidelines related to research
* Good computer skills including working knowledge of a PC and Microsoft Office (Word, Access, and Excel)
* Self-directed and motivated to work independently toward short- and long-term goals
* Good communication, organization, and interpersonal skills
* Good working relationships with colleagues, subordinates, and superiors
Job Responsibilities
Develops, conducts, and facilitates research protocols.
* Supports investigators in writing study protocols.
* Performs participant screening, enrollment, study activities, and communication.
* Coordinates study visits and procedures, including specimen acquisition, transport, documentation, and shipment.
* Maintains equipment and supply resources for research studies.
* Completes data management activities and ensures data integrity.
* Assists in the development and completion of source documents and case report forms.
* Participates in sponsor correspondence, monitoring, and study meetings.
* Monitors compliance throughout all study activities and engages compliance oversight as needed.
* Directs patient interaction to conduct research protocols.
* Obtains informed consent by following policy, procedure, and regulatory requirements.
* Schedules study-specific visits in conjunction with ancillary departments.
* Administers various research surveys in accordance with research study requirements.
* Completes research-only testing as required and applicable per study and system requirements, including electrocardiograms.
* Performs phlebotomy if trained to do so.
* Provides research study education to participants as part of a study protocol.
* Completes documentation as needed within the medical record.
Manages all regulatory processes related to clinical research activities.
* Completes Institutional Review Board preparation, submission, modifications, reporting, and termination activities.
* Maintains all licensure, certification, and system education requirements for role.
* Maintains all regulatory documents.
* Assist with facilitating grants, contracts, and financial tasks for research and clinical trials.
* Assist with supporting Principal Investigator in study budgeting, sponsor interactions, routing, feasibility assessments, account management, and reconciliation.
* Completes research administrative duties according to Children's policies regarding Epic enrollment, Clinical Trial Management System data entry, patient care invoice accuracy.
Participates in education activities to support specific research activities and primary role at Children's Healthcare of Atlanta.
* May participate in departmental policy and quality projects.
* Completes departmental, system-wide, and study-specific education as required.
Children's Healthcare of Atlanta is an equal opportunity employer committed to providing equal employment opportunities to all qualified applicants and employees without regard to race, color, sex, religion, national origin, citizenship, age, veteran status, disability or any other characteristic covered by applicable law.
Primary Location Address
1575 Northeast Expy NE
Job Family
Research
Research Coordinator - Emergency Medicine
Atlanta, GA jobs
Note: If you are CURRENTLY employed at Children's and/or have an active badge or network access, STOP here. Submit your application via Workday using the Career App (Find Jobs). Work Shift Variable Work Day(s) Variable Shift Start Time 3:00 PM Shift End Time
11:00 PM
Worker Sub-Type
Regular
Children's is one of the nation's leading children's hospitals. No matter the role, every member of our team is an essential part of our mission to make kids better today and healthier tomorrow. We're committed to putting you first, and that commitment is at the heart of our company culture: People first. Children always. Find your next career opportunity and make a difference doing what you love at Children's.
Job Description
Develops, implements, and supports the research process by assisting investigators in study design, completion of the approval process, and management of data specific to the subspecialty of involvement. Proactively supports the efforts that ensure delivery of safe patient care and services and promotes a safe environment at Children's Healthcare of Atlanta.
Experience
* One year of research experience. May substitute required experience with equivalent years of education beyond the minimum education requirement
Preferred Qualifications
* Bachelor's degree in Health or Biological Sciences
Education
* Bachelor's degree in a scientific, health related, or business administration related program or relevant experience in lieu of education
Certification Summary
* Basic Life Support (BLS) within 30 days of employment if role requires patient contact
* ARUP Handling, Packaging and Shipping Infectious Substances or similar within 30 days of employment if role requires specimen acquisition
* Collaborative Institutional Training Initiative (CITI) within 30 days of employment
Knowledge, Skills, and Abilities
* Working knowledge of state and federal regulatory guidelines related to research
* Good computer skills including working knowledge of a PC and Microsoft Office (Word, Access, and Excel)
* Self-directed and motivated to work independently toward short- and long-term goals
* Good communication, organization, and interpersonal skills
* Good working relationships with colleagues, subordinates, and superiors
Job Responsibilities
Develops, conducts, and facilitates research protocols.
* Supports investigators in writing study protocols.
* Performs participant screening, enrollment, study activities, and communication.
* Coordinates study visits and procedures, including specimen acquisition, transport, documentation, and shipment.
* Maintains equipment and supply resources for research studies.
