Clinical Research Coordinator Jobs

Iowa Oncology Research Association

Position Description

Position Title: Clinical Research Coordinator

Classification: Clinical Research Associate

Reports To: Administrator

Prepared Date: 12/15/2005

Revision Date(s): 05/30/2014

Summary: This position is responsible for organizing, planning and controlling work flow of all clinical research related activities. The Clinical Research Coordinator is required to have an in-depth knowledge of clinical trial requirements and good clinical practices as set forth by federal regulations. As the primary resource for the 'clinical trials, the coordinator will act as liaison between the investigators, the institutional review board (IRB), and the research bases and/or study sponsors. Along with the investigator, the research coordinator will screen, enroll and follow study subjects, ensuring protocol compliance and close monitoring while the subjects are on study. In addition, the research coordinator will be responsible for all data and source documentation, adverse experience reporting, and maintenance of complete regulatory files.

Essential Duties and Responsibilities include the following. Other duties may be assigned.

Communications / Liaison:

Maintain cooperative relationship with co-workers, component hospital departmental staff, investigator medical office staff, affiliate member staff, research base contacts, and clinical research participants.

Answer telephone, screen calls, take messages, and provide information to appropriate staff.

Communicate on a regular basis with investigators and office nurses regarding the availability of clinical studies.

Act as liaison between investigators and research base staff.

Maintain cooperative relationship with co-workers, component hospital departmental staff, investigator medical office staff, affiliate member staff, research base contacts, and clinical research participants.

Attend component hospital Tumor Board conferences when assigned.

Communicate needs for laboratory, pathology, and/or radiology submissions to designated lab CRA.

Communicate investigational drug orders and schedules to designated pharmacy CRA.

Screening and Enrollment:

Ascertain that there is documented IRB approval and annual reports to the IRB for clinical trials prior to registration/randomization

Review the study design and inclusion/exclusion criteria with the investigator.

Review and verify all relevant source documentation in the subject's medical record to confirm study eligibility. Review the protocol, informed consent form, and follow-up procedures with potential study subjects if so directed by the investigator.

Ensure the current approved informed consent and HIPAA agreement form are signed before subjects are screened and enrolled.

Ensure that the registration/randomization procedure is followed as per protocol guidelines.

Document record of the subject's registration/randomization as well as data assigned and/or waived by the registering research base.

Maintain accrual log and index cards of protocol patients.

Enter registered/randomized subjects into computer data base.

Calculate and verify protocol treatment drug dosages with a second CRA and the treating investigator.

Subject Follow-up:

Prepare, maintain, and distribute a computer-generated subject calendar with treatment schedule, test schedule, and follow-up schedule to ensure adherence to protocol requirements.

Monitor dosage modifications and treatment calculations.

Obtain continuous follow-up information on subject's medical status per protocol.

Assess and record all adverse drug events as outlined in the protocol.

Report adverse drug events / attribution according to federal and research base guidelines by completing required forms and on line data submission.

Ensure appropriate specimen collection as required per protocol.

Data Management:

Collate data for submission to meet protocol requirements.

Abstract data from appropriate sources to complete case report forms.

Key data for remote data entry or submit completed case report forms per protocol guidelines.

Maintain source documentation for all case report form entries, including clinic chart visit notes, lab data, radiology reports, pathology reports, operative reports, and hospitalizations.

Ensure resolution of research base queries in timely manner.

Review research base delinquency reports for deficiencies.

Correct and edit case report forms, as appropriate.

Other:

Assist in administrative responsibilities as assigned.

Assist in preparation of grants for the clinical research program as assigned.

Assist in training of all new CRAs, chemotherapy nurses, and investigator assigned nurses.

Assist Pharmacy CRA in ordering investigational drugs, maintaining drug accountability records, and delivery of investigational drugs to satellite offices.

Assist in internal quality assurance program and research base audits.

Participate in research base activities and committees.

Participate in presentations or seminars related to the field of clinical research.

Supervisory Responsibilities

This job has no supervisory responsibilities.

Qualifications:

Education and/or Experience: Certified Clinical Research Professional, Registered Nurse, or B.S. in Health Related Field. Equivalent related work experience can be substituted for educational experience. Oncology and/or clinical research experience preferred. Computer experience in Database software, Internet software and Word Processing software preferred.

Certificates, Licenses, Registrations: Current driver's license and comprehensive liability car insurance.

Behavioral Skills : Follows policies and procedures; Supports organization's goals and values; Prioritizes and plans work activities; Uses time efficiently; Maintains research patient/participant confidentiality;

Technical Skills: Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality and completes work in timely manner.

Oral Communication: Speaks clearly and persuasively in positive or negative situations; Listens and gets clarification; Responds well to questions; Demonstrates group presentation skills; Participates in meetings.

Written Communication: Writes clearly and informatively; Able to read and interpret written information. Able to write reports and business correspondence.

Professionalism : Approaches others in a tactful manner; Reacts well under pressure; Treats others with respect and consideration regardless of their status or position; Accepts responsibility for own actions; Follows through on commitments.

Safety and Security : Observes safety and security procedures; Reports potentially unsafe conditions; Uses equipment and materials properly.

Adaptability : Adapts to changes in the work environment; Manages competing demands; Able to deal with frequent change, delays, or unexpected events.

Attendance/Punctuality: Is consistently at work and on time'; Ensures work responsibilities are covered when absent; Arrives at meetings and appointments on time.

Dependability: Follows instructions, responds to management direction; Takes responsibility for own actions; Keeps commitments; Completes tasks on time or notifies appropriate person with an alternate plan.

Physical Demands: 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 regularly required to sit and talk or hear. The employee is occasionally required to stand; walk and stoop, kneel, crouch, or crawl. The employee must occasionally lift and/or move up to 10 pounds.

Frequent travel to local component hospitals and medical offices is required. Occasional overnight travel to research bases is also required for training purposes and updates.

Work Environment: The noise level in the work environment is usually mild to moderate.