Clinical Research Coordinator I

Summary

To serve as a clinical research coordinator during the conduct of clinical research at the investigative site. Works under the direct supervision of the Principal Investigator. Coordinates all activities for the implementation and conduct of clinical trials. Responsible for the collection, accuracy, and validity of data for assigned clinical studies in accordance with the study protocol and study timelines. Responsible for the collection and submission of regulatory documents, performance of study specific procedures and regulatory reporting requirements as instructed by the Principal Investigator and governed by Good Clinical Practice and International Council for Harmonization. Works under the supervision of the Principal Investigator to conceptually apply research protocol to clinical settings to allow for accurate and timely completion of all duties. Maintains all appropriate documentation associated with the assigned clinical study. Ensure studies are conducted according to established organization policies and procedures as well as all applicable State and Federal regulations, specifically Good Clinical Practice, International Council for Harmonization and Food and Drug Administration guidelines.

 Qualification Requirements

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

• 2 to 4 years of healthcare experience or 2 to 4 years as a Clinical Research Assistant, or any combination of the two.


• Valid drivers’ license and reliable transportation to allow individuals to provide support to offsite locations, as necessary.


• High School Diploma or equivalent


• Healthcare and/or Research experience preferred.


• Clear criminal history


• Demonstrated human relations and effective communication skills are required.


• Ability to understand the ethics of confidentiality and the ability to maintain confidentiality of sensitive information.


• Skilled in the use of personal computers and related software applications to include Microsoft Office Applications and email.


• Ability to function independently and enjoy a fast paced, challenging, changing environment; possesses the energy and commitment to help the organization move forward.


• Maintain a positive and professional attitude in all aspects of work from patient care to interaction with co-workers and physicians.


• Participates in 24-hour emergency on-call rotation


• Ability to provide a minimum of 4 weeks’ notice in the event resignation is tendered.

 Minimum Qualifications

• Excellent record maintenance skills.


• Ability to communicate effectively both orally and written.


• Proactive individuals with the ability to be a self-starter with strong independent decision-making skills and attention to detail.

 Knowledge, Skills, and Abilities

• Willing to pursue research certification when eligible.


• Maintains confidentiality of patients and their medical information.


• Maintains confidentiality of research activities as required by study sponsor confidentiality agreements and mandates.


• Must be able to meet deadlines for multiple concurrent projects.


• Ability to understand and follow policies, procedures and direction.


• Ability to foster a cooperative work environment. Possess willingness to accept orders and to perform repetitive tasks.


• Strong interpersonal and communication skills and the ability to work effectively with a wide range of constituencies in a diverse community.


• Ability to make evaluative judgments.


• Ability to function well while involved in multiple task assignments.


• Ability to concentrate on details and deal with constant interruption.


• Skill in organizing resources and establishing priorities.


• Ability to travel to attend off-site meetings as necessary and directed.


• Ability to delegate tasks to clinical research assistants and clinical research administrative assistants as applicable.


• Ability to ensure studies are conducted according to established organization policies and procedures as well as all applicable State and Federal regulations, specifically Good Clinical Practice, International Council for Harmonization and Food and Drug Administration guidelines.

 Supervisory Responsibilities: None

 Essential Functions (%)

This position is designated as an on-site, patient-facing role. In-office presence is an essential function due to the need for real-time collaboration with providers, direct interaction with patients and caregivers, and secure handling of health data in compliance with HIPAA.

• Coordinate all aspects of clinical research activities for assigned studies at investigative site- 90%


• Other duties as assigned -10%

 Physical Demands

• The employee may be required to assist in patient transfer and should use appropriate techniques and equipment to safely transfer patients.


• Hearing, visual acuity, depth perception, balancing, handling, and talking and require full range of body motion.


• Reaching, grabbing, holding – fine motor skills with dexterity and eye-hand coordination


• Extended periods in a stationary or standing position


• Repetitive motion such as entering data into computer-based programs


• Lift or move up to 30 pounds. Employees are expected to use appropriate ergonomics and tools such as hand carts for heavier loads.

Work Environment

• Work is normally performed in a typical interior/office work environment.


• The noise level is usually moderate.


• This position requires visual acuity eyesight (corrected or uncorrected).


• Moderate risk of exposure to blood borne pathogens and OPIM.

The above statements are intended to describe the general nature and level of work being performed by individuals assigned to this job. They are not intended to be an exhaustive list of all responsibilities, duties and skills required for the position. All employees may have other duties assigned at any time.

 This position falls under a 180- day evaluation review period.