Coordinating Team Lead

Summary: Responsible for the daily operational oversight of all clinical trials by working closely with the Director(s) of Clinical Operations and other cross-functional representatives, including quality assurance/regulatory services, pharmacy, and laboratory services to ensure successful completion of all clinical activities. Responsible for administrative duties to facilitate clinical research which includes working with affiliate or collaborating research sites by performing the following duties.

Duties and Responsibilities include the following.  Other duties may be assigned as needed.

 1.    Exercises judgement within the allowable limits defined within clinical trial protocols, standard operating procedures, and the direction from the study investigator and supervisor. *

 2.    Maintains subject and document confidentiality at all times, understands and complies with the appropriate sponsor requirements and regulations which includes the Food and Drug Administration, good clinical practices, International Conference on Harmonization, Health Insurance Portability and Accountability Act, institutional review boards, and institutional policies and procedures. *

 3.    Creates and completes study related documents and new study preparation. *

 4.    Assists with regulatory submissions and maintains regulatory files. *

 5.    Coordinate’s study related activities with involved parties. *

 6.    Acts as a liaison with sponsors. *

 7.    Prepares for study monitor visits. *

 8.    Completes case report forms. *

 9.    Creates reports as requested. *

 10.  Completes study directed assessments with patients which includes but not limited to informed consent, subject history, adverse events, test article handling, appointment scheduling, records review, treatment coordination, collecting vital signs, and subject health assessment. *

 11.  Performs subject screening and recruitment. *

 12.  Interacts with internal and external personnel such as physicians, nurses, administrative staff, industry sponsor representatives, central laboratory and imaging personnel, and clinical trial patients.  Acts as a liaison for clinical trial sponsors, vendors and sites. *

 13.  Coordinates multiple projects with competing priorities and deadlines as needed based on clinical trial protocol directives and study volume. *

 14.  Identifies departmental needs, supplies, staffing and equipment goals to continually improve the research process within the established guidelines of the institute. *

 15.  Ensures adherence to good clinical practices (GCPs), appropriate standard operating procedures (SOPs), Food and Drug Administration (FDA) regulations, and International Conference on Harmonization (ICH) guidelines and provides and implements corrective action plan when appropriate. *

 16.  Monitors adherence to protocols and study timelines. *

 17.  Facilitates daily operations of all clinical research programs. *

 Supervisory Responsibilities:

Directly supervises Coordinators and Research Assistants at the site and ensure these employees are in compliance with good clinical practices (GCPs), appropriate standard operating procedures (SOPs), Food and Drug Administration (FDA) regulations, and International Conference on Harmonization (ICH) guidelines. Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include training employees and with guidance from management assist with planning, assigning, and directing work, appraising performance, addressing complaints, and resolving problems.

 Qualifications:

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 accommodations may be made to enable individuals with disabilities to perform the essential functions.

 Language Ability:

Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Ability to write routine reports and correspondence. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.

Math Ability:

Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent and to draw and interpret bar graphs.

Reasoning Ability:

Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form. Ability to deal with problems involving several concrete variables in standardized situations.

 Computer Skills:

To perform this job successfully, an individual should have knowledge of Microsoft Office, Microsoft Excel, Internet Explorer, Google Chrome, Mozilla Foxfire, web-based enterprise solutions software, and electronic case report form systems.

 Education/Experience:

High school diploma or general education degree (GED); Bachelor’s degree preferred and/or two to four years related experience and/or training in a Coordinating role.

 Certificates and Licenses:

·         Collaborative Institutional Training Initiative training certification

·         Good clinical practice training certification

·         IATA training certification

·         Clinical research coordinator certification, preferred

·         Valid driver's license and insurance

Knowledge, Skills, and Other Abilities:

·         Oral and written communication skills

·         Organizational skills

·         Ability to pay attention to details

·         People skills including possessing a positive, friendly, and professional demeanor

·         Ability to be flexible with changing priorities

·         Ability to communicate in a diplomatic and professional manner

·         Good medical knowledge including medical terminology

·         Knowledge of code of federal regulations, good clinical practices, and International Conference on Harmonization guidelines required

 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.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required to stand, walk, use hands, and reach with hands and arms. The employee is occasionally required to sit, stoop, kneel, crouch or crawl, and taste or smell. The employee must occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, peripheral vision, depth perception, ability to adjust focus, and ability to see color.

 Work Environment:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

 While performing the duties of this job, the employee is regularly exposed to blood borne pathogens. The employee is occasionally exposed to work near moving mechanical parts, risk of radiation, and vibration.

 The noise level in the work environment is usually moderate.