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20 days old

Clinical Research Coordinator I

Kelly Services
Winter Park, FL 32789
Kelly Services has been providing outstanding employment opportunities to the most talented individuals in the marketplace. We are proud to offer a **Direct** **hire** opportunity to work as a **Clinical Research Coordinator located in Winter Park, FL.**


**Shift: M-T 8am-5pm, half day on Fridays**


**Job Description:** The Clinical Research Coordinator I is an entry level position at Conquest Research and is meant to fully integrate the new CRC in the Conquest Research Clinical Research process. Although basic responsibilities are similar to the more experienced Conquest CRCs, the CRC I will be expected to carry a slightly reduced study load and will be mentored by a more experienced CRC III during the ensuing months. Over time, it is expected that the CRC I will demonstrate greater proficiency and productivity, a quality work product and develop the skills and capability to progress to the next


**Study Preparation:**

Learn to review and assess protocol (including amendments) for clarity, logistical feasibility, subject safety and inconsistencies, etc.

Discuss study medication, required procedures, eligibility criteria and impact on office flow with investigators and staff

Assist with planning and creation of appropriate recruitment materials

Actively assist in development of recruitment plan and obtain listing of potential candidates to contact from database

Actively work with recruitment team in calling and recruiting subjects for your studies and other site studies

Participate in Investigators meeting and/or coordinate pre-study site visit with clinical staff and Sponsor/CRO representatives

Co-Create (or review sponsor provided) protocol specific source documents

Review and determine facility, equipment and outsource vendor availability

Ensure adequate supplies have arrived on site for protocol initiation (lab kits, study medication, specialized equipment, IVRS/EDC access and passwords)

Work with mentor to ensure education of staff and/or sub-investigators is completed for required tasks


**Study Management:**

Learn to integrate new trial with existing trial load, delegate tasks as necessary, and prioritize activities with regard to protocol timelines

Maintain organized files for blank source documents, patient charts, CRFs, and supplies


Work with mentor to actively handle Investigational Product accountability: receive, inventory, dispense, monitor patient compliance, and re-order as necessary. Document on accountability log and patient records.

Integrate monitoring visits and study teleconferences into existing work schedule to allow for adequate preparation and time for interaction during these meetings

Ensure trial activities are discussed in advance with covering personnel in case of vacation or sick leave

Actively practice and maintain adherence to FDA regulations and ICH guidelines in all aspects of conducting clinical trials

Communicate sponsor updates, patient specific concerns/progress, unforeseen issues, and overall trial management with appropriate members of Conquest team in an ongoing fashion

Develop and maintain effective relationships with study participants and Conquest Research personnel

Interact in a positive, professional manner with patients, sponsor representatives,

offices/investigators, and Conquest Research personnel

Communicate clearly verbally and in writing

Accept accountability for actions and learn to function independently



**Patient Coordination:**

Prescreen study candidates by telephone and review exclusionary conditions or medications prior to scheduling screening appointment

Obtain informed consent per Conquest Research SOP and document process when revised ICF discussed with patients during the course of the trial

Complete visit procedures and ensure proper specimen collection, processing and shipment in accordance with protocol

Coordinate and be prepared to complete basic clinical procedures, such as blood draws, vital signs, and ECGs

Review laboratory results, ECGs, and other test results (e.g., mammogram) for completeness and alert values, ensure investigator review in a timely fashion

Work with mentor to Recognize adverse events (AEs) and Serious Adverse Events (SAEs) and promptly notify Principal Investigator, Sponsor and site regulatory coordinator. Ensure safety monitoring or symptomatic treatment is initiated as prescribed or as specified in protocol.

Schedule patients within visit windows, notify personnel as needed for procedures, and integrate visits with existing schedule to maximize efficient work flow and patient turnaround

With mentor guidance dispense study medication per protocol and/or IVRS systems. Educate patient on proper administration and importance of compliance

Monitor patient progress on study medication


**Documentation:**

Record data legibly, in real time on source documents; note additional information that may assist with causality of adverse events, explain protocol deviations, or document patient progress. Correct errors per SOP

Accurately record study medication inventory, medication dispensation, and patient

compliance. Ensure accurate maintenance of dispensing logs and IVRS confirmations is conducted in a timely fashion

Maintain copies of all prescriptions written for study or non-study medication or procedures in patient chart

Accurately transcribe data to CRFs. Resolve data management queries and correct source data as needed

Record protocol exemptions and deviations as appropriate with sponsor. Complete Memo to File for patient chart and regulatory filing if necessary

Ensure all sponsor correspondence (e-mails, telephone conversations) are printed and given to appropriate personnel for regulatory filing

Maintain copies of patient-specific correspondence in source charts

Assist regulatory personnel with completion of continuing/final review reports

Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.



**Knowledge, Skills, & Abilities**

A working knowledge of medical and research terminology.

A working knowledge of federal regulations, good clinical practices, (GCP).

Ability to communicate and work effectively with a diverse team of professionals.

Excellent organizational, prioritization and leadership skills and capabilities.

Good computer skills with demonstrated abilities using clinical trials database, electronic data capture, MS word and excel.

Excellent interpersonal skills, detailed-oriented and meticulous

Excellent professional writing and communication skills

Ability to learn to work in a fast paced environment with minimal supervision.



**Education:**

BS in nursing, pharmacy or other related science or combination of equivalent education preferred.


**Experience:**

Two (2) years clinical research experience

Some Clinical Research Coordinator experience

**Certification/License:**

RN or LPN preferred

Research Professional Certificate CCRP or exam eligibility preferred


**APPLY NOW FOR IMMEDIATE CONSIDERATION!!**


**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.


**Why Kelly** **** **?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)

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Posted: 2022-05-02 Expires: 2022-06-02

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Clinical Research Coordinator I

Kelly Services
Winter Park, FL 32789

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