* Completes data management activities and ensures data integrity.
* Assists in the development and completion of source documents and case report forms.
* Participates in sponsor correspondence, monitoring, and study meetings.
* Monitors compliance throughout all study activities and engages compliance oversight as needed.
* Directs patient interaction to conduct research protocols.
* Obtains informed consent by following policy, procedure, and regulatory requirements.
* Schedules study-specific visits in conjunction with ancillary departments.
* Administers various research surveys in accordance with research study requirements.
* Completes research-only testing as required and applicable per study and system requirements, including electrocardiograms.
* Performs phlebotomy if trained to do so.
* Provides research study education to participants as part of a study protocol.
* Completes documentation as needed within the medical record.
Manages all regulatory processes related to clinical research activities.
* Completes Institutional Review Board preparation, submission, modifications, reporting, and termination activities.
* Maintains all licensure, certification, and system education requirements for role.
* Maintains all regulatory documents.
* Assist with facilitating grants, contracts, and financial tasks for research and clinical trials.
* Assist with supporting Principal Investigator in study budgeting, sponsor interactions, routing, feasibility assessments, account management, and reconciliation.
* Completes research administrative duties according to Children's policies regarding Epic enrollment, Clinical Trial Management System data entry, patient care invoice accuracy.
Participates in education activities to support specific research activities and primary role at Children's Healthcare of Atlanta.
* May participate in departmental policy and quality projects.
* Completes departmental, system-wide, and study-specific education as required.
Children's Healthcare of Atlanta is an equal opportunity employer committed to providing equal employment opportunities to all qualified applicants and employees without regard to race, color, sex, religion, national origin, citizenship, age, veteran status, disability or any other characteristic covered by applicable law.
Primary Location Address
1575 Northeast Expy NE
Job Family
Research
Research Coordinator
Canton, GA jobs
We currently have an exciting opportunity for a Research Coordinator to join our team!
Benefits: Medical, dental, vision, short/long term disability, 401k, PTO, life insurance, critical illness, hospital indemnity, and holiday pay.
Monday-Friday, 8AM - 5PM, no nights or weekends
Duties may include but not limited to:
Clinical Trial: Oversee all aspects of clinical trials, including patient recruitment, screening, and enrollment. Ensure that protocols are followed meticulously.
Site Operations: Handle day-to-day site management, ensuring that all activities comply with regulatory requirements and study protocols.
Data Management: Collect, verify, and manage clinical trial data, ensuring it is accurate and complete.
Communication & Reporting: Act as the primary point of contact for study sponsors, participants, and other stakeholders. Provide regular updates and progress reports.
Regulatory Compliance: Ensure all documentation, including regulatory submissions and patient records, are kept up-to-date and in compliance with ethical and legal standards.
Problem Solving & Innovation: Identify areas for process improvement and implement solutions to drive efficiency and enhance trial operations.
Requirements:
Valid RN license in the state of practice
Bachelor's degree in a relevant field (e.g., life sciences, healthcare, or clinical research)
Experience managing clinical trials, leading the enrollment for multiple clinical trials, developing a research program
Clinical experience in cardiovascular medicine in any licensed role (i.e. RN, technologist, medical assistant, etc.)
Strong organizational and time management skills
Clinical research certification (e.g., CCRP) is a plus
Knowledge of GCP, ICH guidelines, and regulatory requirements
Heart and Vascular Care is a cardiology practice that places a priority on compassionate patient care and service. In our team-based and family-oriented setting, we strive to set a new bar for patient healthcare through a modern, friendly, and thoughtful approach.
Come be a part of our growing team. Apply and someone will be in touch!
Auto-ApplyClinical Research Coordinator - Full-Time - Wolf River
Germantown, TN jobs
Job Title: Clinical Research Coordinator
About Us
At West Cancer Center, we are dedicated to providing compassionate, patient-centered care while advancing groundbreaking research. Our team fosters collaboration, innovation, and professional growth, ensuring that every role contributes to making a difference in patients' lives. Join us in our mission to provide comprehensive support to those navigating the challenges of cancer treatment.
Position Overview
The Clinical Research Coordinator plays a vital role in managing oncology patients participating in pharmaceutical-sponsored clinical trials. This position is responsible for patient screening, enrollment, education, and ongoing monitoring to ensure compliance with study protocols and regulatory standards. The ideal candidate will have prior experience managing clinical trials and a strong understanding of Good Clinical Practice (GCP) and FDA regulations.
