About the company: ASR is a Clinical Research company. We conduct trials with a specialized focus on women's health and vaccines.

Qualifications

The position requires travel between assigned facilities Boise, Meridian, and Nampa locations.

RN, LPN, Medical Assistant or Phlebotomist

2 years of nursing experience, or has successfully performed in the role of Clinical Research Coordinator for a minimum of 2 years and demonstrated outstanding performance through performance evaluations, certification, and other job performance measures

Willing to pursue CCRC or CCRP certification when eligible

Current state licensure, if applicable

Good computer skills: Microsoft Office, Excel minimally

Excellent communication and organizational skills

Ability to work independently, and exhibit diplomacy and problem-solving skills in the performance of this role

Responsibilities

Responsible for the collection, accuracy, and validity of clinical research data for assigned clinical studies in accordance with the study protocol and timelines

Performs a variety of complex activities to appropriately compile, document and analyze clinical research data, using the subject's medical record as source

Negotiates differing priorities with multiple players whilst balancing a multiple number of tasks and timelines under a complex network of rules and regulations

Ensures research studies are conducted according to established company policies and procedures as well as all applicable State and Federal regulations, specifically Good Clinical Practice (GCP, ICH, and FDA guidelines

Practices cost containment strategies while ensuring appropriate enrollment of subjects in studies

Assists with the determination of the guidelines for the collection of clinical data and coordinates and implements procedures and processes for data collection

Coordinates all aspects of study subject care from recruitment and pre-screening through study completion as defined by the protocol and Principal Investigator (PI) delegation

Protect the rights and the well-being of subjects enrolled in studies

Ensures thorough, individualized, protocol-based study subject education on all study process requirements including but not limited to informed consent, study participation obligations, appropriate use of investigational product, safety, privacy, rights, and responsibilities

Develops processes for methodically monitoring the status of study subjects as they progress through the study's timeline of activities

Regularly evaluates the study subjects' condition and communicates/documents concerns to PI to ensure subject safety

Accurately documents study subject activities as outlined by the protocol

Maintains documents according to applicable HIPAA and regulatory requirements

Implements study-specific quality goals and practices

Acts as the point of contact or lead person in a facility/practice to oversee protocol compliance

Proactively addresses and acts upon adverse event or patient safety issues according to the appropriate procedure

Maintains study site environmental integrity including safe handling of biological specimens as well as study product procurement, administration, and storage

Participates as needed in study related, internal, or State/Federal surveys and audits

Maintains integrity of ASR Medical Care, practice and study-specific medical, administrative, and operational records

Troubleshoots protocol, and strategizes with all participants at every level of the study to assure quality study outcomes

Serves as primary point of contact between sponsor, Sponsor, Clinical Research Organization (CRO), PI and clinical staff

Adheres to SOP and GCP and all regulatory practices as established by law and company policies and procedures

Coordinates logistics of activity for multiple, concurrent studies at multiple study sites

Participates in the recruitment, interview process, and education of new research personnel as directed

Coordinates with facility or practice manager to educate new clinical staff on study specific responsibilities and protocol tasks

Maintains mandatory training requirements according to guidelines such as: Transport Association (IATA), GCP, etc.

Oversees performance of delegated study related activities by all licensed personnel, or direct patient care staff

Coordinates and resolves potentially conflicting patient care treatment protocols involving the clinic and support staff

Collaborates with appropriate management to ensure research activities are not inappropriately or illegally billed, and that research activities are minimally disruptive to clinic routine

Facilitates positive relationships with Medical Director and appropriate management at multiple sites for networking.

Supports physicians by communicating initiatives, policies, and procedures; ensures attending physician receives notifications of patients' participation

Provides the clinic Governing Body and clinic staff with appropriate study documentation

Maintains up-to-date knowledge regarding the operation of study specific equipment and technology

Ensures study enrollment goals are met, study resources are used efficiently, and work with the budget specialist to meet the requirements of research at study sites

Completes the clinical trials management system (CRIO) and electronic/paper case report forms in an accurate and timely manner

Ensures the appropriate maintenance of study subject payment records

Completes application documents with the Regulatory Specialist as needed: internal, Institutional Review Board (IRB) site submission, sponsor required) and coordinates ongoing document processing throughout the entire study or

Coordinates with regulatory monitors, responds to mentoring inquires in a timely manner

Completes study subject records in an accurate and timely completion of all applicable study subject records

Other duties as assigned

The physical demands and work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions

Job Type: Full-time

Pay: $15.00 - $30.00 per hour

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Schedule:

• 10 hour shift

Supplemental pay types:

• Bonus pay

COVID-19 considerations:
We continue to follow and practice CDC guidelines.

Work Location: Multiple Locations

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