Description

Type: This is a full-time position, days and hours of work are Monday-Friday 8 hours per day. Times must be flexible, possible weekends for research meetings.

Supervision Received:  Reports to the Research Manager and Team Leader

Supervises support staff assigned as blinded raters or technicians to studies

Classification: Nonexempt

Summary/ Objective: Responsible for performing a variety of clinical study activities to assist the Medical Research Director, Investigators, Research Manager and Team Leader in the conduct of a clinical study. 

Essential Functions:

• To conduct the clinical study according to FDA regulations and guidelines.
• To maintain good clinical practices and HIPAA standards.
• To recruit, screen and enroll potential study participants according to the protocol’s inclusion and exclusion criteria
• To obtain written informed consent from each study participant prior to participation.
• To schedule study participants’ visits and during the study participant’s visit perform defined activities of the study completely and accurately.
• To ensure the safety and welfare of the study participants
• To assure compliance with all relevant IRB and other regulatory agency requirements
• To identify problems or obstacles in the system/procedures related to implementation of the research protocols and communicates to the study investigators
• To design and maintain organizational tools to conduct the study accurately and in compliance with the GCP and Protocol(s).
• To be knowledgeable of the sponsor’s protocol so that all study activities are completed accurately and completely
• To train other site personnel and other medical staff in understanding and implementing the protocol
• To report all adverse experiences to the Investigator, Research Manager and document appropriately
• To maintain adequate and accurate case histories for each study participant that records all observations and data during the study.
• To complete Case Report Forms for the study accurately and completely.
• To assign study participant numbers and maintain accurate and complete records of the receipt, dispensing, and return of all clinical supplies. All discrepancies must be noted and explained
• To maintain records of study participants’ status in the study.
• To communicate with the Sponsor regarding study activities as necessary.
• To maintain program timeline including tracking deadlines for program components.
• To meet with the Sponsor’s representatives to discuss the conduct of the study and review data.
• To attend investigator meetings (as required) to learn study requirements, meet the Sponsor personnel, represent the site and convey all information to the site study team upon return.
• To perform blood draws and ECG as required by the study

Education: High School diploma or GED; Must complete training in clinical research GCP requirements and medical documentation requirements. Must be willing to become ACRP-certified.

Experience: Two to three years experience in the medical/health related field with exposure and participation in direct patient care or two to three years research experience

Knowledge:

1. Proficiency in basic computer software applications.
2. Knowledge of organizational standards and patient rights.

 Skills:

1. Skill in the effective use of management tools
2. Good organizational skills necessary for record keeping and meeting deadlines.
3. Excellent written and verbal communication skills.
4. Excellent follow through

Abilities:

1. Ability to interact effectively as a member of a health care team
2. Ability to make presentations and train effectively.
3. Ability to be flexible in handling daily schedule changes and interruptions.
4. Ability to demonstrate compassion, tolerance and confidentiality when dealing with patients
5. Ability to work independently

Travel:

Some travel by personal vehicle may be required. Must have valid driver’s license and current auto insurance. Standard mileage reimbursement provided by the organization.

Work Environment:

The job operates in both medical and clerical setting. This role routinely uses medical devices, laboratory equipment and standard office equipment such as ECGs, electronic and manual sphygmomanometer, electronic thermometer, pulse oximeter, cold and ambient centrifuge, incubator, computers, phones, photocopiers, filing cabinets and fax machines.

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

This role requires one to sit, stand, and walk for 8-9 hours per day. This would require the ability to lift objects up to 50 lbs., open filing cabinets and bend or stand on a stool as necessary. This role requires full range of motion, manual dexterity and hand-eye coordination.

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 at any time with or without notice.