Clinical Research Coordinator II - 40 hours, Day shift

Under minimal supervision and direction will be responsible for the coordination and administration of multiple research studies. Responsible for assigned research studies and general research duties. Implements study protocols in accordance to regulatory and institutional requirements.  Works closely with principal investigators, research staff and Research Administration facilitating all aspects of assigned clinical trials. Interacts with study participants diagnosed with various medical conditions and diagnoses.

1) Possesses ongoing knowledge of FDA, OHRP and GCP regulations:

• Ensures adherence to regulations.
• Educates and mentors other study staff as applicable.

2) Responsible for coordinating different phases of research studies with varying degrees of complexity with minimal

    oversight:

• Completes and submits trial feasibility forms; coordinates and obtains non-disclosure agreements.
• Arranges and conducts pre-study qualification and site visits.
• Acts as the main liaison of communication between sponsors and investigators in all aspects of study start up.

3) Implements assigned research studies by reviewing study and assessing protocol and institutional requirements:

• Establishes and communicates study procedures with collaborating departments to ensure compliance with all study requirements; conducts in-services (e.g. arranges special blood draws with phlebotomy, special blood processing with specimen processing, ordering and receiving of drug with the pharmacy and infusion team, and copying and submission of MRI with Radiology).
• Works collaboratively with research finance to process clinical trial agreements, study budget development and other finance issues, as applicable.
• Attends Investigator Meetings as applicable.
• Implements all study protocols in accordance with research SOPs, FDA, OHRP, and GCP regulations.
• Immediately develops coordinator/sponsor relationship.
• Completes start- up checklists and organizes study start-up plan, including source worksheet creation.
• Prepares, completes and submits regulatory documents in a timely manner.
• Prepares, completes and submits start up IRB documents in a timely manner.
• Reviews all pertinent study documents for potential implementation issues and implements plan accordingly.
• Ensures appropriate training and certification for all members of the study team involved in the research protocol.

4) Conducts assigned research studies per protocol requirements, departmental and institutional policy:

• Creates and maintains eRegulatory, patient study and CRF files.
• Thoroughly learns assigned protocols and serves as resource for all study team members.
• Responsible for ensuring protocol adherence by understanding, communicating and making sure the study parameters are ordered and carried out per protocol requirements.
• Advises physicians on required tests, timing of tests and procedures.  Ensures that all appropriate treating physicians receive the results of study tests, as appropriate.
• Administers questionnaires and assessments as mandated by the protocol and delegated by the PI.
• Directly retrieves and/or coordinates the retrieval and submission of patient samples or tests (e.g.,  blood samples, urine samples, tissue, ECG, etc.).
• Submits all IRB submission documents such as protocol amendments and consent form revisions, annual reviews, adverse events, investigator changes, accrual status change and change in risk to the IRB in a timely manner with minimal assistance/guidance from senior staff; Complies with IRB decisions, conditions and requirements.
• Utilizes current systems to schedule tests and appointments and to access patient data and test results.
• Establishes monitoring tools to ensure the adherence to study guidelines (e.g. patient enrollment tracking).
• May assist with the coordination of preparing summary reports, study results, poster presentations and manuscripts for publication.

5) Recruits patients to assigned research studies:

• Works closely with physicians to develop recruitment strategies.
• Creates research brochures and other related recruitment materials; creates and/or reviews study trial listing for the Lahey website.
• Actively screens for and identifies eligible patients through various means (e.g. physician schedules, clinical or research databases, website response). 
• Evaluates patient data to determine if patient meets study eligibility, including reviewing screening eligibility tests, under minimal supervision.
• Contacts and screens potential subjects for the study.
• Participates in the informed consent process; obtains subjects signatures and processes appropriately per research policies. 
• Registers or randomizes study participants to assigned research study and treatment/arm; schedules and attends study follow-up visits, as applicable.

6) Performs Data Management duties:

• Prepares for each study participant visit to ensure all appropriate study procedures are done per protocol; ensures patient visit/test is billed correctly to either insurance or the research account per schema.
• Completes source worksheets and case report forms (CRFs) as dictated by the assigned research study (i.e. required forms in the required format in the required time interval); Ensures CRF’s and source are complete and done correctly.
• Provides source documentation from the medical chart for all information that is recorded.
• Submits CRFs to the sponsor as dictated by the study; Maintains sufficient files in the department to document submission and maintain source documentation.
• Ensures proper placement of consent and related study materials in EMR system.
• Maintains study supplies and reorders as necessary.

7) Maintains a professional relationship with sponsors and/or CRO’s and related members:

• Maintains regular and appropriate communication.
• Works with sponsor monitors during monitoring visits; promptly responds to sponsor requests for additional material, clarifying material or missing material.
• Works cooperatively with sponsor to ensure that good clinical practice are being followed.
• Resolves data queries timely and appropriately.
• Schedules sponsor audits, as requested, and is available during audit to review CRFs and procedures with sponsor personnel, as necessary. 
• Completes study close out activities at the end of the study.
• Retains records and archives documents according to institutional SOPs.

8) Works in collaboration with research finance on all study related finances including clinical trial agreements, budget preparation, patient related study visits, invoicing and helping to resolve study subject billing issues. 

9) Seeks additional training or guidance when necessitated; utilizes available research tools and resources.

10) Completes and maintains all required trainings:

• Participates in and actively seeks continuing education opportunities.
• Maintains required continuing education credits per institutional and departmental SOPs.

11) Participates and assists in other research projects and initiatives as assigned:

• Is a team player within the department.
• Is flexible with time when applicable.

Maintain strict adherence to the Lahey Hospital and Medical Center Confidentiality policy.

Incorporate Lahey Hospital and Medical Center Standards of Behavior and Guiding Principles into daily activities.

Comply with all Lahey Hospital and Medical Center Policies.

Comply with behavioral expectations of the department and Lahey Hospital and Medical Center.

Maintain courteous and effective interactions with colleagues and patients.

Demonstrate an understanding of the job description, performance expectations, and competency assessment.

Demonstrate a commitment toward meeting and exceeding the needs of our customers and consistently adheres to Customer Service standards.

Participate in departmental and/or interdepartmental quality improvement activities. 

Participate in and successfully completes Mandatory Education.

Perform all other duties as needed or directed to meet the needs of the department.

Education:

Bachelor’s degree required

In absence of a Bachelor’s degree, will consider 8 years of relevant work experience in addition to the experience noted below.

 Licensure, Certification & Registration:

 None required

 Experience:

 2-5+ years direct work related experience in a research setting

 Skills, Knowledge & Abilities:

Ability to demonstrate basic knowledge of fundamental concepts, practices and procedures with the ability to use them in varied situations; Ability to make decisions that are guided by general instructions and practices requiring some interpretation; Seeks assistance when confronted with difficult and/or unpredictable situations; Ability to travel nationally to other research sites, attend investigator meetings and educational conferences as required; Strong verbal and written communication, multi-tasking, attention to detail and organizational skills; Ability to interact with professional personnel at all levels; ability to communicate clearly and effectively; Ability to demonstrate a positive attitude and respond to requests in a timely and respectful manner; Ability to function independently, set priorities, provide clear direction and training, take initiative and work collaboratively in small teams; Ability to interact with study participant with various diseases compassionately and respectfully; Working knowledge of medical terminology and medical practice protocols; Experience with computer systems, including web based applications; In the absence of any of these skills, demonstrates the ability to be thoroughly trained to meet organizational standards.