The Clinical Research Coordinator will plan, direct, or coordinate clinical research projects and trials and be responsible for the preparation, initiation, monitoring and closure of participating sites in clinical studies according to the policies and procedures, study protocols and international guidelines such as ICH and GCP as well as relevant local regulations. Deliver according to the commitment in the individual trials.
– Directs the activities of workers engaged in clinical research projects to ensure compliance with protocols and overall clinical objectives.
– 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 or regulatory forms. Tracks enrollment status of subjects and documents dropout information such as dropout causes and subject contact efforts.
– Oversees subject enrollment to ensure that informed consent is properly obtained and documented.
– Prepares for or participates in quality assurance audits. Identifies protocol 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 and management of research budgets.
– Participates in development of IRB protocols for sponsored trials and interacts with relevant IRB boards such as the Western Institutional Review Board (WIRB)
– 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 supplies necessary for study completion., and arranges transshipment to participating sites
– Implements invoicing systems for clinical trials.
– Excellent verbal and written communication skills.
– Excellent interpersonal and customer service skills.
– Excellent organizational skills and attention to detail.
– Excellent time management skills with a proven ability to meet deadlines.
– Strong analytical and problem-solving skills.
– Strong understanding of the medical products being tested
– Ability to prioritize tasks and to delegate them when appropriate.
– Ability to motivate a team that produces results
– Ability to function well in a high-paced and at times stressful environment.
– Proficient with Microsoft Office Suite or related software.
Education and Experience:
– Bachelor’s Degree in a life Science or related field required. Master’s degree preferred.
– 5-10 years of research experience required. Understanding of the LDT development process.
– Good understanding of Clinical Study Management including monitoring, biospecimen. handling and data management.
– Has completed HIPAA training
– Ability to travel as required, if safe to do so.
Working Conditions and Physical Effort:
– Mostly remote, but 2-4 days a month in the lab required
– Flexibility to visit individual clinical sites twice a year
– Work is normally performed in a typical interior/Lab work environment. – High stress, fast-paced environment with a high volume of work to be completed daily.
– Prolonged periods of sitting at a desk and working on a computer.
– Limited physical effort required.
At Lighthouse Lab Services, we offer solutions to help start, grow, and run clinical laboratories. Our recruiting team has over 16 years of proven success placing job seekers in positions ranging from entry level Medical Technologists to seasoned Laboratory Directors. We recruit nationwide, for permanent and travel positions with clients ranging from small hospitals to large reference laboratories.
It is the policy of Lighthouse Lab Services to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Lighthouse Lab Services will provide reasonable accommodations for qualified individuals with disabilities.
Lighthouse Lab Services | 800-838-0602 | lighthouselabservices.com
#JY Job ID: 13273