Job Description

Description:

The Associate Director of Clinical Trials is responsible for overseeing the strategic and operational aspects of clinical trials. This role involves managing trial execution, ensuring compliance with regulatory requirements, and driving the development and implementation of clinical trial strategies. The Associate Director will work closely with cross-functional teams, including research, regulatory affairs, finance, and external partners, to ensure the successful completion of clinical trials and advancement of clinical research objectives.

Strategic Planning and Management:

Develop and implement clinical trial strategies aligned with organizational goals and regulatory requirements. Oversee the planning, execution, and completion of clinical trials, ensuring they are conducted efficiently and effectively.

Regulatory Compliance:

Ensure all clinical trials comply with regulatory guidelines, including FDA regulations, Good Clinical Practice (GCP), and Institutional Review Board (IRB) requirements. Prepare and review regulatory submissions, including study protocols, informed consent forms, and regulatory reports.

Team Leadership and Coordination:

Lead and mentor clinical trial teams, including Clinical Research Coordinators, Clinical Research Associates, and other support staff. Foster a collaborative environment among team members and ensure clear communication and alignment on trial objectives.

Study Design and Implementation:

Oversee the design and development of study protocols, ensuring scientific rigor and alignment with study objectives. Coordinate with internal and external stakeholders to ensure timely initiation and progress of clinical trials.

Budget and Resource Management:

Develop and manage trial budgets, including negotiating and monitoring contracts with vendors and service providers. Collaborate with the Finance and Billing Department to ensure accurate financial planning, tracking, and reporting of trial expenditures. Allocate resources effectively to ensure the successful execution of clinical trials.

Data Management and Analysis:

Oversee the collection, management, and analysis of clinical trial data, ensuring data integrity and accuracy. Collaborate with data management teams to address data-related issues and ensure compliance with data protection regulations.

Stakeholder Engagement:

Build and maintain relationships with key stakeholders, including investigators, regulatory agencies, and industry partners. Represent the organization at meetings, conferences, and other professional events.

Problem Solving and Troubleshooting:

Identify and address issues that arise during the conduct of clinical trials, implementing corrective actions as needed. Provide guidance and support to resolve logistical and operational challenges.

Reporting and Documentation:

Ensure accurate and timely reporting of trial progress, including interim and final study reports. Maintain comprehensive documentation of trial activities, including protocol amendments, adverse events, and regulatory communications.

Admin duties as assigned by manager


Requirements:

Education / Training

Bachelor's Degree in a Health or Life Sciences-related field (e.g., Biology, Nursing, Pharmacy, Public Health) required. Master's Degree in Clinical Research, Public Health, Biology, or a related field, preferred. Doctoral Degree (PhD, PharmD, MD) in a relevant field is an advantage, preferred.

Licenses / Certifications

CITI Program Training in Good Clinical Practice (GCP) required


CITI Program Training in Human Subjects Protection (HSP) required

Experience Requirements

Minimum of 5-10 years of experience in clinical research, with a focus on clinical trial management, coordination, or regulatory compliance.


Proven track record in leading and managing clinical trials across multiple phases (I-IV) in various therapeutic areas, required.


At least 3-5 years of supervisory or management experience within a clinical research setting, including mentoring and leading a team of clinical research professionals.


Experience with regulatory submissions, including IRB protocols, informed consent forms, and clinical trial agreements.


Demonstrated expertise in developing and implementing standard operating procedures (SOPs) to ensure compliance with FDA regulations and ICH-GCP guidelines.


Experience in managing clinical trial budgets, contracts, and site negotiations is preferred.


Strong network within the clinical research community and established relationships with key industry stakeholders is an advantage.

Work Environment

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.


The work of this position is performed in an environmentally controlled medical practice environment. The position requires the ability to work under pressure and with a diverse population, including staff, physicians, clients, patients, insurance companies and other members of the public on a regular basis. The position may cause frequent exposure to communicable diseases, bodily fluids, toxic substances, ionizing radiation, medicinal preparations and other conditions common to a clinical environment.


This position may require occasional travel to study sites and external meetings.


Work is typically performed in an office setting with potential for remote work flexibility.

Compensation Package

At BASS Medical Group, we understand that a comprehensive, high quality, and affordable health benefits program is now more essential than ever. The overall well-being of our employees is at the forefront of our focus. With this in mind, we offer our eligible employees a generous benefits program.

Health & Welfare Benefits:

Medical through Anthem Blue Cross PPO, Low-Cost Dental and Vision, Medical FSA & HSA.

Retirement Savings & Income Security:

Basic Life & AD&D Insurance, Long Term Disability, 401K plan with an employer contribution, Access to Financial Advisors, Identity Theft Program.

Work/Life Balance Benefits:

Paid Time Off and Company Paid holidays, Life Assistance Program, Commuter & Parking Benefits, Secure Travel Services, Healthy Rewards Program, Will Preparation Program, Additional perks to include discounts for Cellular phone and Gym memberships.

Voluntary Benefits

: Optional Life & AD&D Insurance, Aflac Supplemental Insurance, Pet Insurance

Compensation will be based on experience

Pay Scale/Ranges:

$125,000.00/year

* Employees actual pay rate will depend on a host of factors including, without limitation, job location, specialty, skillset, education, and experience. The patey scale/ranges shown are representative of the pay rates for the job title reflected above, but an employees actual pay rate will be determined on a case-by-case basis.