Work Schedule

Environmental Conditions

Job Description

Job Overview:

Under the general direction of the Clin Ops Supervisor, the Assoc Clinical Research Mgr is responsible for the successful completion of the study conduct phase of all early and late phase trials within the Clinical Research Unit. the ACRM is responsible for the successful conduction of multiple ongoing clinical trials involving patients or healthy volunteers/subjects. Completes of all paperwork required to accurately capture all data specified by a study protocol, and for assuring subject safety, understanding, and cooperation during the study process.

Essential Functions:

Accountable for understanding and accomplishing the overall plan for study conduct for multiple assigned studies in order to assure successful study completion with clean and accurate data for submittal to sponsor.

Reviews assigned study protocols, case report forms and investigator's brochure and interfacing with the Team Leader and Project Manager to clarify any study questions prior to study start.

Prepares accurate data collection sheets, dosing regimens, specimen harvest logs (e.g. blood, urine, fecal, and other specimens), and any other study documentation needed.

Communicates and works with the Pharmacy, Food Service, Materials Management, Training Team and Laboratory staff to assure proper support from these areas.

Qualifications:

Education and Experience:

High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification.

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

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

Knowledge, Skills and Abilities:

Demonstrated ability managing multiple responsibilities and completion of projects with overlapping prioritization.

Basic computer skills including knowledge of Microsoft Office and the ability to learn various programs and/or data management or electronic source systems.

Strong communication skills. Ability to clearly explain information to a wide variety of individuals.  

Ability to work closely with multiple types of individuals in potentially difficult or uncomfortable settings.

Strong attention to detail with strong planning and organization capabilities to manage multiple tasks and multiple study groups at one time.

Effective time-management while demonstrating ability to communicate need for assistance.

Management Role:

No management responsibility.

Working Conditions and Environment:  

Work is performed in an office or clinical environment. 

Frequent long hours, weekends, and/or holidays. 

Exposure to blood and biohazardous waste. 

Be available by cell phone after hours. 

Potential occasional travel required. 

Physical Requirements: 

Frequently vertical and /or stationary 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.  

Frequent bending and twisting of upper body and neck.  

Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer 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 moderately complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences.  

Frequently interacts with others, relates sensitive information to diverse groups.  

Ability to apply basic principles to solve conceptual issues.  

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. 

This document is intended to describe the general nature and level of work being performed by this job. This document is not intended to be construed as an exhaustive list of all responsibilities, duties and skills required. Individual responsibilities will be defined by your leadership team and will vary based on business needs.