Senior Clinical Research Coordinator / Manager of Operations

Bethany Medical•High Point, NC

2d•Onsite

About The Position

Established Clinical Research Company is seeking a Senior Clinical Research Study Coordinator / Manager of Operations with management experience to join our team in High Point! Job Description · Complete QC of patient medical records and source documentation. ►Assist in managing all regulatory documents ► Assist with managing clinical trials and collecting data, informing participants about study objectives, and administering questionnaires. · Act as the primary point of contact for sponsors/CROs. Facilitate and coordinate monitoring visits. · Support marketing activities, as needed. · Maintain clinical research professional credentials.

Requirements

Employee must be available during “core” clinic hours of 8:00 a.m. to 5:00 p.m., Monday through Friday, with some flexibility to work from 1-3 hours on Saturday, if needed. This is not a remote position as it requires direct patient care in a clinical setting.
5+ years of Clinical Research experience is required
A bachelor’s Degree is required
A master's Degree is preferred
Management experience is required
Phlebotomy certification is required
Ability to collect patient vitals and ECGs.
Knowledge of GCP and applicable government FDA regulations. Current GCP Certification preferred.
Strong team player and quick to help resolve problems.
Knowledgeable of medical and research terminology, laboratory sanitation, and safety guidelines.
Friendly with patients and clinic staff. Great communication skills, including verbal, written, and personal.
Proficient in MS Applications. Solid data entry skills. EMR and EDC database experience preferred.
Extremely detail-oriented with a focus on quality. Capable of multitasking in a fast-paced clinic environment.
Reliable and dependable to finish projects, deliverables, and tasks on time without close supervision.
Outstanding organizational skills in managing paper and electronic documents.

Responsibilities

Complete QC of patient medical records and source documentation.
Assist in managing all regulatory documents
Assist with managing clinical trials and collecting data, informing participants about study objectives, and administering questionnaires.
Act as the primary point of contact for sponsors/CROs.
Facilitate and coordinate monitoring visits.
Support marketing activities, as needed.
Maintain clinical research professional credentials.