Summary

The Clinical Research Coordinator will work collaboratively with the Director of Clinical Research and the Vice President, Research & New Therapies and other members of Foundation staff to manage the activities of the Foundation’s clinical research program, with specific responsibilities to support the regulatory needs of these programs. Areas of responsibility within the clinical research program include the Rare Epilepsy Network (a PCORI patient-powered research network), the Research Roundtable, the Clinical Trials Portal program, the Human Epilepsy Project, and the Epilepsy Learning Healthcare System.

Epilepsy Learning Healthcare System (50% FTE)

  • Coordinating committee support – supporting regulatory needs of onboarding clinical centers; overseeing center start-up activities; document preparation, sharing and archiving; network-wide collected data compilation and reporting
  • Assist program management team
  • Logistical planning and support for in-person meetings

Responsibilities for the Rare Epilepsy Network (REN: 15% FTE): With the Principal Investigator and Co-Principal Investigators of the Rare Epilepsy Network, play a key role in supporting regulatory needs, recruiting and retaining study participants and to record, analyze, and report metrics on registry performance.

Duties may include, but are not limited to, the following:

  • Manage relationships with rare epilepsy organizations involved in REN; communicating regularly with points of contact about their priorities and user experience with REN survey.
  • Work with REN organizations to design, implement and assess recruitment and retention plans
  • Ability to prioritize and manage a high volume workload and changing priorities.  

Human Epilepsy Project (10% FTE) With the Principal Investigator and Co-Principal Investigators of the Human Epilepsy Project, play a key role in supporting regulatory needs, recruiting and retaining study participants and to record, analyze, and report metrics on performance.

Duties may include, but are not limited to, the following:

  • Manage the regulatory submissions for the Human Epilepsy Project (IRB approvals, Clinicaltrials.gov submission, Certificate of Confidentiality)
  • Manage relationships with EF affiliate/chapter organizations involved in HEP recruitment; communicating regularly with points of contact within the EF staff team about their activities to support the study.
  • Ability to prioritize and manage a high volume workload and changing priorities.  

Responsibilities for Research Roundtable (10% FTE)

The Clinical Research Coordinator will assist Foundation staff and leadership, including Director of Clinical Research, Vice President of Research & New Therapies, and other and research staff in maintaining the annual Research Roundtable process. 

Duties will include:

  • Preparation of background research materials related to discussions of the Roundtable
  • Responsible for developing the content for the Research Roundtable website, and keeping it updated as needed
  • Assist with preparing meeting materials for the Research Roundtable meeting.
  • Assist in research and writing of white paper or research products of the Roundtable
  • Attend Research Roundtable events as requested
  • Oversee and manage speaker reimbursement and other meeting costs with Foundation staff

Responsibilities for epilepsy.com Clinical Trials Portal (10% FTE)

The Clinical Research Coordinator shall assist Foundation staff and leadership, including Director of Clinical Research, Vice President of Research & New Therapies, and other staff with the epilepsy.com Clinical Trials Portal program.

Duties will include:

  • Collect intake information on prospective Portal studies as appropriate for the Tier requested
  • Manage the Foundation’s approval process for vetting prospective Portal studies, including the internal Portal approval committee, and responding to inquiries within expected timeframes
  • Coordinate with Foundation’s scientific staff and leadership to prepare Portal materials for approved studies as required
  • Assist in communication and coordination between Research and Communications teams
  • Monitor the status of Portal studies and request updates from investigators as needed
  • Post study results as they become available

Epilepsy Pipeline Meeting (5% FTE) 

The Clinical Research Coordinator shall assist Foundation staff and leadership, including Director of Clinical Research, Chief Science Officer, Vice President of Research & New Therapies, and other staff with the Epilepsy Foundation Pipeline Conferences and the Epilepsy Pipeline Day at the Antiepileptic Drug and Device Trials conferences, which alternate each year.   

Duties will include:

  • Provide coordination and support for preparatory working calls; overseeing administrative staff reporting of minutes of meetings for Foundation records
  • Represent the Foundation in promotion of the Pipeline activities to outside sponsors, and interested parties as requested
  • Assist with other Pipeline activities as needed, including on-site support
  • Oversee and manage speaker reimbursement and other meeting costs with Foundation staff

Essential Duties and Responsibilities

  • Develop, track, and report on project milestones, study metrics, and deliverables in a timely, effective, and efficient manner, as needed for each project;
  • Ensure accurate and timely progress of clinical research, study reporting, and adherence to all applicable regulations (local, and federal) and standard operating procedures;
  • Prepare and submit required documentation for compliance with all applicable human subjects protections regulations.
  • Manage and arrange regular conference calls with stakeholders to discuss research-related matters and project-specific information; ability to record and disseminate accurate and complete minutes from these calls in a timely manner.
  • Work cross-functionally with multiple departments to maintain the development and maintenance of all clinical research related websites and materials.
  • Collaborate as needed on grant and fundraising efforts for long-term sustainability of research;
  • Help motivate caregivers and patient advocates to help recruit new eligible human subjects for research.
  • Understand clinical research findings and effectively communicate about clinical research for peers and non-technical audiences
  • Other duties as assigned.

Education/Experience

  • MS in Epidemiology, Public Health, Health Informatics, or other related quantitative or medical/scientific discipline is preferred. A Bachelor’s degree or equivalent is required.
  • Minimum 3-5 years professional experience in human subjects research, clinical project management, other research, and/or program evaluation is strongly preferred.

Specific Knowledge, Skills, Abilities, Licenses, Certifications, etc.

  • Prior experience working under a Principal Investigator in the conduct of human subjects research, including, but not limited to, observational studies, clinical trials, and/or social and behavioral research studies.
  • Previous experience conducting research with patient advocates as research partners is desired, but not required.
  • Prior experience with publications and report writing (preferred publication in scientific literature).
  • Knowledge and/or experience in interacting with and reporting on research-related matters to a grant funding agency.
  • Knowledge of quantitative and qualitative research methods, as well as of data management and analysis.
  • Ability to collaborate effectively with a large number and wide variety of stakeholders (including researchers, caregivers, and patient advocates) in the service patient-centered research in a sensitive manner.
  • Ability to request, disseminate, and accommodate requests for research-related and project-specific information to and from stakeholders in a professional manner.
  • Ability to help motivate caregivers and patient advocates to help recruit new eligible human subjects for research.
  • Ability to understand clinical research findings and proven skills in communicating about clinical research for peers and non-technical audiences.
  • Intermediate to expert proficiency in MS Excel, Word, and PowerPoint. Familiarity with clinical research systems such as RedCap preferred. Experience with medical records, such as Epic, preferred.
  • Ability to be trained and obtain human subjects research certification.
  • Ability to handle a large workload quickly to meet short deadlines on a variety of research-related matters.
  • Ability to manage multiple research-related tasks simultaneously and professionally.

How to Apply

Interested candidates should submit a cover letter and resume or CV in Word format to recruitment@efa.org. Please include salary requirement. No phone calls please.