![Ohio Health](https://media.trabajo.org/img/noimg.jpg)
Senior Clinical Research Coordinator
2 months ago
We are more than a health system. We are a belief system. We believe wellness and sickness are both part of a lifelong partnership, and that everyone could use an expert guide. We work hard, care deeply and reach further to help people uncover their own power to be healthy. We inspire hope. We learn, grow, and achieve more - in our careers and in our communities.
Job Description SummaryThe Senior Clinical Consultant Research works in collaboration with the Principal Investigator (PI) to coordinate assigned clinical research studies in accordance with Good Clinical Practice (GCP) guidelines and federal regulations. This position performs day to day activities related to clinical research studies including: recruit and screen participants, obtains informed consent, educate participants regarding study requirements, event reporting and complete case report forms. This position performs activities independently, consistently and accurately and demonstrates skills and abilities resulting in high quality work. This position applies these skills to a broad range of different type of clinical studies, navigates available resources appropriately, effectively uses all tools at their disposal and operates e-technology proficiently. The Senior Clinical Consultant Research performs the majority of activities independently and performs quality checks of their work. This position serves as a formal and informal leader of multidisciplinary teams establishing and maintaining communications with Investigator, research team, sponsor, and other applicable individuals/groups.
Minimum QualificationsBachelor's Degree (Required)
- Degree required from a four year college or university
- Two years of direct human subjects research
- Two years of direct clinical research experience
SPECIALIZED KNOWLEDGE
- Applies critical thinking and creative problem solving skills across a wide variety of clinical studies
- Ability to prioritize the work of multiple projects.
- Experience in a team setting.
- Strong verbal and written communication skills, as well as customer service skills and ability to problem solve, prioritize and manage multiple tasks
- Strong computer skills, including thorough knowledge of systems (EMR, Microsoft)
DESIRED ATTRIBUTES
- Clinical Research Coordinator Certification (or equivalent approved Clinical Research Certification)
- Three or more years of direct human subjects research
- Clinical knowledge in assigned therapeutic area or program
MAJOR DUTIES/RESPONSIBILITIES & ESSENTIAL FUNCTIONS
Study Planning and Coordination
Implements the requirements of clinical research protocols in compliance with local, state, institutional, Federal (FDA, DHHS) and sponsor requirements.
Accountable to PI for study specific responsibilities and functions with assistance on multiple clinical research studies.
Works closely with PI to organize, plan and carryout the research in an efficient and timely manner.
Assists with protocol feasibility, resource requirements and study panning activities including leading internal training to implement the protocol and avoid deviations.
Develop and plan recruitment procedures for potential participants and oversee the enrollment of the clinical trial as directed by the PI.
Ensures that study parameters are correctly applied prior to a research participant enrolling a study and during the research participant's visits and assessments.
Extracts and records physical findings, laboratory data and other details essential to each study onto the required data collection forms accurately and within the designated time period
Attends investigator's meetings, pre-study site visits which may require travel, study initiation visits, and all other study-related visits by monitors or Sponsor representatives.
As needed, organize and/or participate in-house protocol meetings to review study-related procedures, staffing and visit flow.
Participates in the ongoing Informed Consent process with the Investigator to ensure that research participants and their families (if applicable) have their questions answered and understand the consent form, as well as participant's responsibilities in the study.
Responsible for giving participant instructions and serves as the primary contact for subjects by being available to handle study specific questions, concerns or events.
Accurately records and extracts data from source documentation onto report forms (paper or electronic) in a timely manner. Maintains accurate and timely source documentation.
After closeout visits have been conducted, prepares study documents for archiving according to timelines.
Responsible for in-depth knowledge of protocol requirements and GCP guidelines.
Performs other related duties as assigned or required.
Patient Care
Works with nursing and clinical staff and applies skills and knowledge to facilitate the care of research participants.
Works with nursing and clinical staff and utilizes knowledge of disease processes to observe and report adverse events and protocol violations/deviations in a timely and accurate manner to the Investigator to ensure the health, safety and welfare of the participant.
Quality and Compliance
Assume responsibility for audit preparedness activities for OHRI.
Oversees the preparation of records for periodic audits by sponsors, CROs, regulatory agencies, and internal reviews.
Assists with monitoring visits on site and is available during visits for corrections, questions, etc.
Maintains study records according to sponsor and/or regulations.
Keep records in a secure location.
Reporting
Assist in the development of reporting metrics.
Generates reports and reviews to ensure validity of data.
Provide ad hoc reports.
Communication
Demonstrates effective communications and leadership skills.
Communicates information in a timely and accurate manner with minimal supervision.
Functions as a liaison with sponsor and investigator regarding the preparation, execution and completion of studies.
Adapts communication skills in response to various situations including those related to differences in culture, age, education and other communication barriers.
Uses various media forms to maximize communication success.
