Department Research Administrator
Clinical research coordinator job in Providence, RI
SUMMARY: Reporting to the department Chair/Chief and/or Departmental Research Manager, plans, develops, monitors and coordinates the departmental research administrative activities for assigned department/programs at Rhode Island Hospital. Brown University Health employees are expected to successfully role model the organization's values of Compassion, Accountability, Respect, and Excellence as these values guide our everyday actions with patients, customers and one another. In addition to our values, all employees are expected to demonstrate the core Success Factors which tell us how we work together and how we get things done. The core Success Factors include: Instill Trust and Value Differences Patient and Community Focus and Collaborate RESPONSIBILITIES: Serves as point person and facilitates smooth coordination, communication, and problem resolution relative to research administrative matters between department, research administration, faculty, divisional leaders, and other hospital and university departments. Will review matters relating to clinical and basic research, pre- and post-award. Leads and coordinates special research-related projects, such as major grant proposals, investigator incentive programs, departmental and divisional reports and statistics. Coordinates transfers of research funding for the purpose of proper reimbursement and allocation of physician salaries on research accounts. Assists in managing the department post-award aspect of projects, which requires sensitivity to the needs of individual investigators, knowledge of sponsor, institutional and departmental requirements, ability to interpret those requirements and competency in addressing the in-house systems (research administration, accounts payable, accounts receivable, finance, purchasing, human resources, payroll and pharmacy). Determines which principal investigators (PI) or staff need closer monitoring to prevent activity which could affect the institution negatively, such as monetary loss due to audit disallowance, loss of funding or liability incurred due to research conducted without necessary approvals. May intervene to point out available resources or alternative procedures, as appropriate. Communicates institutional and funding agencies ' regulations and policies on grants and contracts. Familiarizes administrative staff regarding Rhode Island Hospital institutional research policies and procedures. Responsible for coordinating and providing information to the faculty about funding opportunities, requirements and deadlines. Reviews project applications in consideration of project budget, application instructions, sponsor rules and unique requirements, and provisions for recovery of indirect costs. Recommends and negotiates changes to appropriate applications with principal investigators or department administration and/or involved individuals at the other institutions which do not compromise the institution, department or investigators. Verifies all necessary approvals, including regulatory committees, to ensure that guidelines are met. Completed applications are forwarded to research administrator for approval prior to submission to the Office of Research Administration. As appropriate, may assist Chair/Chief with research administrative activities of department, including coordinating and overseeing human resource and payroll issues. Interacts with research administration and human resource department regarding new positions, recruiting, job changes, salary reviews and other related policies and procedures to assist PI 's. Coordinates research efforts in the recruitment of new faculty and staff. This may include advising new faculty on transfer procedures, including relocation of equipment and financial arrangements. Is responsible for coordination of facility management staff, new recruits and support departments in the establishment and construction of space for the recruitment program. Maintains confidential and comprehensive records of salary expenses and other disbursements, recommending adjustments where necessary. Reviews and monitors policy and procedure adherence for purchase orders, travel requests, petty cash vouchers, requisitions for payment including all equipment, maintenance agreements, contracts and subscriptions, assisting where necessary. Monitors time sheets and employee change forms for hourly and salaried research oriented personnel within department. Assures that funds are available and notifies PI 's and Chair/Chief when adjustments become necessary. Coordinates with the Chair/Chief/Research Manager and research administration on problem issues as appropriate. Maintains communications with review committees to learn of any new requirements and to help ensure compliance with current regulations. Prepares/provides reports and documents as requested by the managers; attends related meetings on regular basis. Maintains strong daily association with research administration, including collaboration on final reports and some accounting adjustments. This also includes resolution of problem accounts with principal investigators, sponsors, or administrators. Reviews and determines direct cost transfers are allocated to appropriate account and are allowable. Prepares necessary journal vouchers for submission to research administration. Ensures the accuracy of research time and effort reporting system. Works with research investigators to obtain information for submission to research administration on a monthly basis. Responsible for departmental access databases, specifically with regard to maintenance of accounts and accuracy of input of data elements. Maintains current knowledge of sponsor requirements, procedures and areas of interest through active communication with sponsors and professional societies. Maintains awareness of new or changed regulations. Maintains active communication with investigators, administrators and agency officials and other federal, state and local offices, to gather and exchange information. Maintains current knowledge on policies and federal regulations by monitoring the Blue Sheet, NIH Guide, Federal Register, Grants Weekly, Chronicle of Higher Education, etc. If applicable, maintains communication with physician foundation business manager; provides assistance in development of department research budget. May represent department at research administration management meetings and on hospital teams. MINIMUM QUALIFICATIONS: BASIC KNOWLEDGE: Bachelor 's degree in business administration, finance or related area, or lieu, at least 10 years of relevant research administration experience. EXPERIENCE: At least three to five years experience in a researchcademic environment to include federal and non-federal funding, grant application processes, and regulations set by local, federal, hospital, and independent agencies. Excellent verbal and written skills are essential. The ability to interact with persons from diverse backgrounds such as MD 's, PhD 's, research and administrative staff. Thorough knowledge of microcomputers, peripheral equipment and networks. Thorough knowledge of software such as Microsoft Word, Excel, Access and Windows. Ability to learn specific research access programs. WORK ENVIRONMENT AND PHYSICAL REQUIREMENTS: Normal office environment. SUPERVISORY RESPONSIBILITY: None.
