Clinical Research Coordinator
Blood Center Headquarters (La Concha)
Clinical Research Coordinator
Hours Per Week:
8am to 5pm
Monday through Friday
GULF COAST REGIONAL BLOOD CENTER
Location: 1400 La Concha Lane in Houston, Texas 77054
TITLE/CODE: Clinical Research Coordinator
DEPARTMENT: Celluar Life Solutions
SCOPE OF RESPONSIBILITY
Reporting to the Cellular Life Solutions’ Director, and under direct supervision of Chief Medical Officer/Assoc. Vice President of Medical Services, the Clinical Research Coordinator (CRC) serves to lead in the coordination, management and conduct of clinical research trials in the CLS and other Medical Services departments. This individual will be directly involved with vetting and evaluating potential clients. They will also assist the investigating physician(s)/Principal Investigator(s) (PIs) with the preparation of regulatory documents, planning, subject recruitment, enrollment, scheduling, and study conduct for complex (phase I-III) protocols in the fast paced emerging cell and gene therapy and clinical trials areas. The CRC will train and mentor CLS, Clinical Trials and Medical Services health care personnel on protocols and ensure correct protocol adherence under the direction of the PI. This includes both GCRBC institutional studies, client specific protocols/studies, and multi-institutional consortium-sponsored trials.
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.
- Maintain working knowledge of the research process and in the conduct of IRB approved research protocols.
- Follow and enforce ICH/GCP/GTP/GMP guidelines.
- Manage information gathering for vetting and evaluation of potential clients, clinical trial budget preparation, and execution of appropriate protocol/study requirements for new client onboarding process
- Under the direction of Medical Director/CLS Director/Commercial Procurement Manager, conduct screening and interviews to evaluate patient and/or donor eligibility in study.
- Respond promptly and accurately to customer complaints, inquiries, and requests for information and coordinate appropriate follow-up calls and/or appointments.
- Schedule research subject appointments for tests and procedures, such as laboratory tests, x-rays, and other studies specific for the research protocol.
- Maintain records for clinical study and regulatory documents.
- Under the direction of applicable management, capture and report Adverse Events (A/E) or Serious Adverse Events (SAE) to necessary regulatory authorities.
- Assist Administration with research records and regulatory maintenance.
- Compile patient and/or donor information, process, document and enter accurate information in Source Documents, Case Report Forms, Electronic Data Capture portals and Clinical Trial Management System, as applicable, following established procedures
- Maintain inventory of supplies necessary for the study.
- Assists with donor recruitment/scheduling as needed
- Assists with revision/creation of SOPs and trains new and current staff on new/revised clinical research processes
- Perform other reasonably related business/job duties as assigned. GCRBC reserves the right to revise job duties and responsibilities as the need arises.
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.
Must be occasionally able to work at off-site locations and to either transport self or be transported to same.
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/clinical setting.
Computer database management experience preferred.
CERTIFICATES, LICENSES, REGISTRATIONS
Certification as a Clinical Research Coordinator (CCRC or CCRP) preferred.
• Sufficient proficiency in speaking, reading, and writing the English language necessary to perform the essential functions of this job, especially with regard to activities impacting patient, donor or employee safety or security.
• Ability to effectively communicate with patients, donors, physicians, family members and co-workers in a manner consistent with a customer service focus and application of positive language principles
- Ability to read and interpret documents such as clinical trial protocol/study, regulatory documents, safety rules, operating and maintenance instructions, and procedure manuals.
- Ability to listen well and capture notes/details discussed.
- Ability to write routine reports and correspondence independently.
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 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 manager or Director for variances or problems.
OTHER SKILLS AND ABILITIES
- Time management skills
- Ability to understand and implement protocols
- Knowledge of Microsoft Office
- Strong interpersonal communication skills
- Detail-oriented, focus on accuracy
- Ability to manage multiple projects and prioritize own work.
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 frequently required to operate a computer and other office machinery and remain in a stationary position. The employee must frequently 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. Specific vision abilities required by this job include close vision, distance vision, peripheral vision, depth perception, and ability to adjust focus.
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 frequently exposed to blood and blood components as well as other biohazard materials, moving mechanical parts and extreme cold. The employee is occasionally exposed to toxic or caustic chemicals, risk of electrical shock, and risk of radiation. The noise level in the work environment is usually moderate.
Job duties involve 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.