Clinical Research Coordinator

Experienced Clinical Research Coordinator / In-House Rater (On-site, no remote) Job Description

Job Summary: Perform the clinical monitoring aspect of designated projects in accordance with study specific procedures, applicable SOPs, and regulations. Act as direct contact with assigned CRA and use judgment to assess and ensure overall integrity of study implementation and adherence to study protocol at clinical sites. Responsibilities include, but are not limited to applying expertise and independent judgment to independently verifying patient safety and patient rights, oversight of clinical on-site monitoring activities. Drive patient recruitment on assigned studies, timely and completion of source data verification, drug accountability, collection maintenance and upkeep of regulatory documentation ensuring timely and high quality data. Serving as In-house Rater for those rating scales which individual may be approved and seeking educational opportunities to add additional rating scales to individual’s roster.

Education and Experience:

Bachelor’s Degree (Required)

2-4 years Research Coordinator minimum experience (Required)

Phlebotomy (Required)

Essential Skills and Abilities:

Strong analytical aptitudes and pay strict attention to detail during all clinical research.

Relies on extensive experience and judgment to plan and accomplish goals.

Flexibility as schedule can vary according to their projects and company needs.

Proper delegation when appropriate and utilization of department resources.

A wide degree of creativity and latitude is expected.

Familiar with a variety of the field's concepts, practices, and procedures including knowledge of GCP and adherence to CFR 21.

Superior interpersonal and communication skills.

Decisive leadership and above-average judgment

Trustworthiness

Able to effectively sustain multiple simultaneous tasks.

Attentive to detail and accurate.

Ability to anticipate critical issues and design effective interventions.

Required to uphold ethical research practices and maintain advanced safety standards.

Responsibilities:

· Maintaining regulatory documents as mandated by FDA regulations.

· Participating in the informed consent process with the subject when delegated.

· Interpreting and implementing trial protocol procedures and policies.

· Pre-Screening and interviewing potential study participants to determine eligibility.

· Direct study subject care including but not limited to assessing vital signs, performing ECG’s, blood draws/processing labs and interviewing subjects and caregivers.

· Maintaining the subjects medical records via paper and electronic case report forms.

· Obtaining and reviewing medical records and summarizing hospital stays for AE’s and SAE’s to allow timely reporting.

· Logging, accountability, sorting and dispensing trial medications.

· Preparing for and hosting CRA monitor visits.

· Responsible for managing the clinical monitoring process and the administration of clinical trials.

· Adherence to SOPs, Good Clinical Practice and FDA regulations.

· Perform the clinical monitoring aspect of designated projects in accordance with study specific procedures, applicable SOPs, and regulations.

· Act as ANA’s direct contact for assigned trials.

· Use judgment to assess and ensure overall integrity of study implementation and adherence to study protocol

· Expertise and independent judgment to independently verifying patient safety and patient rights.

· Drive patient recruitment, drug accountability, and data collection, management of site regulatory documentation.

· Participate in Investigator and other external or internal meetings as required

· Arrange on-site visits and logistics

· Performs assigned Rating Assessments for assigned trials and adheres to trial specific protocols for the assigned ratings.

· Ensures all materials to perform Ratings are accurate.

· Ensures Rating Queries are completed within 72 hours of receipt from sponsor.

· Maintains and ensures Rating Certificates are up to date.

· Completes all assigned Rating training within designated deadlines.

Other Duties: Performs other duties and assumes various responsibilities as determined by the Research Department Operations Manager.

Work Location: In person

Work Remotely: No

Job Type: Full-time

Pay: $50,000.00 - $60,000.00 per year

Benefits:

401(k)

Dental insurance

Employee assistance program

Flexible spending account

Health insurance

Paid time off

Tuition reimbursement

Vision insurance

Medical Specialty:

Neurology

Schedule:

Day shift

Monday to Friday

Night shift

No weekends