Pay Range:
$54,637.86-$90,148.24
EEO Statement:
Brown University Health is committed to providing equal employment opportunities and maintaining a work environment free from all forms of unlawful discrimination and harassment.
Location:
Rhode Island Hospital - 593 Eddy Street Providence, Rhode Island 02903
Work Type:
M-F, 8:00am-5:00pm
Work Shift:
Day
Daily Hours:
8 hours
Driving Required:
No
Trial Master File (TMF) Specialist Oncology
Clinical research coordinator job in Providence, RI
Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn.
The Trial Master File (TMF) Specialist will be responsible for ensuring that SMPA studies have comprehensive and quality Trial Master Files (TMFs) ready for audits and inspections. Partnering with the Associate Director, Clinical Business Operations, the specialist ensures accountable functions follow the requirements of the TMF SOP and system work instructions. Provide support and guidance to study team members during the full lifecycle of the study, including planning, set-up, maintenance, QC and closure of the study TMF.
**Key Responsibilities**
+ Responsible for overall quality, maintenance, and completeness of Trial Master Files.
+ Working closely with the TMF Process Owner, identify trends or quality concerns and oversee resolution of issues.
+ Develop project specific TMF plan and structure and update the plan as needed.
+ Participate in system UAT as needed and collaborate with Information Technology to ensure system validation is maintained.
+ Work closely with Clinical Operations and Regulatory Affairs to ensure compliance with regulatory requirements.
+ Act as a liaison between the Site IRBs and study team to resolve queries and concerns.
+ Provide study team reports or updates regarding status of TMF on a regular basis.
+ Participate in audits and provide documents as requested.
+ Perform investigation of deviations and monitoring of Corrective actions & preventive actions (CAPA) relating to non-compliance issues and findings.
+ Oversee TMF maintenance done by CROs and ensure final transfer of TMF is sufficient to support any potential regulatory filings.
+ Champion best practices for building and maintaining TMF health.
**Professional Experience / Qualifications**
+ BA/BS with minimum of 3 year of clinical research experience in academic and/or industry settings
+ Knowledge of and direct experience with Trial Master Files.
+ Prior eTMF (e.g. Veeva) administration required.
+ Strong Microsoft Office skills required.
+ Demonstrate a comprehensive knowledge of Good Clinical Practice, Good Documentation Practice, and International Council for Harmonization E6(R2).
+ Fundamental knowledge of the conduct of clinical trials is preferred.
+ Strong focus on teamwork, attention to detail, excellent organizational skills. Must have ability to prioritize, and the ability to work in a multi-task environment.
The base salary range for this role is $72,500 to $90,600. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law.
Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.
**Confidential Data** : All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential.
**Compliance** : Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
**Mental/Physical Requirements** : Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time.
**Sumitomo Pharma America (SMPA)** **is an Equal Employment Opportunity (EEO) employer**
Qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn.
Sumitomo Pharma America (SMPA) endeavors to make its application process accessible to all. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact SMPA at **********************************************
This contact information is for accommodation requests only and cannot be used to inquire about the status of applications.
At Sumitomo Pharma America, our work is guided by the Sumitomo Pharma mission, vision and values, which tie closely to our company's cultural pillars.
**Our** **Mission**
_To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people_ _worldwide_
**Our** **Vision**
_For Longer and Healthier Lives, we unlock the future with cutting edge technology and_ _ideas_
Clinical Territory Associate
Clinical research coordinator job in Providence, RI
At Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints.
As a pioneer and market leader in robotic-assisted surgery, we strive to foster an inclusive and diverse team, committed to making a difference. For more than 25 years, we have worked with hospitals and care teams around the world to help solve some of healthcare's hardest challenges and advance what is possible.
Intuitive has been built by the efforts of great people from diverse backgrounds. We believe great ideas can come from anywhere. We strive to foster an inclusive culture built around diversity of thought and mutual respect. We lead with inclusion and empower our team members to do their best work as their most authentic selves.
Passionate people who want to make a difference drive our culture. Our team members are grounded in integrity, have a strong capacity to learn, the energy to get things done, and bring diverse, real world experiences to help us think in new ways. We actively invest in our team members to support their long-term growth so they can continue to advance our mission and achieve their highest potential.
Join a team committed to taking big leaps forward for a global community of healthcare professionals and their patients. Together, lets advance the world of minimally invasive care.
Job Description
*Please note: Candidates must live within or be willing to relocate to the Providence, RI Area to perform the duties of this role.
Primary Function of Position
The Clinical Territory Associate (CTA) is a 24+ month developmental role that will partner with the Providence, RI team to gain knowledge in all aspects of our business to include technical, clinical, and sales.
Essential Job Duties (Specific responsibilities and tasks an individual would be expected to perform in the role. Additional job duties may be determined by functional people manager)
Assists sales representatives with surgeon trainings, hospitals robotic development, and overall territory management
Guides technical in-services for customers to include OR staff, surgeons, etc.
