Clinical Research Associate
Clinical Research Associate Job 18 miles from Bridgeport
The Clinical Research Associate will support clinical research activities within research sites that are actively participating in clinical trials. Under the direction of the Clinical Study Manager(s), the Clinical Research Associate (CRA) will assist with study and site start-up activities by working directly with assigned clinical sites and assist with overall study execution. The CRA may also assist with data management, vendor management and site monitoring as needed.
Duties and Responsibilities
Act as the primary point of contact with assigned clinical study sites during start-up activities;
Working with finance and legal experts, drive contract and budget negotiations (or amendments) with assigned sites;
Review site-level documents needed for IRB/EC/REC approval;
Support study initiation, monitoring, audit and close-out phases of assigned clinical trials as prescribed in the sponsor SOPs and study monitoring plan;
Ensure clinical study site documentation compliance according to GCPs, ICH and FDA regulations;
Provide relevant, timely study subject updates to the Clinical Study Manager(s) (e.g., upcoming treatment dates, subject withdrawals, etc.);
Facilitate timely and accurate communication flow between the clinical study sites, sponsor and applicable vendors;
Collaborate with clinical study site and sponsor to troubleshoot and provide appropriate solutions to study-related issues, as appropriate;
Assist in patient recruitment activities;
Assist with the development of study-related documents as requested;
Prepare accurate and timely study reports as requested;
Work independently and under general supervision.
Education
Bachelor's degree (or higher) in nursing, health sciences or related field;
Qualifications
Experience with clinical trial contract and budget negotiations
Finance experience preferred
Minimum of two years of CRA experience, with clinical site monitoring experience preferred;
Strong oral and written communication skills;
Good understanding of FDA regulations related to clinical trials; GCPs and ICH Guidance;
Proven organizational skills and the ability to manage multiple priorities;
Strong computer skills;
Ability to travel with adequate prior notification
Clinical Research Associate
Clinical Research Associate Job 18 miles from Bridgeport
Job Description
The Clinical Research Associate will support clinical research activities within research sites that are actively participating in clinical trials. Under the direction of the Clinical Study Manager(s), the Clinical Research Associate (CRA) will assist with study and site start-up activities by working directly with assigned clinical sites and assist with overall study execution. The CRA may also assist with data management, vendor management and site monitoring as needed.
Duties and Responsibilities
Act as the primary point of contact with assigned clinical study sites during start-up activities;
Working with finance and legal experts, drive contract and budget negotiations (or amendments) with assigned sites;
Review site-level documents needed for IRB/EC/REC approval;
Support study initiation, monitoring, audit and close-out phases of assigned clinical trials as prescribed in the sponsor SOPs and study monitoring plan;
Ensure clinical study site documentation compliance according to GCPs, ICH and FDA regulations;
Provide relevant, timely study subject updates to the Clinical Study Manager(s) (e.g., upcoming treatment dates, subject withdrawals, etc.);
Facilitate timely and accurate communication flow between the clinical study sites, sponsor and applicable vendors;
Collaborate with clinical study site and sponsor to troubleshoot and provide appropriate solutions to study-related issues, as appropriate;
Assist in patient recruitment activities;
Assist with the development of study-related documents as requested;
Prepare accurate and timely study reports as requested;
Work independently and under general supervision.
Education
Bachelor’s degree (or higher) in nursing, health sciences or related field;
Qualifications
Experience with clinical trial contract and budget negotiations
Finance experience preferred
Minimum of two years of CRA experience, with clinical site monitoring experience preferred;
Strong oral and written communication skills;
Good understanding of FDA regulations related to clinical trials; GCPs and ICH Guidance;
Proven organizational skills and the ability to manage multiple priorities;
Strong computer skills;
Ability to travel with adequate prior notification
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Clinical Research Associate
Clinical Research Associate Job 31 miles from Bridgeport
Responsible for pre-clinical trial set up, initial and ongoing regulatory submission and IRB activities, subject screening and enrollment, specimen collection and transmittal, data collection and management, adverse event management to ensure protocol compliance in conjunction with the PI, clinical team and clinical research nurses and team.
Responsibilities
Assist in new IRB application and annual renewal process of COG, sponsored, local and other multi-institutional protocols.
Screen and enroll patients onto clinical trials in collaboration with clinical team, ensure protocol compliance; coordination of specimen collection and transmittal in collaboration with clinical team.
Ensure compliance with the Good Clinical Practice guidelines in clinical research.
Monitor study patients for adverse events in collaboration with clinical team and report as required.
Enter data on Hematology, Oncology and Stem Cell Transplant patients on electronic data capture forms; prepare for routine data audits and maintain source documents and regulatory binders. Manage communications- mail, phone, fax, e-mail for COG, sponsored, local and multi-institutional studies. Act as liaison between NYMC and Westchester Medical Center, regarding new study requirements.
Qualifications
Education requirement: BS
Other skills/requirements: Must have a keen attention to detail, be able to multi-task and prioritize assignments.
Minimum Salary USD $48,000.00/Yr. Maximum Salary USD $60,000.00/Yr.
Clinical Research Associate
Clinical Research Associate Job 31 miles from Bridgeport
Responsible for pre-clinical trial set up, initial and ongoing regulatory submission and IRB activities, subject screening and enrollment, specimen collection and transmittal, data collection and management, adverse event management to ensure protocol compliance in conjunction with the PI, clinical team and clinical research nurses and team.
Responsibilities
Assist in new IRB application and annual renewal process of COG, sponsored, local and other multi-institutional protocols.
Screen and enroll patients onto clinical trials in collaboration with clinical team, ensure protocol compliance; coordination of specimen collection and transmittal in collaboration with clinical team.
Ensure compliance with the Good Clinical Practice guidelines in clinical research.
Monitor study patients for adverse events in collaboration with clinical team and report as required.
Enter data on Hematology, Oncology and Stem Cell Transplant patients on electronic data capture forms; prepare for routine data audits and maintain source documents and regulatory binders. Manage communications- mail, phone, fax, e-mail for COG, sponsored, local and multi-institutional studies. Act as liaison between NYMC and Westchester Medical Center, regarding new study requirements.
Qualifications
Education requirement: BS
Other skills/requirements: Must have a keen attention to detail, be able to multi-task and prioritize assignments.
Minimum Salary USD $48,000.00/Yr. Maximum Salary USD $60,000.00/Yr.
Clinical Study Coordinator - Cancer Clinical Trials
Clinical Research Associate Job 17 miles from Bridgeport
At Stony Brook Medicine, a Clinical Study Coordinator is a valuable member of our team, who provides administrative support and has the ability to interface with all levels of management throughout the hospital. Qualified candidates will demonstrate superior patient care and possess outstanding communication skills while adhering to our high standard of excellence.
Duties of a Clinical Study Coordinator may include the following but are not limited to:
Recruit and enroll research subjects and schedule patients. Attend Tumor Board conferences, participate in hospital rounds and staff meetings and review surgical and pathology reports of cancer patients for protocol candidates. Review present protocol patients on therapy to assure toxicity and response to treatment. Follow and maintain records on protocol patients for the duration of the study
Coordinate multiple Oncology Cancer Clinical Trials from inception to closure under the direction of Principal Investigator/Cancer Clinical Trials Administrative Director. Includes screening, eligibility, data collection, adverse event reporting, completion of CRF's and all regulatory requirements per protocol.
Plan and coordinate industry-sponsored, cooperative group and investigator initiated clinical research projects including meeting with industry representatives, contract coordination and budget negotiation. Acts as a resource between outside sponsors, industries and SUNY.
Draft informed consent forms, assent forms, and other documentation for submission to the IRB.
Patient/Staff Education - Educate patients and families as well as oncology staff on the research process and investigational cancer drugs.
All other duties as assigned.
Qualifications
Required Qualifications: Bachelor's degree. At least 3 years of experience working in a healthcare or medical type industry setting to include at least 1 year of human research experience. Excellent communication and organizational skills. Ability to work independently with minimal supervision. Knowledge of medical terminology. Proficiency with Microsoft Word, Excel, and PowerPoint.
Preferred Qualifications: Experience with coordinating multiple clinical trials, preferably in Oncology. Understanding of the IRB/regulatory process. IRB training experience.
Special Notes: Resume/CV should be included with the online application.
Posting Overview: This position will remain posted until filled or for a maximum of 90 days. An initial review of all applicants will occur two weeks from the posting date. Candidates are advised on the application that for full consideration, applications must be received before the initial review date (which is within two weeks of the posting date).
If within the initial review no candidate was selected to fill the position posted, additional applications will be considered for the posted position; however, the posting will close once a finalist is identified, and at minimal, two weeks after the initial posting date. Please note, that if no candidate were identified and hired within 90 days from initial posting, the posting would close for review, and possibly reposted at a later date.
______________________________________________________________________________________________________________________________________
Stony Brook Medicine is a smoke free environment. Smoking is strictly prohibited anywhere on campus, including parking lots and outdoor areas on the premises.
