Clinical Research Coordinator

45321BR

Extended Job Title:

Clinical Research Coordinator

Org Level 1:

Texas Tech Unv Hlth Sci Ctr El Paso

Position Description:

Coordinates daily operations of clinical research studies in assigned department(s). This includes but is not limited to overall clinic conduct, marketing, and data management of all clinical research activities in assigned department(s). Carries out supervisory responsibilities in accordance with policies and applicable laws. Responsibilities may include training new employees; assisting with planning, assigning, and directing work; addressing complaints and resolving problems. The employee is frequently exposed to fumes or airborne particles. The employee is occasionally exposed to toxic or caustic chemicals and dangerous bodily fluids. The noise level in the work environment is usually moderate. Approximately 5-15% travel (often long-distance) is required.

Requisition ID:

45321BR

Optional Attachments:

Transcript

Travel Required:

Up to 25%

Major/Essential Functions:

• Initiates and facilitates study application, regulatory documentation, data collection forms, and additional applicable items for submission and review for ethics committee review and approval (IRB, IBC, IACUC, etc.) or external entity (i.e. UMC).

• Responds to ethics committee inquiries and stipulations as needed, and submits amendments as needed; this includes preparing and submitting additional modifications for protocols, consent forms, surveys, sponsor monitoring reports and any other attachments or revisions as needed.

• Initiates and completes screening, recruiting, registration and informed consent procedures and associated paperwork for both prospective and current subjects. This includes submitting paperwork in a timely manner and randomization if applicable. In addition, is responsible for determining if a subject is a good candidate for research along with the principal investigator’s assessment.

• Coordinates and schedules subject study visits, procedures, IP reconciliation, required clinical testing, imaging and additional study-specific items and procedures as needed.

• Creates and maintains study regulatory documentation. This includes maintenance of subject data by tracking subjects as they complete protocol-specific study procedures and as data collection is performed.

• Maintains communication with sponsor, principal investigator and ethics committee for any unanticipated events that arise and submits all necessary documentation as needed.

• Assists principal investigator in completion of delegated tasks and helps principal investigator by requesting signatures, reviews, and approvals for both study and subject documentation as needed. Maintains and tracks daily communication with sponsor delegates to ensure site activation and continuous protocol adherence. Completion of tasks includes but is not limited to coordinating and performing a wide variety of research related functions such delegated testing, data collection, data entry, collection and submission of blood/tissue/biological samples. Must be proactive and timely in all areas of trials, and must provide principal investigator with consistent updates.

• Monitors and reviews all study-related documentation to ensure that it is complete and correct. In addition, ensures that all clinical research studies are compliant with Federal and institutional regulations.

• Participates in data query resolution with sponsored studies.

• Facilitates communications and meetings with study sponsors and monitors.

• Manages, updates and maintains additional documentation associated with research team training, CVs, financial disclosures, subject payment information and Swift card requests, etc.

• Adhere to all policies, procedures and practices (Regents Rules, TTUS, HSECEP OPs, etc.).

• Personally, and consistently, demonstrate, display and act in accordance with Texas Tech Health El Paso’s Values (Service, Respect, Accountability, Integrity, Advancement, and Teamwork). Serve as a Value's leader while actively promoting and encouraging staff across the institution.

• Remains current with all licensure, certifications and mandatory compliances and trainings required of this position.

• Perform all other duties as assigned.

Grant Funded?:

No

Minimum Hire Rate:

Compensation is commensurate upon the qualifications of the individual selected

Pay Basis:

Monthly

Work Location:

El Paso

Preferred Qualifications:

• Experience working in a research environment in an academic setting.

• Experience in research administration processes.

• Ability to speak effectively and professionally in English (Spanish fluency also desirable).

• Excellent written and verbal communication skills.

• Excellent ability to read, hear and comprehend information and to convey key information to others.

• Strong computer skills. Expertise in Microsoft Office Professional Editions (Word and database programs such as Excel or Access).

• Detail-oriented and able to follow through and anticipate needs.

• Excellent organizational skills; budgeting and accounting skills; ability to prioritize and manage diverse and complex responsibilities in time critical situations; pleasant personality and ability to work well with others.

• Excellent reasoning ability to read, hear and comprehend extensive technical and regulatory information and convey key information to others.

• Experience in Human Resources, recruitment, training.

Campus:

HSC - El Paso

Department:

Research Administration

Required Attachments:

Resume / CV

Job Type:

Full Time

Pay Statement:

Compensation is commensurate upon the qualifications of the individual selected and budgetary guidelines of the hiring department, as well as the institutional pay plan. For additional information, please reference the institutional pay plan website at .

Job Group:

Clinical Research Professional

Shift:

Day

EEO Statement:

All qualified applicants will be considered for employment without regard to sex, race, color, national origin, religion, age, disability, protected veteran status, or genetic information.

Required Qualifications:

• Healthcare related training with current licensure/certification in their field OR

• Bachelor's degree from an accredited university with a major in the area of research being conducted.

• Certification:

• Certified Clinical Research Professional as defined by The Society of Clinical Research Associates or Certified Clinical Research Coordinator as defined by the Association of Clinical Research Professionals. OR

• Ability to obtain certification as a Clinical Research Professional/Coordinator within two years from date of hire or upon eligibility.

Does this position work in a research laboratory?:

No

Navy Enlisted Classification Code:

230X

Air Force Specialty Code:

43BX

Jeanne Clery Act:

The Jeanne Clery Disclosure of Campus Security Policy and Campus Crime Statistics Act is a federal statute requiring colleges and universities participating in federal financial aid programs to maintain and disclose campus crime statistics and security information. By October 1 of each year, institutions must publish and distribute their Annual Campus Security Policy & Crime Statistics Report (ASR) to current and prospective students and employees. To view this report, visit the TTUHSC Clery Act website at .