Sells benefits of advanced technology to existing robotic users to contribute to team overall quotas
Gains experience in goal setting, mapping, and attaining in preparation for quota bearing role to follow CTA position
Manages administrative tasks: reporting of sales/procedures, outcomes of sales activities, submission of expense reports
Qualifications
Required Skills and Experience (Specific skills, knowledge, and experience that an individual must possess in order to successfully perform in job)
Minimum 1-year leadership (military) experience or 1 year of outside sales experience required
Ability to travel up to 25%, and work nights and weekends as needed
Required Education and Training (As applicable - Specific education and training that an individual must possess in order to successfully perform in job)
Bachelor's degree required
Working Conditions (As applicable - Any physical requirements for the job. If not applicable, state “none”)
None
Preferred Skills and Experience (As applicable - Specific skills, knowledge, and experience that are not required to perform the job, but are desirable to have)
Proven record of success
Ambition and exceptional work ethic
Ability to excel in a high-energy, fast-paced environment
Excellent interpersonal skills and persuasive communication skills
Proven ability to work effectively as part of a team
Additional Information
Due to the nature of our business and the role, please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19. Details can vary by role.
Intuitive is an Equal Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws.
Mandatory Notices
We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.
We provide market-competitive compensation packages, inclusive of base pay + commission, benefits, and equity. The on target earnings for this position are listed.
R&D Project Coordinator
Clinical research coordinator job in Warren, RI
Blount Fine Foods is seeking a Project Coordinator to support our Project Manager in executing and delivering key initiatives specific to licensed and owned brand consumer packaged goods (CPG). This role is critical in ensuring projects are completed on time, within scope, and aligned with both Blount and our brand partner's standards. In the event of an absence, position will be filled by trained personnel.
Duties/Responsibilities
Assist the Project Manager in planning, executing, and closing CPG projects across the development, commercialization, product management, and sales support processes.
Compile all relevant project information for the commercialization team to utilize during setup and launch phases. Assist in product set-up, when needed.
Create and monitor detailed project timelines, communicating all changes to appropriate stakeholders in a timely manner. Track project deliverables using project management tools.
Supply all appropriate information to the Project Manager to ensure effective communication with the sales team and customers.
Prepare and maintain project documentation including project scope, status reports, meeting minutes, and timelines at risk.
Facilitate communication between stakeholders and escalate issues as needed.
Monitor transition projects to minimize waste by collaborating with procurement and production for effective change management.
Support procurement and logistics for project-related materials and scheduling.
Work with Regulatory team to ensure compliance with FDA/USDA regulations for new products and label updates.
Assist in conducting post-project evaluations and continuous improvement initiatives.
Other responsibilities w/ similar skill and work conditions as assigned.
Responsibilities for Food Safety
Responsible for completing required paperwork accurately and honestly as applicable.
Must adhere to all corporate GMPs (Good Manufacturing Practices), established SOPs (Standard Operating Procedures) and all Food and Employee Safety policies.
Must adhere to all Allergen control programs and procedures as applicable.
Responsible for reporting suspicious packages, activities, and individuals.
If monitoring CCPs (Critical Control Points), must be trained in HACCP (Hazard Analysis Critical Control Point) and adhere to approved HACCP plan(s).
Required Skills/Abilities
2-year degree in Project Management, Business, or related field: or two years of experience in project coordination, preferably in food manufacturing: or an equivalent combination of education and experiences.
Strong organizational, time management, and communication skills.
Proficiency in Microsoft Office Suite and project management software (e.g., Wrike).
Knowledge of food regulatory compliance is a plus.
Experience with Lean Manufacturing or Six Sigma methodologies.
Familiarity with ERP systems (e.g., SAP, Oracle).
Bilingual (English/Spanish) is a plus.
Education and/or Experience
A Bachelor of Science and/or Business from a four-year college: or two years related experience or an equivalent combination of education and experience to perform successfully in the position.
Certificates, Licenses, Registrations
This position requires the ability to travel; pre-employment and screening of Motor Vehicle Record every two years and personal automobile insurance coverage in accordance with the Blount Fine Foods Employee Handbook.
Physical Requirements
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this Job, the employee is regularly required to talk or hear. The employee is frequently required to stand; walk; sit and taste or smell. The employee is occasionally required to use hands to finger, handle, or feel; reach with hands and arms; climb or balance and stoop, kneel, crouch, or crawl. The employee must occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, depth perception and ability to adjust focus.
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.
While performing the duties of this Job, the employee is occasionally exposed to wet and/or humid conditions; moving mechanical parts; high, precarious places; toxic or caustic chemicals and extreme cold. The noise level in the work environment is usually moderate.
The noise level in the work environment is usually quiet.
Auto-ApplySenior Clinical Research Associate - West Coast - Oncology - FSP
Clinical research coordinator job in Providence, RI
The Senior Clinical Research Associate (SrCRA) has local responsibility for the delivery of the studies at allocated sites and is an active participant in the local study team(s). The SrCRA works in close collaboration with other CRAs and the Local Study Team/ Local Study Associate Director (LSAD) to ensure that study commitments are achieved in a timely and efficient manner. The SrCRA acts as the main contact with the study site and has the responsibility for monitoring the study conduct to ensure proper delivery of the study.
The SrCRA is responsible for the preparation, initiation, monitoring, and closure of assigned sites in clinical studies, in compliance with Client Procedural Documents, international guidelines such as ICHGCP, and relevant local regulations and that the sites deliver according to their respective commitment in the individual studies.
The SrCSA performs all the duties of the CRA with higher proficiency, independency, accountability, and ability to take on additional tasks or tutor more junior personnel.
A SrCRA with longer tenure and experience may take on additional responsibilities that include additional tasks associated with LSAD.