All Hospital positions maybe subject to changes in pass days and shifts as necessary.
This position may require the wearing of respiratory protection, which may prohibit the wearing of facial hair.
This function/position maybe designated as “essential.” This means that when the Hospital is faced with an institutional emergency, employees in such positions may be required to remain at their work location or to report to work to protect, recover, and continue operations at Stony Brook Medicine, Stony Brook University Hospital and related facilities.
Prior to start date, the selected candidate must meet the following requirements:
Successfully complete pre-employment physical examination and obtain medical clearance from Stony Brook Medicine's Employee Health Services*
Complete electronic reference check with a minimum of three (3) professional references.
Successfully complete a 4 panel drug screen*
Meet Regulatory Requirements for pre employment screenings.
Provide a copy of any required New York State license(s)/certificate(s).
Failure to comply with any of the above requirements could result in a delayed start date and/or revocation of the employment offer.
*The hiring department will be responsible for any fee incurred for examination.
_____________________________________________________________________________________________________________________________________
Stony Brook University is committed to excellence in diversity and the creation of an inclusive learning, and working environment. All qualified applicants will receive consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, familial status, sexual orientation, gender identity or expression, age, disability, genetic information, veteran status and all other protected classes under federal or state laws.
If you need a disability-related accommodation, please call the University Office of Equity and Access at *************.
In accordance with the Title II Crime Awareness and Security Act a copy of our crime statistics can be viewed here.
Visit our WHY WORK HERE page to learn about the total rewards we offer.
Stony Brook University Hospital, consistent with our shared core values and our intent to achieve excellence, remains dedicated to supporting healthier and more resilient communities, both locally and globally.
Anticipated Pay Range:
The salary range (or hiring range) for this position is $72,828 - $83,232 / year.
The above salary range represents SBUH's good faith and reasonable estimate of the range of possible compensation at the time of posting. The specific salary offer will be based on the candidate's validated years of comparable experience. Any efforts to inflate or misrepresent experience are grounds for disqualification from the application process or termination of employment if hired.
Some positions offer annual supplemental pay such as:
Location pay for UUP full-time positions ($3400)
Your total compensation goes beyond the number in your paycheck. SBUH provides generous leave, health plans, and a state pension that add to your bottom line. Job Number: 2501463Official Job Title: TH Instructional Support AssociateJob Field: Administrative & Professional (non-Clinical) Primary Location: US-NY-Stony BrookDepartment/Hiring Area: Cancer Clinical TrialsSchedule: Full-time Shift :Day Shift Shift Hours: 9:00 AM - 5:00 PM Pass Days: Sat, SunPosting Start Date: Apr 21, 2025Posting End Date: Jul 21, 2025, 3:59:00 AMSalary:$76,228 - $86,632 / TotalSalary Grade:SL2SBU Area:Stony Brook University Hospital
Clinical Study Coordinator - Cancer Clinical Trials
Clinical Research Associate Job 17 miles from Bridgeport
At Stony Brook Medicine, a Clinical Study Coordinator is a valuable member of our team, who provides administrative support and has the ability to interface with all levels of management throughout the hospital. Qualified candidates will demonstrate superior patient care and possess outstanding communication skills while adhering to our high standard of excellence.
Duties of a Clinical Study Coordinator may include the following but are not limited to:
Recruit and enroll research subjects and schedule patients. Attend Tumor Board conferences, participate in hospital rounds and staff meetings and review surgical and pathology reports of cancer patients for protocol candidates. Review present protocol patients on therapy to assure toxicity and response to treatment. Follow and maintain records on protocol patients for the duration of the study
Coordinate multiple Oncology Cancer Clinical Trials from inception to closure under the direction of Principal Investigator/Cancer Clinical Trials Administrative Director. Includes screening, eligibility, data collection, adverse event reporting, completion of CRF's and all regulatory requirements per protocol.
Plan and coordinate industry-sponsored, cooperative group and investigator initiated clinical research projects including meeting with industry representatives, contract coordination and budget negotiation. Acts as a resource between outside sponsors, industries and SUNY.
Draft informed consent forms, assent forms, and other documentation for submission to the IRB.
Patient/Staff Education - Educate patients and families as well as oncology staff on the research process and investigational cancer drugs.
All other duties as assigned.
Qualifications
Required Qualifications: Bachelor's degree. At least 3 years of experience working in a healthcare or medical type industry setting to include at least 1 year of human research experience. Excellent communication and organizational skills. Ability to work independently with minimal supervision. Knowledge of medical terminology. Proficiency with Microsoft Word, Excel, and PowerPoint.
Preferred Qualifications: Experience with coordinating multiple clinical trials, preferably in Oncology. Understanding of the IRB/regulatory process. IRB training experience.
Special Notes: Resume/CV should be included with the online application.
Posting Overview: This position will remain posted until filled or for a maximum of 90 days. An initial review of all applicants will occur two weeks from the posting date. Candidates are advised on the application that for full consideration, applications must be received before the initial review date (which is within two weeks of the posting date).
If within the initial review no candidate was selected to fill the position posted, additional applications will be considered for the posted position; however, the posting will close once a finalist is identified, and at minimal, two weeks after the initial posting date. Please note, that if no candidate were identified and hired within 90 days from initial posting, the posting would close for review, and possibly reposted at a later date.
______________________________________________________________________________________________________________________________________
Stony Brook Medicine is a smoke free environment. Smoking is strictly prohibited anywhere on campus, including parking lots and outdoor areas on the premises.
All Hospital positions maybe subject to changes in pass days and shifts as necessary.
This position may require the wearing of respiratory protection, which may prohibit the wearing of facial hair.
This function/position maybe designated as “essential.” This means that when the Hospital is faced with an institutional emergency, employees in such positions may be required to remain at their work location or to report to work to protect, recover, and continue operations at Stony Brook Medicine, Stony Brook University Hospital and related facilities.
Prior to start date, the selected candidate must meet the following requirements:
Successfully complete pre-employment physical examination and obtain medical clearance from Stony Brook Medicine's Employee Health Services*
Complete electronic reference check with a minimum of three (3) professional references.
Successfully complete a 4 panel drug screen*
Meet Regulatory Requirements for pre employment screenings.
Provide a copy of any required New York State license(s)/certificate(s).
Failure to comply with any of the above requirements could result in a delayed start date and/or revocation of the employment offer.
*The hiring department will be responsible for any fee incurred for examination.
_____________________________________________________________________________________________________________________________________
Stony Brook University is committed to excellence in diversity and the creation of an inclusive learning, and working environment. All qualified applicants will receive consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, familial status, sexual orientation, gender identity or expression, age, disability, genetic information, veteran status and all other protected classes under federal or state laws.
If you need a disability-related accommodation, please call the University Office of Equity and Access at *************.
In accordance with the Title II Crime Awareness and Security Act a copy of our crime statistics can be viewed here.
Visit our WHY WORK HERE page to learn about the total rewards we offer.
Stony Brook University Hospital, consistent with our shared core values and our intent to achieve excellence, remains dedicated to supporting healthier and more resilient communities, both locally and globally.
Anticipated Pay Range:
The salary range (or hiring range) for this position is $72,828 - $83,232 / year.
The above salary range represents SBUH's good faith and reasonable estimate of the range of possible compensation at the time of posting. The specific salary offer will be based on the candidate's validated years of comparable experience. Any efforts to inflate or misrepresent experience are grounds for disqualification from the application process or termination of employment if hired.
Some positions offer annual supplemental pay such as:
Location pay for UUP full-time positions ($3400)
Your total compensation goes beyond the number in your paycheck. SBUH provides generous leave, health plans, and a state pension that add to your bottom line. Job Number: 2501463Official Job Title: TH Instructional Support AssociateJob Field: Administrative & Professional (non-Clinical) Primary Location: US-NY-Stony BrookDepartment/Hiring Area: Cancer Clinical TrialsSchedule: Full-time Shift :Day Shift Shift Hours: 9:00 AM - 5:00 PM Pass Days: Sat, SunPosting Start Date: Apr 21, 2025Posting End Date: Jul 21, 2025, 3:59:00 AMSalary:$76,228 - $86,632 / TotalSalary Grade:SL2SBU Area:Stony Brook University Hospital
Principal Pharmacovigilance Safety Study Coordinator
Clinical Research Associate Job 18 miles from Bridgeport
Step into a key role at Boehringer Ingelheim as our next Principal Study Coordinator. Drive the integration of patient safety across clinical studies, streamline data processes, and enhance collaboration within our clinical and post-marketing teams. Utilize your technical skills to support and improve pharmacovigilance operations and cross functional processes. If you're passionate about advancing healthcare from within, we want you. Join us in shaping the future of patient care.
This position can be filled in different countries.
If you want to apply for the position in Germany, please use this link: coming soon
If you want to apply for the position in the US, click "Apply now".