Key Responsibilities
Recruit and screen potential clinical trial subjects
Conduct detailed review of patient medical history and current findings for eligibility
Educate nursing staff on proper administration and side effects of study therapies
Educate patients on study protocols, medication adherence, and symptom management
Act as a liaison between the Research Team and non-research clinical staff
Maintain patient safety, rights, and informed consent throughout the study
Ensure regulatory compliance and maintain current knowledge of the Code of Federal Regulations
Monitor study progress and patient outcomes
Interface with multiple departments, including Physicians, Nurses, Radiology, Medical Records, Laboratory, Insurance, and Pharmacy
Document all relevant patient and study information accurately
Maintain a professional demeanor and uphold confidentiality at all times
Perform other duties as assigned
Qualifications
Education & Experience
Associate's degree or equivalent from a two-year college or technical school
Minimum of 1-2 years of related clinical research experience, or successful completion of 1 year as an Associate Clinical Research Coordinator I
Preferred: Registered Nurse (RN) certification
Skills & Abilities
Strong organizational, follow-up, and problem-solving skills
Excellent verbal and written communication abilities
Ability to manage multiple priorities in a fast-paced environment
Proficiency in computer applications, including word processing and email
Ability to collaborate effectively within multidisciplinary teams
Strong knowledge of clinical research regulations, data management, and patient safety
Comfort working near potentially hazardous materials
Ability to analyze complex data and interpret technical documents
Competence in performing necessary calculations (BSA, ANC, drug dosing)
Ability to travel as required
Why West Cancer Center is a Great Place to Work
Meaningful Impact: Play a direct role in supporting patients through one of the most challenging times of their lives.
Collaborative Culture: Work alongside a multidisciplinary team of dedicated professionals committed to improving cancer care.
Professional Development: Benefit from ongoing training, educational resources, and growth opportunities.
Mission-Driven Environment: Be part of an organization guided by compassion, integrity, and innovation.
No nights, weekends, or holidays. Comprehensive benefits package.
Join Us
If you are a detail-oriented clinical research professional looking to make a difference in oncology care, apply today to become a Clinical Research Coordinator at West Cancer Center.
Auto-ApplyEarly Phase Research Nurse
Research nurse job at Tennessee Oncology
Tennessee Oncology, one of the nation's largest, community-based cancer care specialists, is home to one of the leading clinical trial networks in the country. Established 1976 in Nashville, Tennessee Oncology's mission remains unchanged: To provide access to high-quality cancer care and the expertise of clinical research for all patients, at convenient locations within their community and close to their home. Our growing network of physicians and locations is based on this mission. Tennessee Oncology is committed to advancing both the science of detection and targeted treatments, and to making these advances available to every patient. We believe caring for cancer patients is a privilege.
Why Join Us? We are looking for talented and highly-motivated individuals who demonstrate a natural desire to support the meaningful work of community oncologists and the patients we serve.
Job Description:
Tennessee Oncology is seeking a dedicated and detail-oriented Early Phase Research Nurse to join our team. In this role, you will be responsible for screening, enrolling, and following study subjects, ensuring rigorous protocol compliance, and providing close monitoring throughout their participation in the clinical trial. Your role will be critical in maintaining the integrity of the studies and ensuring the safety and well-being of all participants.
ESSENTIAL FUNCTIONS:
* Facilitate the informed consent process and enroll eligible participants into clinical trials.
* You will complete and document the informed consent process accurately and has all parties sign/date as required, including HIPAA Authorization.
* Conduct initial screening of potential study subjects to determine eligibility based on study criteria.
* Conduct and coordinate pharmacokinetic studies, including the collection of biological samples such as blood, urine, and saliva for pharmacokinetic analysis.
* You will review the study design and inclusion/exclusion criteria with physician and patient.
* You will complete and document screening/eligibility accurately.
* Monitor participants throughout the study to ensure adherence to the protocol.
* You will accurately complete and submit on-study forms within required timelines.
* You will document all specific tools required by the protocol (i.e., oral medication forms, pill count diaries, quality of life questionnaires, neuro exams, vital signs sheets, times of PK draws, etc.)
* Track and document patient progress, including any adverse events, and ensure timely reporting as required by the study protocol.
* You will complete eligibility screening for all new patient or patients returning to office with scan results and document appropriately on the patient tracking logs.
* Dispense oral investigation products as required by the study protocol.
* You will accurately calculate and document BSA, Creatinine Clearance, Urine Protein: Creatinine ratio, and any other calculations or conversions required per protocol.
