Clinical Research Coordinator - Cancer Center - $5000 Sign On Bonus

UnityPoint Health St. Lukes

Requisition ID
2020-84259
Category
Research
Location
US-IA-Cedar Rapids
Address
202 10th St SE
Affiliate
1010 UnityPoint Health CR St Lukes Hospital
City
Cedar Rapids
Department
Helen G Nassif Comm Cancer
State
IA
FTE
0.9
FLSA
Non-Exempt
Scheduled Hours/Shift
Monday thru Friday Days
Work Type (Portal Searching)
Full Time Benefits

Overview

$5000 Sign On Bonus will be offered for this position.  24 Month Commitment

 

Description of Position:

Provide a “snapshot” or the principal purpose or focus of the position, consisting of no more than three to five sentences. This summary should provide enough information to differentiate the major function and activities of the position from those of other positions.

Works in collaboration with the Director, Principal Investigator and research team to assure good clinical and regulatory conduct of clinical trials. The role is multifaceted and supports the implementation, evaluation and quality assurance of initiatives supporting the clinical and regulatory functions of the research program. Works in collaboration with the Director, Principal Investigator and research team to assure the research program is meeting the needs of the patients we serve as well as adhering to clinical, regulatory and compliance requirements.

Responsibilities

Essential Functions/Responsibilities:

Essential functions are the duties and responsibilities that are essential to the position (not a task list). Do not include if less than 5% of work time is spent on this duty. Be specific without giving explicit instructions on how to perform the task. Do not include duties that are to be performed in the future. Duties should be action oriented and avoid vague or general statements.

% of Time

(annually)

Program Coordination

·        Assists with new study start-up including but not limited to development of Confidential Disclosure Agreement (CDA), coordination of site qualifying and site initiation visits.

·        Supports regulatory professional with tasks, including but not limited to (Institutional Review Board) IRB submissions, delegation logs and study.

·        Participate in preparation and management of research budgets and monetary disbursements.

·        Coordinates the conduct of clinical trials assuring protocol requirements and all relevant local, federal, and state regulatory and institutional polices are followed.

·        Coordinates projects self-initiated or requested by Cancer Care leadership, physician partners and/or research sponsors.

·        Prepare for and participate in quality assurance audits conducted by study sponsors, federal agencies, or specially designated review groups.

·        Reviews proposals for clinical research studies and makes recommendations to the Medical Director, Program Manager and study investigator(s) regarding feasibility and patient population.

·        Makes recommendations to the Medical Director, Program Manager and study investigator(s) regarding study protocols/ procedures, budgets, recruitment strategies, and working relationships with other departments, agencies, and health care facilities as required by the study.

·        Assists with orientation and training of research personnel to perform assigned job duties according to department standards.

·        Development of Standard Operating Procedures (SOP’s) and Policy and Procedures (P&P’s) as appropriate.

·        Consults with and advises Cancer Care leadership regarding needs, goals and barriers to successfully implement research program activities.

40%

Clinical Trial Management

·        In collaboration with clinical research staff, the research coordinator will:

o    maintain accurate and complete documentation according to sponsor, FDA and IRB requirements, including but not limited to signed informed consent forms, source documentation, drug dispensing logs, subject logs and study-related communications.

o   assure compliance with all study requirements, including but not limited to diagnostic testing, follow-up visits, accounting of all research drugs, timeliness in completing case report forms (CRFs), data entry, reporting adverse drug experiences (ADEs), managing caseload and managing study files.

o   Ensures sound conduct of the clinical trial, including but not limited to recruitment, screening, enrollment and follow-up of eligible subjects according to protocol requirements (e.g., subject follow-up, case report form completion, and reporting of adverse drug experiences).

o   Keep physicians and appropriate individuals informed of laboratory reports, patient progress/ response, and any adverse events through written and oral communication as needed.

·        Assists with completion of regulatory requirements and assure filing deadlines are met.

·        Possess a sound and in-depth understanding of each protocol that has been assigned as a primary responsibility.

·        Assists study investigator(s) to enroll patients in research studies by actively screening potential candidates, reinforcing explanations of study requirements, and assists with informed consent process, as requested.

·        Maintains communication of all protocol-related issues/problems to the appropriate management staff, including but not limited to questions regarding the conduct of the clinical trial, concerns regarding possible ADEs or subject compliance.

·        Organizes laboratory supplies, maintains equipment, and obtains and/or prepares specimens for shipment to local and regional laboratories as required by study protocol.

·        Prepares reports for sponsoring agencies as requested regarding patients interviewed, screened, and enrolled into studies.

·        Follows sponsor, FDA and IRB guidelines as applicable for record retention. Reviews records with sponsor as requested during announced or un-announced visits by sponsor auditors.

·        Assists Principal Investigator and/or sub-investigators with study coordination and regulatory requirements, as needed.