Demonstrates teamwork characteristics.
Ability to manage time, prioritize and follow up on projects as necessary taking into consideration the need for flexibility when working on multiple projects.
Participates in meetings with OHRI, PI and clinical teams to review patient status at a detailed level.
Develops strategies and recommends initiatives/improvements to Manager, Research to meet the needs of OHRI and using resources wisely to achieve maximum results.
Oversee and monitor tasks which impact a process or policy change for the department.
Work with research staff to effectively communicate patient process for each trial for the life of the study.
Advise, communicate and reinforce standard practices, regulations to following regarding research study participation.
Mentorship of the clinical research process to the junior clinical research staff.
Role models best practices and fosters leadership development with the team.
Other
Attends relevant training courses on policy and compliance.
Ensures assigned training is complete and meets internal qualifications.
Responsible for completing all necessary training for their position.
Maintain familiarity with evolving regulatory and compliance context.
Other duties as assigned.
Work ShiftDay
Scheduled Weekly Hours40
Department
Oncology Research Clinical Services
Join us
. if your passion is to work in a caring environment
. if you believe that learning is a life-long process
. if you strive for excellence and want to be among the best in the healthcare industry
Equal Employment Opportunity
OhioHealth is an equal opportunity employer and fully supports and maintains compliance with all state, federal, and local regulations. OhioHealth does not discriminate against associates or applicants because of race, color, genetic information, religion, sex, sexual orientation, gender identity or expression, age, ancestry, national origin, veteran status, military status, pregnancy, disability, marital status, familial status, or other characteristics protected by law. Equal employment is extended to all person in all aspects of the associate-employer relationship including recruitment, hiring, training, promotion, transfer, compensation, discipline, reduction in staff, termination, assignment of benefits, and any other term or condition of employment
-
Clinical Research Coordinator I
1 month ago
Columbus, Ohio, United States Nationwide Children's Hospital Full timeOverview We are seeking a part-time Clinical Research Coordinator to join Principal Investigator Dr Sarah O'Brien's research laboratory. Delayed diagnosis of bleeding disorders in women is an important public health issue. Dr O'Brien's research focuses on the intersections between women's health and hematology and seeks to improve recognition of bleeding...
-
Clinical Research Nurse Specialist
3 hours ago
Columbus, Ohio, United States Ohio State University Wexner Medical Center Full timeJob SummaryWe are seeking a highly skilled and organized Clinical Research Nurse to join our team at the Ohio State University Wexner Medical Center. The successful candidate will be responsible for coordinating and performing daily clinical research activities in accordance with approved protocols.Key ResponsibilitiesCoordinate and manage clinical aspects...
-
Research Compliance Coordinator
1 week ago
Columbus, Ohio, United States The Ohio State University Full timeCurrent Employees and Students If you are currently employed or enrolled as a student at The Ohio State University, please log in to Workday to use the internal application process. Welcome to The Ohio State University's career site. We invite you to explore available positions. To ensure your application is complete, please follow these steps: ...
-
Clinical Research Associate
1 week ago
Columbus, Ohio, United States InsideHigherEd Full timePosition Title: Junior Research ScientistDepartment: Medicine | Surgical OncologyA dedicated Research Associate is sought to contribute to a pioneering research facility. This role encompasses the planning, design, and oversight of research initiatives with a primary focus on pancreatic cancer. Key responsibilities include:Collecting and processing...
-
Research Compliance Coordinator
3 days ago
Columbus, Ohio, United States The Ohio State University Full timeCurrent Employees and Students: If you are currently employed or enrolled as a student at The Ohio State University, please log in to Workday to use the internal application process. Welcome to The Ohio State University's career site. We invite you to explore positions of interest. To ensure your application is complete, please follow these steps: Gather all...
-
Research Compliance Coordinator
3 days ago
Columbus, Ohio, United States The Ohio State University Full timeCurrent Employees and Students: If you are currently employed or enrolled as a student at The Ohio State University, please log in to Workday to use the internal application process. Welcome to The Ohio State University's career site. We invite you to explore available positions of interest. To ensure your application is thorough, please follow these steps:...
-
Research Compliance Coordinator
3 days ago
Columbus, Ohio, United States The Ohio State University Full timeCurrent Employees and Students If you are currently employed or enrolled as a student at The Ohio State University, please log in to Workday to use the internal application process. Welcome to The Ohio State University's career site. We invite you to explore available positions that align with your interests. To ensure your application is thorough, please...
-
Research Compliance Coordinator
3 days ago
Columbus, Ohio, United States The Ohio State University Full timeCurrent Employees and Students If you are currently employed or enrolled as a student at The Ohio State University, please log in to Workday to use the internal application process. Welcome to The Ohio State University's career site. We invite you to explore positions that align with your interests. To ensure your application is thorough, please...
