Clinical Research Coordinator - 229151
Clinical Research Coordinator Job 15 miles from Suffolk
Key Responsibilities:
Manage and lead clinical trials, ensuring adherence to protocol requirements, GCP, ICH Guidelines, and SOPs.
Perform and supervise clinical procedures such as venipuncture, capillary puncture, and other fluid collection activities, in line with the study protocol and regulatory guidelines.
Prepare, process, and dispatch laboratory specimens as per the study protocol and IATA guidelines when applicable.
Oversee the lifecycle of assigned clinical trials, including initiation, vendor coordination, subject recruitment, protocol training, scheduling, regulatory document collection, and adverse event management.
Proactively address project risks and apply project management strategies to ensure quality and timely execution of clinical research.
Develop and implement strategies for both research and administrative functions to manage protocols effectively and ensure smooth trial progression.
Communicate clearly and professionally with study team members, leadership, participants, sponsors, CROs, and external vendors.
Ensure accurate documentation practices per ALCOA-C principles, managing data transfer to sponsor or CRO systems, and resolving any data queries efficiently.
Safeguard participant privacy and confidentiality, adhering to HIPAA regulations and ensuring all data is managed according to sponsor and protocol requirements.
Monitor and escalate patient safety concerns, ensuring proper reporting and follow-up of adverse events, serious adverse events, and special-interest events as per the study protocol.
Ensure that all data is entered into the sponsor's data platform, resolving queries in accordance with the Clinical Trial Agreement.
Delegate tasks effectively and ensure staff are trained and certified in necessary clinical procedures.
Collect, review, and submit necessary regulatory documentation to sponsors and IRBs in compliance with GCP/ICH standards.
Screen and evaluate potential clinical trial participants, conducting prescreening calls and in-person assessments.
Implement recruitment strategies defined by the Clinical Research Team to ensure successful subject enrollment.
Demonstrate a deep understanding of key clinical trial timelines, protocol requirements, required vendors, and the target patient population.
Acquire a thorough understanding of the product development cycle and the significance of protocol design in achieving accurate and meaningful data points.
Work collaboratively with the Clinical Research Team to develop and execute a quality control strategy, ensuring consistency and accuracy in data entry and trial activities.
Perform clinical duties such as drug preparation and administration, ECG, fibroscan, phlebotomy, and lab processing in compliance with protocol requirements.
Carry out additional duties as required to support the success of the clinical trial.
Must Have Education/Experience:
Bachelor's degree and 2 years relevant experience in the life science industry OR
Associate's degree with 4 years relevant experience in the life science industry OR
High School Graduate and/or technical degree with minimum of 6 years relevant experience in the life science industry AND 1 year Clinical Research Coordinator experience
Required Licenses/Certifications:
Phlebotomy if applicable and required by state law
Intramuscular dose administration and preparation if applicable and required by state law
Certified Clinical Research Coordinator through ACRP or SOCRA within six months of being in the role
Clinical Research Coordinator
Clinical Research Coordinator Job 15 miles from Suffolk
Eximia Research is a fully Integrated research sites network of premier investigational sites meeting the clinical research needs of global biopharmaceutical, biotechnology, medical device, pharmaceutical and clinical research organizations (CROs). Our premier, multidisciplinary wholly owned research sites located across country and known for excellent trial execution, rapid subject recruitment/enrollment and delivery of a quality data.
Job Description
The Clinical Research Coordinator II conducts and manages multiple clinical trials from start up through study close out in accordance with the study protocol, GCP, and Eximia Research Network's SOPs.
Role & Responsibilities:
Conduct and manage clinical trials in accordance with the study protocol, GCP, ICH Guidelines and Eximia Clinical Network's SOPs
Perform venipuncture, capillary puncture and/or other fluid collection within scope of the protocol and local law and regulations
Process, package and ship laboratory specimens as required per protocol and IATA regulations, if applicable
Implement and coordinate assigned clinical trials including start up, vendor management, subject recruitment, source development review, scheduling subjects, protocol training, collection of regulatory documents, conducting and participating in the ICF process(es), ensuring data is entered in a timely manner and all queries are resolved, managing and reporting adverse events, serious adverse events, and deviations, implementing new protocol amendments, providing all close outreports.
Apply project management concepts to manage risk and improve quality in the conduct of a clinical research study
Develop, coordinate, and implement research and administrative strategies to successfully manage assigned protocols.
Communicate effectively and professionally with coworkers, leadership, study subjects, sponsors, CROs, and vendors.
Apply good documentation in accordance with ALCOA-C principles when collecting and correcting data, transferring data to sponsor/CRO data capture systems and resolving queries
Maintain confidentiality of patient protected health information, sponsor confidential information and Eximia Clinical Network confidential information
Verify and escalate patient safety concerns by ensuring all adverse events, serious adverse events, and adverse events of special interest are followed and reported in accordance with the protocol and Eximia Clinical Network SOPs.
Ensure all data is entered into the sponsor's data portal and all queries are resolved in a timely manner as set forth in Clinical Trial Agreement
Ensure staff are delegated and trained appropriately and documented
Create, collect and submit regulatory documents to Sponsors and IRBs as required per protocol, GCP/ICH regulations and IRB requirements.
Evaluate potential subjects for participation in clinical trials including phone and in person prescreens.
Create and execute recruitment strategies defined by Clinical Research Team
Understand key timelines, endpoints, required vendors, and patient population for each assigned protocol.
Understand product development lifecycle and significance of protocol design including critical data points
Understand the disease process or condition under study
Collaborate with Clinical Research Team to develop Quality Control strategy for reviewing one's work on an ongoing basis and in preparation for monitor visits.
Perform clinical duties (e.g., drug preparation and administration, fibroscan, phlebotomy, ECG, lab processing) within scope
Other duties as assigned
Qualifications
Education/Experience:
Bachelor's degree and 2 years relevant experience in the life science industry OR
Associate's degree with 4 years relevant experience in the life science industry OR
High School Graduate and/or technical degree with minimum of 6 years relevant experience in the life science industry AND1 year Clinical Research Coordinator experience
Required Licenses/Certifications:
Phlebotomy if applicable and required by state law
Intramuscular dose administration and preparation if applicable and required by state law
Certified Clinical Research Coordinator through ACRP or SOCRA within six months of being in the role
Required Skills:
Demonstrated knowledge of medical terminology
Proficient in the use of the following technology: Computers, Microsoft Office software, fax, copier, and multi-line telephone.
Proficient ability to work in a fast-paced environment
Proficient verbal, written, and organizational skills
Proficient interpersonal and communication skills
Proficient ability to work as a team player
Proficient ability to read, write, and speak English
Proficient ability to multi-task
Proficient ability to follow written guidelines
Proficient ability to work independently, plan and prioritize with minimal guidance
Proficient ability to be flexible/adapt as daily schedule may change rapidly
Must be detail oriented
Demonstrated problem solving and strategic decision making ability.
Proficient in accepting individual responsibility for actions taken and demonstrating professionalism when judged, critiqued and/or praised.
Demonstrated leadership ability
Clinical Coordinator
Clinical Research Coordinator Job 15 miles from Suffolk
JOB SUMMARY: coordinates patient care with physician, assists physician with assessment, gives medication pursuant to physician order and assists with administrative duties that further patient care. Responsibilities include, but are not limited to, the following:
Clinical Support
Greets patient and escorts them from the waiting room to exam rooms; prepares patients for exam or treatment; takes vital signs.
Provides assistance to physician when requested.
Performs Spirometry and other breathing tests as ordered.
Prepares and maintains supplies and equipment for treatments, including sterilization.
Performs patient education when appropriate.
Completes appropriate documentation in patients medical record.
Calls in prescriptions as ordered by physician or nurse practitioner.
Performs allergy prick testing and/or intradermal testing as ordered by physician.
Administers allergy injections to shot patients as set forth on physician approved schedule.
Monitors patients medical status for possible adverse reaction following receipt of allergy injection.
Maintains emergency equipment, including oxygen, code kit, suction, etc.
Answers patient-related telephone calls and respond according to clinical protocol.
Follows up to obtain referrals and insurance authorization as requested and needed.
Maintains clinical supply stock and medication samples.
Other
Maintains patient confidentiality; complies with HIPAA and compliance guidelines established by the practice.
Maintains detailed knowledge of practice management and other computer software as it relates to job functions.
Attends CPR, OSHA, HIPAA, and OIG training programs as required.
Attends all regular meetings.
Performs all other tasks and projects assigned by the Manager.