40%

Professional Practice

·        Communicate regularly with the principal investigator, program coordinator and/or Cancer Care leadership about study-related issues.

·        Organizes and prioritizes work to maximize effectiveness and productivity.

·        Identifies and establishes goals for professional growth and development, reviewing annually with Cancer Care leadership.

·        Participates, when serving as a member on selected committees, forums and council(s) by regular meeting attendance and completion of assigned tasks.

·        Participates within department by giving input into issues that require staff involvement and responds promptly to communication requiring a response.

·        Takes the initiative to proactively resolve problems with other departments/customers.

10%

Basic UPH Performance Criteria        

·        Demonstrates the UnityPoint Health Values and Standards of Behaviors as well as adheres to policies and procedures and safety guidelines.

·        Demonstrates ability to meet business needs of department with regular, reliable attendance.

·        Employee maintains current licenses and/or certifications required for the position.

·        Practices and reflects knowledge of HIPAA, TJC, DNV, OSHA and other federal/state regulatory agencies guiding healthcare.

·        Completes all annual education and competency requirements within the calendar year.

·        Is knowledgeable of hospital and department compliance requirements for federally funded healthcare programs (e.g. Medicare and Medicaid) regarding fraud, waste and abuse. Brings any questions or concerns regarding compliance to the immediate attention of hospital administrative staff. Takes appropriate action on concerns reported by department staff related to compliance.

10%

Disclaimer: This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that required of the employee. Other duties, responsibilities and activities may change or be assigned at any time with or without notice.

Demonstration of UPH Values and Standards of Behaviors

Consistently demonstrates UnityPoint Health’s values in the performance of job duties and responsibilities

Foster Unity:

·        Leverage the skills and abilities of each person to enable great teams.

·        Collaborate across departments, facilities, business units and regions.

·        Seek to understand and are open to diverse thoughts and perspectives.

Own The Moment: 

 

·        Connect with each person treating them with courtesy, compassion, empathy and respect.

·        Enthusiastically engage in our work.

·        Accountable for our individual actions and our team performance.

·        Responsible for solving problems regardless of the origin.

Champion Excellence:

·        Commit to the best outcomes and highest quality.

·        Have a relentless focus on exceeding expectations.

·        Believe in sharing our results, learning from our mistakes and celebrating our successes.

Seize Opportunities:

·        Embrace and promote innovation and transformation.

·        Create partnerships that improve care delivery in our communities.

·        Have the courage to challenge the status quo.

Qualifications

 

Minimum Requirements

Identify items that are minimally required to perform the essential functions of this position.

Preferred or Specialized

Not required to perform the essential functions of the position.

Education:

 

Bachelor of Science in health-related field.

 

Experience:

 

 

 

 

Three to five years clinical research or related experience.

Experience working within the oncology field preferred.

 

Experience with CALGB, RTOG, NSABP and preferably other national study groups and the management of their respective investigational protocols.

License(s)/Certification(s):

 

 

 

 

National Institute of Health (NIH Human Subjects Protection (HSP) certification.

 

Good Clinical Practice (GCP) certification.

 

Valid driver’s license when driving any vehicle for work-related reasons.

 

Must possess and maintain current Basic Life Support (BLS) certification.

Research certification.

Knowledge/Skills/Abilities:

 

Experience with Microsoft products required.

 

Ability to build positive working relationships with physicians and external agencies.

 

Ability to communicate with multiple levels of organizations and community (managers, physicians, clinical, and support staff).

 

Ability to work independently and self-direct work activities.

 

Detailed oriented and able to meet established deadlines.

 

Ability to organize multiple tasks, working with diverse groups of people.

 

Demonstrates professional conduct in the presence of subjects, research staff, sponsors, monitors.

 

Must possess superior analytical and organizational skills.

 

Attend study specific and research department meetings as appropriate.

Broad and varied knowledge base that is continually enhanced and updated through self-directed study and participation in educational opportunities, with experience/emphasis in adult, geriatric and/or oncology care desired.

 

Advanced knowledge of cancer data management including disease process and constantly evolving treatment trends.

 

Proficiency in Medical Terminology, ICD-O, SEER, AJCC staging schemes, anatomy and physiology.

 

Demonstrated proficiency in computer principles, anatomy, physiology and histology, abstracting and coding, statistics and epidemiology, coding of International Classification of Diseases and coding per the standards set by the American College of Surgeons.

 

Other:

 

 

 

Must demonstrate a cooperative, courteous, dependable working performance.

 

Must possess high integrity and maintain confidentiality at all times.

 

Promotes the cancer center’s philosophy of customer service and teamwork by possessing and demonstrating acceptable business etiquette.

 

Must contribute to a positive workflow in the department.

 

Job ID: 72502

Posted 20 days ago

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