JOB TITLE: Clinical Research Coordinator

REPORTS TO: Research Executive Director

FLSA STATUS: Exempt

GENERAL DUTIES

• Perform work independently under the general guidance of a supervisor.
• Create and/or maintain all documents and records related to the study.
• Ongoing visits and correspondence with study participants to monitor the condition of patients and collect study data.
• Careful documentation of participant data per study guidelines. Maintains study records in a timely and detail-oriented fashion.
• Create study specific documents (telephone screen questionnaire, source documents, site-level and master-level general logs, intake forms, etc.).
• Screens potential patients for protocol eligibility. Presents trial concepts and details to the patients, participates in the informed consent process, and enrolls patients on protocol.
• Coordinates patient care in compliance with protocol requirements. May disburse investigational drug and provide patient teaching regarding administration. Maintains investigational drug accountability. -In collaboration with the physician, reviews patients for changes in condition, adverse events, concomitant medication use, protocol compliance, response to study drug and thoroughly documents all findings.
• Responsible for accurate and timely data collection, documentation, entry, and reporting.
• Participates in required training and education programs. Participates in education and awareness of clinical research/active studies to clinical staff.
• Identify quality and performance improvement opportunities and collaborates with staff in the development of action plans to improve quality.
• Communicates with the physician regarding study requirements, need for dose modification, and adverse event reporting.
• Provides a safe environment for patients, families, and clinical staff at all times through compliance with all federal, state, and professional regulatory standards as issued through local and federal regulatory bodies. Maintains strict patient confidentiality according to HIPAA regulations and applicable law.

SUPPLIES/EQUIPMENT

• Ensuring that the necessary supplies and equipment for a study are in stock and in working order.
• Manage the inventory of equipment, supplies, and laboratory kits and order more as needed.
• Understands and follows technical instructions for operating clinical research equipment, problem solves when operational failures occur.
• Equipment inventory management, reconciliation, and return upon closure.

REGULATORY

• Knows the contents and maintenance of study-specific clinical research regulatory binders.
• Assists with the maintenance of regulatory documents for each Investigator Site File (ISF).

INVESTIGATIONAL PRODUCT

• Receives supply and IP orders/shipments and confirms accuracy of delivery. This includes logging and storing the IP as per protocol and procedures.
• Administers Investigational Product (IP) per protocol and pharmacy guidelines - including infusion, subcutaneous injection, oral, etc.

COMMUNICATION

• Acts as a point of reference for study participants by answering questions and keeping them informed on the study progress.

RECRUITMENT

• Recruits and screens potential study participants and performs intake assessments.
• Assists and leads effort for referred patient phone calls. Tracks patient referral and pre-screening progress on applicable site log(s).

LABORATORY

• Collects and processes laboratory specimens per protocol.
• Sound knowledge of collection procedures for central and local laboratories.
• Ships laboratory specimens per protocol.

DATA COLLECTION

• Inputs data and patient information into electronic systems.
• Administer questionnaires.
• Assists in observing and informing the PI/supervisor of adverse events, including those reported by study participants.
• Identifies, reports, and helps problem-solve protocol deviations and unanticipated occurrences.
• Addresses adverse events per protocol, advocating for study participants and quality standards throughout the lifespan of the study.

MONITORING

• Engage with study monitors and prepare for interim monitoring visits.
• Perform monitoring visits: pre-study, initiation, routine monitoring, and closeout visits. Study coordinator should be present during IMVs to make any corrections, file paperwork, make copies, etc.

Education, Experience and Skills

• 2+ years of previous experience working in a research setting.
• Excellent written and verbal communication skills.
• Superior organizational and time management skills.
• Capable of working independently with minimal supervision and also as part of a team.
• Skilled with standard computer programs, including the MS Office suite.
• Understanding of medical terminology as well as standard clinical procedures and protocols.
• Attention to detail and the ability to accurately collect and record data.
• Knowledge of good clinical practice (GCP) guidelines and regulations governing clinical research.
• Proficiency in relevant computer software and electronic data capture systems.
• Ability to work independently and as part of a team.

Compensation and Benefits

• Compensation depends on experience.
• See benefits package for full list of benefits.
• Ten days paid time off.

Working Conditions

Hours of work: Full-time position Monday - Friday; hours may vary based on the current needs of the company. Schedule will be based on a 40-hour work week.

Overtime expectations: This position is not expected to have overtime. If overtime is expected, management will communicate with the Study Coordinator to adjust schedules with at least 2 weeks' notice.

Work environment: Ability to lift up to 20 pounds for a short period and capable of standing for extended periods of time.

Travel requirements: This position requires travel to the additional RASF/Gastromed locations if needed.

Reporting To

• Executive Director

Supervisory Duties

• Research Assistant(s)

Evaluation and Review

• 90-day probationary period upon commencement of employment
• Yearly evaluation with Vice President and Executive Director

Employee Health Ins is covered at 100%. We also offer Dental, Vision, Life and 401K Benefits.