Senior Clinical Research Coordinator

Senior Clinical Research Coordinator

The Senior Clinical Research Coordinator (SCRC) works independently and has responsibility for oversight of a portfolio of Clinical Research projects under minimal guidance from the PI in the Lurie Center for Autism Division. The SCRC is responsible for leading the development, implementation, and analysis of the Center’s Clinical Research projects while assuring that the research adheres to all quality, safety, and IRB requirements. The incumbent must be able to work collaboratively across multidisciplinary teams and internal and external organizations to achieve the Lurie Center for Autism Clinical Research goals.

Under the general supervision of the Senior Clinical Research Program Manager, the SCRC plans and implements study procedures, coordinates the screening and recruitment of study patients, creates data collection tools, and collects and maintains study data. The SCRC will also serve as a resource for teaching other personnel about clinical trials and protocols.

The Lurie Center for Autism at Massachusetts General Hospital and the Massachusetts General Hospital for Children, a multidisciplinary program designed to evaluate and treat children, adolescents and adults with autism spectrum disorder and other neurodevelopmental disabilities conditions.

Responsible for the development, day-to-day implementation, and analysis of the Lurie Center for Autism research initiatives as follows.

Project Development

• Designs research protocols in conjunction with PI, recommends protocol changes and may assist with writing protocols and manuscripts.
• Conducts library searches.
• Assists PI by leading all regulatory activities study regulatory submissions, such as writing of consent forms, filing adverse events, preparing reports and annual reviews, and acting as liaison between Research Affairs and the Lurie Center.
• Develops study documents including protocol and informed consent forms, study manuals, source documentation templates, recruitment materials and other study tools.

Recruitment

• Collaborates with project investigators and other research sites to ensure targets are met for study start up, site activation, patient recruitment and enrollment.
• Develops and implements recruitment strategies and is able to independently judge suitability of research subjects.
• Provides basic explanation of study and obtains informed consent from patients.
• Verifies subject inclusion/exclusion criteria and confirms subject meets criteria.

Implementation and Analysis

• Collects & organizes patient data, organizes and interprets data; obtains patient study data from medical records, physicians, etc.
• Documents patient visits and procedures.
• Administers and scores questionnaires.
• Maintains records and databases.

• Verifies accuracy of study forms and updates study forms per protocol.
• Ensures study related regulatory documents are properly maintained.
• Facilitates integration of regulatory issues to ensure safe practice.
• Responsible for quality control and may develop systems for QA/QC.
• Ensures that adverse events (AE/SAE) are monitored properly and reported to the sponsor, federal regulatory authorities, and IRB.
• Coordinates lab activities and performs study procedures such as EKGs and vitals and assists with phlebotomy.
• Reviews lab results to ensure that protocol requirements are met, reporting any abnormalities to the Research Nurse and/or Physician Investigator.

Supervision and Personnel Responsibilities

• Ensures that all study staff follow GCP procedures.
• Reviews work of trainees.
• Promotes collaboration and a work environment conducive to teamwork and employee satisfaction.

Grant Financial Management

• Supports grant management responsibilities for unit, including the development of study budgets.
• Works closely with Grants Management on study budget related questions and invoicing (site payments, vendor contracts, etc.).

• Assumes additional administrative and Clinical Research tasks, as needed.

• Ability to design, prepare, deliver and evaluate clinical programs.
• High level time management and organization skills.
• Excellent written and verbal communication skills.
• Administrative skills to meet regulatory requirements.
• Ability to prepare and monitor budgets.
• Knowledge of current and developing Clinical Research trends.
• Ability to meet the requirements of varying funding sources.
• Sound interpersonal skills and the ability to supervise others.
• Ability to work independently and display initiative to introduce innovations to research study as well as be a team player.
• Ability to identify problems and develop solutions.
• Ability to make independent, effective decisions.
• Strong database management and overall computer skills with the ability to resolve technical problems.
• Demonstrated analytical skills to problem solve effectively, including technical matters.
• Ability to demonstrate respect and professionalism for subjects’ rights and individual needs.

Bachelor’s degree required; MA/MS/MPH preferred. Certified Clinical Research Coordinator (CCRC) certification preferred.

3 - 5 years of directly related experience required.

May train, orient, educate and address the competency of staff, interns and volunteers.

Collaborative work with Grant Administrator and PI in developing and managing budgets.