EDUCATIONAL REQUIREMENTS:
High school degree required
Registered Nurse License required
QUALIFICATIONS AND EXPERIENCE:
At least one year of experience in clinical assisting
Comfortable using email and interacting with Internet applications
Knowledge of practice management and word processing software
Good communication skills
Neat, professional appearance
Clinical Research Associate
Clinical Research Coordinator Job 15 miles from Suffolk
Full-Time 601 Children's Lane Professional Days 25.8600 Through 38.8100 * The Clinical Research Associate is responsible for working directly with principal investigators to facilitate all aspects of research. Instrumental in study design, coordination, implementation, documentation and data management of research protocols to include budget preparation, monitoring and quarterly reports. Reports to department leadership.
* ESSENTIAL DUTIES AND RESPONSIBILITIES
* Collaborates with hospital departments to coordinate research related activities.
* Monitors and assures study conduct in accordance with Institutional Review Board and Federal Regulations.
* May require travel to various sites.
* Performs other duties as assigned.
* LICENSES AND/OR CERTIFICATIONS
* Completion of IRB (Institutional Review Board) certification in human subject's protection preferred.
* CPR Training required and/or must be obtained within 45 days of hire.
* MINIMUM EDUCATION AND EXPERIENCE REQUIREMENTS
* Bachelor's degree preferred.
* Knowledge of research processes, procedures and regulations acquired through progressive experience in supporting or performing research.
* 3-5 years research experience preferred.
* Must possess effective computer skills to include familiarity with Microsoft Excel, Access, and other standard software.
* Ability to analyze and problem solve independently.
* Exceptional interpersonal skills that display effective and professional customer service skills and interactions.
* Ability to travel to various locations as required for performance of job role.
* WORKING CONDITIONS
* Patient care environment with exposure to environmental hazards including, but not limited to communicable diseases. Job will include normal office environment and travel to and through patient care areas. Moderately adverse working conditions due to patient related activities including irregular or extended work hours.
* PHYSICAL REQUIREMENTS
* Click here to view physical requirements.
Clinical Research Coordinator
Clinical Research Coordinator Job 15 miles from Suffolk
Posting Date 04/09/2025 1711 Church StSte A, Norfolk, Virginia, 23504-2303, United States of America At DaVita Clinical Research, we find that our best leaders are those who create an inspiring vision, have a desire to shape the future of medicine, and empower their team to achieve success. They enjoy tackling difficult problems and believe that the best way to solve them is through a collaborative environment that involves team efforts. They take ownership of results and instill accountability in those they lead. They are driven, compassionate, strong communicators, relationship builders, and find real fulfillment in challenging and impactful work.
Do you love patient care? Are you a LPN or RN, but are tired of the demands of working in a healthcare setting? Have you ever explored using your clinical skills differently? Clinical Research allows a more flexible schedule for healthcare providers interested in a dynamic and fast paced environment that is on the cutting edge of medicine.
Sound like you? Then you might be a great fit for a Clinical Research Coordinator role with DaVita Clinical Research (DCR)
We are looking for a highly motivated, positive and innovative Clinical Research Study Coordinator (Research Coordinator) to lead in the coordination, management and conduct of nephrology clinical research trials in dialysis centers and physicians practices. DaVita Clinical Research (DCR) is a Renal Research site network conducting clinical trials across the country. DCR prides itself on a culture of growth, transparency and feedback and would want our leaders to do that same. We want a teammate who is compassionate, purposeful and motivated by meaningful work.
This position will be based in our Norfolk, VA site and coordinate and execute all aspects of late phase clinical trials in Norfolk and surrounding areas. Based on business needs, a flexible weekly work schedule may be available.
ESSENTIAL DUTIES & RESPONSIBILITIES:
* Accountable for the successful execution of clinical trials through all phase of the study: enrollment, maintenance and close out.
* Responsible for performing research procedures according to the study protocol and working in partnership with the physician investigator to coordinate research activities.
* Serves as a liaison between the physicians (Principal Investigator or Sub-Investigator), study sponsors and DaVita facility teammates.
* Responsible to deliver or exceed project enrollment targets for clinical research studies at their site.
* Responsible for accurate and timely data entry into the electronic data entry systems.
* Responsible for timely resolution of all data queries to meet project timelines for database lock.
* Demonstrates compliance with good clinical practice (GCP) and applicable law, and verifies that study teams comply with GCP and applicable law.
* Demonstrates adherence to DCR standard operating procedures and policies and with the standards customary in the clinical research industry.
* Understands and promotes compliance with all applicable healthcare and research regulations.
MINIMUM QUALIFICATIONS
* High School Diploma or equivalent is required.
* Bachelor's Degree is preferred.
* Minimum 1 year of clinical research experience managing studies from start up to close out or equivalent experience.
* Reliable transportation to travel between local research sites.
* Commitment to and role model of DaVita's values with ability to demonstrate those positively and proactively to patients, teammates, management, physicians, and/or vendors (Village Service Partners) in everyday performance and interactions.
* Ability to manage multiple projects, meet deadlines, and adjust priorities appropriately in an evolving work environment with shifting time frames; self-starter with high degree of initiative, urgency, and follow through.
* Experience in managing confidential information and/or issues using discretion and Judgment
* Certified Clinical Research Coordinator (SOCRA or ACRP) - preferred
DaVita Clinical Research (DCR), a wholly owned subsidiary of DaVita Inc., is the research arm of DaVita. DCR innovates through retrospective outcomes research aimed at improving care and quality of life for people with kidney disease. DCR assists pharmaceutical and medical device companies in the design, recruitment and completion of clinical trials using its renal research site network. For 30 years we have helped 500+ clients with their development projects. DCR is based in Minneapolis, MN and operates in locations across the US.
What We'll Provide:
More than just pay, our DaVita Rewards package connects teammates to what matters most. Teammates are eligible to begin receiving benefits on the first day of the month following or coinciding with one month of continuous employment. Below are some of our benefit offerings.
* Flexible weekly work schedule: This will vary and is based on current business needs
* December Industry wellness break (Week between Christmas and New Year's Day)
* Comprehensive benefits: Medical, dental, vision, 401(k) match, paid time off, PTO cash out
* Support for you and your family: Family resources, EAP counseling sessions, access Headspace, backup child and elder care, maternity/paternity leave and more
* Professional development programs: DaVita offers a variety of programs to help strong performers grow within their career and also offers on-demand virtual leadership and development courses through DaVita's online training platform StarLearning.
Here is what you can expect when you join our Village:
* A "community first, company second" culture based on Core Values that really matter.
* Clinical outcomes consistently ranked above the national average.
* Award-winning education and training across multiple career paths to help you reach your potential.
* Performance-based rewards based on stellar individual and team contributions.
* A comprehensive benefits package designed to enhance your health, your financial well-being and your future.
* Dedication, above all, to caring for patients suffering from chronic kidney failure across the nation.
Join us as we pursue our vision "To Build the Greatest Healthcare Community the World has Ever Seen."
Why wait? Explore a career with DaVita today.
Go to ************************* to learn more or apply
#LI-JD2
At DaVita, we strive to be a community first and a company second. We want all teammates to experience DaVita as "a place where I belong." Our goal is to embed belonging into everything we do in our Village, so that it becomes part of who we are. We are proud to be an equal opportunity workplace and an affirmative action employer. As such, individuals are recruited, hired, assigned and promoted without regard to race, national origin, religion, age, color, sex, sexual orientation, gender identity, disability, protected veteran status, or any other protected characteristic.
This position will be open for a minimum of three days.
Salary/ Wage Range
Compensation for the role will depend on a number of factors, including a candidate's qualifications, skills, competencies and experience. DaVita offers a competitive total rewards package, which includes a 401k match, healthcare coverage and a broad range of other benefits. Learn more at ***********************************
Colorado Residents: Please do not respond to any questions in this initial application that may seek age-identifying information such as age, date of birth, or dates of school attendance or graduation. You may also redact this information from any materials you submit during the application process. You will not be penalized for redacting or removing this information.
Clinical Research Coordinator
Clinical Research Coordinator Job 15 miles from Suffolk
Odyssey is seeking a Clinical Research Coordinator to support the Clinical Investigation Department (CID) at the Navy Medical Center, Portsmouth (NMCP) Virginia. The mission of the command is to support the national interests of the United States by providing professional education and development, providing quality patient care, being responsive and ready for deployment, and taking care of each other as shipmates. NMCP conducts biomedical research in general surgery, psychology, otolaryngology, pediatrics, nursing research, orthopedics, women's health, and emergency medicine, which are relevant to the Graduate Medical Education Program.se include a for all positions
Responsibilities
Duties include, but not limited to:
Provide research support for IRB and IACUC approved research protocols.
Support the Department Head of the CID, Directorate for Professional Education, NMCP.
Support the Department Head of CID and is accountable for research matters to the PIs of each research protocol in accordance with federal and local regulatory guidelines.
Use programs such as Word, Excel, etc., as well as clinical computer systems including Composite Health Care System (CHCS-I) and Armed Forces Health Longitudinal Technology Application (AHLTA).
