Regulatory Director Monroe, NC (Charlotte)

Regulatory Director Monroe, NC (Charlotte)

We are looking for a highly motivated and experienced Regulatory Director to join our company full time in Monroe, NC. Our company is preparing a significant expansion of its clinical research operations, including expanded infrastructure and new clinical trial site locations. We are looking for a Regulatory Director to help lead these expansion efforts. The incoming Regulatory Director will lead our organization's regulatory and GCP compliance efforts. A competitive candidate will have current and direct experience managing regulatory affairs for a clinical trial operation. Those without regulatory experience in clinical trials will not be considered for this role. In the immediate term, this role will require someone who can "hit the ground running" and have the skillset to rapidly assume responsibility for 30+ clinical trials ongoing and starting up at our clinical trial center. The ideal candidate will have the ambition and drive to oversee the regulatory compliance of multiple locations as the company expands in the coming years.

About us:
Since 2015, our company has become one of the highest performing clinical trial centers in the United States. The company works on a diverse array of landmark clinical trials, including studies investigating treatments for pulmonary, metabolic, cardiology, psychiatric, infectious diseases, and vaccine studies for preventing infectious diseases.

Duties:
-Perform study specific regulatory processes across all studies ongoing and starting up our company with appropriate regulations, Standard Operating Procedures (SOP's), and study specific protocols/plans and processes.
-Spearhead study start up including: Delegation logs, Financial Disclosers, and Study related trainings and logs
-Maintain accurate and complete regulatory records for all clinical trials ongoing at our center including: Good Clinical Practice certificates, Curriculum Vitas, Medical Licenses, and Trainings for ongoing studies including: Protocol amendments, Corrective and Preventative Actions, and Equipment calibration and staff certifications
-Manage and maintain all IRB communications and submissions
-Onboard all new staff onto assigned clinical studies including: Submitting all regulatory documents to ensure that coordinators gain access to the necessary study specific training portals, Tracking a coordinator's training progress to ensure that study onboarding stays on track, Following up with the study sponsor to ensure that coordinators gain access to the necessary study portals including but not limited to IWRS, EDC, or equipment vendor portals.
-Disseminate, document, and file the review of important sponsor correspondence to the site staff.
-Oversee, manage, and maintain all requirements for Shared Investigator Space (SIP) for select clinical trials.

Schedule:
-Full time (Monday- Friday)
Requirements:
-Must have at least two years of proven experience as a regulatory specialist in a clinical trial setting.
-Superb communication skills, both written and verbal
-Self-starter and able to work independently
-Be committed to the foundations of ethical study patient recruitment practices, including FDA guidance and Good Clinical Practice
-Candidates whose work has been audited by sponsors or the FDA will be the most competitive.
Salary (range):
-$85k-$100k per year


Benefits:
-Vacation/PTO
-Medical and Dental insurance
-Short-term disability offered as a voluntary (employee paid) benefit
-Matching 401K
-Growth opportunities within a rapidly expanding business

Our company is close to the Charlotte area, with easy highway access. Join our fast-growing company with a passionate, professional, outgoing, and vibrant staff. We have a wonderful work environment, and we aspire to help our employees build a career within the organization. If you are interested in joining our dynamic and growing team, then contact us.
Please send your resume to Brian Torchin.
Brian Torchin / CEO
HCRC Staffing
Office 800-472-9060
Employment Type: Full-Time
Salary: $ 85,000.00 100,000.00 Per Year