Job Title: Clinical Research Manager
Experience Required: See Below
Education Required: See Below
Number of Openings: 1
Job Start Date: ASAP
Job Location: Springdale, AR
Department: Clinical Research & Regulatory Affairs
Supervisors Title: Chief Operating Officer
TOTAL NUMBER OF FTEs DIRECTLY OR INDIRECTLY SUPERVISED: 0-6
PURPOSE OF POSITION: To oversee & participate in the coordination, conduct & analysis of complex clinical research studies & to apply an in depth background of knowledge & experience with diverse study subjects to demonstrate proficiency in clinical research skills, problem-solving & priority setting. To act as a leader within the department through improving clinical research practice & serving as a resource within the department and the company.
-Study Conduct/ Clinical Research Practice:
-Serve as a resource for all aspects of conducting a clinical trial for complex and multi-center trials.
-Develop & implement associated projects related to studies under the guidance of the principal investigator.
-Collaborate effectively with others to ensure proper progress & completion of studies.
-Assist colleagues by educating, providing resources, & consulting on difficult protocols or projects.
-Indirectly (or directly) supervise support staff.
-Train support staff in preparation & conduct of clinical trials.
-Provide oversight and guidance as needed to research staff.
-Collaborate on multiple projects or studies.
-Provide oversight and guidance to research staff for all aspects of conducting a clinical trial for complex and multi-center trials.
-Collect specimens to meet study requirements.
-Oversee timely participant compensation as per department policy.
-Ensure adherence to study budgets.
-Work with other departments as needed to ensure proper handling, processing, storage and tracking of specimens per study requirements.
Regulatory Compliance and Documentation
- Coordinate complex regulatory activities & periodic internal self-audit of records.
- May lead staff in regulatory activities.
- Provide oversight for the preparation, review, submission and maintenance of regulatory activities/submissions, ensure accuracy and timeliness to all collaborative parties.
- Coordinate and participate in monitor visits, audits, and quality reviews (internal and external) in a professional manner.
- Determine which research protocols or issues have additional requirements, i.e. review by additional company Departments, regulatory agencies, or consultants, and coordinate the process to meet these requirements.
- Act as a resource for regulatory affairs.
- Apply federal regulations; state and local law; and company and department standard operating procedures (SOPs) to promote ethical practices in research involving human participants and to ensure compliance to those regulations.
- Ensure the documentation of regulatory activities in appropriate systems.
- Coordinate and maintain up-to-date and accurate written and electronic records and files. -Develop and maintain regulatory binders.
- Prepare study staff for recruitment/enrollment for medium to large/complex complexity projects.
- Oversee study staff performance.
- Perform consent as needed.
- Proactively take initiative to ensure recruitment stays on track with the project timelines.
- Implement and execute successful plan to identify potential participants.
- Engage study staff to assist in identifying and enrolling participants.
- Proactively identify and monitor barriers to recruitment and problem-solve or innovate to overcome them.
- Determine best method/s to identify potential participants for research protocol (advertisements, monitoring of clinic schedule, etc.) and prepare accordingly.
- Create and maintain a detailed tracking system for participants considered for enrollment. -Track progress at regular intervals and report out to PI and or management.
- Compose clear, precise and detailed correspondence.
- Document, organize and maintain all correspondence.
- Oversee and follow through on questions and issues that arise during study conduct.
- Serve as liaison to departments, regulatory agencies, physicians’ offices, city clinics, academic centers, and other organizations.
- Communicate study related issues to investigators, sponsors, coordinating centers, study coordinators, clinical team, managers and other institutions in a timely fashion.
- Develop a rapport with study participants.
- Oversee data entry and validation to ensure accuracy, quality and compliance of data collection process.
- Create case report forms (CRFs), questionnaires, and study payment forms in consultation with other team members, as needed, using existing study data information to promote efficient data collection and data entry.
- Create Data Dictionary, as per protocol and in conjunction with principal investigator and statistician.
- Support the data-management process for clinical research projects, including addressing data queries from management.
- Maintain and audit data, providing status and activity reports as required.
- Organize data to analyze, identify, and report trends. Review reports, tables, and listings.
- Assist in data analysis and maintain record keeping and data storage for clinical research studies.
- Maintain master database files for clinical research protocols.
- Prepare reports from studies of clinical research projects.
- Evaluate and resolve issues regarding contents of reports.
- Ensure quality of data submitted from study sites and assure timely submission of data.
- Oversee the processing of laboratory and other external data.
- Maintain study payment tracking system.
- Train new staff in preparation and conduct of clinical trials.
- Assist in developing and delivering guidelines and educational materials for investigators, research support staff and the clinical team (as applicable).
- Complete required training.
- Serve as a resource to team members.
- Assist investigators in the development of presentations, abstracts, and manuscripts.
Skills & Competencies
- Prioritization: using time efficiently and productively; prioritizing multiple tasks properly to meet deadlines; recognizing time constraints and adjusting work schedule to address them.
- Analysis – Basic: analytical ability sufficient to evaluate data, make judgments and recommendations
- Problem Solving: ability to independently work through details of a problem to reach a positive solution
- Fluent in written and spoken English.
- Excellent verbal, written and interpersonal communication skills.
- Strong organizational and project management skills to handle projects independently.
- Demonstrates an independent work initiative, sound judgment, diplomacy, tact and professional demeanor
- Understanding and showing respect and appreciation for the uniqueness of all individuals; leveraging differences in others’ perspectives and ideas; appreciating cultural differences and adjusting one’s approach to successfully integrate with others who are different from oneself
- Degree in science, nursing or equivalent degree/experience.
- Thorough knowledge of ICH GCP and relevant regulations for the conduct of clinical trials.
- Proficient in Microsoft Excel AND Access