* You will ensure that follow-up appointments, scans, or related procedures are scheduled correctly according to protocol requirements.
* You will document appropriately when patients are removed from protocol.
* You will ensure reconsent of patients at the next scheduled visit, following availability of updated ICF, and documents process appropriately.
* Monitor and ensure patient compliance with investigation medications, providing education and support as needed.
* Work closely with the research team, including principal investigators and coordinators, to support study objectives.
* Communicate effectively with study subjects, addressing any questions or concerns they may have.
KNOWLEDGE, SKILLS & ABILITIES:
* Knowledge of medical and research terminology
* Knowledge of FDA Code of Federal Regulations and GCP
* Knowledge of the clinical research processes
EDUCATION & EXPERIENCE:
* An Associate Degree; preferably a bachelor's degree
* RN License
* Minimum of 2 years of clinical oncology nursing experience required, with 1 year of experience clinical research, particularly in Phase 1 trials
Auto-ApplyManager, Research Nurse
Research nurse job at Tennessee Oncology
Tennessee Oncology, one of the nation's largest, community-based cancer care specialists, is home to one of the leading clinical trial networks in the country. Established 1976 in Nashville, Tennessee Oncology's mission remains unchanged: To provide access to high-quality cancer care and the expertise of clinical research for all patients, at convenient locations within their community and close to their home. Our growing network of physicians and locations is based on this mission. Tennessee Oncology is committed to advancing both the science of detection and targeted treatments, and to making these advances available to every patient. We believe caring for cancer patients is a privilege.
Why Join Us? We are looking for talented and highly-motivated individuals who demonstrate a natural desire to support the meaningful work of community oncologists and the patients we serve.
Job Description:
The Research Nurse Manager ensures the integrity and quality of clinical trials are maintained and conducted in accordance with international, federal, state, and local regulations, and Institutional Review Board (IRB) approvals. This role involves recruiting, supervising, evaluating, and coordinating the activities of a team of professional nurses and/or clinical research support staff; ensures that all clinical activities are carried out in accordance with established research protocol, and with acceptable clinical procedure and safety standards.
ESSENTIAL FUNCTIONS:
* Manage day-to-day clinical research nursing operations, from protocol review/initiation to study close-out, ensuring study integrity throughout, under the guidance of the Principal Investigator (PI) and in collaboration with the clinical/medical officer assigned to the study.
* Oversees daily clinical operations of the Research Nursing Department.
* Ensure clinical staffing needs are met and manage scheduling.
* Ensures staff compliance with clinical and research standard operating procedures.
* Assists adherence to study-related SOPs/scientific manuals; plans, conducts, and evaluates study orientation, oversees protocol-related in-services to research team and clinical staff; institutes process improvements as needed.
* Conducts staff meetings and training sessions.
* Generates performance evaluations and proposes disciplinary actions when appropriate.
* Defines activities in complex clinical research studies to prevent deviations/unanticipated events.
* Provides expertise and leadership in the development, preparation, and implementation of regulatory strategies to support clinical research missions.
* Manages the tasks of direct reports to guide patients through the processes of consenting, screening, treatment, and post-treatment follow-up in clinical trials.
* Ensure timely collection and reporting of adverse events according to institutional, sponsor and FDA timelines.
* Supervises direct reports in the performance of medical tests, including, but not limited to, vital signs, lab, and EKGs.
* Collaborates with other research managers in the management of staff, resources/allocation planning and performance assessments for various clinical research, clinical trials implementation and oversight and regulatory and compliance functions.
* Communicates and collaborates w/ study team including internal and external parties, sponsors, PI, and study participants.
* Evaluates potential protocols to determine feasibility, resource requirements.
* Assists in the development and implementation of clinical research technology systems and infrastructure.
* Develops protocol needs assessment and monitors quality assurance protocol for services provided.
* Prepares for and attends sponsor and FDA audits.
* Provides nursing care to research study patients; ensures compliance with each study's protocol; administers investigational medications and performs patient assessment during clinical visits as needed.
* Ensures that the integrity and quality of the clinical research trial is maintained and that the trial is conducted in accordance with Good Clinical Practice Guidelines, federal and sponsor regulations and guidelines.
* Travel to all research site offices as necessary.
* Maintains a professional approach respecting the dignity and confidentiality of patients.
* Maintains a good attendance record and reports to work on time.
* Maintains a professional attitude and appearance.
* Maintain Tennessee licensure as applicable.
* Performs other duties as assigned.
KNOWLEDGE, SKILLS & ABILITIES:
* Excellent verbal and written communication skills.
