Job no: 519679
Work type: Staff Full-Time
Location: Sumter
Categories: Grant or Research Administration
Department:29680302 - MD-CTSI-VILLAGES HEALTH CRC

Classification Title:

Clinical Research Coord III

Job Description:

The Clinical Research Coordinator will have various responsibilities related to: Preparation and/or Review of the Scientific Proposal, Regulatory and IRB Protocols, Sponsor Contract (Terms & Conditions), Conduct of Research, Clinical Services; Research Associate and other Staff Management, Reporting, and Project Closeout procedures.

Job duties will include, but are not limited to the following:

Conduct of Research

• Reviews and develops a familiarity with the protocol, e.g., study proceedings and timelines, inclusion and exclusion criteria, confidentiality, privacy protections.

• Communication of study requirements to all individuals involved in the study.

• Collects documents needed to initiate the study for submission to the sponsor (e.g., FDA Forms 1572, CVs, etc.).

• Works with the PI/ lead coordinator(s) to develop and implement recruitment strategies in accordance with IRB requirements and approvals.

• Conducts or participates in the informed consent process including interactions with the IRB, discussions with research participants, including answering any questions related to the protocol. Obtains appropriate signatures and dates on forms in appropriate places. Assures that amended consent forms are appropriately implemented and signed.

• Screens subjects for eligibility using protocol specific inclusion and exclusion criteria, documenting each potential participant’s eligibility or exclusion.

• Coordinates participant tests and procedures.

• Collects data as required by the protocol. Assures timely completion of Case Report Forms.

• Maintains study timelines.

• Maintains adequate inventory of study supplies including Investigational Drug/Device Accountability.

• Completes study documentation and maintains study files in accordance with sponsor requirements and University policies and procedures including, but not limited to, consent forms, source documentation, narrative notes if applicable, case report forms, and investigational material accountability forms, etc.

• Retains all study records in accordance with sponsor requirements and University policies and procedures.

• Maintains effective and ongoing communication with research participants, lead coordinator(s) and PI during the course of the study.

• Assists PI/ lead coordinator(s) in preparation and submission of any modifications to the scientific protocol in accordance with Federal regulations and University and sponsoring agency policies and procedures.

• Works with the PI/lead coordinator(s) to manage the day-to-day activities of the study including problem solving, communication and protocol management.

• This position will perform ad hoc assignments as assigned by the Supervisor

Reporting

• Assists Principal Investigator and lead coordinator(s) with scientific and compliance reporting requirements in accordance with Federal regulations and University and sponsoring agency policies and procedures.

• Assists the lead coordinator(s) and Principal Investigator to facilitate the registration of the study at ClinicalTrials.gov and maintains current information on the site (if appropriate).

Supervisory

• This is a leadership level position, ideal for candidates with an established career in clinical research and expertise in translational and implementation science

• This position supervises and assists with development of learning plans for OPS student assistants, researcher support staff (i.e. research assistants) and interns that are assigned to the clinical research projects.

• Act as a resource for research staff in the implementation of clinical research protocols and review of study goals and outcomes, providing guidance informed by your experience and expertise in clinical research topics. 

Project Closeout

• Collaborates with the lead coordinator(s) to facilitate the submission of accurate and timely closeout documents to applicable Federal agencies, University entities, and the sponsoring agency in accordance with Federal regulations and University and sponsoring agency policies and procedures.

• Ensures the secure storage of study documents that will be maintained according to University policy or for the contracted length of time, whichever is longer.

Preparation and/or Review of Scientific Proposal

• Assists the PI and lead coordinator(s) in reviewing protocols

• Review of specific aims

• Perform study feasibility assessments

• Identify resources needed for participants

• Committed to participant protection and privacy.

Regulatory and IRB

• Preparation of revisions to the IRB for submission

• Preparation of continuing reviews to the IRB for submission

• Preparation of all serious adverse events after review with the PI and lead coordinator for submission

• Attendance at all IRB meetings when assigned protocols from the sponsor are scheduled

• Reviews and comprehends the protocol.

• Collaborates with the PI and lead coordinator(s) to prepare IRB and any other regulatory submission documents as required by the protocol.

• Prepares other study materials as requested by the PI/ lead coordinator(s). These study materials include, but are not limited to, the informed consent document

• Ensures proper organization of study files, including but not limited to, regulatory binders, study specific source documentation and other materials by the research coordinator assigned to the investigation

• Maintenance of templates and examples of essential documents frequently used in the preparation of a protocol ie informed consent, telephone script

• Performs quality assurance ensuring proper maintenance of regulatory binder, protected health information and study documents

• Coordinates internal audits as deemed appropriate

Other

• Assist in all other daily activities of research studies

• Other miscellaneous duties as assigned.

• Participate in all required meetings and training sessions as necessary.

Expected Salary:

$75,000-$83,000 commensurate with education and experience.

Minimum Requirements:

Bachelor’s degree in an appropriate area and three years of relevant experience; or an equivalent combination of education and experience.

Preferred Qualifications:

Master's Degree

Phlebotomist Certificate. Licensed Nurse Preferred

EXPERIENCE

Working in healthcare or academic research environments

A customer-service orientation and/or experience working with older adults

KNOWLEDGE

Familiar with regulations surrounding research participant recruitment, including human-subject protection, health studies and Institutional Review Boards

As a certified phlebotomist or licensed nurse, collect blood draws and skin biopsy from patients as needed at various time points in clinical trials.

SKILLS

Clinical-trials management systems and survey tools such as Qualtrics

Proficiency in Microsoft Office Word, Outlook, PowerPoint, and data analysis software (Excel, SPSS)

Excellent written and verbal communication skills.

ABILITIES

Ability to meet tight deadlines and flexibility as expectations and deadlines shift

Ability to handle multiple projects simultaneously and communicate reasonable expectations regarding workflow, deadlines and deliverables.

Ability to plan, execute and complete work assignments independently, efficiently and accurately while working as part of a team in a fast-paced, high-profile, multidisciplinary work environment.

Ability to learn and communicate effectively regarding a variety of technical resources and complex research programs and initiatives

OTHER QUALIFICATIONS

Creativity

Attention to detail

Professionalism

Good judgment

Special Instructions to Applicants:

In order to be considered, you must upload your cover letter and resume.

Application must be submitted by 11:55 p.m. (ET) of the posting end date.

The University of Florida is committed to non-discrimination with respect to race, creed, color, religion, age, disability, sex, sexual orientation, gender identity and expression, marital status, national origin, political opinions or affiliations, genetic information and veteran status in all aspects of employment including recruitment, hiring, promotions, transfers, discipline, terminations, wage and salary administration, benefits, and training.

This is a time limited position.

Health Assessment Required:No

Advertised: 24 Mar 2022 Eastern Daylight Time
Applications close: Open until filled