**Key Accountabilities:**
**Site Management Responsibilities**
+ Contributes to the selection of potential investigators.
+ In some countries, as required, SrCRAs are accountable for study start-up and regulatory maintenance. Tasks may include Site Qualification Visits, collection, preparation, review and tracking of documents for the application process; submission of proper application/documents to EC/IRB and to Regulatory Authorities for start-up and for the duration of the study.
+ Trains, supports, and advises Investigators and site staff in study related matters, including Risk Based Quality Management (RbQM) principles.
+ Confirms that site staff have completed and documented the required training appropriately, including ICH-GCP training, prior to and for the duration of the study. Ensures the sites are always inspection ready.
+ Actively participates in Local Study Team (LST) meetings.
+ Contributes to National Investigators meetings, as applicable.
+ Initiates, monitors, and closes study sites in compliance with Client Procedural Documents. Shares information on patient recruitment and study site progress (site quality/performance) within the LST.
+ Drives performance at the sites. Proactively identifies and ensures timely resolution to study-related issues and escalates them as appropriate.
+ Updates CTMS and other systems with data from study sites as per required timelines.
+ Manages study supplies (Investigator Site File (ISF), etc.), drug supplies and drug accountability at study site. Prepares study drug for destruction, if applicable.
+ Performs monitoring visits (remote and onsite), as well as remote data checks, in accordance with the timelines specified in the study specific Monitoring Plan. If required, determines and discusses with LSAD the correct timing and type of visits.
+ Performs Source Data Review (SDR), Case Report Form (CRF) review and Source Data Verification (SDV), in accordance with the Monitoring Plan.
+ Performs regular Site Quality Risk Assessments and adapts monitoring intensity accordingly during the study.
+ Ensures data query resolution in a timely manner.
+ Works with data management to ensure robust quality of the collected study data.
+ Ensures accurate and timely reporting of Serious Adverse Events and their follow ups.
+ Prepares and finalizes monitoring visit reports in CTMS and provides timely feedback to the Principal Investigator, including follow-up letter, within required timelines and in line with Client SOP.
+ Follows up on outstanding actions with study sites to ensure resolution in a timely manner.
+ Follows quality issue processes by escalating systematic or serious quality issues, data privacy breaches, Clinical Study Protocol (CSP) or ICH-GCP compliance issues to Local Management and/or Clinical Quality Management (CQM) as required.
+ Assists site in maintaining inspection ready ISF.
+ Prepares for and collaborates with the activities associated with audits and regulatory inspections in liaison with LSAD and Clinical Quality Associate Director (CQAD).
+ Ensures timely collection/uploading of essential documents into the eTMF in accordance with ICHGCP, Client SOPs and local requirements. Supports/participates in regular QC checks performed by LSAD or delegate.
+ Ensures that all study documents under their responsibility (i.e., site documents, relevant communications, etc.) are available and ready for final archiving and completion of local part of the eTMF.
+ Provides feedback on any research related information including sites/investigators/competing studies that might be useful for the local market.
+ Collaborates with local Medical Scientific Liaisons (MSLs) as directed by LSAD or line manager
**Skills (Essential):**
+ Excellent attention to detail.
+ Good written and verbal communication skills.
+ Good collaboration and interpersonal skills.
+ Good negotiation skills.
+ Proficient in written and spoken English language required.
+ Fluency in local language(s) required.
**Skills (Desirable):**
+ Ability to work in an environment of remote collaborators. Manages change with a positive approach for self, team and the business. Sees change as an opportunity to improve performance and add value to the business.
+ Ability to look for and champion more efficient and effective methods/processes of delivering quality clinical trials with reduced budget and in less time.
+ Good analytical and problem-solving skills.
+ Demonstrates ability to prioritize and manage multiple tasks with conflicting deadlines.
+ Ability to understand the impact of technology on projects and to use and develop computer skills while making appropriate use of systems/software in an e-enabled environment.
+ Team oriented and flexible; ability to respond quickly to shifting demands and opportunities Knowledge and Experience (Essential):
+ Excellent knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDP. - Good knowledge of relevant local regulations.
+ Good medical knowledge and ability to learn relevant Client Therapeutic Areas.
+ Basic understanding of the drug development process.
+ Good understanding of Clinical Study Management including monitoring, study drug handling and data management.
**Knowledge and Experience (Desirable):**
+ Familiar with risk-based monitoring approach including remote monitoring.
+ Good cultural awareness.
**Education:**
+ Bachelor's degree in related discipline, preferably in life science, (or equivalent adapted to local country market needs), that supports skills and capabilities of the position and ensures successful conduct of responsibilities and appropriate interactions with internal and or external customers.
**Other:**
+ Ability to travel nationally/internationally as required.