**Duties & Responsibilities**
+ Leads cross functional working groups and discussions and steer development of user requirements for both BDS systems as well as PSPV systems.
+ Provides strategic input about processes, landscape of interfaces and common topics and issues and provides solutions that ensure efficient and effective processes as they pertain to safety topics in clinical studies.
+ Give input in other functions' SOPs and drive changes in the interfacing areas with regards to PV processes that affect them. Ensure consistency and process improvements (including system to system automations) with respect to data handling (including reconciliation and end of trial unblinding activities).
+ Leads discussions between PSPV, Clinical Operations, Biostatistics and Data Science (BDS) in the set up and maintenance of clinical studies and ensure patient safety aspects are included in the trial protocol and in the processes of these functions.
+ Communicates, collaborates and when required provides training as appropriate to internal and external (CRO) groups who collect and transfer adverse event information to PSPV. Interface with PSPV patient safety physicians in all those tasks.
+ Ensure safety management plan set up with suppliers and BDS.
+ As necessary program and implement tools, e.g. access databases and SAS programs to ensure efficient and effective processes in the Study Coordination team.
+ Performs tasks as they pertain to clinical trials that are part of other job profiles in Global case management. This can include medical review of clinical trial cases, quality checks of clinical trial cases or reconciliation.
**Requirements**
+ Bachelor's degree required, and in addition fulfill one of the following education levels:o Advanced degree (PharmD, NP, PA, Master's, M.D., DO, Ph.D.) o Combined BSc. with a MBA, or BSN with an MBAo Other medically qualified licensure (e.g., RPh, Respiratory Therapist)
+ Five (5) years or more experience in the pharmaceutical industry, preferably focused on pharmacovigilance and clinical research (i.e. medical documentation specialist, clinical research associate (CRA), study nurse, other health care specialist or other comparable medical background)
+ Proven proficiency in analytical software's and technology, such as SAS, R, or Python
+ Knowledge of international regulatory requirements within Pharmacovigilance and study activities
+ Ability to solve complex problems and take decisions independently.
+ Ability to prioritize workload and perform under stress in situations in which working speed and sustained attention are critical aspects of the job.
+ Application of medical knowledge to collect, interpret and reconcile medical information to precisely capture the adverse event as reported.
+ Must be able to communicate and resolve issues effectively with inter/intra departments through strong interpersonal skills.
**Compensation**
This position offers a base salary typically between $140,000 and $222,000. The position may be eligible for a role specific variable or performance based bonus and or other compensation elements. For an overview of our benefits please click here (***************************************************************** .
All qualified applicants will receive consideration for employment without regard to a person's actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.
Lead Clinical Research Coordinator
Clinical Research Associate Job 12 miles from Bridgeport
Job DescriptionBenefits:
401(k)
401(k) matching
Dental insurance
Health insurance
Opportunity for advancement
Paid time off
Profit sharing
Vision insurance
Ki Health Partners, LLC, dba New England Institute for Clinical Research, is proud to say our core research team has participated in more than one hundred studies. Over 90% of our research endeavors have resulted in the Food and Drug Administration (FDA) approval of new devices and oral and injectable medicines for the diagnosis and treatment of a wide array of diseases. While contributing to the development of safer, stronger, targeted therapies is our mission, we never lose sight of our core value: to provide holistic, patient-centered care in a warm, caring environment.
Our Clinical Research Institute in Stamford is looking for a motivated Lead Clinical Research Coordinator to help us conduct clinical trials in the Fairfield County area, primarily focusing on neurological diseases.
Candidates responsibilities would include, but are not limited to, the following:
Be detail-oriented and manage time effectively
Have outstanding interpersonal skills
Able to provide supervision and guidance to research staff.
Possesses strong written, organizational, and problem-solving skills.
Demonstrate strong follow-through skills and flexibility
Have experience in conducting research visits and performing study assessments, such as: conducting informed consent
processes, obtaining medical and medication history, vital signs, collecting/processing labs, performing ECGs, etc.
Have experience in using different clinical trial electronic data capturing systems (EDC), interactive web randomization systems
(IWRS), sponsor specific training platforms, and other electronic clinical research platforms.
Familiarity with the regulatory processes is preferred, but not required.
3+ years of experience in a research environment is required
Proficient communication and comprehension skills, both verbal and written in the English language, are required
Liaising with direct report, administrative staff, Investigators, research participants, and sponsor/CRO representatives.
Occasionally attending out-of-town Investigator Meetings
Bachelors degree required in the health/science field.
LPN, RN degrees are encouraged to apply, but not required.
Pre-Trial Specialist
Clinical Research Associate Job 34 miles from Bridgeport
JOB DESCRIPTION
Title: Pretrial Specialist
Reports To: Pretrial Supervisor
FLSA: Non-Exempt
Status: Full-time
Supervisory Responsibility: Not Applicable
Purpose of the Role:
Rapidly after release into the program, the Pretrial Specialist meets with new participants to review supervision conditions that will be required under the supervision plan. The Pretrial Specialist assists participants on their case load to comply with supervision appointments and court appearances during the pendency of their legal case, conducts ongoing service need assessments with participants and develops collaborative service plans ensuring participants receive services to achieve their self-identified needs and goals.
Essential Functions of the Role:
Provide supervision and community-based services to a caseload of pretrial participants
Rapidly (within 24-48 hours of release) conduct Supervision Introduction/Orientation meetings with new participants to review supervision conditions, the reporting schedule (as assigned by level of recidivism risk), and the mandatory methods of communication (face-to-face, telephone, and texts) that will be required under the participant's supervision plan.
Work collaboratively with the court and other pretrial staff team to facilitate and ensure caseload participants' successful completion of mandated supervision appointments and court appearances during the pendency of their legal case.
Review legal and court screening documentation and work with participants to analyze their offending behavior patterns, identifying behavioral changes, need for implementation of supports that may reduce likelihood of any pretrial arrests.
On an ongoing basis, conduct service need assessments with participants to examine psychosocial needs and problems, including the severity of mental and substance use disorders, problems affecting participation, engagement, and continuity in supervision and treatment and individual motivation for treatment.
Link participants to treatment based on their eligibility, preferences and needs and provide escort to community services.
Ensure the timely flow of community outreach and case management activities to meet program goals and objectives.
Utilize problem solving techniques, motivational interviewing as an integral part of the pretrial supervision and case management process approach, to help motivate and engage individuals in any needed process of change.
Provide all services in a manner that is gender-responsive, trauma-informed, and that adheres to the core principles of risk-need-responsivity.
Maintain collaborative relationships with community providers (supported housing providers, Health Homes, care management programs, addiction treatment and mental health providers, peer-run providers, education, vocational training and employment services providers, legal services providers, medical care providers, and family providers)
Follow program community-based monitoring protocols for high risk and high need program participants and request/participate in case reviews to addresses complex cases.
Enter assessment, supervision appointment reporting, progress note documentation into program database; conduct all electronic charting activities and reporting in accordance with confidentiality regulations and in a timely fashion.
Meet monthly case management contact and outreach goals as established by supervisory staff
Decision Making Authority:
Decisions regarding Pretrial Services are to be made with guidance and collaboration of the Director to whom the Pretrial staff is assigned. It is expected that the Pretrial Specialist will show an increasing ability to make decisions independently on routine matters as knowledge and experience progresses.
Working Relationships:
Internal: Pretrial Supervisor, Director of Criminal Justice
External: Dept. of Social Services, Mental Health Providers, Primary Care Physicians, Parole Officers, Legal Services, District Attorney's Office, Court Officials, Police Departments, etc.
Work Schedule: Monday - Friday, 9am - 5pm with some flexibility around client needs.
Physical Environment:
Traditional office environment.
Must be comfortable attending appointments at various courts, agencies, facilities and client's homes.
Physical Demands: Must be able to drive a motor vehicle and carry up to 20 lbs.
Mental and Visual Demands: Flow of work and nature of duties involve normal coordination of mind and eyes much of the time.
Must be able to interact with persons having mental health issues, periods of instability (i.e. lack of shelter, food, clothing or support), recently released from an institution (i.e. hospital, prison), limited comprehension and/or ability to manage through complex scenarios
Qualifications for this Role:
Bachelors Degree or equivalent experience
Minimum of four years of experience working in human services with individuals with substance use disorders, co-occurring mental health and substance use disorders and involvement in the criminal justice system.
Extensive knowledge of community treatment, support services and resources
Knowledge of the criminal justice system, court processes and alternative to detention/incarceration services
Valid Driver License required and a driving record that will permit the use of an Agency vehicle to transport clients to appointments or other activities as needed.
Bachelor's Degree required.
Associates accepted with experience.
Bilingual English/Spanish a plus.
Compensation Range: $45,000 - $48,000
Clinical Coordinator-Med Imaging
Clinical Research Associate Job 31 miles from Bridgeport
Clinical Coordinator Due to the complete nature of this baccalaureate degree program in radiologic technology, the role of the clinical coordinator is bipartite in nature. The clinical coordinator is responsible for a host of administrative duties in addition to the management and coordination of the clinical component of the curriculum.
