Clinical Research Coordinator

1 month ago

Fayetteville, United States Medix™ Full time

Position Summary:

The Clinical research Coordinator has a general responsibility for managing Oncology clinicals trials. This includes the responsibility for identifying potential study patients; ascertaining patient eligibility for clinical trials; coordinating, evaluating and following patients in clinical trials; coordinating treatment initiation and continuation; taking call for issues related to clinical trials; completing and filing necessary forms with internal and external departments and agencies as necessary; and maintaining records for patients enrolled in clinical trials.


Duties and Responsibilities:

• Adheres to Research SOPs

• Adhere to Good Clinical Practices and the study protocols

• Coordinates all research activities of the patient, providing assistance, direction, and information as necessary

• Complete and maintain case report forms per FDA guidelines, and review them against the patient’s medical record for completeness, accuracy, and legibility

• Works closely with physicians, nurses, and other health care professionals to identify

patients for clinical trials. Assists with the recruitment and screening of participants according to protocol requirements

• Ensures the accurate transcription of trial data

• Provides education to patients, families and clinic staff regarding research protocol and investigational agents

• Responsible for the comprehensive management of clinical trials conducted at the Cancer Institute, including entering all orders in EMR for all research specific visits and procedures

• Meet with patient for each visit and maintain accessibility to discuss any questions/concerns regarding study participation

• Dispense study medication in a professional and accountable manner following protocol guidelines, patient diaries, where applicable

• Collect, process and ship blood/urine specimens at scheduled patient visits

• Perform ECGs and administer questionnaires

• Ensure that serious and non-serious adverse events are properly documented and reported per protocol/institutional guidelines

• Submit patient reimbursement requests to Clinical Research Manager

• Attend Investigator Meetings and Protocol Specific Training Webinars/Meetings

• Other duties as assigned



Qualifications and Requirements:

• Minimum 3 years in Clinical Research, Oncology experience preferred

• Knowledge of clinical research practices

• Strong written, verbal, computer, attention to detail, organizational and problem-solving skills

• Willingness to continually self-educate and attend scheduled meetings

• Ability to effectively present information and respond to questions from physicians, staff, sponsors, and patients

• Experience at interpreting medical charts, abstracting data from medical records

• Medical terminology

• The ability to organize and coordinate multiple patients’ research activities to adhere to protocol requirements

• The ability to work in a rapidly changing, multiple-demand setting

• Able to function effectively in a team setting

• Prioritize a large volume of work and meet deadlines efficiently


HIPAA Requirements:

Clinical Research Coordinator will have access to PHI and ePHI in the course of his/her duties.

Applying the minimum necessary standard of HIPAA, this employee has access to the minimum

amount of designated record sets required to perform his or her duties.


Interpersonal:

Develops and maintain effective relationships with research staff. Communicates effectively in both print and speech. Skill in preparing and presenting reports. Ability to remain calm and poised in urgent situations.


Critical Thinking:

Planning and organizing. Skill in exercising imitative, judgment, problem solving and decision-

making. Skill in development of comprehensive reports and interpretation of complex operations.

Ability to set priorities and avoid crises management.


Demands of Position:

Requires sitting, walking, some bending, stooping, stretching, and lifting or moving materials

anywhere up to possibly 50 lbs.

Typical Working Conditions:

Normal office environment

Machines, Equipment, Work Aids:

Computer, printer, copier/scanner, telephone, voicemail, and fax

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