+ Valid driving license per country requirements, as applicable
\#LI-REMOTE
EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
Research Nurse
Clinical research coordinator job in Providence, RI
SUMMARY: Under general supervision, and according to established policies and procedures, assists in the identification, recruitment and follow up of patients participating in a clinical research project. Assists in promoting, explaining and implementing clinical investigation studies. Collects data and monitors patients' programs, assuring adherence to established protocols. Recommends changes when indicated. May administer medications or perform other related functions as part of study requirements. Brown University Health employees are expected to successfully role model the organization's values of Compassion, Accountability, Respect, and Excellence as these values guide our everyday actions with patients, customers and one another. In addition to our values, all employees are expected to demonstrate the core Success Factors which tell us how we work together and how we get things done. The core Success Factors include: Instill Trust and Value Differences Patient and Community Focus and Collaborate RESPONSIBILITIES: Assists research physician in identification of patients meeting criteria for involvement in specific clinical investigation studies, assuring all requirements for protocol eligibility have been met. May contact appropriate physician to explain study and gain cooperation. Facilitates obtaining informed consent of patient following guidelines set forth by Patient Protection Committee. Establishes and/or maintains record for each participant, abstracting pertinent information from medical record. Maintains regular contact with patient and members of health care team to monitor adherence to protocols, continuously reviewing patient records and data collection sheets, alerting physician when laboratory studies, follow up data, etc. are due. May have direct patient contact to administer medications, obtain specimens, perform EKG's or other related functions as appropriate for the specific study project. Continuously evaluates patient's response to treatment. Alerts appropriate members of health care and/or research team to any abnormalities or problems associated with patient's response to research protocols. Maintains and enhances professional expertise through participation in appropriate educational activities. MINIMUM QUALIFICATIONS: Licensure as Registered Nurse in the State of Rhode Island by the Rhode Island Board of Nursingorlicensure as a Registered Nurse in accordance with the Nurse Licensure Compact agreement of the National Council of State Boards of Nursing. BASIC KNOWLEDGE: Graduation from an accredited School of Nursing. Must have current licensure to practice as a Registered Nurse in the State of Rhode Island. A professional level of knowledge in nursing to assess patients' eligibility for study inclusion and to assess response to treatment. Interpersonal skills to effectively interact with patients, physicians and research investigators. Organizational ability to develop and maintain records for study patients. Analytical ability to assess abnormalities or problems with protocols. Demonstrated knowledge and skills necessary to provide care to patients with consideration of aging processes, human development stages and cultural patterns in each step of the care process. EXPERIENCE: At least one year on-the-job experience as a staff nurse in an area related to the specific research project in order to gain professional skills to function with little direct supervision. Up to three months on-the-job training to become familiar with research projects. WORK ENVIRONMENT AND PHYSICAL REQUIREMENTS: Some exposure to patient care environments. Some walking between patient care areas. SUPERVISORY RESPONSIBILITY: None
Pay Range:
$35.00-$70.00
EEO Statement:
Brown University Health is committed to providing equal employment opportunities and maintaining a work environment free from all forms of unlawful discrimination and harassment.
Location:
593 Eddy Street - Hasbro - N/A Providence, Rhode Island 02903
Work Type:
Flexible based on study needs. 8:00-12:30 or 12:00-4:30
Work Shift:
Day
Daily Hours:
4 hours
Driving Required:
No
Clinical Coordinator (Gastroenterology) PD
Clinical research coordinator job in Providence, RI
Job Summary: The Clinical Coordinator is responsible for the daily oversight of the patient care related activities for Women's Digestive Health. Provides direct patient care and patient education as well as supervises and facilitates the clinical work of the patient care and other clinical support staff. Resolves issues related to clinical operations, investigates patient care management problems, and provides administrative support in maintaining appropriate records, education, and ensuring compliance with all clinically related policies and regulatory agencies.
Specifications: Bachelors of Science in Nursing (BSN) degree. Must have and maintain licensure as a Registered Nurse (RN) in the State of Rhode Island. Supervisory management experience in a hospital/health care environment/physician's office preferred. Strong leadership and human relations skills required; must possess excellent oral/written communication skills and knowledge of computer applications.
Care New England Health System (CNE) and its member institutions Butler Hospital, Women & Infants Hospital, Kent Hospital, VNA of Care New England, Integra, The Providence Center, and Care New England Medical Group, and our Wellness Centerare trusted organizations fueling the latest advances in medical research, attracting the nations top specialty-trained doctors, and honing renowned services and innovative programs to engage in the important discussions people need to have about their health.
Americans with Disability Act Statement: External and internal applicants, as well as position incumbents who become disabled must be able to perform the essential job-specific functions either unaided or with the assistance of a reasonable accommodation, to be determined by the organization on a case-by-case basis.
EEOC Statement: Care New England is an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.
Ethics Statement: Employee conducts himself/herself consistent with the ethical standards of the organization including, but not limited to hospital policy, mission, vision, and values
WIH Internal Posting Period:
Clinical Research Associate / Senior Clinical Research Associate - Oncology - US - FSP
Clinical research coordinator job in Providence, RI
**Job Purpose:** The Senior Clinical Research Associate I (Sr. CRA) is responsible for the site management, site monitoring and close-out of assigned clinical trials investigator sites to ensure patient safety and quality study execution in accordance with applicable prevailing laws, Good Clinical Practices (GCP), and sponsor standards. The Sr. CRA is accountable for site management and monitoring, managing investigator site relationships to ensure effective delivery of clinical trials (e.g. enrollment, database release), to safeguard the quality of investigator sites (e.g. patient safety, site quality and compliance with GCP), to maintain investigator and site staff engagement and satisfaction, and to enhance the company's image with its external stakeholders. The Sr. CRA is responsible for the resolution of all protocol-related issues for assigned investigator sites and will work closely with the Site Care Partner (SCP), and other members of the study team, as required, in activities associated with the set-up, running and close-out of sites in a clinical trial.
