Clinical Research Coordinator presso Piedmont HealthCare PA

Description

GENERAL SUMMARY OF DUTIES: 

Research Coordinator supports the clinical site in planning and executing multiple phase clinical trials. 

SUPERVISION RECEIVED: 

Clinical Research Manager and Principal Investigator 

SUPERVISION EXERCISED: 

N/A 

ESSENTIAL FUNCTIONS: 

1. Works with Clinical Research Manager to perform study activities related to pre-trial assessment(s), budget development, start up, active phase and the closeout. This may include recruiting and pre-screening participants and the collection and submission of study data, including specimen samples per identified protocols, in accordance with study protocols.  
2. Participates in pre-trial assessments, initiation visits and investigator meetings, as appropriate and assists in communicating with and coordinating visits by study monitors. 
3. Processes regulatory packets for submission to the sponsor. This may include obtaining patient signatures for protocols/ amendments, updating consent forms with site specific information, collecting completed FDA forms, updated C.V.s and medical licenses for investigators and other personnel involved in studies, and responding to requests related to advertisements, indemnification, completed W-9 Forms, appropriate signatures on Clinical Trial Agreements, correspondence/questionnaires to IRB requesting review and approval for site and site information form. 
4. Attends IRB meetings when necessary. 
5. Researches and evaluates additional study opportunities compatibility/viability and makes recommendations to Clinical Research Manager. 

Requirements

EDUCATION: 

Bachelor’s degree in science or health-related field preferred 

EXPERIENCE: 

Two years clinical research experience desired 

REQUIREMENTS: 

Clinical research certification (ACRP or SOCRA preferred). 

KNOWLEDGE AND SKILL REQUIREMENTS: 

• Knowledge of applicable laws, policies and procedures with regard to research. 
• Knowledge of safety hazards and precautions to establish/maintain a safe work environment. 
• Ability to apply/modify research principles/techniques to provide ongoing patient care. 
• Skill in identifying problems and recommending solutions. 
• Skill in preparing/maintaining detailed records and communicate clearly in writing reports and responding to      correspondence. 
• Ability to maintain quality control standards. 
• Ability to react calmly and effectively in all situations. 
• Ability to communicate clearly 

ENVIRONMENTAL/WORKING CONDITIONS: 

Combination of office and exam settings. May involve frequent exposure to communicable diseases, toxic substances, ionizing radiation, medicinal preparations and other conditions common to a clinic environment. 

PHYSICAL/MENTAL DEMANDS: 

Varied activities including standing, walking, reaching, bending, lifting. Requires full range of body motion including handling and lifting patients, manual and finger dexterity and eye-hand coordination. Requires standing and walking for extensive periods of time. Occasionally lifts and carries items weighing up to 100 pounds. Requires corrected vision and hearing to normal range.  Requires working under stressful conditions or working irregular hours. 

This description is intended to provide only basic guidelines for meeting job requirements. Responsibilities, knowledge, skills, abilities and working conditions may change as needs evolve.