The duties and responsibilities of the clinical coordinator/shall include, but not limited to:
1. Promotion and support of the goals and clinical objectives of the program through implementation of an adequate competency-based clinical evaluation system.
2. Coordination of the clinical education with didactic education offered by the program curriculum.
3. Evaluation and assurance of clinical education effectiveness through regular, scheduled visits to the clinical affiliate sites.
4. Appropriate and adequate clinical supervision of students.
5. Appropriate and adequate clinical instruction of students.
6. Completion of clinical competency evaluations for each student assigned to the clinical site.
7. Participation in continuing education to improve evaluation to improve evaluation skills and maintain currency within the medical imaging profession.
8. Participation in regular meetings within program faculty to collect updated information regarding student clinical progress.
9. Coordination and maintenance of student clinical records.
10. Participation in the student selection process for program admission.
11. Development and revision of course descriptions and outlines.
12. Assistance in all procedures required through any accreditation processes.
13. Participation on the Advisory Board for program updates and/or revisions.
14. Continued education in medical imaging and educational methodologies with the purpose of remaining current with the field of medical imaging education.
15. Coordination of a continuing education program in medical imaging which meets the standards set forth by the America Registry of Radiologic Technologists.
16. Implementation of proper student rotations in the clinical settings to achieve course objectives.
17. Didactic instruction of courses within the Medical Imaging major.
Qualifications required by the Long Island University/Post Campus/Post Medical Imaging for the position of Clinical Coordinator include:
1. Proficiency in the areas of curriculum design, program administration, program evaluation instruction and counseling.
2. Credentials in good standing with the American Registry of Radiologic Technologists and New York State Department of Health.
3. A minimum of two years full-time professional experience in medical imaging.
4. A minimum of a Baccalaureate degree
5. A minimum of one (1) year full-time accredited experience as a clinical instructor in an accredited radiography program.
LIU is an equal opportunity employer. LIU is committed to extending equal opportunities in employment to all qualified candidates who can contribute to the diversity and excellence of our academic community. LIU encourages applications from all qualified individuals without regard to race, color, religion, genetic information, sexual orientation, gender and/or gender identity or expression, marital or parental status, national origin, ethnicity, citizenship status, veteran or military status, age, disability, or any other basis protected by applicable local, state or federal laws. Hiring is contingent on eligibility to work in the United States.
Clinical Coordinator (BCBA Supervisor)
Clinical Research Associate Job 35 miles from Bridgeport
Job Title: BCBA Supervisor Reports to: Clinical Director Department: Clinical Compensation: $100,000 - $130,000 per year, depending on experience/licensure Shrub Oak International School (***************** is a therapeutic day and residential school for autistic children, adolescents, and young adults with complex co-occurring conditions. Located in northern Westchester County, Shrub Oak offers unparalleled educational opportunities for autistic students in a family-centric, supportive environment. We offer a variety of programs to meet the needs of students across the spectrum, and our curriculum is based on the most advanced and successful evidence-based clinical and academic approaches in ASD education.
Essential Functions
The BCBA Supervisor (acting as one of our licensed clinical coordinators) is a licensed position, will provide expertise in ABA and human development related services, serving as a member of the clinical leadership and supervisor of BCBAs and/or RBTs. Working with students in the Founders Cohort, they will evaluate treatment progress, conduct assessments, including FBA's, develop behavior plans, and provide clinical supervision and support. This individual will also support the design and development of treatment plans and provide direct support and interventions that meet the individualized needs of students. They will coordinate progress reports, provide on-call clinical crisis coverage, deliver behavioral and family therapy and oversee visitation protocols. They will maintain key relationships and collaborate as needed and required with students, their families and all levels of staff at the Shrub Oak International School to ensure that the individualized needs of each student are met. Having access to confidential information, discretion and independent judgement is required.
Provides leadership in ABA to ensure that students' individualized needs are met, working with the clinical team, education and student life teams, administration, families, and external constituencies as needed and required
Conducts assessments and reassessments of a student's social and emotional needs and develops individualized ITEP goals and behavior plans for each student
Utilizes a variety of treatment modalities that are student centered, strength based, empathic, and creative to address each student's particular needs
Supervises BCBAs, RBTs, and other members of the Shrub Oak clinical team
Design, implements, and/or supervises new systems, groups, and alternative programing for students
Oversees and coordinates the scheduling of clinical staff, and ensuring that clinical session notes and required documentation are appropriately prepared, collected and submitted as required
Supports students clinically in community and workplace environments to promote success for community/social integration, future employment opportunities and other life achievements as appropriate
Proactively maintains communication with students, family members and/or other care givers as appropriate to effectively address student progress, development, and challenges
Participates in clinical and Shrub Oak activities to advance field knowledge and engages in activities to remain at the forefront of professional development and advancements
Actively assists with other programs, events, and services administered through Shrub Oak and may be involved in a wider range of responsibilities
Performs any other responsibilities as needed and required
Please note: This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities and activities may change, or new ones may be assigned at any time with or without notice.
Requirements:
Experience & Education:
New York State Licensed Behavior Analyst (LBA) License in good professional standing required
Master's degree in Applied Behavior Analysis, Psychology, or related field with BCBA Certification or PsyD required; doctoral degree preferred
Minimum 5 years of experience providing behavioral treatment/ABA services required; 10 years of experience preferred
Minimum 2 years of clinical supervisory experience required; 5 years of experience is preferred
Experience working with students with developmental disabilities or on the autistic spectrum is strongly preferred; school experience is a plus
Skills & Abilities:
Exceptional written communication skills, specifically involving documentation, progress notes, incident reports, and other related administrative tasks
Exceptional verbal communication skills
Skilled in managing challenging behaviors and executing de-escalation technique
Demonstrated ability to achieve desired results working collaboratively in a dynamic environment by building strong relationships with multiple stakeholders, including students, families, faculty, and staff
Ability to lead, develop and mentor others
Ability and willingness to learn new skills
Ability to display grit and resilience and maintain composure
Demonstrated ability to achieve desired results working collaboratively in a dynamic environment by building strong relationships with multiple stakeholders, including students, families, faculty, and staff
Demonstrated ability to have a sense of urgency, ability to make sound and appropriate decisions under pressure where situations/circumstances are continually evolving
Ability to multi-task, and handle multiple situations with discretion, and sensitivity to a variety of factors, while exercising sound judgment
Demonstrated ability to succeed in a fast-paced, unpredictable environment
Ability to handle highly challenging behaviors, including those aggressive in nature
Ability to get TCIS trained and complete/maintain all required trainings
Benefits:
Available for full-time employees. An overview of our benefits:
• Insurance coverage: Health, vision, dental, life, and disability insurance
• Flexible spending account (FSA)
• Paid time off (PTO)
• 401k w/ company match
• Tuition/Professional development assistance
• Employee assistance program (EAP)
• Employee discounts
Physical Requirements/Demands:
A workday regularly includes multiple or conflicting demands, deadlines and time pressures; work regularly requires sustained concentration. Standing for sustained periods of time, bending, stretching, walking up and down stairs (building has 6 floors), around a hilly campus as needed, may also require walking between floors or between buildings at a moment's notice. May need to lift/move boxes up to 25 pounds and move or rearrange furniture.
Work Environment:
We are a boarding school located on a 127-acre campus. The work environment will include both indoor and outdoor spaces, mostly inside the classroom or educational environment. May include work within the residential setting. The building has 6 floors accessible by staircases and elevators.
EEO Statement:
Shrub Oak is an equal employment opportunity employer. Sh
Travel Per Diem Mobile Research Nurse
Clinical Research Associate Job 30 miles from Bridgeport
Science 37's Nursing Solutions Group brings together expert nurses who share a passion for organizing, planning and implementing mobile clinical nurse services to participants in clinical trials. Science 37's extraordinary work environment allows continuous collaboration between clinicians, clinical researchers, patient recruitment specialists, data managers and technology developers. The Nursing Solutions Group is involved throughout the trial life cycle, from protocol development and feasibility analysis to clinical trial implementation and closeout.
The Per Diem Mobile Research Nurse is a Registered Nurse who will work per diem and has experience across multiple therapeutic areas with the ability to work independently and integrate well with the Nursing Solutions Group. With interest/expertise in Science 37's decentralized model of care delivery, the Mobile Research Nurse will perform delivery of care to participants as well as collaborate with brick and mortar sites, if indicated, for shared clinical trial implementation. The Mobile Research Nurse ensures the professional delivery of patient care in compliance with all federal and state regulations, Good Clinical Practice, and Standard Operating Procedures.
*This is a travel role that requires on-site visits to participants homes.