**Key Accountabilities:**
**Oversight of Monitoring Responsibilities and Study Conduct**
+ Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan (SMP) and applicable prevailing laws, GCP, and sponsor standards to achieve project goals, timelines and quality
+ Manage assigned operational aspects for implementation of clinical trial activities at assigned investigator sites from site activation through to database lock, ensuring relevant timelines and quality deliverables are met
+ During study conduct, serve as the primary point of contact for assigned investigator sites. Work in partnership with and/or escalate to the SCP to ensure quality of site delivery
+ Interface with the study team as needed, facilitate information flow between members of the study team, vendors and assigned investigator sites
+ Partner with SCP to perform investigator site development, coaching and training of site personnel to ensure ongoing compliance with protocol and the safeguarding of patients; provide protocol training to, and address protocol related questions from the investigator site staff when required, including discussions on known/anticipated operational and clinical trial risks
+ Attend investigator meeting when required (virtual or F2F). Provide enrollment support and ensure progress by responding to site activation and
+ recruitment issues from investigators. Partner with SCP and the study team to define and support recruitment initiatives at site level
+ Conduct onsite, remote/electronic monitoring as needed for study site initiation, routine monitoring and study site closure activities and ensure these are conducted accordance to the SMP, Standard Operating Procedures (SOPs) and commensurate with emerging issues and technologies
+ Monitor site level adverse events (AEs) and serious adverse events (SAEs) and collaborate with the Drug Safety Unit and follow-up with investigators sites, as needed, to bring SAE reports required information to resolution
+ Submit all required reports, documentation, updates and tracking within required timeframes, including but not limited to Trial Master File (TMF) documentation, site reports, site follow up letters, protocol deviations, patient recruitment, clinical supply management, study progress and metrics
+ Identify and resolve investigator site issues within required timeframes; agree and develop corrective and preventative actions with investigator and site personnel to close open issues and to prevent recurrence/persistence of issues
+ Resolve data queries within required timelines, prepare investigator site close-out plan and conduct close-out activities within required timelines
+ Ensures adequate oversight of the investigational product at the investigator site, including receipt, handling, accounting, storage conditions, and destruction activities
+ Support database release as needed
+ May undertake the responsibilities of an unblinded monitor where appropriate
**Clinical/Scientific and Site Monitoring Risk**
+ Maintain thorough understanding of the product, protocol and therapy area in sufficient details to have appropriate discussions with the investigator and site team
+ Interact with investigator site heath care professionals in a manner which enhances sponsor's credibility, scientific leadership and in order to facilitate sponsor's clinical development goals
+ Support the study clinician in ensuring patient safety, eligibility and providing clinical guidance to investigators
+ Drive Quality Event (QE) remediation, when applicable
+ Serve as a point of contact for audit conduct, and drive Audit Observation corrective action/preventive action (CAPA) development and checks, when applicable
**Collaboration**
+ Reports to Director of Clinical Site Operations (DCSO) or Director of Site Management and Monitoring (DSMM)
+ Partners with SCP and Country Study Operations Manager (SOM)
+ When required Partners with other Study Team members (e.g. Clinician, Recruitment Specialist, Clinical Data Scientist)
+ May act as a Mentor for Clinical Research Associates
**Skills:**
+ Monitoring Experience: Minimum 3 years relevant experience in clinical research site monitoring (preferably 2 years in Oncology) in a CRO or pharma organization
+ Preferred therapeutic experience in Oncology
+ Global clinical trial experience preferred
+ Extensive knowledge of clinical trial methodologies, ICH/GCP, Food and Drug Administration (FDA) and local country regulations
+ Must be fluent in English and in the native language(s) of the country they will work in
+ Travel (60-80%) within area is required
+ Valid driver's license and passport required
**Knowledge and Experience:**
+ Demonstrated knowledge of clinical research and development processes and ability to gain command of process details
+ Demonstrated knowledge of global and local regulatory requirements
+ Demonstrated understanding of key operational elements of clinical research (e.g., monitoring, data acquisition and cleaning, reporting, etc.)
+ Demonstrated knowledge in disease and technical areas pertaining to clinical studies, including knowledge of company direction, investigational product(s), and associated development plan(s)
+ Demonstrated ability to support sponsor regulatory interactions/inspections
+ Demonstrated knowledge of the processes around protocol design and feasibility assessment
+ Demonstrated understanding of region/country, culture, and medical practice and how they affect clinical trial delivery
+ Proven ability to work in a matrix team environment with the ability to influence, drive / lead and work through others for successful delivery of clinical trial
+ Ability to evaluate, interpret and present complex issues and data to support risk management and mitigation
+ Effective verbal and written communication skills in relating to colleagues and associates both inside and outside of the organization
**Education:**
+ Bachelor's degree in life sciences or professional degree in life sciences such as nursing, pharmacy, medical is required
\#LI-CF1
\#LI-REMOTE
EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
Clinical Coordinator - Float
Clinical research coordinator job in Woonsocket, RI
At Landmark Medical Center, our dedicated team of professionals is committed to our core values of quality, compassion, and community. As a member of Prime Healthcare, Landmark Medical Center is actively seeking new members to join its award-winning team!