For consultation, reporting, exchange of information, orientation support for the performance of duties, and to guide patients through a research protocol, will maintain and document contact with study subjects and research personnel from government agencies, granting agencies, industry sponsors.
Provide IRB/HRPP support to the PI in the development and implementation of recruitment strategies in accordance with IRB/HRPP requirements and approvals.
Screen recruited research subjects using protocol inclusion/exclusion criteria.
Refer eligible patients to the PI for final evaluation, enrollment, and randomization per protocol design after the informed consent process has taken place effectively, all subject questions are answered satisfactorily, and the process is documented.
Assist the research pharmacist with correct receipt, dispensation and accountability/documentation of investigational drugs per the sponsor protocol on Investigational Drug/Device Accountability.
Provide subjects with education on compliance, possible side effects, drug interactions and the importance of contacting the coordinator and study team members as applicable.
Assist with maintaining adequate inventory of study supplies, including drugs, and devices, and preparation of other study materials. These study materials include the informed consent document, case report forms (CRFs)/data collection forms (DCFs), enrollment logs, concomitant medication/adverse events logs and drug/device accountability logs.
Assist the PI by providing materials and tools necessary for the development of appropriate training of individuals involved in the execution of a study related to protocol requirements, schedule of visits, execution of research plan, and maintain documentation of training.
In collaboration with the PI, check on the performance of phlebotomies, electrocardiograms, vital signs, specimen collection and shipment, and other procedures as required by the protocol.
Observe universal precautions and OSHA standards when processing or handling specimens.
Obtain laboratory results and consult with the PI for follow-up care as per protocol.
Collect data in a timely and accurate manner and submit information to coordinating centers.
Report and document adverse events and unanticipated problems to governing agencies and sponsors as required by protocol and regulations.
Review compliance of research subject and complete documentation of status and progress. Respond to Assurance Specialist discrepancy/findings and, after consultation with PI, communicate approved recommendations.
Conduct telephone, face-to-face interviews or mail information for follow-up visits as per protocol. Maintain detailed documentation of the research study including subject study charts and databases as required by the protocol, and the Investigator's File Binder or Regulatory Binder.
Prepare reports and other correspondence regarding the research protocol for the IRB, granting agencies, industry sponsors and other organizations as required by regulation and/or the protocol.
Interact on a regular basis with the PI and study team members regarding the conduct of the research study.
Attend conferences and other meetings as required by the protocol.
Return telephone calls from research participants within 48 hours and document interactions appropriately.
Work is performed in ambulatory care spaces and inpatient wards with some risk of exposure to infectious disease, for which gloves, masks, or gowns provided by the government entity may be required for safety reasons.
Maintain patient confidentiality in accordance with HIPAA and institutional regulations. Actively participate in CID departmental and command-wide research educational and training programs by providing instruction and presentation materials to assist research staff, as needed.
Actively participate in assurance assist visits and regulatory audits for protocol compliance.
Assist PI, research team members, and other staff in the preparation of and closeout of clinical research studies.
Collaborate with PI, study personnel and CID grants writer to source research funding for future protocols.
Qualifications
Minimum Required Qualifications:
Citizenship: Must be a US citizen
Clearance: Ability to obtain a Secret Clearance
Education: Bachelor's Degree from an accredited college or university
Certifications:
Certified Clinical Trial Investigator (CCTI)
Certified Clinical Research Coordinator (CCRC)
Certified Clinical Research Professional (CCRP) from the Association of Clinical Research Professionals (ACRP) or the Society of Clinical Research Associates (SoCRA).
Years' experience:
A minimum of two (2) years as a Clinical Research Coordinator within the past five years OR Current certification as a Certified Clinical Trial Investigator (CCTI), Certified Clinical Research Coordinator (CCRC), Certified Clinical Research Professional (CCRP) from the Association of Clinical Research Professionals (ACRP) or the Society of Clinical Research Associates (SoCRA).
Minimum of two (2) to four (4) years of monitoring experience in a clinical research environment and administrative Institutional Review Board (IRB) experience.
Possess knowledge of medical terminology and clinical monitoring process and in depth therapeutic and protocol knowledge.
Ability to communicate effectively, both orally and in writing.
Possess effective organizational and analytical skills with ability to work independently and in a team environment.
Proficiency with Windows base computer systems, including Microsoft Windows and Microsoft Office Suites program.
Must possess the ability to complete research subject protection training developed by the Collaborative Institutional Training Initiative (CITTI), and additional protocol specific training, as required, within one month from start date
Preferred Qualifications:
Clearance: (ability to obtain) Secret Clearance
Additional Information:
Location: Navy Medical Center, Portsmouth (NMCP) Virginia
On-site (local candidates only)
#LI-JC1
Company Overview
Odyssey Systems Consulting Group, is an innovative small business committed to providing world-class technical, management, and training support services to government and public sector clients. We focus on people, processes, and performance to deliver superior results. Since our inception in 1997, our commitment to mission success and customer satisfaction has been recognized with exponential growth and exceptional past performance ratings. We accept challenging assignments and drive projects from the planning stages, through implementation, and into operations and support.
Please note: Final compensation for this position will be determined by various factors such as the Federal Government contract labor categories and contract wage rates, relevant work experience, specific skills and competencies, geographic location, education, and certifications.
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
Clinical Research Coordinator, Nurse (RN)
Clinical Research Coordinator Job 15 miles from Suffolk
Virginia Oncology Associates, the largest group of medical professionals in Hampton Roads and Northeast North Carolina devoted exclusively to cancer care and blood disorders, has an exciting opportunity for a Clinical Research Coordinator or Clinical Research RN to support our office in Norfolk.
* Please take this quick survey once you've submitted your resume to complete the application process: Clinical Research PI Link
If you have completed the survey before, even for another position, please do not take it again.
Responsibilities
* Present trial concepts, objectives and treatment details to potential patients for various cellular therapy trials, while conducting detailed assessment and screening to determine their eligibility.
* Participating in the informed consent process and enrolling patients on protocol
* 80% of the job will be computer based, and direct patient care is limited in a non-RN Clinical Research Coordinator role
* Collects and maintains regulatory documents in accordance with USOR SOP and applicable regulations. Participates in scheduling monitoring and auditing visits, as well as interacting with the monitors/auditors while onsite.
* Coordinating patient care in compliance with protocol requirements
* Collaborating with the physician to review patients for changes in condition, adverse events, concomitant medication use, protocol compliance, response to drug study and thoroughly documenting all findings
* Working directly with other research bases and/or sponsors
* Overseeing the preparation of orders by physicians to assure that protocol compliance is maintained
* Communicating with physicians regarding study requirements, need for dose modification and adverse event reporting
Qualifications
* Associates degree in a clinical or scientific related discipline required
* Experience in clinical research preferred
* Experience with computer data entry and database management
* Excellent written and oral communication skills
* Ability to read, analyze, and interpret technical procedures such as protocols, informed consent, and regulatory documents
Additional Qualifications for Nurse Candidates:
* Graduate from an accredited program for nursing education (BSN preferred) preferred
* Minimum of one (1) year nursing experience preferably in oncology
* Current licensure as an RN in Virginia preferred
* Current BCLS or ACLS certification required
* OCN, SoCRA, or ACRP certification preferred
WORK ENVIRONMENT:
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Exposure to communicable diseases, toxic substances, ionizing radiation, medical preparations and other conditions common to an oncology/hematology clinic environment. While performing the duties of this job, the employee is regularly exposed to direct contact with patients with potential for exposure to toxic substances, medicinal preparations, and chemotherapeutic agents.
PHYSICAL DEMANDS:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Requires full range of body motion including handling and lifting patients, manual and finger dexterity, and eye-hand coordination. Requires standing and walking for extensive periods of time. Occasionally lifts and carries items weighing up to 40 lbs. Requires corrected vision and hearing to normal range.
Coordinator Clinical Research (RN)
Clinical Research Coordinator Job 15 miles from Suffolk
The Clinical Research Coordinator provides complete management of the clinical trials for the Department of Obstetrics and Gynecology, including research in the areas of Maternal Fetal Medicine, Obstetrics, Gynecology, and Urogynecology. The coordinator acts as liaison between the academic community, local community, multiple government agencies and/or commercial sponsors and the Department to facilitate all clinical and practical aspects of the clinical trial. The coordinator, working independently, interacts with members of the unit to promote the goals of research, education, and patient care as defined in the mission statement of the Department. Along with the investigator, the Clinical Research Coordinator will screen, enroll and follow study subjects, ensuring protocol compliance and close monitoring while the subjects are on study. In addition, the Clinical Research Coordinator is responsible for all data and source documentation, adverse experience reporting, and maintenance of complete regulatory file. The coordinator is available to answer questions or evaluate symptoms and/or problems of patients in trials using sound clinical judgment to suggest additional referrals or appropriate follow-up. Weekend and holiday call rotation may be necessary to perform clinical procedures, if required by specific protocols. The coordinator manages multiple complex projects simultaneously with overlapping critical time frames, assigning priorities and delegating work appropriately.
