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Clinical Research Coordinator II

  • ... Posted on: Feb 02, 2024
  • ... University of WisconsinMadison
  • ... Madison, Wiltz
  • ... Salary: Not Available
  • ... Full-time

Clinical Research Coordinator II   

Job Title :

Clinical Research Coordinator II

Job Type :

Full-time

Job Location :

Madison Wiltz United States

Remote :

Yes

Jobcon Logo Job Description :

Job Summary:

The Department of Dermatology seeks an experienced Clinical Research Coordinator II to join our team of world-renowned researchers and investigators committed to basic, clinical, and translational research designed to address dermatologic diseases and other skin-related research questions. This position will play a pivotal role in contributing to the conduct of state-of-the-art skin disease research to advance scientific knowledge and thus provide better care to patients. A summary of duties is described below.

1.Protocol Development and Review
  • Collaborating with principal investigators to develop and review research protocols.
2. Study Planning
  • Developing and implementing study timelines and milestones.
  • Creating study budgets and ensuring financial compliance.
3. Regulatory Compliance
  • Ensuring adherence to regulatory requirements and ethical standards.
  • Preparing and submitting regulatory documents to Institutional Review Boards (IRBs) and regulatory agencies.
4. Participant Recruitment and Informed Consent
  • Developing strategies for participant recruitment.
  • Obtaining informed consent from study participants.
5. Data Collection and Management
  • Overseeing the collection, verification, and management of study data.
  • Implementing data quality control measures.
6. Site Management
  • Coordinating activities at the study site.
  • Training and supervising other study staff.
7. Monitoring and Auditing
  • Conducting regular monitoring visits to ensure compliance with protocols.
  • Preparing for and participating in audits.
8. Communication
  • Serving as the primary point of contact for study sponsors, investigators, and study participants.
  • Communicating study progress to relevant stakeholders.
9. Safety Monitoring
  • Monitoring and reporting adverse events.
  • Ensuring participant safety throughout the study.
10. Documentation and Record Keeping
  • Maintaining accurate and complete study documentation.
  • Keeping records in accordance with regulatory requirements.
11. Quality Assurance
  • Implementing quality assurance processes to ensure data integrity and protocol compliance.
12. Reporting
  • Generating and submitting study progress reports to sponsors and regulatory authorities.
13. Continuous Process Improvement
  • Identifying areas for process improvement and implementing corrective actions.
14. Education and Training
  • Providing education and training to study team members.
15. Closeout Activities
  • Managing study closeout activities, including finalizing study reports and archiving study documentation.

Responsibilities:

Coordinates clinical research studies, performing a variety of tasks and activities. Recruits, screens, selects, determines eligibility, and enrolls study participants and ensures subjects follow the research protocol. Develops study-related documents. Applies expertise, knowledge, and skills to a broad range of different types of clinical studies, navigates resources, and identifies issues needing escalation. Contributes to development of new team and unit processes, procedures, staff, and tools.
  • 25% Schedules logistics, determines workflows, and secures resources for clinical research trials
  • 15% Recruits, screens, selects, determines eligibility and enrolls trial participants, collects more complex information, performs medical assessments, and answers varied questions under supervision of a medically licensed professional. Performs medical assessments after completion of required training/certification, such as collecting vital signs, obtaining weight, and performing phlebotomy
  • 5% Manages research workflow components, collects, prepares, processes, and submits participant data and samples to appropriate entities, adhering to research protocols
  • 5% Identifies work unit resources needs and manages supply and equipment inventory levels
  • 5% Serves as a main point of contact for clinical research participants, providing information regarding research procedures, expectations, and informational inquiries. Ensures participants follow the research protocol and alerts Principal Investigator of issues
  • 5% Performs quality checks
  • 15% Identifies resource needs and develops clinical research documents, such as job aids, tools, processes, procedures, and training. Contributes to the development of protocols
  • 5% May assist with training of staff
  • 10% Performs administrative duties related to managing clinical research protocols in the Department of Dermatology
  • 10% Performs clinical research finances

Institutional Statement on Diversity:

Diversity is a source of strength, creativity, and innovation for UW-Madison. We value the contributions of each person and respect the profound ways their identity, culture, background, experience, status, abilities, and opinion enrich the university community. We commit ourselves to the pursuit of excellence in teaching, research, outreach, and diversity as inextricably linked goals.