* Strong organizational and follow-up skills.
* Ability to handle multiple priorities in a fast-paced environment.
* Understanding complex clinical trials protocols.
* Ability to direct, manage, implement, and evaluate department operations.
* Ability to establish department goals, and objectives that support strategic plan.
* Effective planning, delegation, and supervision skills.
* Ability to travel up to 25% (local/regional).
* Proficiency in Microsoft Office products (Word, Excel, PowerPoint, etc.)
* Knowledge of protocol and clinical drug development processes, study design, study planning and management, and monitoring.
* Knowledge of ICH/GCP guidelines
EDUCATION & EXPERIENCE:
* Associate in nursing or Bachelor's in nursing required.
* Current Tennessee RN license
* 5+ years of experience as registered nurse
* 3+ years of experience in oncology setting
* Previous clinical research experience required, oncology research preferred.
* Previous supervisory and/or management experience, preferred
Auto-ApplyResearch Nurse
Research nurse job at Tennessee Oncology
Tennessee Oncology, one of the nation's largest, community-based cancer care specialists, is home to one of the leading clinical trial networks in the country. Established 1976 in Nashville, Tennessee Oncology's mission remains unchanged: To provide access to high-quality cancer care and the expertise of clinical research for all patients, at convenient locations within their community and close to their home. Our growing network of physicians and locations is based on this mission. Tennessee Oncology is committed to advancing both the science of detection and targeted treatments, and to making these advances available to every patient. We believe caring for cancer patients is a privilege.
Why Join Us? We are looking for talented and highly-motivated individuals who demonstrate a natural desire to support the meaningful work of community oncologists and the patients we serve.
Job Description:
As the Research Nurse for Tennessee Oncology Greco Hainsworth Center for Research you will play a critical role in advancing oncology research by ensuring the successful execution of clinical trials. You will be responsible for screening, enrolling, documenting, and monitoring study subjects by ensuring strict protocol compliance and delivering exceptional patient care.
ESSENTIAL FUNCTIONS:
* Enroll patients onto clinical trials through recruitment, screening, enrollment, treatment, and follow-up of eligible participants according to protocol requirements.
* Provide thorough education about study requirements and expectations.
* Complete and document the informed consent process accurately, ensuring all parties sign and date as required, including obtaining HIPAA Authorization.
* Obtains and maintains informed consents of each patient for the duration of a study.
* Review the study design and inclusion/exclusion criteria with physician and patient.
* Complete and submit on-study forms within required timelines.
* Maintain accurate and detailed source documentation, including study visits findings, and outcomes.
* Screen all new patients or patients returning to office with scan results and document appropriately on patient tracking logs.
* Monitor subjects throughout the study, ensuring compliance with protocols and maintaining patient safety.
* Ensure that all medications are approved prior to initiating treatment or when changing medication regimens, such as crossover studies.
* Dispense oral investigational products to study participants and provide guidance to ensure compliance with medication regimens.
* Accurately calculate and document BSA, Creatinine Clearance, Urine Protein: Creatinine ratio, and any other calculations or conversions required per protocol.
* Ensure that follow-up appointments, scans, or related procedures are scheduled correctly according to protocol requirements.
* Record and report adverse events in accordance with study protocols and regulatory requirements.
* Document appropriately when patients are removed from protocol.
* Ensure reconsent of patients at the next scheduled visit, following availability of updated ICF, and documents process appropriately.
* Provide patient education and medical information to study patients to ensure understanding or proper medication dosage, administration, and disease treatment.
* Maintains medication inventory and reconciliation.
* Collaborate with the clinical research team to ensure timely completion of study-related tasks and reporting.
* Serve as a liaison between study participants, investigators, and the research team to address questions and concerns.
* Float to other research Tennessee Oncology clinics as needed
KNOWLEDGE, SKILLS & ABILITIES:
* Strong attention to detail and organizational skills.
* Ability to work independently while collaborating effectively with a multidisciplinary team.
* Knowledge of medical and research terminology
* Knowledge of FDA Code of Federal Regulations and GCP
* Knowledge of the clinical research processes
* At least one year of experience in a research setting preferred.