Responsibilities
Possesses a full understanding of the clinical research process, study designs and regulatory standards of Good Clinical Practice and adheres to standards for scientific integrity mandating honest and truthful behavior in collecting and interpreting data for patients and sponsors
Supervises clinical research related activities including registration, maintenance and submission of patient data; pathology and laboratories results; drug dispensing; patient compliance; study results; adverse events; and follow up
Independently conducts, analyzes and evaluates all clinical research activities and makes recommendations to principal investigators or designated persons for any required changes
Maintains historical references by facilitating entry, editing, reviewing, management, reporting, and documentation of clinical trials data
Orders investigational drugs and/or devices as needed for protocol purposes and maintains inventories of drugs and devices to ensure that federal guidelines are met
Develops consent forms consistent with Food and Drug Administration (FDA), Institutional Review Board (IRB), and sponsor requirements
Maintains data from clinical studies in order to prepare interim, annual, and close out reports, and to provide statistical information on all clinical research protocols as required by the IRB, sponsor, and department
Maintains responsibility for updating Protocol, Regulatory Binders with addenda, amendments, closure notices, severe adverse drug reaction reports, and other FDA regulated documentation
Evaluates potential volunteers on an individual basis and obtains in depth medical history as related to study inclusion/exclusion criteria
Meets personally with patient volunteers to explain study requirements, and obtains informed consent prior to study screening
Organizes exam rooms in preparation for participants' exams and procedures, determining equipment and other supplies
Assist with physical exams, endometrial and cervical biopsy, ultrasound, pap smears, colposcopy, catheterization, contraceptive rod insertion and removal, cervical mucus checks, post coital exams, and other procedures as required by protocols
Dispenses medication and educates patients on the correct method of administration of study drug and/or device, and documentation of pertinent medical information required
Provides health education to patient volunteers and encourages interventions for healthy living
Identifies potential disease processes and brings to physicians' attention for evaluation, diagnosis and treatment
Provides counseling to patients in regards to laboratory results, side effects, etc., and suggests required follow up
Orchestrates protocol specific patient assessment throughout duration of study and any additional visits necessary to evaluate the health and safety of participants
Attends off site patient care visits at other laboratories, pharmacies, doctors' offices, and hospital departments, to assess and evaluate participants according to protocol requirements
Oversees patients' adherence to study requirements and makes necessary adjustments to ensure compliance with protocol (medication administration, diary card completion, concomitant medications, and adverse events)
Maintains proficiency in phlebotomy skills, intramuscular injections, ECG, and other clinical skills
Qualifications
Bachelor's degree in nursing. Prior nursing experience in research projects. Must be licensed RN in Virginia. Ambulatory care and Clinical experience in family medicine desired. Customer service-oriented individual is required.
Location : Location US-VA-Norfolk
Clinical Research Associate (CRA- Contract)
Clinical Research Coordinator Job 31 miles from Suffolk
Clinical Research Associate (CRA - Contract)
Are you an independent contract CRA passionate about advancing human health? Are you driven by a constant desire to enhance your exposure to industry leading clinical trials? Are you ready to work with a company leading multiple projects with a shared sense of purpose? If this grabs your attention, please consider the opportunity below.
Beaufort seeks a skilled and dedicated Contract Based Clinical Research Associate with experience supporting in vitro diagnostic (IVD) clinical trials. We participate in an exciting and growing industry. We share our passion, knowledge and commitment to our projects and clients. Our clinical team works with multiple sponsors in multiple therapeutic areas with an emphasis in IVD.
A Clinical Research Associate at Beaufort holds the following key responsibilities:
Build relationships with investigators and site staff
Understand the protocol and therapeutic area in sufficient detail to be able to advise and discuss with the study site personnel
Monitor patient recruitment timelines at sites and report this information to the project leadership.
Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol, SOPs and adherence to applicable regulations and GCP compliance
Participate in Investigator and other external or internal meetings as required
Perform site qualification visits, initiation visits, interim monitoring visits, and close-out visits as necessary
Responsible for conducting source data verification and providing written follow-up requests to the site in order to correct any issues identified at the monitoring visit
Update all relevant tracking systems on an ongoing basis
Generate site visit reports and expense reports within specified timelines
Arrange on-site visits and logistics (e.g., travel arrangements)
Conduct on-site study-specific training (if applicable)
Maintain day-to-day contact with the study sites, including regular telephone contact with the sites as agreed with Sponsor and Project Manager
There is a great amount of depth and breadth in this role. Because of this, we ask that you bring with you the education and/or experience that sets you up for success in this position. This generally looks like:
Bachelor's Degree required
Must have at least 5 years of experience as a field monitor CRA
Experience monitoring IVD clinical trials is required
Experience working in a self-driven capacity, with a sense of urgency and limited oversight
The ability to manage multiple tasks, evaluate a variety of unpredictable scenarios and achieve project timelines while being able to apply your understanding of study protocol(s)
Must have excellent communication and interpersonal skills
Demonstrate flexibility regarding project or organization shifts in priorities
Ability travel: at least 1 to 2 site-visits per week (regionally)
Familiarity and working knowledge of electronic data capture systems (eDC), clinical databases, Case Report Forms, edit checks, query resolution, and resolving data management issues
While the above are the standard requirements, you'd really impress with:
If you were well versed in current industry standards (GCP, ICH, FDA) and guidelines
If you had a proven track record of monitoring sites and executing successful projects
The ability to work with multiple sponsors in multiple therapeutic areas and indications
This position reports to Beaufort's CRA Manager. As a contract role, it offers flexibility and the opportunity for you to partner with a great team.
Beaufort offers a different CRO experience. It's not just about what we do, it's how we do it. Together our team brings a level of passion knowledge and commitment to our projects and clients. We foster a culture of excellence specializing in in vitro Diagnostic clinical project management and regulatory support.
At Beaufort you will be part of industry leading expertise with a shared sense of purpose and unwavering accountability to help clients achieve successful market authorization.
Beaufort is an equal opportunity employer and values diversity.
Clinical Transformation Project Manager
Clinical Research Coordinator Job 15 miles from Suffolk
The Clinical Transformation Project Manager is responsible for managing and supporting the implementation of clinical transformation initiatives within EVMS Medical Group. As part of the transformation team, this role, reporting to the Executive Director, will focus on optimizing clinical workflows through the Epic electronic record system, enhancing patient care delivery, increasing operational efficiencies and fostering a culture of continuous improvement. The Clinical Transformation Project Manager in tandem with the transformation team will work closely with the clinical practices and department leadership to ensure the successful execution of clinical transformation initiatives, driving quality, efficiency, and the optimal patient experience. This role requires a blend of clinical and operational expertise, change management insight and strategic thinking.
Responsibilities
Strategic Oversight:
* Manager the implementation of healthcare transformation strategics across EVMS Medical Group.
* Partner with department leadership, providers and interdisciplinary teams to define transformation goals and develop action plans.
* Ensure alignment of transformation efforts with the organization's overall strategic objectives, mission and vision.
* Develop and maintain strong relationships with key stakeholders, including operational and clinical staff, management and external partners to facilitate successful transformation.
Project Management & Process Improvement:
* Oversee and manage transformation projects, ensuring timely execution, effective resource utilization and budget adherence.
* Identify areas for process improvement within workflows, patient care delivery and practice operations.
* Mentor, support, and develop nursing and clinical staff in adopting new practices, technologies, and workflows.
* Foster a culture of patient-centered care, collaboration, and excellence.
* Utilize process improvement methodologies (e.g., Lean, Six Sigma, or similar) to reduce inefficiencies, improve quality, and optimize practice performance.
* Monitor performance metrics to evaluate the success of transformation initiatives
Healthcare Transformation Initiatives:
* Lead the planning and execution of clinical transformation initiatives optimizing the patient experience, improving clinical workflows, patient access and increasing operational efficiencies.
* Partner with department leadership and staff to identify areas of improvement and implement innovative solutions aligning with EVMS Medical Group's transformation initiatives
Training & Education:
* Provide leadership and support for training programs designed to educate staff on transformation initiatives to include new technologies, and workflow changes.
Collaboration & Communication:
* Collaborate with physicians, nurses, front office, business and administrative staff, and other healthcare professionals to foster a culture of transformation and improvement.
* Lead cross-functional teams to address challenges and implement solutions to improve care delivery and operational performance.