The University of Wisconsin-Madison fulfills its public mission by creating a welcoming and inclusive community for people from every background - people who as students, faculty, and staff serve Wisconsin and the world.


Education:

Preferred
Bachelor's Degree

Qualifications:

Experience:
  • Experience with clinical research regulations, including OHRP, CRMS, GCP
  • 1-2 years working in a research or clinical trials environment preferred.
  • Experience in approaching patients to discuss clinical trials and their potential participation, and obtaining informed consent preferred.
  • Demonstrated experience in scheduling, coordinating, and conducting visits and study meetings preferred.

Knowledge and Skills:
  • Reading and understanding of research principles and methodology and be able to apply that knowledge to a clinical trials environment.
  • Strong oral and written communication skills
  • Strong attention to detail.
  • Ability to interact well with patients and researchers independently.
  • Ability to use good initiative and judgement.
  • Ability to structure time to meet multiple deadlines.

License/Certification:

Preferred
Drivers License - Valid and Meets UW Risk Management Standards

Work Type:

Full Time: 100%

This position may require some work to be performed in-person, onsite, at a designated campus work location. Some work may be performed remotely, at an offsite, non-campus work location.

Appointment Type, Duration:

Ongoing/Renewable

Salary:

Minimum $45,000 ANNUAL (12 months)
Depending on Qualifications
Employees in this position can expect to receive benefits such as generous vacation, holidays, and paid time off; competitive insurances and savings accounts; retirement benefits. Benefits information can be found at (https://hr.wisc.edu/benefits/). SMPH Academic Staff Benefits flyer: (https://uwmadison.box.com/s/r50myohfvfd15bqltljn0g4laubuz7t0).

Additional Information:

This position has been identified as a position of trust with access to vulnerable populations. The selected candidate will be required to pass an initial caregiver check to be eligible for employment under the Wisconsin Caregiver Law and every four years.

The successful applicant will be responsible for ensuring eligibility for employment in the United States on or before the effective date of the appointment. University sponsorship is not available for this position.

How to Apply:

To apply for this position, please click on the \\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\"Apply Now\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\" button. You will be asked to upload a current resume/CV and a cover letter briefly describing your qualifications and experience, and a document listing contact information for three (3) references, including your current/most recent supervisor. References will not be contacted without prior notice.

Contact:

Caitlin Staley
caitlin.staley@wisc.edu
608-265-1325
Relay Access (WTRS): 7-1-1. See RELAY_SERVICE for further information.

Official Title:

Clin Res Coord II(RE016)

Department(s):

A53-MEDICAL SCHOOL/DERMATOLOGY/DERMATOLOG

Employment Class:

Academic Staff-Renewable

Job Number:

292793-AS


The University of Wisconsin-Madison is an Equal Opportunity and Affirmative Action Employer.

Qualified applicants will receive consideration for employment without regard to, including but not limited to, race, color, religion, sex, sexual orientation, gender identity, national origin, age, pregnancy, disability, or status as a protected veteran and other bases as defined by federal regulations and UW System policies. We promote excellence through diversity and encourage all qualified individuals to apply.

Employment will require a criminal background check. It will also require you and your references to answer questions regarding sexual violence and sexual harassment.

The University of Wisconsin System will not reveal the identities of applicants who request confidentiality in writing, except that the identity of the successful candidate will be released. See Wis. Stat. sec. 19.36(7).

The Annual Security and Fire Safety Report contains current campus safety and disciplinary policies, crime statistics for the previous 3 calendar years, and on-campus student housing fire safety policies and fire statistics for the previous 3 calendar years. UW-Madison will provide a paper copy upon request; please contact the University of Wisconsin Police Department.

