What are the responsibilities and job description for the Administrative Research Coordinator position at AMR Wichita?
Are you in the medical field looking for a new challenge?
Do you enjoy problem solving and thrive in a fast paced environment?
The Administrative Coordinator will perform multiple and varied tasks critical to the management of clinical research studies. The Administrative Coordinator is expected to exhibit basic knowledge of clinical research activities and adhere to federal and other applicable regulations. The Administrative Coordinator must ensure compliance with protocol guidelines, identify problems and/or inconsistencies and monitor subject process throughout the clinical research study.
To consistently embody AMR’s Core Values:
· Excellence and Consistency
· Collaborative Innovation
· Respect for our Subjects, Sponsors and Team Members
· Community
· Unimpeachable Ethics
The Clinical Research Coordinator reports to the Team Lead, Site Manager and General Manager
Classification: Non-Exempt
Primary Responsibilities:
- Coordinate clinical trials per FDA requirements and GCP guidelines per sponsor protocols.
- Basic understanding of SOPs and ensure they are adhered to in the conduct of the clinical research study.
- Assist in general office work flow which includes telephone answering.
- Basic understanding of medications per clinical trial.
- Acquire detailed knowledge of the protocol and procedures associated with each clinical research study.
- Effectively communicate with clinical research sponsors, CROs, monitors/CRAs, IRBS, laboratories and clinical personnel within the research industry.
- Advise Investigator, Sub-Investigator and staff on protocols, procedures required for the successful implementation and completion of each clinical research study.
- Notify Investigator, monitor/CRA of any adverse events or serious adverse events per the protocol.
- Maintain familiarity with each clinical research study’s requirements and apply all applicable regulations accurately.
- Ensure all necessary documents are appropriately signed and dated.
- Possess a willingness to assume responsibility for tasks outside of your current role and to work flexible hours as needed.
- Responsible for assisting regulatory administration work for necessary periodic IRB reviews, both ongoing and final.
- Obtains detailed knowledge of each assigned study protocol through review of study information, Site Initiation Visit (SIV), and Investigator Meetings, when approved and applicable.
- Follows ALCOA standards in all documentation.
- Provides required information to Contract Research Organization (CRO), Institutional Review Board (IRB), sponsoring organization, Food and Drug Administration (FDA), and/or other appropriate agency as required.
- Assists study monitors during onsite visits with open queries. Prepares for each monitoring visit by ensuring queries are complete prior to the visit.
o Assists with study start-up to include but not limited to:
- Set-up and train on study specific equipment
- Attend webinar investigator meetings, if applicable. There could be opportunities to travel to Investigator Meetings.
o Manage study vendor procedures which includes the following:
- Handle vendor start-up training to ensure training is complete within the required timeframe
- Create cheat sheet instructions (if needed) to simplify study requirements for each vendor.
- Upload images to the study-specific program, if possible.
- Liaison between the Sponsors and vendors
- Schedule subject vendor appointments
o Inventory study specific supplies and order when supplies are low (Example: diaries)
o Back-up data entry when applicable.
o Administrative CRC may be assigned to Patient CRC duties as needed.
Desired Skills and Qualifications:
· Successful completion of a formal medical/clinical educational program or alternatively, has a strong knowledge of medical terminology and the ability to learn quickly.
· Clinical experience involving patient care in a healthcare environment preferred but not required.
· Ability to interpret and perform clinical, laboratory and diagnostic tests (such as vital signs, height, weight, temperature, etc.) preferred.
· Proven success in effectively managing project timelines
· Ability to function independently with minimal supervision, and to exercise discretion and a high level of good clinical and other professional judgement.
· Ability to multi-task and perform multiple critical tasks simultaneously (under dynamic and ever-changing conditions and deadlines).
· Exceptional written and verbal communication skills.
· Ability to work independently, lead clinical research studies and complete tasks.
· Calm, friendly, approachable, and presents a professional image.
· Excellent listening, written, and verbal communication skills.
· Committed, highly energetic, self- motivated and highly organized.
· Demonstrated proficiency in office equipment including (but not limited to) copy machines, facsimile machine, multi-line telephones and computers.
· Proficient in Microsoft Office products including Outlook, Word, and Excel.
· Professional and highly motivated “self-starter” with the ability to exercise initiative.
· Excellent task management and prioritization skills.
Alliance of Multispecialty Research does not discriminate in employment on the basis of race, color, religion, sex (including pregnancy and gender identity), national origin, political affiliation, sexual orientation, marital status, disability, genetic information, age, retaliation, parental status, military service, or other non-merit factor.
** This job description is intended to be a representative summary of the major responsibilities and accountabilities of the staff holding this position. The staff may be requested to perform job-related tasks other than those stated in this description.
Salary : $20 - $0
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