* Research Certification (ACRP or CCRP) Preferred
EDUCATION & EXPERIENCE:
* An Associate Degree; preferably a bachelor's degree
* RN License
* At least one year of oncology experience
PHYSICAL REQUIREMENTS:
Job Title:
Physical Activity Required
Amount of time
None
Less than 1/3
(Occasionally)
1/3 to 2/3
(Frequently)
More than 2/3
(Regularly)
Standing
X
Walking
X
Sitting
X
Fingering or manual dexterity
X
Repetitive finger motion
X
Lifting or exerting force
Up to 10 pounds
Up to 25 pounds
X
Up to 50 pounds
Up to 100 pounds
Over 100 pounds
Reaching or stretching
X
Climbing or balancing
X
Crouching or stooping
X
Speaking
X
Hearing
X
Seeing (with correction)
X
Auto-ApplyResearch Nurse
Research nurse job at Tennessee Oncology
Tennessee Oncology, one of the nation's largest, community-based cancer care specialists, is home to one of the leading clinical trial networks in the country. Established 1976 in Nashville, Tennessee Oncology's mission remains unchanged: To provide access to high-quality cancer care and the expertise of clinical research for all patients, at convenient locations within their community and close to their home. Our growing network of physicians and locations is based on this mission. Tennessee Oncology is committed to advancing both the science of detection and targeted treatments, and to making these advances available to every patient. We believe caring for cancer patients is a privilege.
Why Join Us? We are looking for talented and highly-motivated individuals who demonstrate a natural desire to support the meaningful work of community oncologists and the patients we serve.
Job Description:
As the Research Nurse for Tennessee Oncology Greco Hainsworth Center for Research you will play a critical role in advancing oncology research by ensuring the successful execution of clinical trials. You will be responsible for screening, enrolling, documenting, and monitoring study subjects by ensuring strict protocol compliance and delivering exceptional patient care.
ESSENTIAL FUNCTIONS:
• Enroll patients onto clinical trials through recruitment, screening, enrollment, treatment, and follow-up of eligible participants according to protocol requirements.
• Provide thorough education about study requirements and expectations.
• Complete and document the informed consent process accurately, ensuring all parties sign and date as required, including obtaining HIPAA Authorization.
• Obtains and maintains informed consents of each patient for the duration of a study.
• Review the study design and inclusion/exclusion criteria with physician and patient.
• Complete and submit on-study forms within required timelines.
• Maintain accurate and detailed source documentation, including study visits findings, and outcomes.
• Screen all new patients or patients returning to office with scan results and document appropriately on patient tracking logs.
• Monitor subjects throughout the study, ensuring compliance with protocols and maintaining patient safety.
• Ensure that all medications are approved prior to initiating treatment or when changing medication regimens, such as crossover studies.
• Dispense oral investigational products to study participants and provide guidance to ensure compliance with medication regimens.
• Accurately calculate and document BSA, Creatinine Clearance, Urine Protein: Creatinine ratio, and any other calculations or conversions required per protocol.
• Ensure that follow-up appointments, scans, or related procedures are scheduled correctly according to protocol requirements.
• Record and report adverse events in accordance with study protocols and regulatory requirements.
• Document appropriately when patients are removed from protocol.
• Ensure reconsent of patients at the next scheduled visit, following availability of updated ICF, and documents process appropriately.
• Provide patient education and medical information to study patients to ensure understanding or proper medication dosage, administration, and disease treatment.
• Maintains medication inventory and reconciliation.
• Collaborate with the clinical research team to ensure timely completion of study-related tasks and reporting.
• Serve as a liaison between study participants, investigators, and the research team to address questions and concerns.
• Float to other research Tennessee Oncology clinics as needed
KNOWLEDGE, SKILLS & ABILITIES:
• Strong attention to detail and organizational skills.
• Ability to work independently while collaborating effectively with a multidisciplinary team.
• Knowledge of medical and research terminology
• Knowledge of FDA Code of Federal Regulations and GCP
• Knowledge of the clinical research processes
• At least one year of experience in a research setting preferred.
• Research Certification (ACRP or CCRP) Preferred
EDUCATION & EXPERIENCE:
• An Associate Degree; preferably a bachelor's degree
• RN License
• At least one year of oncology experience
PHYSICAL REQUIREMENTS:
Job Title:
Physical Activity Required
Amount of time
None
Less than 1/3
(Occasionally)
1/3 to 2/3
(Frequently)
More than 2/3
(Regularly)
Standing
X
Walking
X
Sitting
X
Fingering or manual dexterity
X
Repetitive finger motion
X
Lifting or exerting force
Up to 10 pounds
Up to 25 pounds
X
Up to 50 pounds
Up to 100 pounds
Over 100 pounds
Reaching or stretching
X
Climbing or balancing
X
Crouching or stooping
X
Speaking
X
Hearing
X
Seeing (with correction)
X
Auto-ApplyManager, Research Nurse
Research nurse job at Tennessee Oncology
Tennessee Oncology, one of the nation's largest, community-based cancer care specialists, is home to one of the leading clinical trial networks in the country. Established 1976 in Nashville, Tennessee Oncology's mission remains unchanged: To provide access to high-quality cancer care and the expertise of clinical research for all patients, at convenient locations within their community and close to their home. Our growing network of physicians and locations is based on this mission. Tennessee Oncology is committed to advancing both the science of detection and targeted treatments, and to making these advances available to every patient. We believe caring for cancer patients is a privilege.
