Clinical Research Site Manager

Job Description

Job Description

JOB DESCRIPTION :

Immediate opening for a Clinical Research Manager to continue to develop, shape and grow the clinical research team. The ideal candidate will be a proven leader who is detail-oriented with drive and focus.

Experienced project management skills and mindset, experience in clinical trials, and the ability to deliver results often on a tight timeline consistently.

The candidate will have leadership skills and training experience to provide operational leadership to a group of Clinical Research Staff, including Senior Clinical Research Coordinators, Clinical Research Coordinators, and Assistant Clinical Research Coordinators, while monitoring workload and productivity.

The Clinical Research Manager is responsible for strategic planning to meet program goals, along with ensuring all reporting and study milestones are met, including recruitment targets, data entry timelines, budget, and sponsor requirements.

This position also requires the candidate to be responsive to Principal Investigators and scientific oversight committees.

Experience collaborating with senior leadership and research staff is a plus.

The candidate understands that the success of the team is dependent on managing performance, maintaining morale, upholding consistency in terms of workload and assignment management, as well as maintaining high quality customer service.

To achieve service quality, the Clinical Research Manager will work closely with staff to identify areas in need of training and development, review, and refreshers.

RESPONSIBILITIES :

• Have in-depth knowledge of all active studies assigned at site while providing direct oversite to the study team
• Serve as a resource for the clinical team to help navigate through the study protocol, problem-solve any issues that may arise, navigate new studies and anticipate problems before they arise
• Responsible for managing day to day functioning of the (CRC / RS / RA) research team
• Attend all relevant study meetings to help clinical staff project manage and prioritize projects and tasks
• If needed, serve as primary CRC for studies to provide direct oversight and mentorship for junior staff
• Assist the team by managing clinical evaluators and clinical vendors (such as anesthesia, PT, psych)
• Assist / clinical team in communications with medical monitors, CRA and other internal and external parties to ensure clinical trial activities and deliverables are completed on time and within budget.
• Works directly with the investigators on planning and coordination of clinical trials from Start-Up to study closure.
• Supports quality assurance on study documents to ensure that studies are being conducted effectively and with strong adherence to protocols and standardization.
• Phlebotomy Skilled
• Directly manage Research Assistants and Research Specialists and their work to assist in their growth towards becoming a CRC.
• Directly manage CRCs and their work to assist in their growth towards becoming a CRC II.
• Responsible for onboarding via a hands-on mentorship approach to assess and train new RDR clinical staff, including contract and part-time staff
• Knowledge of IRB reporting requirements, including the initial start-up & close-out submissions and annual reporting requirements
• Assist in creating and maintaining Standard Operating Procedures
• Report to the Head of Research
• Evaluate all CRCs, RSs, and RAs on a bi-annual and as-needed basis, addressing issues in Real-Time
• Basic computer skills with working knowledge of Microsoft Office software
• Effective time management skills· Strong leadership and team-building skills
• Excellent written and verbal communication skills
• Ability to prioritize the elements of each unique study plan and to alter the elements on a continuous basis according to study progress
• Ability to effectively handle multiple tasks and priorities professionally, assuring sponsor satisfaction and staff cooperation
• Effective planning skills for accomplishing both short and long-term goals for each study
• Ability to analyze and interpret study financial statements and contractual agreements with sponsors and subcontractors
• In depth knowledge of the clinical research process (i.e. Good Clinical Practices, obtaining informed consent, drug dispensation and accountability, process for handling protocol amendments, obtaining ethical reviews and providing ongoing reports to IRBs)
• Other duties may also be assigned

EDUCATION & EXPERIENCE (REQUIRED) :

Bachelor's degree in related scientific field and four years of relevant work experience; or Associates degree in related scientific field and six years of relevant work experience;

KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED) :

• Comprehensive understanding of scientific principles.
• Expert-level knowledge and skills in the field of science related to research projects.
• General computer skills, experience with databases and scientific applications, and ability to quickly learn and master computer programs.
• Strong analytical skills and excellent judgment.
• Ability to work under deadlines with general guidance is essential.
• Excellent organizational skills and demonstrated ability to complete detailed work accurately.
• Developing project management skills.

PHYSICAL REQUIREMENTS* :

• Frequently stand, walk, twist, bend, stoop, squat, grasp lightly, use fine manipulation, grasp forcefully, perform desk-based computer tasks, use telephone, write by hand, lift, carry, push and pull objects weighing over 40 pounds.
• Occasionally sit, kneel, crawl, reach and work above shoulders, sort and file paperwork or parts.
• Rarely climb, scrub, sweep, mop, chop and mix or operate hand and foot controls.
• Must have correctible vision to perform duties of the job.
• Ability to bend, squat, kneel, stand, reach above shoulder level, and move on hard surfaces for up to eight hours.
• Ability to lift heavy objects weighing up to 50 pounds.
• Ability to work in a dusty, dirty, and odorous environment.
• Position may require repetitive motion.

Company Description

Drug Studies America (DSA) is a Clinical Research Facility, with the experience and history of providing prestigious quality services to Sponsors / CROs.

Since 2002, DSA has provided the clinical research industry with an innovative site and put our patient's safety first by staying compliance with Good Clinical Practices / ICH Guidelines.

Our patients love the quality of interaction we provide.

Company Description

Drug Studies America (DSA) is a Clinical Research Facility, with the experience and history of providing prestigious quality services to Sponsors / CROs.

Since 2002, DSA has provided the clinical research industry with an innovative site and put our patient's safety first by staying compliance with Good Clinical Practices / ICH Guidelines.

Our patients love the quality of interaction we provide.