Duties for this position include but are not limited to:
Participate and provide research nurse services to qualified study participants at home
Apply clinical research and nursing practices to develop solutions to complex problems
Collaborate with Lead and Per Diem Mobile Research Nurses on solutioning, education, and resource support
Participate in activities that will further the operational development of Science 37 nursing service delivery
Develop relationships with study team members and serve as the subject matter expert (SME) on all nursing processes
Other duties as assigned as the needs of Science 37 evolve and change
This position has the following qualifications:
BSN degree preferred
Full Covid Vaccination strongly preferred. Science 37 follows CDC guidelines for vaccination recommendations and such guidelines are subject to change.
Active RN licensure in home state as well as eligibility for Compact Licensure required
Minimum 2+ years clinical/research experience preferred
Basic Life Support (BLS) Certification
Maintain a positive reflection of the company by representation in participant's homes or in clinic settings
Travel and availability qualifications are as follows:
1-2 days minimum a week dedicated to support Science 37's study visits
Weekday/night availability required
Must be willing to travel to a participants homes
Active Driver's License
Science 37 is looking for people with the following skills and competencies:
BSN degree preferred
Active RN licensure in home state as well as eligibility for Compact Licensure required
Minimum 2+ years clinical/research experience preferred
Basic Life Support (BLS) Certification
Active Driver's License
Weekday/night availability required
Maintain a positive reflection of the company by representation in participant's homes or in clinic settings
Up to 100% travel, as needed, for study participant visits, project team meetings, and other professional meetings/conferences as needed
Occasional Travel to NYC may be required for visits
Ability to obtain nursing license in multiple states based on study needs
Physical ability to perform nursing tasks and lift equipment up to 15 kg in weight
Access to a reliable vehicle to perform study participant visits and transport equipment
Ability to drive to local and/or remote locations to perform study participant visits
Ability to use technology effectively and appropriately for study participant assessments and documentation including but not limited to study participant care equipment, laptop computers, communication devices and tablets
Ability to communicate in English (both verbal and written)
There is minimal supervision for this position, with individuals reporting to the Manager, Nursing Solutions Group.
Compensation varies based on location and work being performed. The starting pay range for a candidate selected for this position is generally within the range of $50-55 per hour. Employees may be eligible for additional discretionary bonuses and commissions. The successful candidate's actual pay will also be based on qualifications and experience, so the actual starting pay may be above or below this range.
Science 37 is an equal opportunity employer.
We are committed to creating a diverse environment and is an equal opportunity employer. All qualified applicants receive consideration for employment without regard to age, race, ethnicity (including but not limited to hair texture and protected hairstyles), ancestry, color, sex, national origin, sexual orientation, gender, gender identity, gender expression, transgender status, religious creed, physical or mental disability (including actual or perceived disability), medical condition (including HIV/AIDS), pregnancy, perceived pregnancy and pregnancy related conditions, genetic information, marital status, political affiliation or activities, status as a victim of domestic violence, assault, or stalking, veteran status or participation in the uniformed military services of the United States, including the National Guard, or any other basis prohibited by applicable law.
Science 37 values the well-being of its employees and aims to provide team members with everything they need to succeed.
Submit your resume to apply!
To learn about Science 37's privacy practices including compliance with applicable privacy laws, please click here
Clinical Research Coordinator
Clinical Research Associate Job 38 miles from Bridgeport
Iterative Health is a healthcare technology and services company on a mission to advance gastrointestinal care through relentless innovation. With deep expertise in artificial intelligence and clinical research, we empower healthcare professionals to provide consistently high-quality colorectal cancer screenings and support clinical research teams and study sponsors to expand and accelerate patient access to novel therapeutics.
Conformance Statements
In the performance of their respective tasks and duties all employees are expected to conform to the following:
* Perform quality work within deadlines with or without direct supervision. • Interact professionally with other employees, customers and suppliers. • Work effectively as a team contributor on all assignments.
* Work independently while understanding the necessity for communicating and coordinating work efforts with other employees and organizations.
Position purpose
The Clinical Research Coordinator (CRC) is a specialized research professional working with and under the direction of the Site Manager and Principal Investigator (PI). The CRC supports, facilitates and coordinates the daily clinical trial activities and plays a critical role in the conduct of the study.
Responsibilities/Duties/Functions/Tasks:
* Regular communication of study requirements and changes to relevant members of study staff Implement recruitment strategies in order to prescreen, screen, and enroll subjects in active trials Screen subjects for eligibility using protocol specific inclusion and exclusion criteria, documenting each potential participant's eligibility or exclusion.
* Acts as a point of reference for study participants by answering questions and keeping them informed of study progress
General Business
* Ensure relevant study and subject specific information is entered into the CTMS system on a regular basis. Maintains adequate inventory of study equipment and supplies onsite at all times. .
* Conducts patient visits as outlined within each study protocol.
* Complete study documentation and maintenance of study files including, but not limited to, consent forms, source documentation, progress notes if applicable, case report forms, and investigational accountability forms.
* Maintains ongoing communication with the CRO, sponsor, research participants, Site Manager and PI throughout course of the study.
* Manage the day to day activities of the study including problem solving, communication and protocol management.
* Ensure all safety data is reviewed by the PI in a timely manner.
* Protects the rights and welfare of all human research participants involved in research • Other duties as assigned.
Qualifications
Education: Bachelor's Degree preferred
Experience: Minimum 1-2 years of clinical research experience. Experience in phlebotomy preferred
Other Requirements: None
Performance Requirements:
* Knowledge of grammar, spelling, and punctuation.
* Knowledge of purchasing, budgeting, and inventory control.
* Skill in taking and transcribing dictation and operating office equipment. • Skill in answering the phone and responding to questions.
* Skill in time management, prioritization, and multitasking.
* Skill in writing and communicating effectively.
* Ability to work under pressure, communicate and present information. • Ability to read, interpret, and apply clinic policies and procedures.
* Ability to identify problems, recommend solutions, organize and analyze information. • Ability to multi-task, establish priorities, and coordinate work activities. • Ability to competently use Microsoft Office, including Word, PowerPoint, Excel, and appropriate practice management software.
Equipment Operated: Standard office equipment including computers, fax machines, copiers, printers, telephones, etc.
Work Environment: Position is in a well-lighted medical office environment. Occasional evening and weekend work.
General Business
Physical Requirements: Must possess the physical and mental abilities to perform tasks such as sitting for 90 percent of the day; manual dexterity to operate office machines including computer and calculator; stooping, bending to handle files and supplies; and mobility to complete errands or deliveries. Stress can be triggered by multiple staff demands and deadlines
Some of our benefits include:
* Vision/Dental/ Medical Insurance
* Life/Disability Insurance
* Parental Leave
* Stock Options
* Flexible Work Hours
* Unlimited Paid Time Off
At Iterative Health, we're actively working towards creating an environment that is representative of the diversity of patients our technology serves. We are focused on building an equitable and inclusive culture, and by extension, hiring process. If you require any accommodations to make the application process or interviewing experience more accessible to you, please contact CandidateAccommodations@iterative.health.
Clinical Research Coordinator
Clinical Research Associate Job 38 miles from Bridgeport
Iterative Health is a healthcare technology and services company on a mission to advance gastrointestinal care through relentless innovation. With deep expertise in artificial intelligence and clinical research, we empower healthcare professionals to provide consistently high-quality colorectal cancer screenings and support clinical research teams and study sponsors to expand and accelerate patient access to novel therapeutics.
Conformance Statements
In the performance of their respective tasks and duties all employees are expected to conform to the following:
Perform quality work within deadlines with or without direct supervision. • Interact professionally with other employees, customers and suppliers. • Work effectively as a team contributor on all assignments.
Work independently while understanding the necessity for communicating and coordinating work efforts with other employees and organizations.
Position purpose
The Clinical Research Coordinator (CRC) is a specialized research professional working with and under the direction of the Site Manager and Principal Investigator (PI). The CRC supports, facilitates and coordinates the daily clinical trial activities and plays a critical role in the conduct of the study.
Responsibilities/Duties/Functions/Tasks:
Regular communication of study requirements and changes to relevant members of study staff Implement recruitment strategies in order to prescreen, screen, and enroll subjects in active trials Screen subjects for eligibility using protocol specific inclusion and exclusion criteria, documenting each potential participant's eligibility or exclusion.
Acts as a point of reference for study participants by answering questions and keeping them informed of study progress
General Business
Ensure relevant study and subject specific information is entered into the CTMS system on a regular basis. Maintains adequate inventory of study equipment and supplies onsite at all times. .
Conducts patient visits as outlined within each study protocol.
Complete study documentation and maintenance of study files including, but not limited to, consent forms, source documentation, progress notes if applicable, case report forms, and investigational accountability forms.
Maintains ongoing communication with the CRO, sponsor, research participants, Site Manager and PI throughout course of the study.
Manage the day to day activities of the study including problem solving, communication and protocol management.
Ensure all safety data is reviewed by the PI in a timely manner.
Protects the rights and welfare of all human research participants involved in research • Other duties as assigned.