Why Join Us? We are looking for talented and highly-motivated individuals who demonstrate a natural desire to support the meaningful work of community oncologists and the patients we serve.
Job Description:
The Research Nurse Manager ensures the integrity and quality of clinical trials are maintained and conducted in accordance with international, federal, state, and local regulations, and Institutional Review Board (IRB) approvals. This role involves recruiting, supervising, evaluating, and coordinating the activities of a team of professional nurses and/or clinical research support staff; ensures that all clinical activities are carried out in accordance with established research protocol, and with acceptable clinical procedure and safety standards.
ESSENTIAL FUNCTIONS:
Manage day-to-day clinical research nursing operations, from protocol review/initiation to study close-out, ensuring study integrity throughout, under the guidance of the Principal Investigator (PI) and in collaboration with the clinical/medical officer assigned to the study.
Oversees daily clinical operations of the Research Nursing Department.
Ensure clinical staffing needs are met and manage scheduling.
Ensures staff compliance with clinical and research standard operating procedures.
Assists adherence to study-related SOPs/scientific manuals; plans, conducts, and evaluates study orientation, oversees protocol-related in-services to research team and clinical staff; institutes process improvements as needed.
Conducts staff meetings and training sessions.
Generates performance evaluations and proposes disciplinary actions when appropriate.
Defines activities in complex clinical research studies to prevent deviations/unanticipated events.
Provides expertise and leadership in the development, preparation, and implementation of regulatory strategies to support clinical research missions.
Manages the tasks of direct reports to guide patients through the processes of consenting, screening, treatment, and post-treatment follow-up in clinical trials.
Ensure timely collection and reporting of adverse events according to institutional, sponsor and FDA timelines.
Supervises direct reports in the performance of medical tests, including, but not limited to, vital signs, lab, and EKGs.
Collaborates with other research managers in the management of staff, resources/allocation planning and performance assessments for various clinical research, clinical trials implementation and oversight and regulatory and compliance functions.
Communicates and collaborates w/ study team including internal and external parties, sponsors, PI, and study participants.
Evaluates potential protocols to determine feasibility, resource requirements.
Assists in the development and implementation of clinical research technology systems and infrastructure.
Develops protocol needs assessment and monitors quality assurance protocol for services provided.
Prepares for and attends sponsor and FDA audits.
Provides nursing care to research study patients; ensures compliance with each study's protocol; administers investigational medications and performs patient assessment during clinical visits as needed.
Ensures that the integrity and quality of the clinical research trial is maintained and that the trial is conducted in accordance with Good Clinical Practice Guidelines, federal and sponsor regulations and guidelines.
Travel to all research site offices as necessary.
Maintains a professional approach respecting the dignity and confidentiality of patients.
Maintains a good attendance record and reports to work on time.
Maintains a professional attitude and appearance.
Maintain Tennessee licensure as applicable.
Performs other duties as assigned.
KNOWLEDGE, SKILLS & ABILITIES:
Excellent verbal and written communication skills.
Strong organizational and follow-up skills.
Ability to handle multiple priorities in a fast-paced environment.
Understanding complex clinical trials protocols.
Ability to direct, manage, implement, and evaluate department operations.
Ability to establish department goals, and objectives that support strategic plan.
Effective planning, delegation, and supervision skills.
Ability to travel up to 25% (local/regional).
Proficiency in Microsoft Office products (Word, Excel, PowerPoint, etc.)
Knowledge of protocol and clinical drug development processes, study design, study planning and management, and monitoring.
