Job Description

Position Status:
Full time
Shift:
First Shift (Days - Less than 12 hours per shift) (United States of America)
Hours per week:
40
Job Information
Exemption Status: Exempt

A Brief Overview
The Associate Clinical Research Coordinator is responsible for the coordination of clinical research protocols. Activities include, but are not limited to: protocol feasibility, subject recruitment, eligibility assessment, informed consent, study-specific procedures, data collection, case report form maintenance, protocol compliance, drug supply inventory, and interactions with physicians, clinical research associates, patients and others. The Associate Clinical Research Coordinator promotes Good Clinical Practice in the conduct of clinical investigations by possessing an in-depth knowledge of FDA regulations, human subject protection, and research regulation requirements.

Education Qualifications

• Associate's Degree Health related field. Preferred

Experience Qualifications

• 2 years Experience in research (i.e. coordinating, research phlebotomy, research recruitment, regulatory administration, industry sponsor/CRO experience). LPN license can be substituted for experience. Required
• 2 years Clinical research experience. Preferred
• less than 1 year Nursing or medical professional experience. Preferred

Skills and Abilities

• Ability to learn individual protocol-specific software and web-based systems. (Required proficiency)
• Ability to read, analyze, and interpret research protocols, technical information, or government regulations. Ability to interpret and respond to queries in a written or verbal manner. Ability to effectively present information and respond to questions from patients, family members, physicians, or the public. (Required proficiency)
• Computer skills: Knowledge of EPIC EMR, Microsoft Office, and Outlook. (Preferred proficiency)

Licenses and Certifications

• Licensed Practical Nurse - KSBN Required experience can be substituted for license. Required
• Basic Life Support - BLS Required within 90 days of hire.

What you will do

• Coordinate the conduct of clinical trials. Adhering to the protocol and coordinating the research subject through the protocol requirements and schedule. Coordinate subject identification and eligibility activities, including database lists, incoming calls and inquiries, telephone screening, chart reviewing, discussing the protocol with prospective subjects, presenting/re-presenting candidates to PIs and Sub-I's, and scheduling per protocol requirements.
• Develop and/or adapt study-specific source documentation. Document subject's relevant medical history, research source documentation, and EPIC documentation per Clinical Research Center SOPs.
• Conduct informed consent following the Clinical Research Center SOPs and demonstrate an in depth understanding of the protocol and the ICF document.
• Manage IRB communication, complying with the Clinical Research Center SOP. Manage monitor visits, including scheduling and follow-up. Manage protocol queries per Clinical Research Center SOPs and sponsor requirements. Manage documentation and organization of un-blinding processes. Manage protocol amendments per Clinical Research Center SOPs and by using the Amendment Flow Sheet. Manage study close-outs activities per sponsor requirements, using the Clinical Research Center Study Close-out Checklist.
• Assist in recruiting participants for clinical trials. Study, learn and apply all Food and Drug Administration regulations and guidelines applicable to clinical research. Establish and maintain working knowledge of the Code of Federal Regulations. Establish and maintain working knowledge of International Code of Harmonization. Establish and maintain expert knowledge of SVHC/COC Policies. Establish and maintain expert knowledge of HIPPA guidelines and protect patient/subject personal health information per SVHC/COC guidelines.
• Assist with quality assurance to ensure credentialing as a study site. Establish and maintain expert knowledge of Clinical Research Center Standard Operating Procedures. Sign-off on knowledge at time of employment and during annual competencies.
• Assist in completion and submission of all forms and documentation as required by the various studies. Maintain SVHC competency on all procedures required for clinical research protocol execution, such as ECG, waived laboratory testing, vital signs, or other protocol-specific procedures.
• Coordinate, supervise, and engage in direct patient/subject care associated with and during various clinical research protocols, including conducting ECGs, vital signs.
• Maintain any required training and credentialing. Maintain current curricula vitae.
• Actively participate in study enrollment goal fulfillment, including: requesting EPIC queries and maintaining records of results and chart reviews, organizing all referred patients and PCP communication, organizing all advertising-generated calls, working closely with PI concerning status of enrollment and plans to meet the enrollment goal, communicating frequently with Director about status of enrollment, and other tasks as appropriate.
• Manage IVRS (interactive voice response systems) and randomization codes per protocol requirements.
• Manage laboratory requirements of protocol, including requisitions, education of phlebotomy staff, review of results, and coordination with PI/Sub-I's per Clinical Research Center SOPs. Coordinate study supply inventories, including ordering and documentation. Complete required log as required by sponsor and department, such as protocol-specific Screening & Enrollment logs, Clinical Research Center study summaries, and Subject ID logs.
• Assist with study start-up, including: planning, organizing, trouble-shooting, and coordinating activities with SVHC/COC departments for needed protocol procedures, such as radiology, ultrasound, respiratory therapy, endoscopy, etc. Serve as a backup coordinator, assist with training other coordinators/department staff, participate in protocol planning meetings and department meetings, attend protocol-specific and industry meetings, as assigned.
• Assist/comply with quality assurance and process improvement systems per Clinical Research Center SOPs.
• Document and address Adverse Events, IND Safety Letters, and Serious Adverse Events per Clinical Research SOPs and sponsor requirements.
• Manage drug accountability, case report form reporting, other data collection, and subject reimbursement for assigned protocols, complying with the Clinical Research Center SOPs and sponsor requirements. Establish and maintain computer system knowledge to master electronic data capture, SVHC/COC electronic medical records and scheduling systems, down-loadable training programs, web-based training platforms, and other systems as needed.

