Research Coordinator I- Epilepsy Biorepository - Cleveland, United States - Cleveland Clinic

Description

Join the Cleveland Clinic team, where you will work alongside passionate caregivers and provide patient-first healthcare. Cleveland Clinic is recognized as one of the top hospitals in the nation.

At Cleveland Clinic, you will work alongside passionate and dedicated caregivers, receive endless support and appreciation, and build a rewarding career with one of the most respected healthcare organizations in the world.

Clinical research is the only way to move the edge of medicine forward.

As Research Coordinator, you will coordinate the compliant implementation and conduct of human subject research projects, typically of low workload and low complexity.

The ideal future caregiver is someone who:
Is experience with conflict resolution and problem-solving. Has written and verbal communication skills. Has teamwork and motivational skills. Has organizational and multitasking skills.
This role offers a robust career ladder spanning all kinds of interests, skill levels, and experience within clinical research.

Everyone on this team is willing to help and support one another and they have a tangible work environment of trust and open communication.

At Cleveland Clinic, we know what matters most.

That's why we treat our caregivers as if they are our own family, and we are always creating ways to be there for you.

Here, you'll find that we offer:

resources to learn and grow, a fulfilling career for everyone, and comprehensive benefits that invest in your health, your physical and mental well-being and your future.

When you join Cleveland Clinic, you'll be part of a supportive caregiver family that will be united in shared values and purpose to fulfill our promise of being the best place to receive care and the best place to work in healthcare.

Responsibilities:
Communicates information concerning subject health and safety to CRC and/or Principal Investigator in a timely and responsible manner.

Observes regulations and ethical standards with regards to the rights and welfare of human municates concerns regarding ethical violations to Manager/ Principal Investigator.

Functions as a team player with the department and works effectively with other coordinators in the department to foster an efficient and productive environment for Clinical Research.

Implements and conducts multiple research projects in a timely and efficient manner.
Maintains working knowledge of all departmental protocols, covers other departments if necessary on a temporary basis.
Assists in preparation of IRB documents as requested.
Secures/orders investigational devices or study supplies as necessary.
Participates in meetings with research residents and research staff prior to implementation of protocol as necessary.
Prepares/Creates/OA's source documents prior to study start and according to SOP's.
Assembles source documents as necessary.
Adheres to schedule and required procedures and follows research protocols.
Collects data accurately and completes CRFs in a timely manner.

Maintains neat, organized, accurate and detailed source documentation, records and municates to all appropriate research staff/supervisor/PI, and IRB of any deviations/violations from protocols as necessary.

Oversees/coordinates IRB renewal process as necessary and keeps abreast of due municates closely with Regulatory Coordinator to ensure the timely completion of these documents.

Ensures proper collection, processing and shipment of specimen.
Prepares on-site monitor visits, including pre-study, initiation, and closeout visits.
Assists as needed in preparing for FDA and internal audits.
Prepares for study closures and ensures proper documentation and document storage to enable easy retrieval when necessary.
Reports subject dropouts and exits them from study per procedure.

Maintains and updates essential documents as required by the FDA, IRB, Sponsor/CRO or any other regulatory agencies or funding agencies as necessary.

Prepares study advertisements and ensures sponsor and IRB approval are obtained as necessary.
Tracks patient visits in the study management software program as necessary.
May assist Regulatory Coordinator in the preparation of protocol documents for IRB submission as necessary.

Ensures the preparation, submission and obtaining approval for any check request, purchase requisitions in accordance with study protocols and Cleveland Clinic Florida guidelines.

Attends meetings at Cleveland Clinic Florida as expected and arrives in a timely manner.
Oversees and assists with data clarification forms as necessary and in a timely fashion.

Ensures appropriate coordination of the scheduling of external monitor/sponsor visits with PI, Research Coordinator and any other key personnel and ensures meeting space availability.

Maintains data integrity where applicable.
Ensures study supplies, office supplies and research equipment for research personnel/projects are maintained.
Aids in the development of research tools, such as spreadsheets or questionnaires.