Knowledge of ICH/GCP guidelines
EDUCATION & EXPERIENCE:
Bachelor's degree, BSN
Current Tennessee RN license
5+ years of experience as registered nurse
3+ years of experience in oncology setting
3+ years of experience in clinical research, preferred
Previous supervisory and/or management experience, preferred
Auto-ApplyClinical Research Coordinator
Gibson, TN jobs
Job Details ADMIN - Hixson, TNDescription
Clinical Research Coordinator
Galen Medical Group offers several medical specialties throughout the Chattanooga region. We provide quality care and patient-friendly services to adults and children of all ages. Our mission is to elevate the health of our community through multiple medical specialties providing excellent care delivered with wisdom, compassion, integrity, and a commitment to technology, education, and scientific inquiry. We are seeking qualified, like-minded Individuals to join our team!
PURPOSE:
The Clinical Research Coordinator (CRC) is responsible for conducting trials as per the GCP guidelines under the supervision of the Principal Investigator (PI). In addition to providing and coordinating clinical care, a CRC has a central role in assuring subject safety, ongoing maintenance of informed consent, the integrity of protocol implementation, the accuracy of data collection, data recording, and follow-up. Care received by research subjects is driven by study requirements and the collection of research data as well as clinical indications. The CRCs ultimate goal is to protect subjects participating in clinical trials and promote good clinical practices and professional management of clinical studies.
DUTIES AND RESPONSIBILITIES:
Assisting trial Investigator in screening and reviewing potential study participant's eligibility by reviewing medical records, and discussions with the study subjects, physicians, and nurses.
Ensuring that all clinical activities are carried out in accordance with the established research protocol and standards in compliance with all applicable laws, regulations, policies, and procedural requirements.
Monitor study activities to ensure compliance with protocols and with all relevant local, federal, and state regulatory and institutional policies.
Ensure all data is accurately documented, such as patient vital signs, dispensation, and administration of the investigational product, adverse events, and concomitant medications. Available to subjects, subjects' families, and investigators to answer questions at any time relating to specific clinical trials. Strive to advocate for their subjects while ensuring the integrity of the clinical research trial.
Maintain required records of study activity including case report forms, drug dispensation records, or regulatory forms.
Communicate with laboratories or investigators regarding laboratory findings.
Solicit industry-sponsored trials through contacts and professional organizations.
Direct the requisition, collection, labeling, storage, or shipment of specimens.
Participate in continuing education activities or attend conferences and seminars to maintain current knowledge of clinical studies affairs and issues.
Prepare for or participate in quality assurance audits conducted by study sponsors, federal agencies, or specially designated review groups.
Perform specific protocol procedures such as interviewing subjects, taking vital signs, phlebotomy, and performing electrocardiograms.
Prepare study-related documentation such as protocol worksheets, procedural manuals, adverse event reports, institutional review board documents, and progress reports.
Oversee subject enrollment to ensure that informed consent is properly obtained and documented.
Schedule subjects for appointments, procedures, or inpatient stays as required by study protocols.
Performs other related duties as needed.
Knowledge, Abilities, and Expectations:
Promote the mission, vision, and values of Galen Medical Group.
Maintain confidentiality of all patient, medical, financial, and legal information.
Report to work on time and as scheduled.
Wear identification during work hours.
Represent the organization in a positive & professional manner.
Ability to handle difficult situations involving patients, physicians, or others in a professional manner.
Ability to work independently, exercise creativity, be attentive to detail, and maintain a positive attitude.
Comply with all organizational policies and standards regarding ethical business practices.
Participate in performance improvement and continuous quality improvement activities.
Attend regular staff meetings and in-services as directed by your manager.
Consistently demonstrate the value of the team concept.
Ability to manage multiple and simultaneous responsibilities.
Complete assignments efficiently and in a timely manner.
Understands and abides by OSHA, HIPAA & CLIA standards.
Qualifications
Qualifications:
Associates Degree in the health care field, specialized training certificate, or equivalent research experience. Certification as Clinical Research Coordinator through ACRP (CCRC) or equivalent organization desired.
Minimum 2 to 3 years of clinical research coordinator experience preferred
Clinical skills, including the ability to perform phlebotomy
Exceptional attention to detail with strong interpersonal skills
Excellent verbal & written communication and organizational skills
Ability to manage multiple tasks and prioritization
Must be proficient in Excel, Microsoft Office, and other computer programs
As part of the Galen Medical Group, the applicant must be a team player and provide excellent customer service while assessing our patient's needs efficiently. Perform all duties in compliance with Galen Medical policies, HIPAA, and OSHA standards.
Galen Medical Group is a member of the TN Drug-Free Workplace and it is a requirement that we conduct a pre-employment drug screen, as part of the hiring process.
Why should you apply?
401(k) benefits.
Education reimbursement.
Holiday Pay.
Great earned time-off policy.
Company-paid Life Insurance & Long Term Disability.