Clinical Research Specialist - 40 hours, Day shift

Functioning independently with minimal supervision and direction, will be responsible for coordinating multiple research studies by implementing study protocols in accordance with regulatory, departmental and institutional requirements. Provides mentoring, direction, supervision and guidance to Clinical Research Coordinators. May serve as a project manager or team lead with supervisory responsibilities.  Performs diverse duties requiring analysis, sound judgment and a high level of knowledge of specific protocols. Maintains interdisciplinary relationship with participating physicians and clinical departments. Interacts with study participants diagnosed with various medical conditions and diagnoses.

1) Possesses direct knowledge and experience in the implementation of all aspects of clinical trials research complying

    with Research SOPs, GCP, FDA and OHRP regulations. 

2) Functions as a mentor, resource and educator for clinical research coordinators and other colleagues  

    related to research conducted within the department:

1. 1. May serve as a team lead and be responsible for direction and oversight of research staff.
   2. Assists research manager/director with interviewing and training new staff.
   3. May be responsible for other supervisory responsibilities (e.g., study assignment, workload evaluation, staff coaching, etc.).

3) Coordinates, implements and conducts assigned research projects with a proven ability to:

1. implement assigned research studies with little direction or oversight by reviewing study and assessing  departmental and institutional requirements; Assignments may include more complex studies.
2. conduct research studies of varying degrees of complexity and workload.
3. directly retrieve and/or coordinate the retrieval and submission of patient samples or tests (e.g.,  blood samples, urine samples, tissue, ECG, etc.).
4. develop recruitment plans and successfully recruit patients to assigned research studies.
5. perform data management duties ensuring strong quality of data.
6. ensure protocol adherence by understanding, communicating and ensuring all study parameters are ordered and carried out per protocol requirements.
7. maintain a professional relationship with sponsors, CRO’s, colleagues, investigators, coordinators, and other interdepartmental members.
8. ensure scientific integrity of study data and protect the rights, safety, and well-being of patients enrolled in clinical trials.
1. comply with IRB decisions, conditions and requirements.
10. exercise all other responsibilities of clinical research coordination.

4) May help to expand research opportunities by soliciting sponsors and CRO’s for new trials: 

1. Seeks out new research protocols.
2. Completes and submits trial feasibility forms; coordinates and obtains non-disclosure agreements.
3. Arranges and conducts pre-study qualification and site visits.
4. Acts as the main liaison of communication between sponsors and investigators in all aspects of study start up.

5) May assist the program manager or director with research development:

1. Develops new research initiatives in collaboration with physicians and sponsors.
2. Assists physicians with study protocol development (i.e., homegrown or multicenter physician initiated studies).

1. Reviews homegrown study for potential implementation issues or problems; implements plans accordingly and/or revises study as necessary.

3. Creates and revises source documents as needed; notifies all associated departments of change.
4. Assists with the identification, development and/or submission of grants or applications for funding.
5. Assists in preparing summary reports, study results, poster presentations and manuscripts for publication.
6. May serve as the “Project Manager” for one or more homegrown, physician initiated, multicenter studies.

6) Approaches and assists in other research projects as assigned:

1. Assists with chart review submissions and implementation.
2. Designs abstraction forms for purposes of medical chart abstraction.
3. Abstracts medical records to gather data for assigned research projects.
4. Creates and maintains project databases.

7) Accesses, utilizes and adheres to current research SOPs; Identifies problem areas or makes suggestions for 

    improvement.

8) Completes and maintains all required trainings:

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

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

1. Is a team player within the department.
2. 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. Master’s degree preferred.

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:

 CCRP/CCRC Certification, or equivalent certification, preferred

 Experience:

 4+ years direct work related experience in a research setting; proven leadership ability and ability to successfully work independently with little to no direction; proven ability to comprehend and apply regulations; supervisory experience a plus; Epic experience a plus.

 Skills, Knowledge & Abilities:

 Ability to demonstrate basic knowledge of fundamental concepts, practices and procedures with the ability to use them in varied situations; Seeks assistance when confronted with difficult and/or unpredictable situations; Strong verbal and written communication, multi-tasking, attention to detail, organizational and leadership skills; Proven ability to function independently,  set priorities, take direction and initiative; Ability to travel nationally to other research sites, attend investigator meetings and educational conferences as required; Ability to communicate clearly and effectively and work collaboratively in small teams; Ability to act as a team leader creating a collaborative and respectful team environment and improving workflows; Ability to provide a high level of customer service to patients, colleagues, professional staff and external contacts to offer ideas, identify issues, obtain information or deliver services;  Ability to interact with study participants with various diseases compassionately and respectfully; In the absence of any of these skills, demonstrates the ability to be thoroughly trained to meet organizational standards.