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Job Description Summary:

The 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.

Responsibilities And Duties:

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
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, 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.
As a High Reliability Organization (HRO), responsibilities require focus on safety, quality and efficiency in performing job duties.
The job profile provides an overview of responsibilities and duties and is not intended to be an exhaustive list and is subject to change at any time

Minimum Qualifications:

Bachelor's Degree (Required)

Additional Job Description:

• Degree required from a four year college or university
• Two years of direct human subjects research
• Twoyears 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 Shift:

Day

Scheduled Weekly Hours :

40

Department

Oncology Research Clinical Services

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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 employ...