Qualifications
Education: Bachelor's Degree preferred
Experience: Minimum 1-2 years of clinical research experience. Experience in phlebotomy preferred
Other Requirements: None
Performance Requirements:
Knowledge of grammar, spelling, and punctuation.
Knowledge of purchasing, budgeting, and inventory control.
Skill in taking and transcribing dictation and operating office equipment. • Skill in answering the phone and responding to questions.
Skill in time management, prioritization, and multitasking.
Skill in writing and communicating effectively.
Ability to work under pressure, communicate and present information. • Ability to read, interpret, and apply clinic policies and procedures.
Ability to identify problems, recommend solutions, organize and analyze information. • Ability to multi-task, establish priorities, and coordinate work activities. • Ability to competently use Microsoft Office, including Word, PowerPoint, Excel, and appropriate practice management software.
Equipment Operated: Standard office equipment including computers, fax machines, copiers, printers, telephones, etc.
Work Environment: Position is in a well-lighted medical office environment. Occasional evening and weekend work.
General Business
Physical Requirements: Must possess the physical and mental abilities to perform tasks such as sitting for 90 percent of the day; manual dexterity to operate office machines including computer and calculator; stooping, bending to handle files and supplies; and mobility to complete errands or deliveries. Stress can be triggered by multiple staff demands and deadlines
Some of our benefits include:
Vision/Dental/ Medical Insurance
Life/Disability Insurance
Parental Leave
Stock Options
Flexible Work Hours
Unlimited Paid Time Off
At Iterative Health, we're actively working towards creating an environment that is representative of the diversity of patients our technology serves. We are focused on building an equitable and inclusive culture, and by extension, hiring process. If you require any accommodations to make the application process or interviewing experience more accessible to you, please contact CandidateAccommodations@iterative.health.
TPP Clinical Coordinator
Clinical Research Associate Job In Bridgeport, CT
Job Details CCIH - Bridgeport, CT Full Time DayDescription
In accordance with RNP's Mission Statement, Philosophy of Client Care and Code of Ethics as stated in the Personnel Policies and under the supervision of the Department Head of Grants and Innovation. Provides clinical assessments on individuals who are currently in lock-up awaiting arraignment, recommendations will be reported to Judge.
CORE FUNCTIONS
Create and maintain a positive collaboration between Bail Office, Judges, Probation Office, Court Support Services and RNP.
Conducts, at courthouse, screening, intake, orientation, and assessment of clients to obtain information concerning substance abuse, mental health, medical history, trauma, and other pertinent information. In addition, providing following-up with clients and service providers on services recommended for the client once placed in a program within RNP or outside agency.
Upon completion of assessment, appropriate referrals will be made for substance use treatment, mental health treatment, vocational, educational, social services, and housing services.
Providing all recommendations to presiding Judges. May be required to provide information regarding TPP program and services to new Judges.
Prepares and maintains quality clinical records for assigned caseload and issues accurate and timely reports as requested. Enter clinical information in Accumedic or current EHR system within 24hours of service or referral.
Maintain and report on all program measures to the Quality Department.
Provide clinical updates/reports to judicial staff on all TPP clients. Attend all monthly TPP meetings and other meetings as assigned.
Provide effective clinical supervision to program staff. Document supervision using RNP's supervision forms and following supervision guidelines.
Consider and project shared goals of legal and clinical with TPP clients with an emphasis placed on client's responsibility and accountability to the program and judicial system.
Contact and re-engage clients who have missed services, documenting absences and efforts to re-engage. Immediately notify Probation and Bail for any clients that are missing from services and/or have new arrests.
Prepare and maintain all documentation for DPH and Quality Department audits to maintain TPP licensure renewal.
Assist Recovery Coach and/or other staff with coordinating additional services such as, MATS, residential, detoxification, housing, transportation, entitlements, and/or other appropriate referrals.
With Recovery Coach and/or other staff enter with accuracy, daily, data on TPP clients in the CDCS database.
Learn and implement the new SOR Tracking (GPRAs) for TPP clients.
Maintain oversight and serve as back up for the ESI (State's Atty) program. Assist with obtaining requested court reports as needed and tracking system.
Collaborate with Outpatient Department Head on any issues or concerns affecting the judicial system, TPP, and ESI problems, changes, or concerns.
Support and provide education to TPP primary counselors and probation officers and new Judges for the purpose of improving their understanding of judicial process or clients' legal issues.
Works in collaboration with 2 specific Bridgeport Probation Officers to serve TPP clients. This program is under the CSSD contract (Court Support Services Division).
Supervise the Early Screening Intervention program, collaborate with the State's Attorney and provide quarterly updates to the Executive team.
Monitor and record weekly urine tests for all TPP clients.
Manage and update weekly data bases inputting data into GPRA and CDCS
Some flexibility with work schedule may be required to communicate with clients in inpatient programs and/or providing transportation for clients directly to inpatient or detox programs. Must take RNP driving course.
Transport clients as necessary
Flexibility for travel and hours
Assumes all other appropriate duties as deemed necessary by the supervisor.
CORE COMPETENCIES
Master's degree in the behavioral sciences. Experience working within the criminal justice system.
Knowledge of principles and techniques of counseling.
Knowledge of Criminal Justice system required.
Ability to gather, analyze and evaluate information pertinent to the care of clients.
Knowledge of the physical, psychological, social, and economic effects of substance abuse, homelessness, medical and mental health issues.
Knowledge of community resources.
Considerable knowledge of federal and state laws and regulations regarding client confidentiality.
Ability to establish and maintain cooperative professional relationships.
Excellent communication skills.
Ability to always project a professional image.
CERTIFICATES, LICENSES
CAC/LADC/SCCD/ Licensed Clinician; minimum provisional licensure required.
Valid Connecticut driver's license required.
Clinical Research Coordinator
Clinical Research Associate Job 23 miles from Bridgeport
Job Title : Clinical Research Coordinator
Department : Site Operations
Reports To : Site Manager
Status : Non-exempt (hourly)
Compensation : $17.00 - $19.00
: We are seeking a reliable and experienced Clinical Research Coordinator to join our growing team at Elite Clinical Network. This position will be responsible for collaborating with the Principal Investigator, human subjects, IRB, and pharmaceutical company to ensure smooth, accurate progress of clinical trials from the planning stage through trial completion and post-study closure. Ideal candidates will possess working knowledge of clinical trial procedures.
Essential Duties:
Ensures site compliance with research protocols by reviewing all regulatory requirements to confirm implementation of appropriate methods, practices, and procedures for all research activities
Provides accurate and timely data collection, documentation, entry, and reporting
Interfaces with research participants to support efforts to determine eligibility and consenting of study participants according to protocol
Communicates and collaborates specific study requirements to the research team, including internal and external parties, sponsor, monitors, PI, and study participants
Qualifications :
Bachelor's degree or certified Medical Assistant
If you are a dedicated and reliable Clinical Research Coordinator, we invite you to apply for this exciting opportunity. Join us and be a key player in shaping the future of our business.
ECN is an equal opportunity employer. We make every effort to make our hiring process accessible to all users. If you need assistance completing the application process, please contact Human Resources via *********************************
Clinical Trial Specialist
Clinical Research Associate Job 18 miles from Bridgeport
Job Description
Clinical Trial Specialist (CTS)
The CTS will work remotely as a member of the Clinical Trial Team in the Study Management and Conduct Group supporting the Clinical Trial Leader (CTL), Clinical Trial Manager (CTM), and Feasibility Manager (FM). The CTS is responsible for end-to-end site management activities.
In addition, may be responsible for supporting the CTL and/or CTM in leading the trial teams and is responsible for end-to-end Site Management activities.
Requirements:
Four (4) year degree, preferably in life sciences, or an RN with relevant clinical trial experience.
Experience:
oncology: 5 years (Preferred)
in-house monitoring: 7 years (Preferred)
General Responsibilities
Represent clients PI with the highest ethical and professional standards with all business contacts including, but not limited to the following representatives: investigator and site staff, clinical trial team, Regulatory Affairs, Client Site Monitoring staff, other departments in Clinical Operations and clinical trial vendors, if required.
Maintain expertise of currently assigned Client SOPs, Client WIs and where applicable; departmental practices, and systems.
Maintain current knowledge of ICH, GCPs, and applicable FDA guidelines, US Federal Regulations pertaining to Clinical Trials and Guidance Documents and Information Sheets. PhRMA code, and industry standards for the monitoring of clinical trials at no cost to Client.
Provide documentation, including but not limited to invoices, time recording, schedule of monitoring visits, and schedule of time off at the direction of Client.
Invoices should be submitted monthly as directed by Client. The invoices may not be processed until all work products for that period have been received.
CTS Duties and Responsibilities:
Under the direction of the CTL/CTM or Feasibility Manager (depending on the task/activity), the CTS will:
Serve as first line of contact for site staff in trial related questions pertaining to planning, conduct and closure of assigned clinical trials and sites.