Landmark Medical Center is a 214-bed acute care hospital in Woonsocket, RI. The hospital has been "A"rated for patient safety by The Leapfrog Group and has received numerous Healthgrades awards for patient safety excellence, heart care, and orthopedics. Originally known as the "Woonsocket Hospital," Landmark Medical Center has been serving the communities of northern Rhode Island and southern Massachusetts since 1873. Learn more at ************************
Responsibilities
The Clinical Coordinator supports clinical and administrative responsibilities for the acute care units. In collaboration with unit directors and department of education, develops and implements plans related to the onboarding, orientation and training of staff. Coordinates the orientation of the new hire by acting as preceptor as needed and meeting daily with the preceptor and orientee to review progress and address any learning gaps. Oversees the clinical performance of staff, delivered on the shift. Acts as a mentor to staff by providing bedside education and assistance. Acts as first line supervisor by directing, supervising and evaluating performance and providing feedback and conflict resolution. Acts as RN resource during codes. Provides direct patient care during volume surges, increased patient acuity or staffing needs. Collaborates with the house supervisor to facilitate patient flow, address patient complaints and conduct patient rounds. Participates in performance improvement activities including medical record reviews and environment of care rounds.
Qualifications
EDUCATION, EXPERIENCE, TRAINING
1. Must have current and valid license as a Registered Nurse issued by the state.2. BCLS and ALS ( AHA, ARC) upon hire and maintain current.3. Five (5) previous acute care hospital experience preferred.4. Bachelor Degree in Nursing preferred.5. Knowledge of Microsoft Word, Excel preferred.
Employment Status
Full Time
Shift
Days
Equal Employment Opportunity
Company is an equal employment opportunity employer. Company prohibits discrimination against any applicant or employee based on race, color, sex, sexual orientation, gender identity, religion, national origin, age (subject to applicable law), disability, military status, genetic information or any other basis protected by applicable federal, state, or local laws. The Company also prohibits harassment of applicants or employees based on any of these protected categories. Know Your Rights: ********************************************************************************************
Auto-ApplySpecialist, Clinical Business Operations, Oncology
Clinical research coordinator job in Providence, RI
Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn.
**Job Duties and Responsibilities**
+ Collaborate effectively with key internal and external stakeholders at the departmental and cross-department levels leading the creation and execution of Confidential Disclosure Agreements (CDA).
+ Assist with the entry of Contractual Agreements into an electronic document repository.
+ Ensure all outsourcing decisions are properly documented, compliant, and audit-ready.
+ Manage and/or facilitate issue escalations at the operational level and ensure timely escalation to senior leadership when appropriate.
+ Work cross-functionally with clinical teams, Finance and Legal, towards solutions; process, and communication improvements.
+ Perform other duties as requested.
**Key Core Competencies**
+ Strong strategic and analytical reasoning and problem-solving ability. Able to deliver at high quality, in a fast-paced, dynamic environment and able to manage competing priorities
+ Ability to proactively identify and act on opportunities for operational efficiencies
+ Ability to work within a team as well as independently on specifically assigned tasks. The individual will be organized, detail-oriented, and will possess a financial aptitude
+ Proficient with MS Office Suite (Excel, Word and PowerPoint), Smartsheet and Contract Repository Solution
+ Excellent written and oral communication skills
**Education and Experience**
+ BA/BS preferred with at least 2 years experience, or 5 years equivalent experience
+ Clinical Operations, Project Management, Clinical Outsourcing, and/or CRO relevant industry provider Outline the relevant work experience required, including any specific industries or roles.
The base salary range for this role is $72,500 to $90,600. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law.
Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.
**Confidential Data** : All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential.
**Compliance** : Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
**Mental/Physical Requirements** : Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time.
**Sumitomo Pharma America (SMPA)** **is an Equal Employment Opportunity (EEO) employer**
Qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn.
Sumitomo Pharma America (SMPA) endeavors to make its application process accessible to all. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact SMPA at **********************************************
This contact information is for accommodation requests only and cannot be used to inquire about the status of applications.
At Sumitomo Pharma America, our work is guided by the Sumitomo Pharma mission, vision and values, which tie closely to our company's cultural pillars.