Travel Requirements

• 20% Required to perform essential duties.

Required for All Jobs

• Complies with all policies, standards, mandatory training and requirements of Stormont Vail Health
• Performs other duties as assigned

Patient Facing Options

• Position is Patient Facing

Remote Work Guidelines

• Workspace is a quiet and distraction-free allowing the ability to comply with all security and privacy standards.
• Stable access to electricity and a minimum of 25mb upload and internet speed.
• Dedicate full attention to the job duties and communication with others during working hours.
• Adhere to break and attendance schedules agreed upon with supervisor.
• Abide by Stormont Vail's Remote Worker Policy and will review and acknowledge the Remote Work Agreement annually.

Remote Work Capability

• Hybrid

Scope

• No Supervisory Responsibility
• No Budget Responsibility No Budget Responsibility

Physical Demands

• Balancing: Occasionally 1-3 Hours
• Carrying: Occasionally 1-3 Hours
• Climbing (Ladders): Rarely less than 1 hour
• Climbing (Stairs): Rarely less than 1 hour
• Crouching: Rarely less than 1 hour
• Driving (Automatic): Rarely less than 1 hour
• Eye/Hand/Foot Coordination: Frequently 3-5 Hours
• Feeling: Occasionally 1-3 Hours
• Grasping (Fine Motor): Occasionally 1-3 Hours
• Grasping (Gross Hand): Occasionally 1-3 Hours
• Handling: Occasionally 1-3 Hours
• Hearing: Frequently 3-5 Hours
• Kneeling: Rarely less than 1 hour
• Lifting: Occasionally 1-3 Hours up to 10 lbs
• Pulling: Occasionally 1-3 Hours up to 10 lbs
• Pushing: Occasionally 1-3 Hours up to 10 lbs
• Reaching (Forward): Occasionally 1-3 Hours up to 10 lbs
• Reaching (Overhead): Rarely less than 1 hour up to 10 lbs
• Repetitive Motions: Frequently 3-5 Hours
• Sitting: Frequently 3-5 Hours
• Standing: Occasionally 1-3 Hours
• Stooping: Rarely less than 1 hour
• Talking: Frequently 3-5 Hours
• Walking: Frequently 3-5 Hours

Working Conditions

• Infectious Diseases: Rarely less than 1 hour
• Noise/Sounds: Rarely less than 1 hour

Stormont Vail is an equal opportunity employer and adheres to the philosophy and practice of providing equal opportunities for all employees and prospective employees, without regard to the following classifications: race, color, ethnicity, sex, sexual orientation, gender identity and expression, religion, national origin, citizenship, age, marital status, uniformed service, disability or genetic information. This applies to all aspects of employment practices including hiring, firing, pay, benefits, promotions, lateral movements, job training, and any other terms or conditions of employment.

Retaliation is prohibited against any person who files a claim of discrimination, participates in a discrimination investigation, or otherwise opposes an unlawful employment act based upon the above classifications.

Job Tags

Full time, Remote job, Shift work, Day shift,

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