What are the responsibilities and job description for the Clinical Research Coordinator position at Actalent?
Description:
80% Study Coordination:
• Responsible for coordinating multiple clinical research studies simultaneously including multicenter clinical trials, NIH and industry-sponsored studies, and local investigator-initiated clinical trials.
• Identify subjects, develop recruitment and retention strategies, obtain informed consent, screen and enroll study subjects.
• Schedule subjects for study visits and/or coordinate the scheduling of required laboratory tests and/or exams; meet with participants to administer questionnaires, collect medical history and perform study procedures according to the study protocol.
• Monitor participants for evidence of study related adverse events.
• Document adverse events and protocol deviations and submit to appropriate departments.
• Document study participants’ progress in electronic medical record and study records as per protocol.
• Maintain data collection forms for effective data collection, entry, and analysis.
• Maintain subject data and address study specific data queries promptly.
• Maintain rapport and relationships with subjects to ensure effective communication and retention; respond to their diverse needs, schedule follow-up appointments, and become their intermediary; discuss study outcomes with providers to ensure continuity of care.
• Oversee subject reimbursement; work to resolve discrepancies and issues.
• Work with staff to ensure procedures are completed, specimens properly stored, and required data collected at visits; and ensure correct shipping and labeling measures.
• Develop and maintain required documentation for clinical trials.
• Reconciliation of subject encounters with billing to ensure correct billing practices and avoid improper billing of Medicare, private insurance, or patients.
• Assure studies are carried out in accordance with all relevant regulations including Code of Federal Regulations, Good Clinical Practice, regulations, and in accordance with Departmental SOPs
• Assist in the development of databases and participant trackers needed to capture specific protocol required data.
• Remain up to date on all required trainings (E.g., trainings, Departmental trainings, study specific trainings, etc.)
• Serve as a resource for investigators and clinical research staff for all aspects of conducting a clinical trial for complex and multi-center trials.
• Ensures proper collection, processing, storage, transport, and handling of biological specimens.
• Coordinate, communicate and network with other studies and technicians to ensure scheduling efficiency; communicate with any affiliated groups.
• Conduct reviews of medical charts and electronic records to extract medical information and other data for use in studies.
• Implement needs assessments and recommendations for enhancements on patient coordination, data collection, data management, protocol adherence and study collaboration.
• Ensure optimal systems are in place to ensure compliance with regulatory requirements for the safe conduct of clinical research.
• Participate in and cooperate with any internal and external audits or reviews of study protocols; prepare necessary documentation.
• Maintain patient confidentiality when communicating with agencies, healthcare providers, other studies, and outside departments.
• Maintain regulatory documents, monitor timelines for data submission.
• Interface with departments to obtain approval prior to study initiation.
• Responsible for the maintenance and integrity of the patient reported outcomes Collect data during subject visits; enter data from visits, procedures, lab tests, and other subject-related participation into databases in a timely manner.
• Manage database structure for each study protocol; update databases to improve data analysis and management. Create and maintain comprehensive data sets as requested by supervisor and/or PI.
• Provide quality assurance checks to note if protocols or CHR applications need to be modified; evaluate protocols on an ongoing basis and implement improvements as needed; ensure reporting of protocol violations to study sponsors and reporting of adverse events to the CHR within stated timelines.
Skills:
clinical research, consent, Patient recruitment, IRB, Regulatory
Additional Skills & Qualifications:
BA/BS with a major in biology, public health, psychology, sociology, or related field
2 years’ experience in a clinical research environment
Experience applying the following regulations and guidelines:
Good Clinical Practice Guidelines
Health Information and Accountability Act (HIPAA)
The Protection of Human Research Subjects
CHR regulations for recruitment and consent of research subjects X
Experience Level:
Intermediate Level
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
Diversity, Equity & Inclusion
At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
- Hiring diverse talent
- Maintaining an inclusive environment through persistent self-reflection
- Building a culture of care, engagement, and recognition with clear outcomes
- Ensuring growth opportunities for our people
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.
Salary : $28 - $32