Coordinate and provide oversight to site start-up and conduct-related activities (e.g. contracts, Essential Documents (e.g. RegDocs), training, Informed Consent Form (ICF) updates, Investigational Medicine Product (IMP) re-supply.
Be responsible for site logistics including review, distribution and tracking of site related documents & materials (e.g. protocols, supplies).
Update and maintain trial-specific system/databases/tracker (e.g. IVRS, BI CTMS, Feasibility Database & Site outreach metrics).
Adhere to project compliance according to project plans and related tools.
In close partnership with additional stakeholders (e.g. ISP Manager, Site Monitoring) maintain/improve quality, performance and operational oversight for assigned sites, take appropriate actions, escalate, implement mitigation strategies and make recommendations to the CTM and/or FM as appropriate
Perform monitoring trip report review according to current SOPs and guidance documents. Communicate significant issues to the CTL and CTM.
Serve as CAPA lead.
Develop trial specific documents or communications (e.g. newsletters). Submit for review and approval to CTL and CTM.
Closely track site recruitment and patient retention.
Ensure data quality and integrity through review of systems and trackers (e.g. BRAVE, lab portals, Clinergize).
In collaboration with partners ensure quality of TMF for assigned sites.
Review and reconcile invoices/payments with internal partner(s), as appropriate.
Actively participate in trial team meetings including the creation and distribution of meeting minutes.
Create trial specific slide decks, training material, etc. in accordance with BI requirements.
Support Customer Relations Group (CRG) in answering and appropriately triaging calls from (potential) sites, as needed and/or requested to appropriate stakeholders.
Participate in (local/regional) Investigator Meetings, as requested.
Support site & sponsor inspection readiness activities.
If US CTL assigned, provide additional support of global/local activities as required
Support Investigator Site File (ISF) development according to SOP and guidance documents. Adapt Trial/OPU documents/templates for study specific trial.
Perform quality control of Clinical Trial Report (CTR) Appendices, as requested.
Provide operational support to the assigned study Feasibility Manager with tasks to support site identification and country feasibility, i.e., tiering of potential investigator sites, vetting requests assess investigator qualifications, etc.
Additional Provisions for CTS Role:
Additional CTS non-trial services may be requested from time-to-time on an as-needed basis related to leveraging service knowledge and insights supporting other activities.
In addition to the CTS responsibilities and duties, they may provide assistance in leading the trial team:
Operationalize the strategic direction given by the CTL/CTM during planning, conduct and closure of assigned trials.
Provide quality oversight for assigned trial.
Enter country level information in BI Clinical Trial Management System (CTMS) and related systems.
Perform user acceptance testing.
Facilitate local trial team meetings.
Update trial budget, systems, project plans and tracker.
Serve as single point of contact for all CTSs assigned to the trial including the coordination and harmonization of activities, answering trial related questions, etc.
Provide reports to CTL/CTM on OPU contribution status, local issues, budget etc.
Partner with the CTL/CTM in the development of a local trial implementation strategy (incl. site engagement/selection/start-up strategy).
Work with local colleagues to ensure start-up is achieved according to local timelines/goals.
Support the CTL/CTM in study sites review and selection.
Support CTL/CTM in the preparation and conduct (may include delivery of presentations and trainings) in (local/regional) Investigator Meetings if required.
Provide updates on key trial deliverables; take appropriate actions and make recommendations to the CTM (e.g. site initiation, patient recruitment, data cleaning, DBL).
Follow up on audit/inspection findings and actively support implementation of CAPA.
Support accurate local budget and collaborate with CTM to ensure alignment with controlling.
In collaboration with partners, ensure quality of country level TMF.
Supports the CTL/CTM in ensuring quality oversight and data integrity of the trial at the country level.
Support site & sponsor inspection readiness preparation, represent the trial (Trial/OPU level) during inspections if requested and as appropriate.
In close partnership with Recruitment and Retention group, CTL and CTM, implement recruitment and retention strategies.
Assist with vendor oversight (e.g. lab, ancillary supplies, and pharmacy cards).
Coordinate close out activities (collection of essential documents, etc.).
Desired Experience, Skills and Abilities:
Excellent communication skills (written and oral)
Be a highly motivated individual with the ability to think critically, that is detail oriented, can multi-task and understand the clinical trial process, meet deadlines and keep a trial /site on track along with any other qualifications provided by Sponsor.
Proficiency in computer skills, with direct working experience in multiple electronic platforms such as but not limited to: CTMS Sharepoint, Clinical Trial portals, Central IRB portals, eSurvey platforms, Time reporting portals, eLearning portals, Access Databases, Microsoft Excel, Microsoft Teams, Adobe Acrobat Professional and scanning software etc.
Maintain expertise of currently assigned Sponsor SOPs, Working Instructions (WI) and where applicable, departmental practices.
Maintain current knowledge of ICH, GCPs, applicable FDA guidelines, US Federal Regulations pertaining to Clinical Trials and Guidance Documents and Information Sheets, PhRMA code, and industry standards for the monitoring of clinical trials at no cost to Sponsor.
Represent Sponsor with the highest ethical and professional standards with all business contacts including, but not limited to the following representatives: investigator and site staff, clinical trial team, Regulatory Affairs, Site Monitoring staff, other departments within Clinical Operations and if required clinical trial vendors.
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Clinical Trial Specialist
Clinical Research Associate Job 18 miles from Bridgeport
Clinical Trial Specialist (CTS)
The CTS will work remotely as a member of the Clinical Trial Team in the Study Management and Conduct Group supporting the Clinical Trial Leader (CTL), Clinical Trial Manager (CTM), and Feasibility Manager (FM). The CTS is responsible for end-to-end site management activities.
In addition, may be responsible for supporting the CTL and/or CTM in leading the trial teams and is responsible for end-to-end Site Management activities.
Requirements:
Four (4) year degree, preferably in life sciences, or an RN with relevant clinical trial experience.
Experience:
oncology: 5 years (Preferred)
in-house monitoring: 7 years (Preferred)
General Responsibilities
Represent clients PI with the highest ethical and professional standards with all business contacts including, but not limited to the following representatives: investigator and site staff, clinical trial team, Regulatory Affairs, Client Site Monitoring staff, other departments in Clinical Operations and clinical trial vendors, if required.
Maintain expertise of currently assigned Client SOPs, Client WIs and where applicable; departmental practices, and systems.
Maintain current knowledge of ICH, GCPs, and applicable FDA guidelines, US Federal Regulations pertaining to Clinical Trials and Guidance Documents and Information Sheets. PhRMA code, and industry standards for the monitoring of clinical trials at no cost to Client.
Provide documentation, including but not limited to invoices, time recording, schedule of monitoring visits, and schedule of time off at the direction of Client.
Invoices should be submitted monthly as directed by Client. The invoices may not be processed until all work products for that period have been received.
CTS Duties and Responsibilities:
Under the direction of the CTL/CTM or Feasibility Manager (depending on the task/activity), the CTS will:
Serve as first line of contact for site staff in trial related questions pertaining to planning, conduct and closure of assigned clinical trials and sites.
Coordinate and provide oversight to site start-up and conduct-related activities (e.g. contracts, Essential Documents (e.g. RegDocs), training, Informed Consent Form (ICF) updates, Investigational Medicine Product (IMP) re-supply.
Be responsible for site logistics including review, distribution and tracking of site related documents & materials (e.g. protocols, supplies).
Update and maintain trial-specific system/databases/tracker (e.g. IVRS, BI CTMS, Feasibility Database & Site outreach metrics).
Adhere to project compliance according to project plans and related tools.
In close partnership with additional stakeholders (e.g. ISP Manager, Site Monitoring) maintain/improve quality, performance and operational oversight for assigned sites, take appropriate actions, escalate, implement mitigation strategies and make recommendations to the CTM and/or FM as appropriate
Perform monitoring trip report review according to current SOPs and guidance documents. Communicate significant issues to the CTL and CTM.
Serve as CAPA lead.
Develop trial specific documents or communications (e.g. newsletters). Submit for review and approval to CTL and CTM.
Closely track site recruitment and patient retention.
Ensure data quality and integrity through review of systems and trackers (e.g. BRAVE, lab portals, Clinergize).
In collaboration with partners ensure quality of TMF for assigned sites.
Review and reconcile invoices/payments with internal partner(s), as appropriate.
Actively participate in trial team meetings including the creation and distribution of meeting minutes.
Create trial specific slide decks, training material, etc. in accordance with BI requirements.
Support Customer Relations Group (CRG) in answering and appropriately triaging calls from (potential) sites, as needed and/or requested to appropriate stakeholders.
Participate in (local/regional) Investigator Meetings, as requested.
Support site & sponsor inspection readiness activities.
If US CTL assigned, provide additional support of global/local activities as required
Support Investigator Site File (ISF) development according to SOP and guidance documents. Adapt Trial/OPU documents/templates for study specific trial.
Perform quality control of Clinical Trial Report (CTR) Appendices, as requested.