* Lead meetings, presentations, and training sessions to communicate changes, progress, and results to internal and external stakeholders.
* Address resistance to change by using effective communication strategies, engaging stakeholders, and providing necessary support throughout the transformation process.
Qualifications
* Registered Nurse (RN), Nurse Practitioner or Physician Assistant with active Virginia licensure.
* Experience working with the Epic electronic health record system to include hands-on involvement in system optimization, a strong understanding of Epic's clinical modules, scheduling templates, workflow and design are required.
* Certification in healthcare transformation, quality improvement, or change management (e.g., Lean, Six Sigma, or similar) highly desirable.
* At least 5 years of clinical experience. Knowledge of Lean, Six Sigma or similar quality improvement frameworks to drive transformation preferred.
* Demonstrated experience in clinical process redesign, managing or leading cross-functional teams and complex projects, prioritize tasks and meet deadlines.
* Familiarity with healthcare IT systems, electronic health records and other technologies used to facilitate transformation.
* Ability to inspire, motivate and manage teams in a fast paced and every-changing environment.
* Strong verbal and written communication skills to interact with stakeholders (clinical and nonclinical staff, department leadership)
* Ability to think critically, analyze complex problems and implement effective solutions
Location : Location
US-VA-Norfolk
Clinical Coordinator/Skill Builder Supervisor-Must have LPC, LCSW, Resident in Counseling, Supervisee in Social work
Clinical Research Coordinator Job 15 miles from Suffolk
Full-time Description
The Hope Unity and Freedom Center is a diverse team of professionals providing psychosocial day support to male and female adults with a primary mental health diagnosis, dual diagnosis, and/or a coexisting disorder. Our work helps to decrease psychiatric hospitalization and provide stabilization for individuals with less intervention in the community. By providing daily routine and structure in a safe environment, everyone is able to achieve their best and improve their quality of life.
Position Summary
As a Clinical Coordinator with the Hope, Unity, and Freedom (H.U.F.) Center, you are provided the opportunity to make a difference in the daily functioning of adults in need. Clinical Coordinators assist in the admission process for each of our members, interviewing, assessing, and creating Individualized Services Plans for each member that seeks the services of the HUF Center. Clinical Coordinators are the ultimate resource to make sure all documentation is completed and inputted appropriately and are part of the clinical supervision team for all our Case Managers at each site. Our Clinical Coordinators use their skillsets and clinical expertise to improve the lives of those we serve while assisting in the professional growth of our Case Managers.
Position Responsibilities:
Must be able to travel to Colonial Heights, Newport News, Norfolk and Richmond.
Complete initial and annual comprehensive needs assessments for referred individuals.
Complete all Continued Stay Authorization paperwork for assigned caseload using sound clinical documentation and abiding by all agency, Medicaid, and managed care organization standards.
Develop clinically sound individualized person-centered service plans and monitor that the service plan is being implemented. Assist in making revisions/updates to service plan(s) as clinically necessary.
Manage and respond to pending denials received, contacting respective MCO or agency responsible for authorizations, to discuss issues as they arise.
Identify clinical areas that require strengthening and seek out opportunities to attend training in such areas.
Provide training to agency staff to include new employee orientation and other specialized training.
Promote the program in a positive manner to elicit referrals and maintain the census and growth of the program.
Attend all annual mandatory agency training (Handle with Care, CPR & First Aid, Human Rights, HIPAA, etc.).
Perform all duties of case manager, including providing direct services, as needed.
During the COVID-19 pandemic, it is required that all employees wear pre-approved masks as designated by the CDC guidelines, including surgical masks, KN95 masks, or N95 masks.
Other duties and responsibilities as assigned.
Will travel between two locations Norfolk and Newport News
Benefits and Perks
Heath, Vision and Dental Benefits, Life Insurance, Paid Time Off, 401K, Pet Insurance, Training Reimbursement, and more!
FLSA status: Exempt
Reports to: Director of Clinical Services
Supervises: Staff and volunteers seeking licensure or certification
Requirements
Role Qualifications:
Graduated with a master's degree from an accredited college or university with a focus on Social Work or a related field.
Must currently possess a state-approved license (LMHP)- or can be license eligible.
Must be able to complete and pass: a CPR/First Aid certification; Handle with Care physical and/or verbal intervention training; annual tuberculosis (TB) screening test; and clear criminal background and central registry check.
Must have a valid Virginia Driver's License.
Strong and assertive personality.
Excellent verbal and written communication.
Supervisory experience would be preferred.
Clinical Faculty Coordinator - ABSN Education
Clinical Research Coordinator Job 15 miles from Suffolk
If you're looking for an opportunity to expand your nursing education skills, talk to us about the Clinical Faculty Coordinator (CFC) role. You will have the opportunity to coach, orient and mentor adjunct clinical instructors. The CFC will build her/his network by forging and maintaining relationships with the University's clinical partners in Greater Norfolk. In this position you will stay connected to the clinical environment while supporting an academic program. Help us support the next generation of nurses in your community!
Who is Orbis Education? Orbis partners with colleges and universities to expand their pre-licensure healthcare programs. Our partners leverage our expertise to produce thousands of high-quality graduates ready to enter the workforce and meet employers' demands.
Academic Partner: Averett University Accelerated BSN program
Site address: 6320 North Center Drive, Norfolk VA
Schedule: Mon-Fri, full time days with time spent at the ABSN site and visiting clinical partners in the Norfolk area
Benefits: Full benefit portfolio including tuition package
Sign On Bonus: $5,000 eligibility
What You Will Do:
* Work alongside the Director to identify, select, monitor, and evaluate all clinical adjunct faculty and clinical sites
* Work in conjunction with course faculty to establish alignment of clinical experiences with course and program outcomes/goals
* Serve as the first point-of-contact for resolution of clinical personnel issues that may arise between staff at the clinical site and clinical faculty and students
* Coordinate orientation and training for clinical faculty regarding their clinical site and related nursing coursework
* Act as a mentor to assist new adjunct faculty in clinical related teaching activities
* Verify student and faculty clinical compliance
* Monitor clinical attendance and manage clinical makeups
* May have teaching responsibilities in lab or clinical course
What You Will Have:
* Master of Science in Nursing
* Unencumbered VA RN License
* Two years combined teaching experience as a preceptor, adjunct clinical instructor, or classroom/lab
* Able to meet challenges of adult learners with diverse backgrounds; Self-directed and innovative; Excellent oral and written communication skills
* Able to build strong working relationships, communicate on a variety of educational levels and work effectively in a team
What we'll offer in return:
* A career where your work genuinely makes a difference
* A stable income with a good salary
* Extensive training with team and management support
* Structured professional development plans and opportunities
* Outstanding benefits and work perks
* Collaborative and supportive team environment...and more!
Clinical Faculty Coordinator - ABSN Education
Clinical Research Coordinator Job 15 miles from Suffolk
If you're looking for an opportunity to expand your nursing education skills, talk to us about the Clinical Faculty Coordinator (CFC) role. You will have the opportunity to coach, orient and mentor adjunct clinical instructors. The CFC will build her/his network by forging and maintaining relationships with the University's clinical partners in Greater Norfolk. In this position you will stay connected to the clinical environment while supporting an academic program. Help us support the next generation of nurses in your community!
Who is Orbis Education? Orbis partners with colleges and universities to expand their pre-licensure healthcare programs. Our partners leverage our expertise to produce thousands of high-quality graduates ready to enter the workforce and meet employers' demands.
Academic Partner: Averett University Accelerated BSN program
Site address: 6320 North Center Drive, Norfolk VA
Schedule: Mon-Fri, full time days with time spent at the ABSN site and visiting clinical partners in the Norfolk area
Benefits: Full benefit portfolio including tuition package
Sign On Bonus: $5,000 eligibility
What You Will Do:
Work alongside the Director to identify, select, monitor, and evaluate all clinical adjunct faculty and clinical sites
Work in conjunction with course faculty to establish alignment of clinical experiences with course and program outcomes/goals
Serve as the first point-of-contact for resolution of clinical personnel issues that may arise between staff at the clinical site and clinical faculty and students
Coordinate orientation and training for clinical faculty regarding their clinical site and related nursing coursework
Act as a mentor to assist new adjunct faculty in clinical related teaching activities
Verify student and faculty clinical compliance
Monitor clinical attendance and manage clinical makeups
May have teaching responsibilities in lab or clinical course
What You Will Have:
Master of Science in Nursing
Unencumbered VA RN License
Two years combined teaching experience as a preceptor, adjunct clinical instructor, or classroom/lab
Able to meet challenges of adult learners with diverse backgrounds; Self-directed and innovative; Excellent oral and written communication skills
Able to build strong working relationships, communicate on a variety of educational levels and work effectively in a team
What we'll offer in return:
A career where your work genuinely makes a difference
A stable income with a good salary
Extensive training with team and management support
Structured professional development plans and opportunities
Outstanding benefits and work perks
Collaborative and supportive team environment...and more!
