Clinical Research Nurse

Work Schedule

Environmental Conditions

Job Description

Conducts multiple ongoing clinical trials of varying size and complexity involving patients or healthyvolunteers/subjects. Completes all paperwork required to capture all data as specified by a studyprotocol and for ensuring subject safety understanding and cooperation during the study process.
Interacts with the research site team and other interdepartmental staff. Engages in the entire siteoperations process which includes recruitment enrolment and retention of study participants. Providestraining and guidance to junior team members. Acts as a lead coordinator for certain studies taking theoverall responsibility thereof at the site liaising with monitors and other stakeholders

Day to day responsibilities:

• Conducts clinical studies according to FDA/GCP and ICH regulations andguidelines

• Provides medical care to patients always ensuring patient safety comes first

• Schedules subject visits within protocol windows ensuring scheduling capacity ismaximized

• Performs all defined study activities (i.e. informed consent screening and

• protocol procedures which include but not limited to vital signs pregnancy testsheight weight ECGs blood samples etc.)

• Records all patient information and results from test as per protocol on therequired forms

• Where required may complete IP accountability logs and associated information

• Reports suspected non-compliance to relevant site staff

• Ensures that IRB approval is obtained prior to study initiation and IRBrequirements are met throughout the study

• Promotes the company and builds a positive relationship with patients to ensureretention

• Attends site initiation meetings and all other relevant meetings to receivetraining on protocol

• Reviews the overall plan for study conduct for multiple assigned studies anddetermines how to accomplish

• Identifies and communicates any obstaclesimpeding efficient study conduct

• Accurately collects and documents data. Ensures correct study documents andcomputer generated forms are used in compliance with protocol.

• Ensures that timelines are met by working with relevant staff.

• Monitors safety and well-being of all study participants through direct andindirect interaction with subjects and communicates problems to relevantstakeholders

• Performs clinical assessments of participants monitors laboratory safety reports and communicates any serious or potentially serious adverse events as per thecompany procedure

• Serves as a primary point of sponsor contact for all research activities for studiesassigned

• Ensures all communications are documented and shared with the appropriateteam members

• Acts as a back-up to direct people manager. This includes but is not limited tooverseeing and assigning work to team members scheduling and monitoringtime.

• Involved in the interview and hiring process of new team members. Assistsin the training of new team members and provides mentoring. Provides inputinto evaluations performance reviews of team members . Performs other studyrelated duties as qualified by documented training

Qualifications:
Education and Experience:

• Bachelors degree or equivalent and relevant formal academic / vocational qualification in the clinical /

• medical field

• Must hold a valid nursing license (RN LVN LPN) within the country operating. Must be registered withlocal health care authority.

• Previous experience that provides the knowledge skills and abilities to perform the job (comparable to5 years).

In some cases an equivalency consisting of a combination of appropriate education trainingand/or directly related experience will be considered sufficient for an individual to meet therequirements of the role.
Accelerated Enrollment Solutions is a business unit of Pharmaceutical Product Development LLC a Delaware limited liability company (PPD)
collectively made up of Acurian Inc. and Synexus each a subsidiary of PPD.

Knowledge Skills and Abilities:

• Thorough understanding of the clinical research process (i.e. GCP SOPs informed consent safetymonitoring etc.)

• Capable of working independently analyzing and working with attention to detail processing and

• prioritizing sensitive complex information and problem solving

• Demonstrated ability to exercise discretion and sound judgement

• Solid decision-making negotiation and influencing skills

• Strong communication skills and English fluency will be an advantage

• Strong organizational skills

• Strong proficiency in basic computer applications

• Solid interpersonal skills to work in a team environment

Working Conditions and Environment:

• Work is performed in an office/ laboratory and/or a clinical environment.

• Exposure to biological fluids with potential exposure to infectious organisms.

• Exposure to electrical office equipment.

• Personal protective equipment required such as protective eyewear garments and gloves.

• Occasional travel may be domestic or international.

Physical Requirements:

• Ability to work in an upright and /or stationary position for 6-8 hours per day.

• Repetitive hand movement of both hands with the ability to make fast simple repeated movements

• of the fingers hands and wrists.

• Frequent mobility required.

• Occasional crouching stooping with frequent bending and twisting of upper body and neck.

• Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptopcomputer with a maximum lift of 15-20 lbs.

• Ability to access and use a variety of computer software developed both in-house and off-the-shelf.

• Ability to communicate information and ideas so others will understand; with the ability to listen toand understand information and ideas presented through spoken words and sentences.

• Frequently interacts with others to obtain or relate information to diverse groups.

• Performs a wide range of variable tasks as dictated by variable demands and changing conditions

• with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task.

• Regular and consistent attendance.