Jobcon Logo Position Details

Posted:

Feb 02, 2024

Employment:

Full-time

Salary:

Not Available

Snaprecruit ID:

S-1707240486-426339131c37c9e5b1362fbcfa222909

City:

Madison

Job Origin:

jpick2

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Job Summary:

The Department of Dermatology seeks an experienced Clinical Research Coordinator II to join our team of world-renowned researchers and investigators committed to basic, clinical, and translational research designed to address dermatologic diseases and other skin-related research questions. This position will play a pivotal role in contributing to the conduct of state-of-the-art skin disease research to advance scientific knowledge and thus provide better care to patients. A summary of duties is described below.

1.Protocol Development and Review
  • Collaborating with principal investigators to develop and review research protocols.
2. Study Planning
  • Developing and implementing study timelines and milestones.
  • Creating study budgets and ensuring financial compliance.
3. Regulatory Compliance
  • Ensuring adherence to regulatory requirements and ethical standards.
  • Preparing and submitting regulatory documents to Institutional Review Boards (IRBs) and regulatory agencies.
4. Participant Recruitment and Informed Consent
  • Developing strategies for participant recruitment.
  • Obtaining informed consent from study participants.
5. Data Collection and Management
  • Overseeing the collection, verification, and management of study data.
  • Implementing data quality control measures.
6. Site Management
  • Coordinating activities at the study site.
  • Training and supervising other study staff.
7. Monitoring and Auditing
  • Conducting regular monitoring visits to ensure compliance with protocols.
  • Preparing for and participating in audits.
8. Communication
  • Serving as the primary point of contact for study sponsors, investigators, and study participants.
  • Communicating study progress to relevant stakeholders.
9. Safety Monitoring
  • Monitoring and reporting adverse events.
  • Ensuring participant safety throughout the study.
10. Documentation and Record Keeping
  • Maintaining accurate and complete study documentation.
  • Keeping records in accordance with regulatory requirements.
11. Quality Assurance
  • Implementing quality assurance processes to ensure data integrity and protocol compliance.
12. Reporting
  • Generating and submitting study progress reports to sponsors and regulatory authorities.
13. Continuous Process Improvement
  • Identifying areas for process improvement and implementing corrective actions.
14. Education and Training
  • Providing education and training to study team members.
15. Closeout Activities
  • Managing study closeout activities, including finalizing study reports and archiving study documentation.

Responsibilities:

Coordinates clinical research studies, performing a variety of tasks and activities. Recruits, screens, selects, determines eligibility, and enrolls study participants and ensures subjects follow the research protocol. Develops study-related documents. Applies expertise, knowledge, and skills to a broad range of different types of clinical studies, navigates resources, and identifies issues needing escalation. Contributes to development of new team and unit processes, procedures, staff, and tools.
  • 25% Schedules logistics, determines workflows, and secures resources for clinical research trials
  • 15% Recruits, screens, selects, determines eligibility and enrolls trial participants, collects more complex information, performs medical assessments, and answers varied questions under supervision of a medically licensed professional. Performs medical assessments after completion of required training/certification, such as collecting vital signs, obtaining weight, and performing phlebotomy
  • 5% Manages research workflow components, collects, prepares, processes, and submits participant data and samples to appropriate entities, adhering to research protocols
  • 5% Identifies work unit resources needs and manages supply and equipment inventory levels
  • 5% Serves as a main point of contact for clinical research participants, providing information regarding research procedures, expectations, and informational inquiries. Ensures participants follow the research protocol and alerts Principal Investigator of issues
  • 5% Performs quality checks
  • 15% Identifies resource needs and develops clinical research documents, such as job aids, tools, processes, procedures, and training. Contributes to the development of protocols
  • 5% May assist with training of staff
  • 10% Performs administrative duties related to managing clinical research protocols in the Department of Dermatology
  • 10% Performs clinical research finances

Institutional Statement on Diversity:

Diversity is a source of strength, creativity, and innovation for UW-Madison. We value the contributions of each person and respect the profound ways their identity, culture, background, experience, status, abilities, and opinion enrich the university community. We commit ourselves to the pursuit of excellence in teaching, research, outreach, and diversity as inextricably linked goals.