EMS Clinical Coordinator
Clinical Research Coordinator Job 15 miles from Suffolk
is based at our Newport News, VA campus location. Transform your Career at ECPI University Since 1966, ECPI University's employees have been dedicated to helping students achieve their academic and career goals through our unique education model. Our culture is to prioritize our students' success through the support of our dynamic team and industry focused curriculum.
ECPI University provides a stable work environment, with professional growth opportunities, and competitive benefits. If you are interested in joining us in making a difference in students' lives, we would love to hear from you to discuss the opportunity.
The Clinical Coordinator is responsible for the management and coordination of the clinical education component of the Emergency Medical Services (EMS) Program of ECPI University.
Responsibilities
Clinical Responsibilities:
* Ensures all students are in compliance with clinical site requirements prior to scheduling clinical shifts
* Coordinates and schedules clinical site orientation sessions for students with each clinical agency
* Coordinates and maintains clinical schedules with clinical and field internship sites.
* Conducts site visits at clinical agencies and facilities to observe students during clinical shifts and field internship.
* Provides program orientation and training to clinical and field preceptors.
* Maintains regular contact with clinical preceptors, clinical sites and EMS agencies.
* Assists the EMS Program Director with the evaluation of the program clinical sites.
* Assists clinical preceptors by providing evaluation devices of student learning and clinical experience to measure progress and competency.
* Functions as a liaison between the EMS program and the clinical sites.
* Monitors student clinical progress and clinical competency based on program objectives.
* Audits all clinical documentation to ensure students are maintaining satisfactory progress in achieving clinical requirements.
* Maintains all clinical documentation as required by CoAEMSP standards and OEMS regulations
* Assists the EMS Program Director with seeking new clinical agencies/facilities as needed to provide quality experiences for EMS students and to support program growth.
* Maintains professional qualifications through participation in continuing education programs and academic courses.
Teaching Responsibilities:
* The Emergency Medical Services (EMS) Program Clinical Coordinator is responsible for providing didactic and lab content, evaluating students, reporting progress, and for the periodic review and updating of course material. Faculty must be familiar with program goals, able to demonstrate the ability to follow an organized plan of instruction and have appropriate credentials for the learning areas they teach. In each location where students are assigned for didactic or supervised practice, there must be instructional faculty designated to provide frequent assessments of the students' progress in achieving program requirements. Performs duties assigned under the direction and delegation of the Paramedic Program Director.
Educational Delivery Content:
* Provides instruction including lectures, lab, simulation sessions, testing, attendance, and - communication with students, classroom and clinical safety, security, and discipline.
* Maintains and updates course syllabi.
* Assists in the development of new curricula.
* Prepares and utilizes approved lesson plans.
* Provides for the care of supplies and equipment.
* Ensures equipment is maintained in optimal condition for instruction.
* Implements evaluation devices of student learning and lab experience to measure progress and competency.
* Evaluates student competence based on program objectives.
* Prepares student progress and grade reports.
* Maintains accurate attendance records.
* Attends regularly scheduled faculty meetings.
* Assesses student progress in achieving theory (cognitive content) performance (psychomotor competencies) and professional behavior (affective) requirements of the program.
* Recommends revisions and updates for the University Catalog.
* Demonstrates evidence-based teaching.
* Maintains current standards of practice in all courses taught.
* Provides evaluation and feedback to the program on course materials, current changes in practice, standards of practice, and student accomplishment of course and program outcomes.
* Responsible to follow the educational objectives and schedule that meets the requirements set forth by the certifying agency.
* Maintains a student to instructor ratio of no more than 6 students per instructor for skills training and testing.
* Maintains security of examinations, OEMS assigned course numbers and other sensitive information.
Student:
* Participates in academic advisement of students.
* Prepares student progress reports and enters grades
* Participates in graduation and program ceremonies.
* Approaches teaching and learning from a coaching-mentoring paradigm where non-punitive feedback is encouraged.
Education/Licensure:
* AAS degree in Emergency Medical Services or related healthcare field required; BS degree preferred (Lead Instructors - Bachelors degree required).
* Current, unrestricted Paramedic license required.
Experience:
* A minimum of 5 years experience as a National Registered Paramedic.
* 3-5 years progressive field experience in the emergency setting
* Prior clinical supervisory experience preferred.
* Two years teaching experience
* Appropriate program instructor credentials
Skills & Abilities:
* Ability to create and maintain relationships
* Motivated, self-starter
* Excellent verbal and written communication skills
* Ability to organize and prioritize work flow
* Ability to meet deadlines
* Ability to work independently
Benefits of Employment
ECPI University provides a comprehensive benefits program designed to help our faculty and staff stay healthy, feel supported, and maintain a work/life balance. To learn more about benefits at ECPI University, click HERE.
Committed to excellence and innovation, ECPI University is proud to be an equal opportunity employer.
Clinical Research Coordinator
Clinical Research Coordinator Job 15 miles from Suffolk
Odyssey is seeking a Clinical Research Coordinator to support the Clinical Investigation Department (CID) at the Navy Medical Center, Portsmouth (NMCP) Virginia. The mission of the command is to support the national interests of the United States by providing professional education and development, providing quality patient care, being responsive and ready for deployment, and taking care of each other as shipmates. NMCP conducts biomedical research in general surgery, psychology, otolaryngology, pediatrics, nursing research, orthopedics, women's health, and emergency medicine, which are relevant to the Graduate Medical Education Program.se include a for all positions
Responsibilities
Duties include, but not limited to:
Provide research support for IRB and IACUC approved research protocols.
Support the Department Head of the CID, Directorate for Professional Education, NMCP.
Support the Department Head of CID and is accountable for research matters to the PIs of each research protocol in accordance with federal and local regulatory guidelines.
Use programs such as Word, Excel, etc., as well as clinical computer systems including Composite Health Care System (CHCS-I) and Armed Forces Health Longitudinal Technology Application (AHLTA).
For consultation, reporting, exchange of information, orientation support for the performance of duties, and to guide patients through a research protocol, will maintain and document contact with study subjects and research personnel from government agencies, granting agencies, industry sponsors.
Provide IRB/HRPP support to the PI in the development and implementation of recruitment strategies in accordance with IRB/HRPP requirements and approvals.
Screen recruited research subjects using protocol inclusion/exclusion criteria.
Refer eligible patients to the PI for final evaluation, enrollment, and randomization per protocol design after the informed consent process has taken place effectively, all subject questions are answered satisfactorily, and the process is documented.
Assist the research pharmacist with correct receipt, dispensation and accountability/documentation of investigational drugs per the sponsor protocol on Investigational Drug/Device Accountability.
Provide subjects with education on compliance, possible side effects, drug interactions and the importance of contacting the coordinator and study team members as applicable.
Assist with maintaining adequate inventory of study supplies, including drugs, and devices, and preparation of other study materials. These study materials include the informed consent document, case report forms (CRFs)/data collection forms (DCFs), enrollment logs, concomitant medication/adverse events logs and drug/device accountability logs.
Assist the PI by providing materials and tools necessary for the development of appropriate training of individuals involved in the execution of a study related to protocol requirements, schedule of visits, execution of research plan, and maintain documentation of training.
In collaboration with the PI, check on the performance of phlebotomies, electrocardiograms, vital signs, specimen collection and shipment, and other procedures as required by the protocol.
Observe universal precautions and OSHA standards when processing or handling specimens.
Obtain laboratory results and consult with the PI for follow-up care as per protocol.
Collect data in a timely and accurate manner and submit information to coordinating centers.
Report and document adverse events and unanticipated problems to governing agencies and sponsors as required by protocol and regulations.
Review compliance of research subject and complete documentation of status and progress. Respond to Assurance Specialist discrepancy/findings and, after consultation with PI, communicate approved recommendations.
Conduct telephone, face-to-face interviews or mail information for follow-up visits as per protocol. Maintain detailed documentation of the research study including subject study charts and databases as required by the protocol, and the Investigator's File Binder or Regulatory Binder.
Prepare reports and other correspondence regarding the research protocol for the IRB, granting agencies, industry sponsors and other organizations as required by regulation and/or the protocol.
Interact on a regular basis with the PI and study team members regarding the conduct of the research study.
Attend conferences and other meetings as required by the protocol.
Return telephone calls from research participants within 48 hours and document interactions appropriately.
Work is performed in ambulatory care spaces and inpatient wards with some risk of exposure to infectious disease, for which gloves, masks, or gowns provided by the government entity may be required for safety reasons.
