CLINICAL RESEARCH COORDINATOR

Clinical Research Coordinator

Galen Medical Group offers several medical specialties throughout the Chattanooga region. We provide quality care and patient-friendly services to adults and children of all ages. Our mission is to elevate the health of our community through multiple medical specialties providing excellent care delivered with wisdom, compassion, integrity, and a commitment to technology, education, and scientific inquiry. We are seeking qualified, like-minded Individuals to join our team!

PURPOSE:

The Clinical Research Coordinator (CRC) is responsible for conducting trials as per the GCP guidelines under the supervision of the Principal Investigator (PI). In addition to providing and coordinating clinical care, a CRC has a central role in assuring subject safety, ongoing maintenance of informed consent, the integrity of protocol implementation, the accuracy of data collection, data recording, and follow-up. Care received by research subjects is driven by study requirements and the collection of research data as well as clinical indications. The CRCs ultimate goal is to protect subjects participating in clinical trials and promote good clinical practices and professional management of clinical studies.

DUTIES AND RESPONSIBILITIES:

• Assisting trial Investigator in screening and reviewing potential study participant's eligibility by reviewing medical records, and discussions with the study subjects, physicians, and nurses.
• Ensuring that all clinical activities are carried out in accordance with the established research protocol and standards in compliance with all applicable laws, regulations, policies, and procedural requirements.
• Monitor study activities to ensure compliance with protocols and with all relevant local, federal, and state regulatory and institutional policies.
• Ensure all data is accurately documented, such as patient vital signs, dispensation, and administration of the investigational product, adverse events, and concomitant medications. Available to subjects, subjects' families, and investigators to answer questions at any time relating to specific clinical trials. Strive to advocate for their subjects while ensuring the integrity of the clinical research trial.
• Maintain required records of study activity including case report forms, drug dispensation records, or regulatory forms.
• Communicate with laboratories or investigators regarding laboratory findings.
• Solicit industry-sponsored trials through contacts and professional organizations.
• Direct the requisition, collection, labeling, storage, or shipment of specimens.
• Participate in continuing education activities or attend conferences and seminars to maintain current knowledge of clinical studies affairs and issues.
• Prepare for or participate in quality assurance audits conducted by study sponsors, federal agencies, or specially designated review groups.
• Perform specific protocol procedures such as interviewing subjects, taking vital signs, phlebotomy, and performing electrocardiograms.
• Prepare study-related documentation such as protocol worksheets, procedural manuals, adverse event reports, institutional review board documents, and progress reports.
• Oversee subject enrollment to ensure that informed consent is properly obtained and documented.
• Schedule subjects for appointments, procedures, or inpatient stays as required by study protocols.
• Performs other related duties as needed.

Knowledge, Abilities, and Expectations:

• Promote the mission, vision, and values of Galen Medical Group.
• Maintain confidentiality of all patient, medical, financial, and legal information.
• Report to work on time and as scheduled.
• Wear identification during work hours.
• Represent the organization in a positive & professional manner.
• Ability to handle difficult situations involving patients, physicians, or others in a professional manner.
• Ability to work independently, exercise creativity, be attentive to detail, and maintain a positive attitude.
• Comply with all organizational policies and standards regarding ethical business practices.
• Participate in performance improvement and continuous quality improvement activities.
• Attend regular staff meetings and in-services as directed by your manager.
• Consistently demonstrate the value of the team concept.
• Ability to manage multiple and simultaneous responsibilities.
• Complete assignments efficiently and in a timely manner.
• Understands and abides by OSHA, HIPAA & CLIA standards.

Qualifications:

• Associates Degree in the health care field, specialized training certificate, or equivalent research experience. Certification as Clinical Research Coordinator through ACRP (CCRC) or equivalent organization desired.
• Minimum 2 to 3 years of clinical research coordinator experience preferred
• Clinical skills, including the ability to perform phlebotomy
• Exceptional attention to detail with strong interpersonal skills
• Excellent verbal & written communication and organizational skills
• Ability to manage multiple tasks and prioritization
• Must be proficient in Excel, Microsoft Office, and other computer programs

As part of the Galen Medical Group, the applicant must be a team player and provide excellent customer service while assessing our patient's needs efficiently. Perform all duties in compliance with Galen Medical policies, HIPAA, and OSHA standards.

Galen Medical Group is a member of the TN Drug-Free Workplace and it is a requirement that we conduct a pre-employment drug screen, as part of the hiring process.

Why should you apply?

• 401(k) benefits.
• Education reimbursement.
• Holiday Pay.
• Great earned time-off policy.
• Company-paid Life Insurance & Long Term Disability.