Provide operational support to the assigned study Feasibility Manager with tasks to support site identification and country feasibility, i.e., tiering of potential investigator sites, vetting requests assess investigator qualifications, etc.
Additional Provisions for CTS Role:
Additional CTS non-trial services may be requested from time-to-time on an as-needed basis related to leveraging service knowledge and insights supporting other activities.
In addition to the CTS responsibilities and duties, they may provide assistance in leading the trial team:
Operationalize the strategic direction given by the CTL/CTM during planning, conduct and closure of assigned trials.
Provide quality oversight for assigned trial.
Enter country level information in BI Clinical Trial Management System (CTMS) and related systems.
Perform user acceptance testing.
Facilitate local trial team meetings.
Update trial budget, systems, project plans and tracker.
Serve as single point of contact for all CTSs assigned to the trial including the coordination and harmonization of activities, answering trial related questions, etc.
Provide reports to CTL/CTM on OPU contribution status, local issues, budget etc.
Partner with the CTL/CTM in the development of a local trial implementation strategy (incl. site engagement/selection/start-up strategy).
Work with local colleagues to ensure start-up is achieved according to local timelines/goals.
Support the CTL/CTM in study sites review and selection.
Support CTL/CTM in the preparation and conduct (may include delivery of presentations and trainings) in (local/regional) Investigator Meetings if required.
Provide updates on key trial deliverables; take appropriate actions and make recommendations to the CTM (e.g. site initiation, patient recruitment, data cleaning, DBL).
Follow up on audit/inspection findings and actively support implementation of CAPA.
Support accurate local budget and collaborate with CTM to ensure alignment with controlling.
In collaboration with partners, ensure quality of country level TMF.
Supports the CTL/CTM in ensuring quality oversight and data integrity of the trial at the country level.
Support site & sponsor inspection readiness preparation, represent the trial (Trial/OPU level) during inspections if requested and as appropriate.
In close partnership with Recruitment and Retention group, CTL and CTM, implement recruitment and retention strategies.
Assist with vendor oversight (e.g. lab, ancillary supplies, and pharmacy cards).
Coordinate close out activities (collection of essential documents, etc.).
Desired Experience, Skills and Abilities:
Excellent communication skills (written and oral)
Be a highly motivated individual with the ability to think critically, that is detail oriented, can multi-task and understand the clinical trial process, meet deadlines and keep a trial /site on track along with any other qualifications provided by Sponsor.
Proficiency in computer skills, with direct working experience in multiple electronic platforms such as but not limited to: CTMS Sharepoint, Clinical Trial portals, Central IRB portals, eSurvey platforms, Time reporting portals, eLearning portals, Access Databases, Microsoft Excel, Microsoft Teams, Adobe Acrobat Professional and scanning software etc.
Maintain expertise of currently assigned Sponsor SOPs, Working Instructions (WI) and where applicable, departmental practices.
Maintain current knowledge of ICH, GCPs, applicable FDA guidelines, US Federal Regulations pertaining to Clinical Trials and Guidance Documents and Information Sheets, PhRMA code, and industry standards for the monitoring of clinical trials at no cost to Sponsor.
Represent Sponsor with the highest ethical and professional standards with all business contacts including, but not limited to the following representatives: investigator and site staff, clinical trial team, Regulatory Affairs, Site Monitoring staff, other departments within Clinical Operations and if required clinical trial vendors.
IND124
Pre-Trial Specialist
Clinical Research Associate Job 34 miles from Bridgeport
Title: Pretrial Specialist
Reports To: Pretrial Supervisor
FLSA: Non-Exempt
Status: Full-time
Supervisory Responsibility: Not Applicable
Purpose of the Role:
Rapidly after release into the program, the Pretrial Specialist meets with new participants to review supervision conditions that will be required under the supervision plan. The Pretrial Specialist assists participants on their case load to comply with supervision appointments and court appearances during the pendency of their legal case, conducts ongoing service need assessments with participants and develops collaborative service plans ensuring participants receive services to achieve their self-identified needs and goals.
Essential Functions of the Role:
Provide supervision and community-based services to a caseload of pretrial participants
Rapidly (within 24-48 hours of release) conduct Supervision Introduction/Orientation meetings with new participants to review supervision conditions, the reporting schedule (as assigned by level of recidivism risk), and the mandatory methods of communication (face-to-face, telephone, and texts) that will be required under the participant's supervision plan.
Work collaboratively with the court and other pretrial staff team to facilitate and ensure caseload participants' successful completion of mandated supervision appointments and court appearances during the pendency of their legal case.
Review legal and court screening documentation and work with participants to analyze their offending behavior patterns, identifying behavioral changes, need for implementation of supports that may reduce likelihood of any pretrial arrests.
On an ongoing basis, conduct service need assessments with participants to examine psychosocial needs and problems, including the severity of mental and substance use disorders, problems affecting participation, engagement, and continuity in supervision and treatment and individual motivation for treatment.
Link participants to treatment based on their eligibility, preferences and needs and provide escort to community services.
Ensure the timely flow of community outreach and case management activities to meet program goals and objectives.
Utilize problem solving techniques, motivational interviewing as an integral part of the pretrial supervision and case management process approach, to help motivate and engage individuals in any needed process of change.
Provide all services in a manner that is gender-responsive, trauma-informed, and that adheres to the core principles of risk-need-responsivity.
Maintain collaborative relationships with community providers (supported housing providers, Health Homes, care management programs, addiction treatment and mental health providers, peer-run providers, education, vocational training and employment services providers, legal services providers, medical care providers, and family providers)
Follow program community-based monitoring protocols for high risk and high need program participants and request/participate in case reviews to addresses complex cases.
Enter assessment, supervision appointment reporting, progress note documentation into program database; conduct all electronic charting activities and reporting in accordance with confidentiality regulations and in a timely fashion.
Meet monthly case management contact and outreach goals as established by supervisory staff
Decision Making Authority:
Decisions regarding Pretrial Services are to be made with guidance and collaboration of the Director to whom the Pretrial staff is assigned. It is expected that the Pretrial Specialist will show an increasing ability to make decisions independently on routine matters as knowledge and experience progresses.
Working Relationships:
Internal: Pretrial Supervisor, Director of Criminal Justice
External: Dept. of Social Services, Mental Health Providers, Primary Care Physicians, Parole Officers, Legal Services, District Attorney’s Office, Court Officials, Police Departments, etc.
Work Schedule: Monday – Friday, 9am – 5pm with some flexibility around client needs.
Physical Environment:
Traditional office environment.
Must be comfortable attending appointments at various courts, agencies, facilities and client’s homes.
Physical Demands: Must be able to drive a motor vehicle and carry up to 20 lbs.
Mental and Visual Demands: Flow of work and nature of duties involve normal coordination of mind and eyes much of the time.
Must be able to interact with persons having mental health issues, periods of instability (i.e. lack of shelter, food, clothing or support), recently released from an institution (i.e. hospital, prison), limited comprehension and/or ability to manage through complex scenarios
Qualifications for this Role:
Bachelors Degree or equivalent experience
Minimum of four years of experience working in human services with individuals with substance use disorders, co-occurring mental health and substance use disorders and involvement in the criminal justice system.
Extensive knowledge of community treatment, support services and resources
Knowledge of the criminal justice system, court processes and alternative to detention/incarceration services
Valid Driver License required and a driving record that will permit the use of an Agency vehicle to transport clients to appointments or other activities as needed.
Bachelor’s Degree required.
Associates accepted with experience.
Bilingual English/Spanish a plus.
Compensation Range: $45,000 - $48,000
Clinical Research Coordinator
Clinical Research Associate Job 22 miles from Bridgeport
Job Description
Job Title: Clinical Research Coordinator
Department: Site Operations
Reports To: Site Manager
Status: Non-exempt (hourly)
Compensation: $17.00 - $19.00
Position Summary: We are seeking a reliable and experienced Clinical Research Coordinator to join our growing team at Elite Clinical Network. This position will be responsible for collaborating with the Principal Investigator, human subjects, IRB, and pharmaceutical company to ensure smooth, accurate progress of clinical trials from the planning stage through trial completion and post-study closure. Ideal candidates will possess working knowledge of clinical trial procedures.
Essential Duties:
Ensures site compliance with research protocols by reviewing all regulatory requirements to confirm implementation of appropriate methods, practices, and procedures for all research activities
Provides accurate and timely data collection, documentation, entry, and reporting
Interfaces with research participants to support efforts to determine eligibility and consenting of study participants according to protocol
Communicates and collaborates specific study requirements to the research team, including internal and external parties, sponsor, monitors, PI, and study participants
Qualifications:
Bachelor’s degree or certified Medical Assistant
If you are a dedicated and reliable Clinical Research Coordinator, we invite you to apply for this exciting opportunity. Join us and be a key player in shaping the future of our business.
ECN is an equal opportunity employer. We make every effort to make our hiring process accessible to all users. If you need assistance completing the application process, please contact Human Resources via *********************************