Clinical Trials Coordinator
|Location:||Blood Center Headquarters (La Concha)|
|Position Title:||Clinical Trials Coordinator|
|Hours Per Week:||40|
|Work Week:||7am-3:30 pm|
|Shift:||Monday through Friday|
Location: 1400 La Concha Lane in Houston, Texas 77054
TITLE/CODE: Clinical Trials Coordinator
DEPARTMENT: Clinical Trials
SCOPE OF RESPONSIBILITY
Under immediate supervision of the Commercial Procurement Manager, Technical Services. Assists with the Procurement Program and coordinates clinical trial activities undertaken by the NDTS laboratory.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following; other duties may be assigned. Management retains the discretion to add to or change the duties of the position at any time.
· SOP management, training, annual document review, internal and external inspection coordination, incident and error management, trial monitoring, equipment and reagent tracking, and all other GCP activities for clinical trials performed by the NDTS Laboratory.
· Handles clinical trial planning and execution with other departments as needed.
Assists Medical Services with the IRB process – coordination with investigators, Medical Services, and Donor Collections.
· Communicates directly with clients to schedule procurement orders and determine status of orders.
· Secures purchase order numbers for procurement orders. Maintains client files and keeps track of overdue invoices.
· Communicates with current and potential clients to maintain and grow client base.
· Trains new and current employees on new/revised processes.
· Assists with procurement activities as required. (Prepares and organizes aliquoting and shipping orders and supplies as needed. Enter specimens or study consent forms into computer as directed. Discards old samples and stores test tubes in the refrigerator).
· Assists with recalls, lookbacks and commercial donor recruitment / scheduling as needed.
· Assists with equipment QC as needed.
· Follows safety procedures including proper use of personal protective equipment, appropriate use of engineering controls, and performance of safe work practices as stated in the safety manual.
Must not pose a direct threat or significant risk of substantial harm to the safety or health of himself/herself or others. Must comply with all applicable safety rules and policies and be willing to report actual and potential safety violations to the appropriate supervisor or manager.
Must maintain regular and acceptable attendance at such level as is determined in The Blood Center’s sole discretion.
Full time: must be regularly available to work at least 8 hours per day, 40 hours per week, or such other days or hours per week as The Blood Center determines are necessary to meet business needs.
Overtime (applicable only to non-exempt positions)
Must be available and willing to work such overtime per day or per week as The Blood Center determines is necessary or desirable to meet business needs.
Weekend and Holidays
Must be available and willing to work such weekends and holidays as The Blood Center determines are necessary or desirable to meet its business needs.
This job has no supervisory responsibilities.
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.
EDUCATION AND EXPERIENCE
Bachelor’s Degree (BS) from an accredited college or university in Biology or Chemistry with a minimum of one year related experience in clinical or research laboratory.
CERTIFICATES, LICENSES, REGISTRATIONS
Certification as a Clinical Research Coordinator is preferable
Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public. Ability to clearly present information through the spoken word; influence or persuade others through oral presentation in positive or negative circumstances and to listen well; write clearly and effectively present ideas to document activities and to read and interpret a variety of written information.
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.
Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form. Must be able to exercise sufficient judgment to determine when to involve supervisor or manager for variances or problems.
OTHER SKILLS AND ABILITIES
Must be flexible with working hours and days
POSITION DRIVING STATUS
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 use hands to finger, handle, or feel; reach with hands and arms; and talk or hear. The employee frequently is required to sit and stoop, kneel or crouch. The employee is occasionally required to stand and walk. The employee must occasionally lift and/or move up to 10 pounds. Employees are required to be familiar with and abide by the team lift requirements as specified in the Safety Program in an effort to prevent bodily injury and for the health and safety of others. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus.
The work environment described here are representative of the employee will encounter while performing the essential functions of this job.
While performing the duties of this job, the employee is regularly exposed to blood and/or blood components, as well as any other biohazard materials. The employee is occasionally exposed to moving mechanical parts and risk of radiation. The noise level in the work environment is usually moderate.
Job duties involved an inherent potential for mucous membrane or skin contact with blood with a risk of exposure to Hepatitis and HIV.
The Blood Center is an Affirmative Action/Equal Employment Opportunity Employer. Qualified applicants for positions are considered without regard to race/ethnicity, color, religion, national origin, age, pregnancy, sex, sexual orientation, gender identity, transgender status, military status, protected veteran status, disability status, genetic testing results or any other basis or characteristic prohibited by applicable law, statute, regulation or Executive Order.
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