Clinical Research Associate

Hematology Oncology Associates of CNY, PC

JOB TITLE: Clinical Research Associate

POSITION STATUS: Exempt

GENERAL STATEMENT OF DUTIES: A Clinical Research Associate is responsible for all aspects of clinical treatment trials in accordance with HOA policies and procedures, federal and international regulations regarding the conduct of research involving human subjects, including but not limited to: study evaluation and initiation, subject screening and recruitment, timely and accurate data collection and submission. Focus on regulatory/start up.

Responsible for protocol evaluation and feasibility, including budget evaluation and trial preparation involving the planning, development and evaluation of patient information and patient recruitment materials.

Responsible for preparation of required forms and materials for initial and continuing Institutional Review Board (IRB) review, tracks and completes all regulatory-related processes, including reporting of adverse events on assigned studies.

JOB REQUIREMENTS: Strong verbal and written communication skills

Strong interpersonal skills; enjoys collaboration; works well with patients and colleagues

Ability to work in teams

Ability to work autonomously

Strong critical thinking and problem solving skills

Strong organizational skills

Attention to detail

Ability to set priorities and reprioritize quickly

Advanced computer skills/high comfort level with technology/electronic medical records

SUPERVISION RECEIVED: Direct Report to the Lead Clinical Research Nurse, additional supervision by the Director of Research

SUPERVISION EXERCISED: None

TYPICAL PHYSICAL DEMANDS: Requires full range of body motion including handling and lifting patients, manual and finger dexterity and eye-hand coordination. Requires standing and walking for extensive periods of time. Requires corrected vision that allows for accessing computer data, and hearing must be in the normal range for telephone contacts. Work may require sitting for long periods of time; also stooping, bending and stretching for files and supplies. Occasionally lifting files or paper weighing up to 30 pounds. Requires manual dexterity sufficient to operate a keyboard, type at 30 wpm, operate a calculator, fax machine, telephone, copier, and such other office equipment as necessary. It is necessary to view and type on computer screens for long periods. May be asked to travel between sites on a daily basis; must have own transportation.

TYPICAL WORKING CONDITIONS: Requires working under stressful conditions or working irregular hours. Exposure to communicable diseases, bodily fluids, toxic substances, ionizing radiation, medicinal preparations and other conditions common to a clinic environment.

EXAMPLES OF DUTIES: (This list may not include all of the duties assigned).

* Reviews new consult patient charts using OncoTrials/OncoEMR for potential clinical trial eligibility
* Verify documented institutional review board approval prior to consenting a patient to protocol
* Reviews and executes consent documents with patients and family; including potential side effects of study medication/treatment interventions (within scope of practice) and answers any questions about the protocol
* Initiate insurance review letters
* Ascertain eligibility requirements of protocol have been met including informed

consent prior to registration

* Request or provide final eligibility check with, CRC, physician, or AP staff
* Document in patients electronic chart a record of patient consenting process on the day that consent occurs
* Communicates with patients at appropriate intervals in accordance with established protocol guidelines
* Prepares equipment and aids physician during treatment, examination, and testing of patients participating in clinical trials
* Responds to and refers incoming telephone calls; instructs patient and family regarding study protocol, interventions and protocol treatment instructions within scope of practice
* Recognize normal and abnormal laboratory findings and the pathology involved
* Maintain source documents; documents and maintains accurate information in OncoEMR and OncoTrials.
* Coordinates appointments (labs, imaging, vascular access etc.,) per protocol with advanced practice staff and physicians
* Prepares for and participates in study visits with clinical trial monitor, sponsor, and auditors.
* Maintains close contact with physician and team to ensure protocol therapy is administered at the correct dose and frequency, dose modifications are implemented when indicated, and adherence to protocol testing requirements is maintained
* Reporting and completing required documentation of adverse events/drug reactions according to CTEP-AERS designated procedures
* Register protocol patients with the appropriate statistical center/sponsor EDC
* Initiation and updating of patient calendars using electronic chart and/or Microsoft excel
* Log data submission date onto Excel spread sheet (on the follow up list)
* Assist with research billing as needed by informing Billing Dept of newly enrolled patients and clarify appropriate charges to patients versus study provided charges
* Provides ongoing support and education of staff as needed and assists in the orientation of new staff
* Attends required meetings and participates in committees as requested
* Participates in professional development activities and maintains professional affiliations
* Maintains patient confidentiality
* Assists with coordinating various site visits and audits
* Create new protocol notification
* Prepares separation of allowable charges document for new protocols
* Monitor and respond to Research InBox throughout the day and respond in a timely manner
* Follows IRB specific reporting requirements and all federal and state regulations for human researh
* Submits serious adverse events/IND safety reports and protocol deviations, to IRB per FDA/IRB guidelines
* Communicates effectively with research personnel, pharmacy, clinical staff, physicians to inform them of changes to protocols, consents, safety issues, or other changes effecting study administration
* Other duties as assigned

PERFORMANCE REQUIREMENTS

Knowledge, Skills, & Abilities:

* Demonstrates knowledge of organizational policies, regulations and procedures to administer patient care
* Demonstrates knowledge of common safety hazards and precautions to establish a safe work environment.
* Demonstrates skill in identifying problems and recommending solutions.
* Demonstrates skill in preparing and maintaining records, writing reports, and responding to correspondence
* Demonstrates advanced computer skills/high comfort level with technology/electronic medical records
* Demonstrates skill in developing and maintaining department quality assurance
* Demonstrates skill in establishing and maintaining effective working relationships with patients, medical staff, and the public
* Demonstrates ability to maintain quality control standards
* Demonstrates ability to react calmly and effectively in emergency situations
* Demonstrates ability to interpret, adapt and apply guidelines and procedures.
* Ability to communicate clearly.

Education: College Degree required

Experience: Two years experience in a clinical research environment.

Two years medical experience with medical terminology familiarity

Oncology experience preferred

Certificate/License: Certified Clinical Research Associate (CCRA) or Certified Clinical Research Coordinator (CCRC) desirable at time of hire; must obtain within three years of employment

ALTERNATIVE TO MINIMUM QUALIFICATIONS: Additional appropriate education or work experience may be substituted for clinical research experience.