-
Clinical Research Scientist
3 days ago
Columbus, Ohio, United States The Ohio State University Full timeCurrent Employees and Students: If you are currently employed or enrolled as a student at The Ohio State University, please log in to Workday to use the internal application process. Welcome to The Ohio State University's career site. We invite you to apply to positions of interest. In order to ensure your application is complete, you must complete the...
-
Columbus, Ohio, United States InsideHigherEd Full timeSenior Research Associate - Lung Injury Research InitiativeInsideHigherEd is looking for a **Senior Research Associate** to contribute to our **Lung Injury Research Initiative**. This initiative is dedicated to exploring the underlying mechanisms of lung damage and recovery utilizing cutting-edge molecular, biochemical, and clinical methodologies. The...
-
Senior Research Investigator
1 week ago
Columbus, Ohio, United States Ohio State University Wexner Medical Center Full timePosition OverviewThe Ohio State University Wexner Medical Center is seeking a Senior Research Investigator to lead innovative research initiatives within the Department of Microbial Infection and Immunity. This role emphasizes the exploration of biofilms and their implications in dental and orthopedic conditions.Key ResponsibilitiesConduct independent and...
-
Clinical Research Operations Manager
1 week ago
Columbus, Ohio, United States The Ohio State University Full timeCurrent Employees and Students: If you are currently employed or enrolled as a student at The Ohio State University, please log in to Workday to use the internal application process. Welcome to The Ohio State University's career site. We invite you to apply to positions of interest. In order to ensure your application is complete, you must complete the...
-
Clinical Research Team Leader
1 week ago
Columbus, Ohio, United States Ohio State University Wexner Medical Center Full timePosition OverviewThe Clinical Research Team Leader oversees a dedicated group of 4-7 clinical research professionals engaged in innovative scientific exploration within the domains of health, wellness, disease management, and prevention strategies. This role is pivotal in managing the daily operations of technical, administrative, and clinical staff,...
-
Pharmacy Clinical Coordinator
8 hours ago
Columbus, Ohio, United States Columbus Regional Health Full timeJob Summary:Columbus Regional Health is seeking a highly skilled Pharmacy Clinical Coordinator to drive clinical pharmacy practice within our health system. This role will work closely with pharmacy leaders to coordinate clinical pharmacy activities, develop clinical policies, and provide educational offerings to staff.Key Responsibilities:Coordinate...
-
Clinical Research Nutrition Specialist
1 week ago
Columbus, Ohio, United States The Ohio State University Full timeAs a vital component of a translational nutrition and cancer research initiative, this position serves as a clinical research nutritionist. The role is integral to supporting clinical trials funded by the NIH and the American Cancer Society.Key Responsibilities:Designing clinical trials and obtaining necessary regulatory approvalsCreating nutrition education...
-
Clinical Research Nutrition Specialist
1 week ago
Columbus, Ohio, United States The Ohio State University Full timeThe role of a Clinical Research Nutrition Specialist is essential in a translational nutrition and oncology research initiative. This position is integral to supporting federally funded clinical trials.Key Responsibilities:Designing clinical trials and securing necessary regulatory approvalsCreating tailored nutrition education plans and associated materials...
-
Senior Clinical Informatics Specialist
8 hours ago
Columbus, Ohio, United States OhioHealth Full timeJob SummaryWe are seeking a highly skilled Senior Clinical Informatics Specialist to join our team at OhioHealth. The successful candidate will be responsible for providing expert-level support for the optimization of clinical informatics in our organization.Key ResponsibilitiesProvide technical expertise to clinical leadership and operational teams to...
-
Senior Project Coordinator
1 week ago
Columbus, Ohio, United States EMC Engineering Services Full timeJob TitleSenior Project CoordinatorLocationColumbus, GAEducationBachelor's DegreeCategoryEngineeringJob TypeFull-timeTravelSome Travel RequiredJob OverviewThe SENIOR PROJECT COORDINATOR will oversee the comprehensive management of engineering initiatives or specific project components assigned to them. This role ensures that all projects adhere to the...
-
Senior Research Consultant
1 month ago
Columbus, Ohio, United States The Ohio State University Full timeScreen reader users may encounter difficulty with this site. For assistance with applying, please contact hr- If you have questions while submitting an application, please review these frequently asked questions.Current Employees and Students:If you are currently employed or enrolled as a student at The Ohio State University, please log in to Workday to use...
-
Clinical Research Vice-Chair Position
1 week ago
Columbus, Ohio, United States The Ohio State University Wexner Medical Center Full timeThe Department of Plastic and Reconstructive Surgery at The Ohio State University Wexner Medical Center is seeking a distinguished and innovative leader to oversee a nationally acclaimed research program as the Vice-Chair of Clinical Research. This full-time, tenure-track position offers a rank and salary that reflect the candidate's qualifications and...