Campus Pride Jobs

The Clinical Trials Regulatory Assistant provides administrative and regulatory support to the Regulatory Administrator and clinical trials team. This position supports the advancement of clinical research by ensuring regulatory compliance. Other core activities of this role include:

· Assists the regulatory administrator and clinical trials team with Institutional Review Board (IRB) preparation and submission, including collation and preparation of documents.

· Collaborates with staff to maintain appropriate and timely documentation per federal, state, local and institutional requirements, and policies.

· Prepares and participates in site initiation and closeout visits, and long-term document storage activities

· Assists with audits and/or monitoring administratively.

· Assists with communication and submission of Sponsor requested training, signature pages, etc.

· Assists in maintaining and updating regulatory documents (e.g. 1572, FDF, DOA, training, FDF's, CVs, MLs)

· Collaborates with clinical trials leads to update and maintain the Clinical Trial Management System

· Supports and helps maintains the e-Regulatory binder application.

Salary Range: $27.93/hour-$32.84/hour

Job Summary:

Serves as a key contributor on a multi-disciplinary health services or clinical research team, including project coordinators/managers, research specialists, data specialists, analysts, and investigators. Depending on the nature of the scientific research, activities may include interacting with study participants, developing and using data collection instruments, drafting operations manuals, preparing and filing scientific and/or regulatory reports, orienting new staff, and organizing project logistics. Maintains a culture of compliance, ethics and integrity. Maintains knowledge of policies and procedures and performs in accordance with applicable regulatory requirements, external laws and accreditation standards as they relate to clinical or health services research. Performs in accordance with the Principles of Responsibility and appropriately reports observed fraud or abuse.

Essential Responsibilities:

• Contributes to the development and maintenance of the research project timeline and procedures, and as needed creates forms, scripts, manuals, and tracking systems.

• Collaborates with other research team members on a wide range of technical, operational and clinical functions specific to a research study. Owns portions of study activities, which may include: Participant recruitment; data collection and database development; participant tracking; facilitation of pilot protocols; medical chart abstraction; performing literature searches for grant preparation; maintenance of reference databases for manuscript preparation; and other duties specified.

• Assignments may require recruitment of research participants, coordination of communication and follow-up with study participants and study-site staff, as well as other participating research partners.

• Contributes to the creation of survey tools and coding forms, and documentation of this process for use in manuscript development.

• Exercises judgment and takes proactive steps to resolve issues as they arise. Briefs the study coordinator/manager, PI, supervisor or other appropriate IHR staff as appropriate (e.g. director, compliance administrator) on emerging issues with the project.

• Conducts interviews with participants including screening for eligibility and primary data collection.

• Coordinates with medical office staff and physicians to determine participant eligibility and the medical appropriateness of study for participants.

• Administers informed consent per regulations, drawing upon specialized research training. Answers participant questions concerning their involvement in study. Coordinates, as necessary, communications between prospective study participants and other members of the study team, including the principal investigator.

• Collects data for research studies using appropriate electronic or paper methods. Ensures that data collection instruments are properly completed and performs quality assurance on the data. Per the study, may also interpret results, or may code qualitative data.

• Participates in the development and testing of chart abstraction tools. Applies abstraction tools and methodology to collect research data from medical charts using the Electronic Medical Record. Uses medical terminology and medical procedure knowledge as needed to interpret chart information.

• Develops and maintains databases for tracking participants, including creation of standard queries and ad hoc reports. Records and cleans data, and transfers it to data specialists and project analysts on a timely basis. Ensures that project participant database records and electronic or hard-copy files are maintained per applicable regulations.

• Creates reports including tables for use by members of the study team to assure study activities remain on track and goals are achieved (e.g. recruitment reports, participant visit reports).

• Adheres to federal and local regulations governing research. Adheres to the study protocol and good clinical practices.

Basic Qualifications:

Experience

• Minimum two (2) years of experience working in health care, laboratory or social science research setting or clinical trials research setting.

Education

• Bachelors degree in a related field with course work in science, social science, allied health science, public health or medical sciences OR four (4) years of experience in a directly related field.

• High School Diploma OR General Education Development (GED) required.

License, Certification, Registration

• N/A

Additional Requirements:

• N/A

Preferred Qualifications:

• Understanding of all aspects of health related research from proposal submission to data collection and analysis and creation of scientific reports and papers.

• Comprehensive understanding of the conduct of health services or clinical research, including development and modifications to the project plan, documentation of project team discussions and decisions, data collection standards, monitoring participant activity, and implementation and tracking of quality assurance plans.

• Comprehensive knowledge of software applications, including Microsoft Word, Excel, PowerPoint, and Access (as well as specialized software specific to the project, if applicable).

• Proven ability to work independently in a team environment, proactively identify problems or concerns that might affect a project and to implement a resolution once problems are identified.

Core responsibilities of a Clinical Trials SPRa:

Part of the regulatory team to assist with IRB preparation and submission of documents.

Collaborates with coordinating staff to maintain appropriate regulatory notification and documentation.

Maintains compliance with institutional requirements and policies. Maintains a familiarity with the ethical conduct of research and safeguards needed when conducting clinical research.

Prepares for and takes part in site initiation, monitoring, closeout visits, and document storage activities. Conducts and documents visits and testing/interviews according to all regulatory and organizational protocols.

Communicates with sponsors, other team members and regulatory staff.

COMPANY: KAISER

TITLE: Clinical Trials Regulatory Assistant

LOCATION: Aurora, Colorado

REQNUMBER: 1282048

External hires must pass a background check/drug screen. Qualified applicants with arrest and/or conviction records will be considered for employment in a manner consistent with Federal, state and local laws, including but not limited to the San Francisco Fair Chance Ordinance. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, protected veteran, or disability status.