**Our** **Mission**
_To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people_ _worldwide_
**Our** **Vision**
_For Longer and Healthier Lives, we unlock the future with cutting edge technology and_ _ideas_
GME Institutional Coordinator
Clinical research coordinator job in Providence, RI
SUMMARY: Under direct supervision of the Graduate Medical Education Manager, and according to established polices and procedures, performs administrative support functions related to graduate medical education (GME) at the institutional and program levels. Provides administrative support to Alpert Medical students, as well as other visiting residents, fellows, students, and observers. Utilizes a thorough knowledge of the GME department, Hospital, Brown University Health and specific training programs to gather and interpret material, and to prepare reports and records. Participates in coordinating onboarding efforts, institutional and training program compliance with accreditation requirements (ACGME and other), Department schedules and activities, and establishment and maintenance of required filing and record systems. Acts as a resource person to training program directors, training program coordinators, other faculty and staff, residents/fellows; medical students, other visiting residents and students, as well as other Brown University Health staff. Brown University Health employees are expected to successfully role model the organization's values of Compassion, Accountability, Respect, and Excellence as these values guide our everyday actions with patients, customers and one another. In addition to our values, all employees are expected to demonstrate the core Success Factors which tell us how we work together and how we get things done. The core Success Factors include: Instill Trust and Value Differences Patient and Community Focus and Collaborate RESPONSIBILITIES: Performs a variety of administrative tasks relative to collection, organization, preparation, distribution and record keeping of large volumes of information necessary to meet documentation and information requirements of graduate medical education training program specifications. Please refer to position specific addenda. Utilizing a thorough knowledge of the Hospital, Brown University Health, accreditation requirements and GME department policies and procedures, acts as a resource person to all GME related training program directors, training program coordinators, other faculty and staff, residents/fellows; as well as medical students, other visiting residents and students, as well as other Brown University Health staff. Acts to resolve matters independently within the scope of responsibility and authority. Creates and distributes correspondence, forms, statistical analyses, agendas and reports, including large volumes of material related to department and/or training programs for GME department members, training program faculty and staff, and regulatory or accrediting agencies. Develops, maintains and revises, as necessary, records and filing systems, including updating department manuals and documents as instructed. Maintains GME statistics as required by the Department, Brown University Health and outside agencies. May tabulate data and perform statistical analyses to prepare reports. Manages departmental records, including those needed for major national organizations, including confidential information. Initiates, files, updates and purges records as necessary including data entry, storage and retrieval. Provides reports and verifications to organizations as requested. Answers the telephone and receives visitors to GME. Ascertains customers' needs, establishes priorities and investigates issues, often resolving matters independently and on own authority. Manages departmental calendars without prior clearance for most appointments, often coordinating department managers' meetings and other obligations. Schedules, coordinates and attends inter-departmental meetings. Maintains inventory and orders office supplies at own discretion according to knowledge of usage patterns and budgeted allowances. Prepares and follows up on check requests and purchase orders. Performs other related duties as required. MINIMUM QUALIFICATIONS:
Pay Range:
$60,211.42-$99,331.96
EEO Statement:
Brown University Health is an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, ethnicity, sexual orientation, ancestry, genetics, gender identity or expression, disability, protected veteran, or marital status. Brown University Health is a VEVRAA Federal Contractor.
Location:
Rhode Island Hospital - 593 Eddy Street Providence, Rhode Island 02903
Work Type:
M-F 8:00am-4:30pm
Work Shift:
Day
Daily Hours:
8 hours
Driving Required:
No
GME Institutional Coordinator
Clinical research coordinator job in Providence, RI
SUMMARY: Under direct supervision of the Graduate Medical Education Manager, and according to established polices and procedures, performs administrative support functions related to graduate medical education (GME) at the institutional and program levels. Provides administrative support to Alpert Medical students, as well as other visiting residents, fellows, students, and observers. Utilizes a thorough knowledge of the GME department, Hospital, Brown University Health and specific training programs to gather and interpret material, and to prepare reports and records. Participates in coordinating onboarding efforts, institutional and training program compliance with accreditation requirements (ACGME and other), Department schedules and activities, and establishment and maintenance of required filing and record systems. Acts as a resource person to training program directors, training program coordinators, other faculty and staff, residents/fellows; medical students, other visiting residents and students, as well as other Brown University Health staff. Brown University Health employees are expected to successfully role model the organization's values of Compassion, Accountability, Respect, and Excellence as these values guide our everyday actions with patients, customers and one another. In addition to our values, all employees are expected to demonstrate the core Success Factors which tell us how we work together and how we get things done. The core Success Factors include: Instill Trust and Value Differences Patient and Community Focus and Collaborate RESPONSIBILITIES: Performs a variety of administrative tasks relative to collection, organization, preparation, distribution and record keeping of large volumes of information necessary to meet documentation and information requirements of graduate medical education training program specifications. Please refer to position specific addenda. Utilizing a thorough knowledge of the Hospital, Brown University Health, accreditation requirements and GME department policies and procedures, acts as a resource person to all GME related training program directors, training program coordinators, other faculty and staff, residents/fellows; as well as medical students, other visiting residents and students, as well as other Brown University Health staff. Acts to resolve matters independently within the scope of responsibility and authority. Creates and distributes correspondence, forms, statistical analyses, agendas and reports, including large volumes of material related to department and/or training programs for GME department members, training program faculty and staff, and regulatory or accrediting agencies. Develops, maintains and revises, as necessary, records and filing systems, including updating department manuals and documents as instructed. Maintains GME statistics as required by the Department, Brown University Health and outside agencies. May tabulate data and perform statistical analyses to prepare reports. Manages departmental records, including those needed for major national organizations, including confidential information. Initiates, files, updates and purges records as necessary including data entry, storage and retrieval. Provides reports and verifications to organizations as requested. Answers the telephone and receives visitors to GME. Ascertains customers' needs, establishes priorities and investigates issues, often resolving matters independently and on own authority. Manages departmental calendars without prior clearance for most appointments, often coordinating department managers' meetings and other obligations. Schedules, coordinates and attends inter-departmental meetings. Maintains inventory and orders office supplies at own discretion according to knowledge of usage patterns and budgeted allowances. Prepares and follows up on check requests and purchase orders. Performs other related duties as required. MINIMUM QUALIFICATIONS:
Pay Range:
$60,211.42-$99,331.96
EEO Statement:
Brown University Health is committed to providing equal employment opportunities and maintaining a work environment free from all forms of unlawful discrimination and harassment.
Location:
Rhode Island Hospital - 593 Eddy Street Providence, Rhode Island 02903
Work Type:
M-F 8:00am-4:30pm
Work Shift:
Day
Daily Hours:
8 hours
Driving Required:
No