Position Summary & Objectives

In general, the Study Coordinator (SC) helps to ensure clinical research studies maintain accordance with the protocol, applicable regulations, and Good Clinical Practice (GCP) and Institutional Review Board (IRB) requirements. Beyond administrative duties, responsibilities of a SC may include acting as a liaison for the clinical site, ensuring staff are properly trained per the protocol, recruiting and/or registering participants, maintaining study guidelines, and collecting and/or reviewing the data or review before it is entered into a study database. the SC works with the PI, department, sponsor, and institution to support compliance, personnel and other related aspects of the clinical study. Research must be done ethically and every aspect of the trial must adhere to compliance.

Essential Functions

• Coordinate, evaluate, and follow patient progress while maintaining knowledge of adverse events, protocol-related labs and research tests, and protocol responses.
• Screen patients for protocol eligibility through personal interviews and/or medical record review in inpatient and outpatient settings.
• Perform protocol-specific duties under the direct supervision of the PI, as needed or appropriate.
• Assist in obtaining informed consent for treatment studies by discussing the study requirements and answering any study-specific questions for the patient and family. Administers questionnaires, conducts data collection and monitors patients to ensure they are compliant to the protocol
• Facilitate screening study patients, and all study visits, and report adverse events as required per the trial sponsor.
• Ensure that patients are scheduled for research-required tests and appointments and coordinating with schedules as needed.
• Creates and maintains delegation of authority log, as needed.
• Creates and maintains study-specific training logs, as needed.
• Ensures that data and regulatory documents are complete for audits and monitoring per standard operating procedures visits.
• Conducts quality assurance data reviews to evaluate protocol compliance and data accuracy as assigned.
• Maintains research records of study activity, including case report forms, drug dispensation records or other on-site regulatory forms as per FDA guidelines
• Participates in internal/external research related site visits, conferences, investigator meetings to build and maintain relationships
• Works with and trains research participants about the trial and participation rules
• Assists in the recruitment and relationship building of study subjects, arranges study visits and provides instructions to meet the goals of the study
• Maintains inventory of supplies or equipment, prepares study kits and requisitions prior to study visits to ensure the appropriate items are available when necessary
• Manages the collection, labelling, storage and transport of all specimens
• Ensures all equipment and supplies needed for the study are in-stock, calibrated and in good working order
• Oversee medication administration or device usage
• Possesses the following organizational competencies: customer & patient focused, professionalism, teamwork, attention to detail, ability to problem-solve, organized and methodical approach and effective communication
• Other duties as assigned.

Competency

Knowledge

• Knowledge of clinical research and its direct impact on the practice’s revenue cycle
• Knowledge of Microsoft Office, especially Word, Excel, Outlook, and PowerPoint.

Skills

• Skill in training a variety of users on clinical processes and programs.
• Skill in effective interpersonal skills and communication methods.
• Skill in effective written and verbal communication.

Abilities

• Ability to effectively set expectations with stakeholders and to communicate when needed.
• Ability to effectively interact with staff members at all knowledge and skill levels.
• Ability to be well organized, work independently and prioritize effectively.

Physical Demands

Manual dexterity is required for heavy amounts of computer input.While performing the duties of this job, the employee is regularly required to sit. Will need to see, talk, and hear to accommodate all candidates through the process.The employee is occasionally required to stand; walk; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl.Be able to lift and/or move up to 25 lbs.

Equipment Operated

Standard office equipment including computers, fax machines, copiers, printers, telephones, etc.

Work Environment

The position is in well-lighted, well ventilated office environment. Occasional evening and weekend work.

Education / Experience / Licenses / Certifications

Required

• Successful candidates will have excellent communication, management and problem-solving skills
• 0-2 years professional experience in research
• Communicates effectively on the phone and in writing
• High school diploma or GED

Preferred (in addition to Required)

• Bachelor’s degree (or equivalent) in Business Administration, Healthcare Administration, Finance or similar
• Desire to grow professionally through ongoing education
• GCP Certification
• Dangerous Good Training Certification

FLSA Classification

Non-Exempt

Position Type & Expected Work Hours

This is a full-time on-site position. Work hours are typically sometime between Monday through Friday, 8:00 a.m. to 5:00 p.m., or other approved hours agreed upon with immediate leader. Occasional extended work hours may be required as business needs demand. Some employees in this position may be scheduled to work weekend shifts. Work location is primarily at the OPA University Lakes location, but may vary dependent on business needs.

Reports to

Director of Rheumatology and Infusion

Supervisory Responsibilities

This position does not directory supervise.

Travel Requirements

Travel not expected.

Remote Work

Not eligible for remote work

Other Duties

This job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee who holds this position. Job duties, responsibilities, and activities may change, or new ones may be assigned at any time with or without notice.

EEO Statement

OrthoAlaska is proud to provide equal employment opportunities to all applicants and employees without regard to race, color, ancestry, national origin, sex, sexual orientation, gender identity, marital status, religion, age, pregnancy, protected veteran status, disability, or other protected categories.