Job Description

Job Description

Job Description

The Clinical Research Coordinator (CRC) is an essential role in the clinical research landscape, operating under the guidance of the Principal Investigator (PI) to manage and facilitate the daily operations of multiple research studies. While the PI holds ultimate accountability for the trial, the CRC is pivotal in coordinating activities, ensuring compliance with protocols, and fostering collaboration among the research team, sponsors, and monitors to drive the timely and effective progression of the clinical trials.

Responsibilities for Clinical Research Coordinator

• Monitors study activities to ensure compliance with protocols and with relevant local, federal, and state regulatory and institutional polices. Maintains required records of study activity including case report forms, drug dispensation records, or regulatory forms. Tracks enrollment status of subjects and documents dropout information such as dropout causes and subject contact efforts.
• Assesses eligibility of potential subjects through methods such as screening interviews, reviews of medical records, and discussions with physicians and staff. Oversees subject enrollment to ensure that informed consent is properly obtained and documented.
• Records adverse event and side effect data and confers with investigators regarding the reporting of events to oversight agencies. Prepares for or participates in quality assurance audits conducted by study sponsors, federal agencies, or specially designated review groups. Identifies protocol problems, informs investigators of problems, or assists in problem resolution efforts such as protocol revisions.
• Prepares study-related documentation such as protocol worksheets, procedural manuals, adverse event reports, institutional review board documents, and progress reports.
• Reviews proposed study protocols to evaluate factors such as sample collection processes, data management plans, and potential subject risks.
• Participates in preparation of research studies.
• Instructs research staff in scientific and procedural aspects of studies including standards of care, informed consent procedures, or documentation procedures.
• Collaborates with investigators to prepare presentations or reports of clinical study procedures, results, and conclusions. Communicates with laboratories or investigators regarding laboratory findings.
• Reviews scientific literature participates in continuing education activities, and/or attends conferences and seminars to maintain knowledge of clinical studies affairs and issues.
• Orders drugs or devices necessary for study completion.
• Support implantation of department procedures.
• Keeps GCP and IATA in good standing.
• Other duties as assigned.

All offers of employment at Carolina Nephrology, PA are contingent upon clear results of a thorough background check. Background checks will be conducted on all final candidates and on all employees who are promoted, as deemed necessary.

Background checks will include:

• Social Security Verification: validates the applicant's Social Security number, date of birth and former addresses.
• Prior Employment Verification: confirms applicant's employment with the listed companies, including dates of employment, position held and additional information available pertaining to performance rating, reason for departure and eligibility for rehire. This verification will be run on the past two employers or the previous five years, whichever comes first.
• Personal and Professional References: calls will be placed to individuals listed as references by the applicant.
• Educational Verification: confirms the applicant's claimed educational institution, including the years attended and the degree/diploma received.
• Criminal History: includes review of criminal convictions and probation. The following factors will be considered for applicants with a criminal history:
• The nature of the crime and its relationship to the position.
• The time since the conviction.
• The number (if more than one) of convictions.
• Whether hiring, transferring or promoting the applicant would pose an unreasonable risk to the business, its employees or its customers and vendors.

Procedure

Final candidates must complete a background check authorization form and return it to Human Resources.

Human Resources will order the background check upon receipt of the signed release form, and either internal HR staff or an employment screening service will conduct the checks. A designated HR representative will review all results.

The HR representative will notify the hiring manager regarding the results of the check. In instances where negative or incomplete information is obtained, the appropriate management and the director of Human Resources will assess the potential risks and liabilities related to the job's requirements and determine whether the individual should be hired. If a decision not to hire or promote a candidate is made based on the results of a background check, there may be certain additional Fair Credit Reporting Act (FCRA) requirements that will be handled by Human Resources in conjunction with the employment screening service (if applicable).

Background check information will be maintained in a file separate from employees' personnel files for a minimum of five years.

Carolina Nephrology, PA reserves the right to modify this policy at any time without notice.

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