Assists with grant applications, compiling literature reviews or the preparation of abstracts, entering information and/or maintaining databases for research department, ordering patient charts and placing reminder calls to patients as necessary.

Develops, implements and continually evaluates patient recruitment strategies for effectiveness.
Promotes patient recruitment by preparing patient mailers, postcards or mass communications and participating in presentations as necessary.
Screens and assigns patients to appropriate research protocols.
Provides general support functions, including copying, filing correspondence transcriptions, obtaining required signatures as required.
Reviews study documents and oversees assembly and/or assembles source documents based on the protocol.
Presents scientific statements or endorsements related to investigational devices/drugs with full disclosure.
Provides information to research residents and staff regarding protocol requirements.
Works with department supervisor/manager to assist and train new hires in the research department/across all specialties.
Submits the IND to the FDA for investigator initiated studies and formulate/track regulatory documents necessary.

Assists the staff physician and fellows, or independently writes, abstracts or manuscripts for submission to professional scientific meetings or journals.

Performs study-related procedures and visits as required.

Conducts follow-up visits of research subjects to evaluate progress and educate them regarding protocol, adverse events and compliance issues as requested.

Reports and records adverse events/severe adverse events to Regulatory Coordinator, IRB Sponsor and PI and other agencies as required.
Serves as primary contract for patient while enrolled in clinical trial.
Reviews and documents lab and test results to ensure patient safety.
Reports all abnormal values to the PI in a timely manner.
Attends conferences and meetings related to research as required.
Other duties as assigned.


Education:
Bachelor's Degree or 3 years research experience. Familiar with medical terminology and procedures.
Demonstrates proficiency in personal computers and various software and database applications.
Excellent interpersonal, written and verbal communication skills and command the English language, both written and verbally.
Excellent organizational and problem solving skills.
Ability to work independently.
Demonstrates clinic competency within 90 days of hire.


Languages:

Language requiredLanguage preferredCertifications:
Certified Clinical Research Coordinator (CCRC) plexity of Work:All employees are expected to meet the standards of performance outlined in the Organizational-Wide Competencies listed below as applied to the position:

World Class Service Orientation:
Includes attitude, behavior, interpersonal skill, and problem solving that enable an employee to respond to internal and external customer needs and expectations in a positive manner

Adaptability:
Includes teamwork and flexibility needed to fulfill job responsibilities including adapting to changes in work environment and accepting supervisory feedback

Efficiency and Effectiveness:
Includes quantity and quality of desired work, as well as organization skills necessary to perform successfully

Essential Job Requirements:

Includes adherence to all relevant policies, procedures, and guidelines affecting the work environment, including maintenance of required competencies and communication skills.

Supervisory Responsibilities (if applicable): Includes overall accountability for assigned work group relative to operational goals, personnel requirements, and budgetary constraints

Note:
The above stated duties are intended to outline those functions typically performed by individuals assigned to this classification.

This description of duties is not intended to be all inclusive nor to limit the discretionary authority of supervisors to assign other tasks of similar nature or level of responsibility.

Phlebotomy skills or the ability/willingness to learn required.
Knowledge of all phases of the research process.


Work Experience:
Clinical Research experience or other clinical training required.
Experience working with Federal Regulations and IRBs preferred.


Physical Requirements:
Ability to perform work in a stationary position for extended periodsAbility to operate a computer and other office equipmentAbility to communicate and exchange accurate informationIn some locations, ability to move up to 50 pounds

Personal Protective Equipment:
There are high potential for frequent exposure to blood, blood-borne pathogens and bodily fluids.
Use of personal protective equipment is required as per clinic/hospital policy.
Video display screen protectors are available upon request.
Follows Standard Precautions using personal protective equipment as required for procedures.

Salaries [which may be] shown on independent job search websites reflect various market averages and do not represent information obtained directly from The Cleveland Clinic.

Because we value each individual candidate, we invite and encourage each candidate to discuss salary/hourly specifics during the application and hiring process.