Research Coordinator
Roth Staffing Companies

Job Info

Job description

The Clinical Research Coordinator (CRC) is responsible for the coordination and administration of clinical trials under the direction of our Medical Director. The CRC will develop, implement, and coordinate research and administrative procedures for the successful management of clinical trials. The CRC will perform diverse administrative duties requiring analysis, sound judgment, and a high level of knowledge of study specific protocols.

QUALIFICATIONS & REQUIREMENTS

• Able to read, analyze, and interpret information from professional journals, technical procedures, or governmental regulations.

• Able to effectively present information and respond to questions from physicians, staff and patients.

• Knowledge of Good Clinical Practices and the regulations necessary for the protection of human subjects and the conduct of clinical research required. Knowledge of the International Air Transport Association (IATA) regulations for the transportation of Dangerous Goods also necessary.

• Knowledge of EMR system / data submission.

• Able to function effectively in a team setting.

• Needs to demonstrate consistent professional conduct and meticulous attention to detail.

• Must possess excellent verbal and written communication skills as well as excellent interpersonal skills with patients, staff, and other health care professionals.

• Excellent Power Point creation for scientific presentations/lectures.

• PubMed and other database research.

• Previous experience with clinical trials desired.

DUTIES AND RESPONSIBILITIES

• Administratively and clinically manage an average of six to eight clinical trials.

• Adhere to Research SOP's.

• Adhere to Good Clinical Practices and the study protocols.

• Ensure scientific integrity of data and protect the rights, safety, and well-being of patients enrolled in clinical trials.

• Discuss study protocols with patients and verify the informed consent documentation.

• Provide patients with written communication of their participation (i.e. copy of the signed informed consent).

• Ensure patient's referring physician receives notification of patient's participation in studies as requested by the patient.

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

• Dispense study medication in a professional and accountable manner following protocol requirements.

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

• Perform ECGs and obtain vital signs of patients.

• Schedule all patient research visits and procedures consistent with protocol requirements.

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

• Administer questionnaires/diaries per protocol.

• Ensure that non-serious and serious adverse events are properly documented and reported.

• Screen all laboratory results when received and follow protocol procedure regarding abnormal results.

• Ensure all laboratory results are given to appropriate doctors for review of clinical significance, then file results in the patient study binder.

• Submit patient reimbursement requests at the conclusion of patient's participation in protocol.

• Ensure the filing and maintenance of all regulatory documents.

• Schedule monitor visits and set up for monitoring visits prior to monitor's arrival.

• Other duties as assigned in general practice if not busy in clinical trials.

We are an equal Opportunity Employer:

We are committed to a policy of Equal Employment Opportunity and will not discriminate against an applicant or employee based on age, sex, sexual orientation, race, color, creed, religion, ethnicity, national origin, alienage or citizenship, disabili