Clinical Research Coordinator II

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POST DATE 12/4/2019
END DATE 1/16/2020

Medical City Heart & Spine Dallas, TX

Location
Dallas, TX
AJE Ref #
585677733
Job Classification
Full Time
Job Type
Regular
Company Ref #
26857-6644
Experience
Mid-Career (2 - 15 years)
Education
Bachelors Degree

JOB DESCRIPTION

DESCRIPTION SHIFT: No Weekends

SCHEDULE: Full-time

HCA RESEARCH INSTITUTE'S Cardiovascular Research has conducted over 180 industry-sponsored trials and enrolled more than 2,000 patients since the program's inception providing innovative approaches to clinical trial management.

Since 2007, the network has grown to 11 hospital programs across the country working in collaboration with more than 125 physician investigators in multiple sub-specialties: interventional, electrophysiology, heart failure, cardiothoracic surgery, endovascular surgery, peripheral, and structural heart.

BENEFITS:
WE OFFER YOU AN EXCELLENT TOTAL COMPENSATION PACKAGE, INCLUDING COMPETITIVE SALARY, EXCELLENT BENEFIT PACKAGE AND GROWTH OPPORTUNITIES. WE BELIEVE IN OUR TEAM AND YOUR ABILITY TO DO EXCELLENT WORK WITH US. YOUR BENEFITS INCLUDE 401K, PTO MEDICAL, DENTAL, FLEX SPENDING, LIFE, DISABILITY, TUITION REIMBURSEMENT, EMPLOYEE DISCOUNT PROGRAM, EMPLOYEE STOCK PURCHASE PROGRAM AND STUDENT LOAN REPAYMENT. WE WOULD LOVE TO TALK TO YOU ABOUT THIS FANTASTIC OPPORTUNITY.

SUMMARY OF YOUR KEY RESPONSIBILITIES:

The Clinical Research Coordinator II is responsible for coordinating multiple research protocols; serving as a liaison with local investigators and research personnel; and acting as a central resource for assigned research projects. This individual seeks to demonstrate a moderate to advanced level of independence when performing research coordination duties and can apply skills to a broad range of study types.

Duties and Responsibilities:
Your duties and responsibilities include:

* Ability to satisfy all responsibilities of the CRC Level I Job Description

* Perform routine operational activities for multiple research protocols

* Liaise between site research personnel, industry sponsors, and Supervisor

* Collaborate closely with various site departments/teams, including finance, relevant hospital administrative representatives, and the local IRB, if applicable

* Coordinate schedule of assessments from initial submission of feasibility until study closeout

* Review the study design and inclusion/exclusion criteria with physician and patient

* Ensure the protection of study patients by verifying informed consent procedures and adhering to protocol requirements

* Ensure the integrity of the data submitted on Case Report Forms or other data collection tools by careful source document review; monitors data for missing or implausible data

* Create study specific tools for source documentation when not provided by sponsor

* Collect, complete, and enter data into study specific case report forms or electronic data capture systems

* Generate and track drug shipments, device shipments, and supplies as needed

* Ensure timely and accurate data completion

* Track and report adverse events, serious adverse events, protocol waivers, deviations, and violations

* Communicate all protocol-related issues to appropriate study personnel or manager

* Attend study specific on-site meetings, investigator meetings, conference calls and monthly CRC meetings, as required

* Review and respond to any monitoring and auditing findings

* Assist in providing coverage for satellite clinic sites as necessary

* Document all specific tasks required by the protocol (i.e. medication forms, quality of life questionnaires, neuro exams vital signs sheets, times of lab draws, etc.)

* Accurately perform/calculate and document the BSA, mRS, NIHSS, STS risk score, or any other approved CRC task,as needed per protocol

* Document all patient, staff, and sponsor correspondence, including follow-up encounters, adverse events, interventions, pharmacy dispensations, and patient phone calls

* Ensure follow-up appointments, imaging, or any related procedures are scheduled correctly according to protocol requirements

QUALIFICATIONS

COMPETENCIES:

KNOWLEDGE:

* Knowledge of organizational policies, standard operating procedures, and systems

* Demonstrate understanding and application of ICH guidelines and the Code of Federal Regulations within the clinical research environment.

* Fundamental understanding of medical and research operations terminology

* Recognize circumstances requiring prompt escalation to PI, IRB, and/or Supervisor

SKILLS:

* Effective communication skills

* Strong organizational skills and time management

* Basic clinical trial procedures, including ECG acquisition, phlebotomy, and specimen processing, handling, storing, and shipping.

* Effective interfacing with site stakeholders

ABILITIES:

* Interpersonal skills

* Self-motivated

* Meticulous eye for detail

CLINICAL COMPETENCIES: This role may require competency in performing clinical tasks, including ECG, phlebotomy, and the process of handling, centrifuging, storing and shipping of specimens. Demonstrating the ability to perform core competencies will be evaluated, at a minimum, annually. Training and/or certification will be provided when mandatory, per protocol.

EDUCATION:

Bachelor Degree required

EXPERIENCE:

Your experience should include:

* Research experience: Minimum of two years of progressive clinical research coordination or related experience in a patient care setting

* Proficiency in using various Microsoft Office, EDC, and CTMS applications

* Knowledge of basic medical terminology and GCP

* Preferred: Research certification (ACRP or CCRP)

DO YOU WANT TO BE A PART OF A TEAM WORKING TOGETHER TO END CARDIOVASCULAR DISEASE? WE LOOK FORWARD TO SPEAKING WITH YOU ABOUT THIS PHENOMENAL OPPORTUNITY. APPLY TO HEAR MORE.

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

NOTICE

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