"Alerted.org

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Summarized Purpose:

Performs remote or on-site activities on assigned projects at the direction of the PI. Provides support with regards to site preparedness, logistical support to the study coordination tasks, and assists with assigned responsibilities for site management in accordance with site SOPs and regulatory guidelines.

**Role:** Clinical Study Coordinator

**Location:** Houston, TX

**Please Note:** this is an ON SITE position, so candidates MUST be located within this geographic location.

Essential Functions and Other Job Information:

+ Completes study and site management activities, and Functions as applicable

+ Completes study-specific training.

+ Orients and trains on any study- and/or site-specific systems.

+ Could assist with patient recruitment, identification, or chart review tasks.

+ Scheduling participant study visits, visit reminders, and diary reminders, as applicable.

+ EDC data entry and query resolution

+ Reviews patient-facing materials and advises on recruitment strategy.

+ Device and equipment management/training.

+ Maintain regulatory documents.

+ Provides support for various types of monitoring visits.

+ Maintains logs.

+ Coordinates study/site supply management during pre-activation and subsequent course of the study.

+ Supports Essential Document collection, review and updates in systems, as applicable.

+ Follows up and supports missing study data like ECGs, lab samples, and e-diaries

+ Performs reconciliation tasks on assigned trials including but not limited to CRF and query status, deviations, SAEs and safety reports, as applicable.

+ May perform other assigned site management tasks, such as informed consent, as directed by PI

+ May perform a specific role profile for FSP opportunities according to Client requests.

+ Maintains & completes administrative tasks such as expense reports and timesheets in a timely manner.

+ Job Knowledge Learns to use professional concepts. Applies company and site policies and procedures to resolve routine issues.

Qualifications:

Education and Experience:

+ Bachelor's degree in a life science or related field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification.

+ Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 2 years).

+ In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills and Abilities:

+ Basic medical/therapeutic area knowledge and understanding of medical terminology

+ Ability to attain and maintain a solid understanding of ICH GCP, applicable regulations and site procedural documents

+ Effective oral and written communication skills

+ Excellent interpersonal and customer service skills

+ Good organizational and time management skills and strong attention to detail, with ability to handle multiple tasks efficiently and effectively

+ Shown flexibility and adaptability

+ Ability to work in a team or independently, as required

+ Well-developed critical thinking skills

+ Proficient computer skills with good knowledge of MS Office

+ Ability to extract pertinent information from all study documents, electronic study data systems, and dashboards

+ Excellent English language and grammar skills

Working Conditions and Environment:

+ Work is performed most of the time in an office or home office environment.; travel to clinics/hospitals may be required.

+ Exposure to electrical office equipment.

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.

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

+ Occasional light lifting and/or carrying of objects with a maximum lift of 5-15 lbs. (2-6 kgs.)

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

+ Performs a wide range of variable tasks as instructed 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.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.