Maintain patient confidentiality in accordance with HIPAA and institutional regulations. Actively participate in CID departmental and command-wide research educational and training programs by providing instruction and presentation materials to assist research staff, as needed.
Actively participate in assurance assist visits and regulatory audits for protocol compliance.
Assist PI, research team members, and other staff in the preparation of and closeout of clinical research studies.
Collaborate with PI, study personnel and CID grants writer to source research funding for future protocols.
Qualifications
Minimum Required Qualifications:
Citizenship: Must be a US citizen
Clearance: Ability to obtain a Secret Clearance
Education: Bachelor's Degree from an accredited college or university
Certifications:
Certified Clinical Trial Investigator (CCTI)
Certified Clinical Research Coordinator (CCRC)
Certified Clinical Research Professional (CCRP) from the Association of Clinical Research Professionals (ACRP) or the Society of Clinical Research Associates (SoCRA).
Years' experience:
A minimum of two (2) years as a Clinical Research Coordinator within the past five years OR Current certification as a Certified Clinical Trial Investigator (CCTI), Certified Clinical Research Coordinator (CCRC), Certified Clinical Research Professional (CCRP) from the Association of Clinical Research Professionals (ACRP) or the Society of Clinical Research Associates (SoCRA).
Minimum of two (2) to four (4) years of monitoring experience in a clinical research environment and administrative Institutional Review Board (IRB) experience.
Possess knowledge of medical terminology and clinical monitoring process and in depth therapeutic and protocol knowledge.
Ability to communicate effectively, both orally and in writing.
Possess effective organizational and analytical skills with ability to work independently and in a team environment.
Proficiency with Windows base computer systems, including Microsoft Windows and Microsoft Office Suites program.
Must possess the ability to complete research subject protection training developed by the Collaborative Institutional Training Initiative (CITTI), and additional protocol specific training, as required, within one month from start date
Preferred Qualifications:
Clearance: (ability to obtain) Secret Clearance
Additional Information:
Location: Navy Medical Center, Portsmouth (NMCP) Virginia
On-site (local candidates only)
#LI-JC1
Company Overview
Odyssey Systems Consulting Group, is an innovative small business committed to providing world-class technical, management, and training support services to government and public sector clients. We focus on people, processes, and performance to deliver superior results. Since our inception in 1997, our commitment to mission success and customer satisfaction has been recognized with exponential growth and exceptional past performance ratings. We accept challenging assignments and drive projects from the planning stages, through implementation, and into operations and support.
Please note: Final compensation for this position will be determined by various factors such as the Federal Government contract labor categories and contract wage rates, relevant work experience, specific skills and competencies, geographic location, education, and certifications.
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
Clinical Research Coordinator
Clinical Research Coordinator Job 15 miles from Suffolk
Virginia Oncology Associates, the largest group of medical professionals in Hampton Roads and Northeast North Carolina devoted exclusively to cancer care and blood disorders, has an exciting opportunity for a Clinical Research Coordinator or Clinical Research RN to support our office in Newport News.
* Please take this quick survey once you've submitted your resume to complete the application process: Clinical Research PI Link
If you have completed the survey before, even for another position, please do not take it again.
Responsibilities
* Present trial concepts, objectives and treatment details to potential patients for various cellular therapy trials, while conducting detailed assessment and screening to determine their eligibility.
* Participating in the informed consent process and enrolling patients on protocol
* 80% of the job will be computer based, and direct patient care is limited in a non-RN Clinical Research Coordinator role
* Collects and maintains regulatory documents in accordance with USOR SOP and applicable regulations. Participates in scheduling monitoring and auditing visits, as well as interacting with the monitors/auditors while onsite.
* Coordinating patient care in compliance with protocol requirements
* Collaborating with the physician to review patients for changes in condition, adverse events, concomitant medication use, protocol compliance, response to drug study and thoroughly documenting all findings
* Working directly with other research bases and/or sponsors
* Overseeing the preparation of orders by physicians to assure that protocol compliance is maintained
* Communicating with physicians regarding study requirements, need for dose modification and adverse event reporting
Qualifications
* Associates degree in a clinical or scientific related discipline required
* Experience in clinical research preferred
* Experience with computer data entry and database management
* Excellent written and oral communication skills
* Ability to read, analyze, and interpret technical procedures such as protocols, informed consent, and regulatory documents
Additional Qualifications for Nurse Candidates:
* Graduate from an accredited program for nursing education (BSN preferred) preferred
* Minimum of one (1) year nursing experience preferably in oncology
* Current licensure as an RN in Virginia preferred
* Current BCLS or ACLS certification required
* OCN, SoCRA, or ACRP certification preferred
WORK ENVIRONMENT:
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Exposure to communicable diseases, toxic substances, ionizing radiation, medical preparations and other conditions common to an oncology/hematology clinic environment. While performing the duties of this job, the employee is regularly exposed to direct contact with patients with potential for exposure to toxic substances, medicinal preparations, and chemotherapeutic agents.
PHYSICAL DEMANDS:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Requires full range of body motion including handling and lifting patients, manual and finger dexterity, and eye-hand coordination. Requires standing and walking for extensive periods of time. Occasionally lifts and carries items weighing up to 40 lbs. Requires corrected vision and hearing to normal range.
Clinical Research Coordinator - RN
Clinical Research Coordinator Job 15 miles from Suffolk
Full-Time 850 Southampton Ave Professional Days 29.9500 Through 44.9300 * Under the supervision of the department manager and responsible research investigator(s), this position is responsible for the administration, coordination, database management and reporting requirements for designated approved clinical research. Reports to department leadership.
* ESSENTIAL DUTIES AND RESPONSIBILITIES
* Assures and maintains professional standards for clinical practices in conducting clinical investigations.
* Possesses and maintains an in-depth knowledge of federal regulations and guidance documents required for clinical trials and human subject protection, assuring compliance with protocol and regulatory requirements, and by collecting, recording and maintaining data and source documents.
* Performs other duties as assigned.
* LICENSES AND/OR CERTIFICATIONS
* Current RN license required or other licensed medical provider working under MD supervision.
* MINIMUM EDUCATION AND EXPERIENCE REQUIREMENTS
* Bachelor's degree required.
* Knowledge of clinical research processes, procedures and regulations acquired through progressive experience in supporting or performing clinical research.
* 3-5 years clinical research experience preferred.
* IRB familiarity preferred.
* Must possess effective computer skills to include familiarity with Microsoft Excel, Access, and other standard software.
* Ability to analyze and problem solve independently.
* Exceptional interpersonal skills that display effective and professional customer service skills and interactions.
* Ability to travel to various locations as required for performance of job role.
* WORKING CONDITIONS
* Frequent exposure to communicable diseases, toxic substances, hazardous materials, radiation, radio nucleotides, medicinal preparations, body fluids and other conditions common to the healthcare environment.
* PHYSICAL REQUIREMENTS
* Click here to view physical requirements.
Clinical Transformation Project Manager
Clinical Research Coordinator Job 15 miles from Suffolk
The Clinical Transformation Project Manager is responsible for managing and supporting the implementation of clinical transformation initiatives within EVMS Medical Group. As part of the transformation team, this role, reporting to the Executive Director, will focus on optimizing clinical workflows through the Epic electronic record system, enhancing patient care delivery, increasing operational efficiencies and fostering a culture of continuous improvement. The Clinical Transformation Project Manager in tandem with the transformation team will work closely with the clinical practices and department leadership to ensure the successful execution of clinical transformation initiatives, driving quality, efficiency, and the optimal patient experience. This role requires a blend of clinical and operational expertise, change management insight and strategic thinking.
Responsibilities
Strategic Oversight:
Manager the implementation of healthcare transformation strategics across EVMS Medical Group.
Partner with department leadership, providers and interdisciplinary teams to define transformation goals and develop action plans.
Ensure alignment of transformation efforts with the organization's overall strategic objectives, mission and vision.
Develop and maintain strong relationships with key stakeholders, including operational and clinical staff, management and external partners to facilitate successful transformation.
Project Management & Process Improvement:
Oversee and manage transformation projects, ensuring timely execution, effective resource utilization and budget adherence.
Identify areas for process improvement within workflows, patient care delivery and practice operations.
Mentor, support, and develop nursing and clinical staff in adopting new practices, technologies, and workflows.
Foster a culture of patient-centered care, collaboration, and excellence.
Utilize process improvement methodologies (e.g., Lean, Six Sigma, or similar) to reduce inefficiencies, improve quality, and optimize practice performance.
Monitor performance metrics to evaluate the success of transformation initiatives
Healthcare Transformation Initiatives:
Lead the planning and execution of clinical transformation initiatives optimizing the patient experience, improving clinical workflows, patient access and increasing operational efficiencies.