The University of Wisconsin-Madison fulfills its public mission by creating a welcoming and inclusive community for people from every background - people who as students, faculty, and staff serve Wisconsin and the world.


Education:

Preferred
Bachelor's Degree

Qualifications:

Experience:
  • Experience with clinical research regulations, including OHRP, CRMS, GCP
  • 1-2 years working in a research or clinical trials environment preferred.
  • Experience in approaching patients to discuss clinical trials and their potential participation, and obtaining informed consent preferred.
  • Demonstrated experience in scheduling, coordinating, and conducting visits and study meetings preferred.

Knowledge and Skills:
  • Reading and understanding of research principles and methodology and be able to apply that knowledge to a clinical trials environment.
  • Strong oral and written communication skills
  • Strong attention to detail.
  • Ability to interact well with patients and researchers independently.
  • Ability to use good initiative and judgement.
  • Ability to structure time to meet multiple deadlines.

License/Certification:

Preferred
Drivers License - Valid and Meets UW Risk Management Standards

Work Type:

Full Time: 100%

This position may require some work to be performed in-person, onsite, at a designated campus work location. Some work may be performed remotely, at an offsite, non-campus work location.

Appointment Type, Duration:

Ongoing/Renewable

Salary:

Minimum $45,000 ANNUAL (12 months)
Depending on Qualifications
Employees in this position can expect to receive benefits such as generous vacation, holidays, and paid time off; competitive insurances and savings accounts; retirement benefits. Benefits information can be found at (https://hr.wisc.edu/benefits/). SMPH Academic Staff Benefits flyer: (https://uwmadison.box.com/s/r50myohfvfd15bqltljn0g4laubuz7t0).

Additional Information:

This position has been identified as a position of trust with access to vulnerable populations. The selected candidate will be required to pass an initial caregiver check to be eligible for employment under the Wisconsin Caregiver Law and every four years.

The successful applicant will be responsible for ensuring eligibility for employment in the United States on or before the effective date of the appointment. University sponsorship is not available for this position.

How to Apply:

To apply for this position, please click on the \\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\"Apply Now\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\" button. You will be asked to upload a current resume/CV and a cover letter briefly describing your qualifications and experience, and a document listing contact information for three (3) references, including your current/most recent supervisor. References will not be contacted without prior notice.

Contact:

Caitlin Staley
caitlin.staley@wisc.edu
608-265-1325
Relay Access (WTRS): 7-1-1. See RELAY_SERVICE for further information.

Official Title:

Clin Res Coord II(RE016)

Department(s):

A53-MEDICAL SCHOOL/DERMATOLOGY/DERMATOLOG

Employment Class:

Academic Staff-Renewable

Job Number:

292793-AS


The University of Wisconsin-Madison is an Equal Opportunity and Affirmative Action Employer.

Qualified applicants will receive consideration for employment without regard to, including but not limited to, race, color, religion, sex, sexual orientation, gender identity, national origin, age, pregnancy, disability, or status as a protected veteran and other bases as defined by federal regulations and UW System policies. We promote excellence through diversity and encourage all qualified individuals to apply.

Employment will require a criminal background check. It will also require you and your references to answer questions regarding sexual violence and sexual harassment.

The University of Wisconsin System will not reveal the identities of applicants who request confidentiality in writing, except that the identity of the successful candidate will be released. See Wis. Stat. sec. 19.36(7).

The Annual Security and Fire Safety Report contains current campus safety and disciplinary policies, crime statistics for the previous 3 calendar years, and on-campus student housing fire safety policies and fire statistics for the previous 3 calendar years. UW-Madison will provide a paper copy upon request; please contact the University of Wisconsin Police Department.

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