Partner with department leadership and staff to identify areas of improvement and implement innovative solutions aligning with EVMS Medical Group's transformation initiatives
Training & Education:
Provide leadership and support for training programs designed to educate staff on transformation initiatives to include new technologies, and workflow changes.
Collaboration & Communication:
Collaborate with physicians, nurses, front office, business and administrative staff, and other healthcare professionals to foster a culture of transformation and improvement.
Lead cross-functional teams to address challenges and implement solutions to improve care delivery and operational performance.
Lead meetings, presentations, and training sessions to communicate changes, progress, and results to internal and external stakeholders.
Address resistance to change by using effective communication strategies, engaging stakeholders, and providing necessary support throughout the transformation process.
Qualifications
Registered Nurse (RN), Nurse Practitioner or Physician Assistant with active Virginia licensure.
Experience working with the Epic electronic health record system to include hands-on involvement in system optimization, a strong understanding of Epic's clinical modules, scheduling templates, workflow and design are required.
Certification in healthcare transformation, quality improvement, or change management (e.g., Lean, Six Sigma, or similar) highly desirable.
At least 5 years of clinical experience. Knowledge of Lean, Six Sigma or similar quality improvement frameworks to drive transformation preferred.
Demonstrated experience in clinical process redesign, managing or leading cross-functional teams and complex projects, prioritize tasks and meet deadlines.
Familiarity with healthcare IT systems, electronic health records and other technologies used to facilitate transformation.
Ability to inspire, motivate and manage teams in a fast paced and every-changing environment.
Strong verbal and written communication skills to interact with stakeholders (clinical and nonclinical staff, department leadership)
Ability to think critically, analyze complex problems and implement effective solutions
Location : Location US-VA-Norfolk
Clinical Project Manager
Clinical Research Coordinator Job 31 miles from Suffolk
Clinical Project Manager-CPM (IVD)
Are you ready to put your in vitro diagnostic clinical trial leadership skills to work? Would you like to work with other industry leaders in an organization that partners with innovators in healthcare? Are you ready to work for a company that focuses on life-changing diagnostics? Read on if this describes you.
Beaufort seeks a skilled Clinical Project Manager to work alongside a top-notch team of clinical researchers. We participate in an exciting and growing industry and that growth fuels the need to continue to build our team. Our managers support the team while remaining, flexible and adaptable which continues to be a key to supporting our mission.
You might be wondering what a day in the life of a Clinical Project Manager at Beaufort looks like. This critical role can be counted on to:
Direct and coordinate the staff and activities to ensure goals and objectives are accomplished within projected timeframes and budget requirements
Review status reports and modify project schedules and/or plans as required
Prepare and present project reports for management, clients, or others
Act as the main point of contact/liaison between the Sponsor/Client and Beaufort
Conduct clinical protocol training and Standard Operating Procedure (SOP) training
Participate in business development activities such as assisting with the clinical aspects of RPFs and participating on scoping calls, as needed.
Act as the main point of contact for any study issues that arise and site escalation; may perform co-monitoring/monitoring visits as needed (e.g. Quality assurance, SWAT, interim monitoring visits, etc.)
Support team members to improve their efficiency and effectiveness at prioritizing work and improving performance
As you can see, there is a great amount of depth and breadth in this role. Because of this, we ask that you bring with you the education and/or experience that sets you up for success in this position. This generally looks like:
Bachelor's Degree required. (In science related field)
Minimum of three (3) years of project management experience
Minimum of two (2) years of experience in in-vitro diagnostic trials
Field monitoring and/or in-house Clinical Research Associate (CRA) experience required
Must have excellent analytical skills as well as the ability to communicate effectively with all levels of the company
Must be willing to travel to 25%. This includes travel to Beaufort offices in Virginia Beach, VA for trainings, meetings, etc.
Five or more years of professional experience monitoring multiple studies involving complex therapeutic areas simultaneously
CLS, MT (ASCP), CCRA, and or CCRP certifications preferred
While the above are just basic requirements, preferred qualifications include:
Prior experience as a project lead managing global in vitro diagnostics trials
A great collaborator with Senior Management
Documented experience with any of the applications listed
Beaufort provides a highly competitive compensation and benefits package. This position reports to the Senior Vice President, Global Clinical Operations.
Beaufort offers a different CRO experience. It's not just about what we do, it's how we do it. Together our team brings a level of passion knowledge and commitment to our projects and clients. We foster a culture of excellence specializing in in vitro diagnostic clinical project management and regulatory support.
At Beaufort you will be part of industry leading expertise with a shared sense of purpose and unwavering accountability to help clients achieve successful market authorization.
Beaufort is an equal opportunity employer and values diversity.
Clinical Coordinator
Clinical Research Coordinator Job 29 miles from Suffolk
500 Sentara CirSte 103, Williamsburg, Virginia, 23188-5727, United States of America DaVita is seeking a Clinical Coordinator who is looking to give life in an outpatient dialysis center. You can make an exceptional difference in the lives of our patients and their families dealing with end-stage renal failure or chronic kidney disease. Do you desire to deliver care in an empathetic, compassionate way - the way you'd want your own care to be?
If you haven't considered Nephrology before, read on as we think that you should.
DaVita - which is Italian for "giving life" - is working to provide quality service to patients, partners, and teammates. Our mission is to be the Provider, Partner, and Employer of Choice.
Some details about this position:
* At least 6 months dialysis experience is required.
* Coordinate ESRD patient care and services (trend lab values, track metrics on vital signs, weight, outcome management, etc.)• Ensure you and your clinical team are delivering the highest level of care to our patients by ensuring their safety, comfort, and well-being.
* Training may take place in a facility or a training clinic other than your assigned home clinic
* Potential to float to various clinics during and after your training
* You must have a flexible schedule and be able to work mornings, evenings, weekends, and holidays
What you can expect:
* Build meaningful and long term relationships with patients and their family in an intimate outpatient setting.
* Be a part of a team that supports and relies on each other in a positive environment. Staff RNs are a central part of a small interdisciplinary team of clinicians.
* Deliver care to patients who are often dealing with multiple co-morbidities which require unique treatment plans and the ability to leverage a broad range of nursing skills and knowledge.
* Oversee a group of patients with the support of PCTs to conduct patient observations, measuring stats and machine set up.
* You will work with your head, heart and hands each day in a fast paced environment.
What we'll provide:
DaVita Rewards package connects teammates to what matters most including:
* Comprehensive benefits: Medical, dental, vision, 401(k) match, paid time off, PTO cash out
* Support for you and your family: family resources, EAP counseling sessions, access Headspace, backup child and elder care, maternity/paternity leave, pet insurance, and more
* Paid training
Requirements:
* Current Registered Nurse (RN) license in the state of practice
* Current CPR certification required
* At least 18 months of registered nursing experience
* Dialysis Charge RN readiness approval by Clinical Nurse Manager or RN-licensed FA/GFA required
* Certified Nephrology Nurse (CNN) or Certified Dialysis Nurse (CDN) preferred
* Intensive Care Unit (ICU), Critical Care Unit (CCU), Emergency Room (ER), or Medical Surgical (Med Surg) experience is preferred
* Associates Degree in Nursing (A.D.N) from accredited school of nursing required; Bachelor of Science in Nursing (B.S.N) preferred; three-year diploma from accredited diploma program may be substituted for nursing degree
* Current CPR certification required
* Completed training approved by the medical director and the governing body as required by CMS guidelines prior to operating the water treatment system
* Supervisory experience preferred; willingness, desire, and ability to supervise required
* Basic computer skills and proficiency in MS Word and Outlook required
DaVita is a clinical leader! We have the highest percentage of facilities meeting or exceeding CMS's standards in the government's two key performance programs. We expect our nurses to commit to improving patient health through clinical goal setting and quality improvement initiatives.
Ready to make a difference in the lives of patients? Take the first step and apply now.
#LI-LV1
At DaVita, we strive to be a community first and a company second. We want all teammates to experience DaVita as "a place where I belong." Our goal is to embed belonging into everything we do in our Village, so that it becomes part of who we are. We are proud to be an equal opportunity workplace and an affirmative action employer. As such, individuals are recruited, hired, assigned and promoted without regard to race, national origin, religion, age, color, sex, sexual orientation, gender identity, disability, protected veteran status, or any other protected characteristic.
This position will be open for a minimum of three days.
Salary/ Wage Range
Compensation for the role will depend on a number of factors, including a candidate's qualifications, skills, competencies and experience and may fall outside of the range shown. DaVita offers a competitive total rewards package, which includes a 401k match, healthcare coverage and a broad range of other benefits. Learn more at ***********************************
Colorado Residents: Please do not respond to any questions in this initial application that may seek age-identifying information such as age, date of birth, or dates of school attendance or graduation. You may also redact this information from any materials you submit during the application process. You will not be penalized for redacting or removing this information.